U.S. Department of Health & Human Services Divider Arrow National Institutes of Health Divider Arrow NCATS

Details

Stereochemistry ABSOLUTE
Molecular Formula C47H73NO17
Molecular Weight 924.079
Optical Activity UNSPECIFIED
Defined Stereocenters 19 / 19
E/Z Centers 0
Charge 0

SHOW SMILES / InChI
Structure of Amphotericin B

SMILES

[H][C@]12C[C@@H](O[C@]3([H])O[C@H](C)[C@@H](O)[C@H](N)[C@@H]3O)\C=C\C=C\C=C\C=C\C=C\C=C\C=C\[C@H](C)[C@@H](O)[C@@H](C)[C@H](C)OC(=O)C[C@H](O)C[C@H](O)CC[C@@H](O)[C@H](O)C[C@H](O)C[C@](O)(C[C@H](O)[C@H]1C(O)=O)O2

InChI

InChIKey=APKFDSVGJQXUKY-INPOYWNPSA-N
InChI=1S/C47H73NO17/c1-27-17-15-13-11-9-7-5-6-8-10-12-14-16-18-34(64-46-44(58)41(48)43(57)30(4)63-46)24-38-40(45(59)60)37(54)26-47(61,65-38)25-33(51)22-36(53)35(52)20-19-31(49)21-32(50)23-39(55)62-29(3)28(2)42(27)56/h5-18,27-38,40-44,46,49-54,56-58,61H,19-26,48H2,1-4H3,(H,59,60)/b6-5+,9-7+,10-8+,13-11+,14-12+,17-15+,18-16+/t27-,28-,29-,30+,31+,32+,33-,34-,35+,36+,37-,38-,40+,41-,42+,43+,44-,46-,47+/m0/s1

HIDE SMILES / InChI

Description
Curator's Comment: Description was created based on several sources, including https://www.ncbi.nlm.nih.gov/pubmed/24366747 | https://www.aceabiotech.com/corifungin/ | https://www.aceabiotech.com/clinical-development-of-corifungin/ | https://www.google.com/patents/US20130123205 | https://www.ncbi.nlm.nih.gov/pubmed/26259797

Corifungin refers to the sodium salt of amphotericin B. Although amphotericin B has become the primary drug of choice for treating primary amoebic meningoencephalitis, its use is associated with multiple side effects, including use-limiting renal toxicity. Initial reports for the in vivo efficacy of corifungin in a mouse model of primary amoebic meningoencephalitis showed activity superior to that of amphotericin B at equivalent dosing. Chemically, corifungin is the sodium salt of amphotericin B with excellent aqueous solubility. The increased solubility of corifungin is likely to account for the described increase in activity. Acea Biotech is developing corifungin for the treatment of fungal infections and amebic diseases. Acea has completed of host of animal studies on corifungin setting the stage to take the drug into the clinic. U.S. FDA has approved orphan drug status for corifungin for the treatment of primary amebic meningoencephalitis.

CNS Activity

CNS Penetrant
2554
Curator's Comment: The absence of detectable amebae in the brain of a corifungin-treated mouse model of primary amebic meningoencephalitis was demonstrated. This suggests that corifungin may have the ability to cross the blood-brain barrier because of enhanced solubility although this has not been tested.

Originator

Acea Biotech
3
Curator's Comment: Amphotericin B was originally extracted from Streptomyces nodosus in 1955 at the Squibb Institute for Medical Research. The first synthesis of the Amphotericin B was achieved in 1988 at the University of Pennsylvania. Today X-gen Pharms (formerly Pharma Tek) develop conventional Amphotericin B for Injection (approved since 1992).

Approval Year

1958
128
Targets

Targets

Primary TargetPharmacologyConditionPotency
Binding Agent
1064
Interacts
323
Conditions

Conditions

ConditionModalityTargetsHighest PhaseProduct
Curative
Preclinical
Unknown

Approved Use

Unknown
Curative
Preclinical
Unknown

Approved Use

Unknown
Curative
Approved
8429
AMPHOTERICIN B

Approved Use

Amphotericin B for Injection USP should be administered primarily to patients with progressive, potentially life-threatening fungal infections. This potent drug should not be used to treat noninvasive fungal infections, such as oral thrush, vaginal candidiasis and esophageal candidiasis in patients with normal neutrophil counts. Amphotericin B for Injection USP is specifically intended to treat potentially life-threatening fungal infections: aspergillosis, cryptococcosis (torulosis), North American blastomycosis, systemic candidiasis, coccidioido-mycosis, histoplasmosis, zygomycosis including mucormycosis due to susceptible species of the genera Absidia, Mucor and Rhizopus, and infections due to related susceptible species of Conidiobolus and Basidiobolus, and sporotrichosis. Amphotericin B may be useful in the treatment of American mucocutaneous leishmaniasis, but it is not the drug of choice as primary therapy.

Launch Date

1992
Curative
Approved
8429
AMPHOTERICIN B

Approved Use

Amphotericin B for Injection USP should be administered primarily to patients with progressive, potentially life-threatening fungal infections. This potent drug should not be used to treat noninvasive fungal infections, such as oral thrush, vaginal candidiasis and esophageal candidiasis in patients with normal neutrophil counts. Amphotericin B for Injection USP is specifically intended to treat potentially life-threatening fungal infections: aspergillosis, cryptococcosis (torulosis), North American blastomycosis, systemic candidiasis, coccidioido-mycosis, histoplasmosis, zygomycosis including mucormycosis due to susceptible species of the genera Absidia, Mucor and Rhizopus, and infections due to related susceptible species of Conidiobolus and Basidiobolus, and sporotrichosis. Amphotericin B may be useful in the treatment of American mucocutaneous leishmaniasis, but it is not the drug of choice as primary therapy.

Launch Date

1992
Curative
Approved
8429
AMPHOTERICIN B

Approved Use

Amphotericin B for Injection USP should be administered primarily to patients with progressive, potentially life-threatening fungal infections. This potent drug should not be used to treat noninvasive fungal infections, such as oral thrush, vaginal candidiasis and esophageal candidiasis in patients with normal neutrophil counts. Amphotericin B for Injection USP is specifically intended to treat potentially life-threatening fungal infections: aspergillosis, cryptococcosis (torulosis), North American blastomycosis, systemic candidiasis, coccidioido-mycosis, histoplasmosis, zygomycosis including mucormycosis due to susceptible species of the genera Absidia, Mucor and Rhizopus, and infections due to related susceptible species of Conidiobolus and Basidiobolus, and sporotrichosis. Amphotericin B may be useful in the treatment of American mucocutaneous leishmaniasis, but it is not the drug of choice as primary therapy.

Launch Date

1992
Curative
Approved
8429
AMPHOTERICIN B

Approved Use

Amphotericin B for Injection USP should be administered primarily to patients with progressive, potentially life-threatening fungal infections. This potent drug should not be used to treat noninvasive fungal infections, such as oral thrush, vaginal candidiasis and esophageal candidiasis in patients with normal neutrophil counts. Amphotericin B for Injection USP is specifically intended to treat potentially life-threatening fungal infections: aspergillosis, cryptococcosis (torulosis), North American blastomycosis, systemic candidiasis, coccidioido-mycosis, histoplasmosis, zygomycosis including mucormycosis due to susceptible species of the genera Absidia, Mucor and Rhizopus, and infections due to related susceptible species of Conidiobolus and Basidiobolus, and sporotrichosis. Amphotericin B may be useful in the treatment of American mucocutaneous leishmaniasis, but it is not the drug of choice as primary therapy.

Launch Date

1992
Curative
Approved
8429
AMPHOTERICIN B

Approved Use

Amphotericin B for Injection USP should be administered primarily to patients with progressive, potentially life-threatening fungal infections. This potent drug should not be used to treat noninvasive fungal infections, such as oral thrush, vaginal candidiasis and esophageal candidiasis in patients with normal neutrophil counts. Amphotericin B for Injection USP is specifically intended to treat potentially life-threatening fungal infections: aspergillosis, cryptococcosis (torulosis), North American blastomycosis, systemic candidiasis, coccidioido-mycosis, histoplasmosis, zygomycosis including mucormycosis due to susceptible species of the genera Absidia, Mucor and Rhizopus, and infections due to related susceptible species of Conidiobolus and Basidiobolus, and sporotrichosis. Amphotericin B may be useful in the treatment of American mucocutaneous leishmaniasis, but it is not the drug of choice as primary therapy.

Launch Date

1992
Curative
Approved
8429
AMPHOTERICIN B

Approved Use

Amphotericin B for Injection USP should be administered primarily to patients with progressive, potentially life-threatening fungal infections. This potent drug should not be used to treat noninvasive fungal infections, such as oral thrush, vaginal candidiasis and esophageal candidiasis in patients with normal neutrophil counts. Amphotericin B for Injection USP is specifically intended to treat potentially life-threatening fungal infections: aspergillosis, cryptococcosis (torulosis), North American blastomycosis, systemic candidiasis, coccidioido-mycosis, histoplasmosis, zygomycosis including mucormycosis due to susceptible species of the genera Absidia, Mucor and Rhizopus, and infections due to related susceptible species of Conidiobolus and Basidiobolus, and sporotrichosis. Amphotericin B may be useful in the treatment of American mucocutaneous leishmaniasis, but it is not the drug of choice as primary therapy.

Launch Date

1992
Curative
Approved
8429
AMPHOTERICIN B

Approved Use

Amphotericin B for Injection USP should be administered primarily to patients with progressive, potentially life-threatening fungal infections. This potent drug should not be used to treat noninvasive fungal infections, such as oral thrush, vaginal candidiasis and esophageal candidiasis in patients with normal neutrophil counts. Amphotericin B for Injection USP is specifically intended to treat potentially life-threatening fungal infections: aspergillosis, cryptococcosis (torulosis), North American blastomycosis, systemic candidiasis, coccidioido-mycosis, histoplasmosis, zygomycosis including mucormycosis due to susceptible species of the genera Absidia, Mucor and Rhizopus, and infections due to related susceptible species of Conidiobolus and Basidiobolus, and sporotrichosis. Amphotericin B may be useful in the treatment of American mucocutaneous leishmaniasis, but it is not the drug of choice as primary therapy.

Launch Date

1992
Curative
Approved
8429
AMPHOTERICIN B

Approved Use

Amphotericin B for Injection USP should be administered primarily to patients with progressive, potentially life-threatening fungal infections. This potent drug should not be used to treat noninvasive fungal infections, such as oral thrush, vaginal candidiasis and esophageal candidiasis in patients with normal neutrophil counts. Amphotericin B for Injection USP is specifically intended to treat potentially life-threatening fungal infections: aspergillosis, cryptococcosis (torulosis), North American blastomycosis, systemic candidiasis, coccidioido-mycosis, histoplasmosis, zygomycosis including mucormycosis due to susceptible species of the genera Absidia, Mucor and Rhizopus, and infections due to related susceptible species of Conidiobolus and Basidiobolus, and sporotrichosis. Amphotericin B may be useful in the treatment of American mucocutaneous leishmaniasis, but it is not the drug of choice as primary therapy.

Launch Date

1992
Curative
Approved
8429
AMPHOTERICIN B

Approved Use

Amphotericin B for Injection USP should be administered primarily to patients with progressive, potentially life-threatening fungal infections. This potent drug should not be used to treat noninvasive fungal infections, such as oral thrush, vaginal candidiasis and esophageal candidiasis in patients with normal neutrophil counts. Amphotericin B for Injection USP is specifically intended to treat potentially life-threatening fungal infections: aspergillosis, cryptococcosis (torulosis), North American blastomycosis, systemic candidiasis, coccidioido-mycosis, histoplasmosis, zygomycosis including mucormycosis due to susceptible species of the genera Absidia, Mucor and Rhizopus, and infections due to related susceptible species of Conidiobolus and Basidiobolus, and sporotrichosis. Amphotericin B may be useful in the treatment of American mucocutaneous leishmaniasis, but it is not the drug of choice as primary therapy.

Launch Date

1992
Curative
Approved
8429
AMPHOTERICIN B

Approved Use

Amphotericin B for Injection USP should be administered primarily to patients with progressive, potentially life-threatening fungal infections. This potent drug should not be used to treat noninvasive fungal infections, such as oral thrush, vaginal candidiasis and esophageal candidiasis in patients with normal neutrophil counts. Amphotericin B for Injection USP is specifically intended to treat potentially life-threatening fungal infections: aspergillosis, cryptococcosis (torulosis), North American blastomycosis, systemic candidiasis, coccidioido-mycosis, histoplasmosis, zygomycosis including mucormycosis due to susceptible species of the genera Absidia, Mucor and Rhizopus, and infections due to related susceptible species of Conidiobolus and Basidiobolus, and sporotrichosis. Amphotericin B may be useful in the treatment of American mucocutaneous leishmaniasis, but it is not the drug of choice as primary therapy.

Launch Date

1992
Cmax

Cmax

ValueDoseCo-administeredAnalytePopulation
31.4 μg/mL
DRUG LABEL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050740Orig1s031lbl.pdf
2.5 mg/kg 1 times / day multiple, intravenous
dose: 2.5 mg/kg
route of administration: Intravenous
experiment type: MULTIPLE
co-administered:
AMPHOTERICIN B serum
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
57.6 μg/mL
DRUG LABEL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050740Orig1s031lbl.pdf
5 mg/kg single, intravenous
dose: 5 mg/kg
route of administration: Intravenous
experiment type: SINGLE
co-administered:
AMPHOTERICIN B serum
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
7.3 μg/mL
DRUG LABEL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050740Orig1s031lbl.pdf
1 mg/kg single, intravenous
dose: 1 mg/kg
route of administration: Intravenous
experiment type: SINGLE
co-administered:
AMPHOTERICIN B serum
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
62.4 μg/mL
REVIEW
https://www.pmda.go.jp/drugs/2006/P200600024/40009300_21800AMY10095_K254_2.pdf
7.5 mg/kg 1 times / day multiple, intravenous
dose: 7.5 mg/kg
route of administration: Intravenous
experiment type: MULTIPLE
co-administered:
AMPHOTERICIN B serum
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
83.7 μg/mL
REVIEW
https://www.pmda.go.jp/drugs/2006/P200600024/40009300_21800AMY10095_K254_2.pdf
7.5 mg/kg single, intravenous
dose: 7.5 mg/kg
route of administration: Intravenous
experiment type: SINGLE
co-administered:
AMPHOTERICIN B serum
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
83 μg/mL
DRUG LABEL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050740Orig1s031lbl.pdf
5 mg/kg 1 times / day multiple, intravenous
dose: 5 mg/kg
route of administration: Intravenous
experiment type: MULTIPLE
co-administered:
AMPHOTERICIN B serum
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
12.2 μg/mL
DRUG LABEL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050740Orig1s031lbl.pdf
1 mg/kg 1 times / day multiple, intravenous
dose: 1 mg/kg
route of administration: Intravenous
experiment type: MULTIPLE
co-administered:
AMPHOTERICIN B serum
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
17.2 μg/mL
DRUG LABEL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050740Orig1s031lbl.pdf
2.5 mg/kg single, intravenous
dose: 2.5 mg/kg
route of administration: Intravenous
experiment type: SINGLE
co-administered:
AMPHOTERICIN B serum
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
AUC

AUC

ValueDoseCo-administeredAnalytePopulation
197 μg × h/mL
DRUG LABEL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050740Orig1s031lbl.pdf
2.5 mg/kg 1 times / day multiple, intravenous
dose: 2.5 mg/kg
route of administration: Intravenous
experiment type: MULTIPLE
co-administered:
AMPHOTERICIN B serum
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
269 μg × h/mL
DRUG LABEL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050740Orig1s031lbl.pdf
5 mg/kg single, intravenous
dose: 5 mg/kg
route of administration: Intravenous
experiment type: SINGLE
co-administered:
AMPHOTERICIN B serum
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
27 μg × h/mL
DRUG LABEL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050740Orig1s031lbl.pdf
1 mg/kg single, intravenous
dose: 1 mg/kg
route of administration: Intravenous
experiment type: SINGLE
co-administered:
AMPHOTERICIN B serum
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
382 μg × h/mL
REVIEW
https://www.pmda.go.jp/drugs/2006/P200600024/40009300_21800AMY10095_K254_2.pdf
7.5 mg/kg 1 times / day multiple, intravenous
dose: 7.5 mg/kg
route of administration: Intravenous
experiment type: MULTIPLE
co-administered:
AMPHOTERICIN B serum
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
476 μg × h/mL
REVIEW
https://www.pmda.go.jp/drugs/2006/P200600024/40009300_21800AMY10095_K254_2.pdf
7.5 mg/kg single, intravenous
dose: 7.5 mg/kg
route of administration: Intravenous
experiment type: SINGLE
co-administered:
AMPHOTERICIN B serum
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
555 μg × h/mL
DRUG LABEL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050740Orig1s031lbl.pdf
5 mg/kg 1 times / day multiple, intravenous
dose: 5 mg/kg
route of administration: Intravenous
experiment type: MULTIPLE
co-administered:
AMPHOTERICIN B serum
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
60 μg × h/mL
DRUG LABEL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050740Orig1s031lbl.pdf
1 mg/kg 1 times / day multiple, intravenous
dose: 1 mg/kg
route of administration: Intravenous
experiment type: MULTIPLE
co-administered:
AMPHOTERICIN B serum
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
65 μg × h/mL
DRUG LABEL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050740Orig1s031lbl.pdf
2.5 mg/kg single, intravenous
dose: 2.5 mg/kg
route of administration: Intravenous
experiment type: SINGLE
co-administered:
AMPHOTERICIN B serum
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
T1/2

T1/2

ValueDoseCo-administeredAnalytePopulation
6.3 h
DRUG LABEL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050740Orig1s031lbl.pdf
2.5 mg/kg 1 times / day multiple, intravenous
dose: 2.5 mg/kg
route of administration: Intravenous
experiment type: MULTIPLE
co-administered:
AMPHOTERICIN B serum
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
6.4 h
DRUG LABEL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050740Orig1s031lbl.pdf
5 mg/kg single, intravenous
dose: 5 mg/kg
route of administration: Intravenous
experiment type: SINGLE
co-administered:
AMPHOTERICIN B serum
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
10.7 h
DRUG LABEL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050740Orig1s031lbl.pdf
1 mg/kg single, intravenous
dose: 1 mg/kg
route of administration: Intravenous
experiment type: SINGLE
co-administered:
AMPHOTERICIN B serum
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
6.9 h
REVIEW
https://www.pmda.go.jp/drugs/2006/P200600024/40009300_21800AMY10095_K254_2.pdf
7.5 mg/kg 1 times / day multiple, intravenous
dose: 7.5 mg/kg
route of administration: Intravenous
experiment type: MULTIPLE
co-administered:
AMPHOTERICIN B serum
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
8.5 h
REVIEW
https://www.pmda.go.jp/drugs/2006/P200600024/40009300_21800AMY10095_K254_2.pdf
7.5 mg/kg single, intravenous
dose: 7.5 mg/kg
route of administration: Intravenous
experiment type: SINGLE
co-administered:
AMPHOTERICIN B serum
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
6.8 h
DRUG LABEL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050740Orig1s031lbl.pdf
5 mg/kg 1 times / day multiple, intravenous
dose: 5 mg/kg
route of administration: Intravenous
experiment type: MULTIPLE
co-administered:
AMPHOTERICIN B serum
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
7 h
DRUG LABEL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050740Orig1s031lbl.pdf
1 mg/kg 1 times / day multiple, intravenous
dose: 1 mg/kg
route of administration: Intravenous
experiment type: MULTIPLE
co-administered:
AMPHOTERICIN B serum
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
8.1 h
DRUG LABEL
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/050740Orig1s031lbl.pdf
2.5 mg/kg single, intravenous
dose: 2.5 mg/kg
route of administration: Intravenous
experiment type: SINGLE
co-administered:
AMPHOTERICIN B serum
Homo sapiens
population: UNHEALTHY
age: ADULT
sex: FEMALE / MALE
food status: UNKNOWN
Funbound

Funbound

ValueDoseCo-administeredAnalytePopulation
2.1%
EXPERIMENT
https://aac.asm.org/content/46/3/834.long
AMPHOTERICIN B plasma
Homo sapiens
Doses

Doses

DosePopulationAdverse events​
0.7 mg/kg 1 times / day multiple, intravenous
Recommended
Dose: 0.7 mg/kg, 1 times / day
Route: intravenous
Route: multiple
Dose: 0.7 mg/kg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-740s2_AmBisome_medr.pdf
Page: p. 27
unhealthy, 39 years (range: 21-68 years)
n = 87
Health Status: unhealthy
Age Group: 39 years (range: 21-68 years)
Sex: M+F
Population Size: 87
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-740s2_AmBisome_medr.pdf
Page: p. 27
Disc. AE: Creatinine increased...
Other AEs: Nervous system disorder NOS, Cardiovascular injuries...
AEs leading to
discontinuation/dose reduction:
Creatinine increased (3.4%)
Other AEs:
Nervous system disorder NOS (3.4%)
Cardiovascular injuries (3.4%)
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-740s2_AmBisome_medr.pdf
Page: p. 27
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Other AEs: Thrombocytopenia, Anaemia...
Other AEs:
Thrombocytopenia (serious, 2 patients)
Anaemia (serious, 1 patient)
Neutropenia (serious, 1 patient)
Pancytopenia (serious, 1 patient)
Cardiac arrest (serious, 4 patients)
Cardio-respiratory arrest (serious, 1 patient)
Pancreatitis (serious, 2 patients)
Ileus (serious, 1 patient)
Intestinal obstruction (serious, 1 patient)
Upper gastrointestinal haemorrhage (serious, 1 patient)
Vomiting (serious, 1 patient)
Chills (serious, 1 patient)
Mucosal inflammation (serious, 1 patient)
Multi-organ failure (serious, 1 patient)
Hepatic failure (serious, 2 patients)
Bile duct stone (serious, 1 patient)
Cholecystitis (serious, 1 patient)
Cholecystitis acute (serious, 1 patient)
Hepatic steatosis (serious, 1 patient)
Hepatocellular injury (serious, 1 patient)
Hyperbilirubinaemia (serious, 1 patient)
Liver disorder (serious, 1 patient)
Drug hypersensitivity (serious, 1 patient)
Hypersensitivity (serious, 1 patient)
Septic shock (serious, 13 patients)
Pneumonia (serious, 7 patients)
Device related infection (serious, 3 patients)
Clostridium difficile colitis (serious, 1 patient)
Enterococcal bacteraemia (serious, 1 patient)
Gastroenteritis (serious, 1 patient)
Infection staphylococcal (serious, 1 patient)
Streptococcal sepsis (serious, 1 patient)
Blood creatinine increased (serious, 3 patients)
Creatinine renal clearance decreased (serious, 2 patients)
Lymphocyte count decreased (serious, 1 patient)
White blood cell count decreased (serious, 1 patient)
Hypokalaemia (serious, 2 patients)
Hyperglycaemia (serious, 1 patient)
Hyponatraemia (serious, 1 patient)
Back pain (serious, 1 patient)
Joint swelling (serious, 1 patient)
Metastases to central nervous system (serious, 1 patient)
Cerebrovascular accident (serious, 1 patient)
Encephalitis (serious, 1 patient)
Encephalopathy hepatic (serious, 1 patient)
Renal tubular necrosis (serious, 1 patient)
Acute respiratory distress syndrome (serious, 2 patients)
Bronchospasm (serious, 1 patient)
Dyspnoea (serious, 1 patient)
Pneumothorax (serious, 1 patient)
Respiratory distress (serious, 1 patient)
Rash papular (serious, 1 patient)
Hypotension (serious, 1 patient)
Thrombocytopenia (below serious, 42 patients)
Nausea (below serious, 118 patients)
Abdominal pain upper (below serious, 39 patients)
Dyspepsia (below serious, 14 patients)
Oedema peripheral (below serious, 56 patients)
Chest pain (below serious, 18 patients)
Oedema (below serious, 15 patients)
Oral herpes (below serious, 22 patients)
Pneumonia (below serious, 15 patients)
Aspartate aminotransferase increased (below serious, 19 patients)
Blood bilirubin increased (below serious, 16 patients)
Blood creatinine increased (below serious, 20 patients)
Weight decreased (below serious, 13 patients)
Hypokalaemia (below serious, 83 patients)
Hypoalbuminaemia (below serious, 24 patients)
Hypocalcaemia (below serious, 18 patients)
Fluid retention (below serious, 15 patients)
Hypomagnesaemia (below serious, 12 patients)
Back pain (below serious, 34 patients)
Depression (below serious, 12 patients)
Rash (below serious, 39 patients)
Erythema (below serious, 19 patients)
Alopecia (below serious, 17 patients)
Pruritus (below serious, 13 patients)
Haematoma (below serious, 15 patients)
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
AEs

AEs

AESignificanceDosePopulation
Cardiovascular injuries 3.4%
0.7 mg/kg 1 times / day multiple, intravenous
Recommended
Dose: 0.7 mg/kg, 1 times / day
Route: intravenous
Route: multiple
Dose: 0.7 mg/kg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-740s2_AmBisome_medr.pdf
Page: p. 27
unhealthy, 39 years (range: 21-68 years)
n = 87
Health Status: unhealthy
Age Group: 39 years (range: 21-68 years)
Sex: M+F
Population Size: 87
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-740s2_AmBisome_medr.pdf
Page: p. 27
Nervous system disorder NOS 3.4%
0.7 mg/kg 1 times / day multiple, intravenous
Recommended
Dose: 0.7 mg/kg, 1 times / day
Route: intravenous
Route: multiple
Dose: 0.7 mg/kg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-740s2_AmBisome_medr.pdf
Page: p. 27
unhealthy, 39 years (range: 21-68 years)
n = 87
Health Status: unhealthy
Age Group: 39 years (range: 21-68 years)
Sex: M+F
Population Size: 87
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-740s2_AmBisome_medr.pdf
Page: p. 27
Creatinine increased 3.4%
Disc. AE
0.7 mg/kg 1 times / day multiple, intravenous
Recommended
Dose: 0.7 mg/kg, 1 times / day
Route: intravenous
Route: multiple
Dose: 0.7 mg/kg, 1 times / day
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-740s2_AmBisome_medr.pdf
Page: p. 27
unhealthy, 39 years (range: 21-68 years)
n = 87
Health Status: unhealthy
Age Group: 39 years (range: 21-68 years)
Sex: M+F
Population Size: 87
Sources:
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-740s2_AmBisome_medr.pdf
Page: p. 27
Nausea below serious, 118 patients
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Depression below serious, 12 patients
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Hypomagnesaemia below serious, 12 patients
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Pruritus below serious, 13 patients
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Weight decreased below serious, 13 patients
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Dyspepsia below serious, 14 patients
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Fluid retention below serious, 15 patients
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Haematoma below serious, 15 patients
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Oedema below serious, 15 patients
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Pneumonia below serious, 15 patients
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Blood bilirubin increased below serious, 16 patients
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Alopecia below serious, 17 patients
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Chest pain below serious, 18 patients
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Hypocalcaemia below serious, 18 patients
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Aspartate aminotransferase increased below serious, 19 patients
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Erythema below serious, 19 patients
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Blood creatinine increased below serious, 20 patients
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Oral herpes below serious, 22 patients
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Hypoalbuminaemia below serious, 24 patients
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Back pain below serious, 34 patients
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Abdominal pain upper below serious, 39 patients
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Rash below serious, 39 patients
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Thrombocytopenia below serious, 42 patients
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Oedema peripheral below serious, 56 patients
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Hypokalaemia below serious, 83 patients
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Anaemia serious, 1 patient
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Back pain serious, 1 patient
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Bile duct stone serious, 1 patient
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Bronchospasm serious, 1 patient
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Cardio-respiratory arrest serious, 1 patient
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Cerebrovascular accident serious, 1 patient
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Chills serious, 1 patient
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Cholecystitis acute serious, 1 patient
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Cholecystitis serious, 1 patient
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Clostridium difficile colitis serious, 1 patient
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Drug hypersensitivity serious, 1 patient
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Dyspnoea serious, 1 patient
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Encephalitis serious, 1 patient
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Encephalopathy hepatic serious, 1 patient
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Enterococcal bacteraemia serious, 1 patient
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Gastroenteritis serious, 1 patient
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Hepatic steatosis serious, 1 patient
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Hepatocellular injury serious, 1 patient
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Hyperbilirubinaemia serious, 1 patient
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Hyperglycaemia serious, 1 patient
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Hypersensitivity serious, 1 patient
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Hyponatraemia serious, 1 patient
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Hypotension serious, 1 patient
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Ileus serious, 1 patient
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Infection staphylococcal serious, 1 patient
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Intestinal obstruction serious, 1 patient
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Joint swelling serious, 1 patient
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Liver disorder serious, 1 patient
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Lymphocyte count decreased serious, 1 patient
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Metastases to central nervous system serious, 1 patient
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Mucosal inflammation serious, 1 patient
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Multi-organ failure serious, 1 patient
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Neutropenia serious, 1 patient
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Pancytopenia serious, 1 patient
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Pneumothorax serious, 1 patient
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Rash papular serious, 1 patient
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Renal tubular necrosis serious, 1 patient
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Respiratory distress serious, 1 patient
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Streptococcal sepsis serious, 1 patient
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Upper gastrointestinal haemorrhage serious, 1 patient
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Vomiting serious, 1 patient
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
White blood cell count decreased serious, 1 patient
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Septic shock serious, 13 patients
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Acute respiratory distress syndrome serious, 2 patients
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Creatinine renal clearance decreased serious, 2 patients
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Hepatic failure serious, 2 patients
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Hypokalaemia serious, 2 patients
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Pancreatitis serious, 2 patients
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Thrombocytopenia serious, 2 patients
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Blood creatinine increased serious, 3 patients
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Device related infection serious, 3 patients
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Cardiac arrest serious, 4 patients
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Pneumonia serious, 7 patients
5 mg/kg 2 times / week steady, intravenous
Dose: 5 mg/kg, 2 times / week
Route: intravenous
Route: steady
Dose: 5 mg/kg, 2 times / week
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
https://clinicaltrials.gov/ct2/show/NCT01259713
Overview

Overview

CYP3A4CYP2C9CYP2D6hERG
inhibitor
1612

OverviewOther

Other InhibitorOther SubstrateOther Inducer
MRP3
157

OCT2
647

OAT1
599

BCRP
699

BSEP
402

P-gp
1461

MRP1
106

MRP2
383

MRP4
204

MRP5
22
P-gp
1537
Drug as perpetrator​

Drug as perpetrator​

TargetModalityActivityMetaboliteClinical evidence
BSEP
403
 no
MRP1
172
 no
MRP2
475
 no
MRP3
207
 no
MRP4
238
 no
MRP5
48
 no
OAT1
603
 no
P-gp
1650
 no
BCRP
773
 weak [IC50 127 uM]
OCT2
648
 yes [IC50 7.6 uM]
Drug as victim

Drug as victim

TargetModalityActivityMetaboliteClinical evidence
P-gp
1537
 yes
Tox targets

Tox targets

TargetModalityActivityMetaboliteClinical evidence
hERG
1647
Sourcing

Sourcing

Vendor/AggregatorIDURL
ChEBI
CHEBI:2682
https://www.ebi.ac.uk/chebi/searchId.do?chebiId=CHEBI:2682
ChemicalBook
CB3425912
https://www.chemicalbook.com/ChemicalProductProperty_EN_CB3425912
MolPort
MolPort-006-113-274
https://www.molport.com/shop/molecule-link/MolPort-006-113-274
ZINC
ZINC000253387843
http://zinc15.docking.org/substances/ZINC000253387843
eMolecules
30513061
https://www.emolecules.com/cgi-bin/more?vid=30513061
eMolecules
36772192
https://www.emolecules.com/cgi-bin/more?vid=36772192
PubMed

PubMed

TitleDatePubMed
The influence of Myrj 59 on the solubility, toxicity and activity of amphotericin B.
1991 May
Rapid intravenous infusion of amphotericin B: a pilot study.
1992 Aug
Bradycardia after amphotericin, irradiation, and anthracycline.
1992 Aug 8
Acute and chronic effects of flucytosine on amphotericin B nephrotoxicity in rats.
1992 Dec
Effect of fenoldopam on the acute and subacute nephrotoxicity produced by amphotericin B in the dog.
1992 Jan
Risk of ventricular dysrhythmias during 1-hour infusions of amphotericin B in patients with preserved renal function.
1992 Nov
Bradycardia due to anthracyclines.
1992 Oct 3
[Drug-induced benign intracranial hypertension. Apropos of a case with amphotericin B. Review of the literature].
1992 Sep-Oct
[Chronic visceral leishmaniasis during chemotherapy for metastatic osteosarcoma].
1998 Mar
Differential decline in Leishmania membrane antigen-specific immunoglobulin G (IgG), IgM, IgE, and IgG subclass antibodies in Indian kala-azar patients after chemotherapy.
1999 Dec
Amphotericin B deoxycholate treatment of visceral leishmaniasis with newer modes of administration and precautions: a study of 938 cases.
1999 May-Jun
Pentamidine isethionate as treatment and secondary prophylaxis for disseminated cutaneous leishmaniasis during HIV infection: case report.
2001 Dec
Successful unrelated bone marrow transplantation for a patient with chronic granulomatous disease and associated resistant pneumonitis and Aspergillus osteomyelitis.
2001 Jul
Correlates of acute renal failure in patients receiving parenteral amphotericin B.
2001 Oct
Amphotericin B induced ventricular arrhythmia and its relation to central venous line.
2001 Oct-Dec
Amphotericin B-induced seizures in a patient with AIDS.
2001 Sep
A prospective and retrospective analysis of the nephrotoxicity and efficacy of lipid-based amphotericin B formulations.
2001 Sep
[Radioprotective and antineoplastic activity of polyene antibiotics combined with dimethyl sulfoxide].
2002
Reduced nephrotoxicity of conventional amphotericin B therapy after minimal nephroprotective measures: animal experiments and clinical study.
2002 Aug 1
Spironolactone: is it a novel drug for the prevention of amphotericin B-related hypokalemia in cancer patients?
2002 Jan
Amphotericin B-induced hepatorenal failure in cystic fibrosis.
2002 Jun
[Acute renal failure induced by amphotericin B during the treatment of invasive aspergillosis in patients with acute myeloblastic leukemia (two case reports and literature review)].
2003
Antileishmanial drugs cause up-regulation of interferon-gamma receptor 1, not only in the monocytes of visceral leishmaniasis cases but also in cultured THP1 cells.
2003 Apr
In vitro activity of voriconazole, itraconazole, caspofungin, anidulafungin (VER002, LY303366) and amphotericin B against aspergillus spp.
2003 Feb
Persistent acute tubular toxicity after switch from conventional amphotericin B to liposomal amphotericin B (Ambisome).
2003 Feb
Possible liposomal amphotericin B-induced nephrogenic diabetes insipidus.
2003 Jan
[A case of chronic necrotizing pulmonary aspergillosis diagnosed using percutaneous intracavitary endoscopy].
2003 Jul
In vitro susceptibility of Aspergillus spp. clinical isolates to albendazole.
2003 Jun
Amphotericin B binds to amyloid fibrils and delays their formation: a therapeutic mechanism?
2003 May 27
Single-dose liposomal amphotericin B in the treatment of visceral leishmaniasis in India: a multicenter study.
2003 Sep 15
Successful treatment with micafungin of invasive pulmonary aspergillosis in acute myeloid leukemia, with renal failure due to amphotericin B therapy.
2004 Jan
Reversible dilated cardiomyopathy related to amphotericin B therapy.
2004 Jan
Effects of fluid and electrolyte management on amphotericin B-induced nephrotoxicity among extremely low birth weight infants.
2004 Jun
Disseminated cutaneous leishmaniasis after visceral disease in a patient with AIDS.
2004 Mar
Lipid formulations of amphotericin B preserve and stabilize renal function in HSCT recipients.
2004 Mar
Low-dose amphotericin B lipid complex vs. conventional amphotericin B for empirical antifungal therapy of neutropenic fever in patients with hematologic malignancies--a randomized, controlled trial.
2004 May
Corticosteroid induced Cryptococcus meningitis.
2005 Jul
Caspofungin versus amphotericin B for candidemia: a pharmacoeconomic analysis.
2005 Jun
Prediction of genotoxicity of chemical compounds by statistical learning methods.
2005 Jun
Amphotericin B-induced nephrogenic diabetes insipidus in a case of cryptococcemia.
2005 May
Candida glabrata prosthetic valve endocarditis treated successfully with fluconazole plus caspofungin without surgery: a case report and literature review.
2005 Nov
[Amphotericin B associated with hypertension: haemodynamic profile].
2005 Nov-Dec
Use of Leishmania donovani field isolates expressing the luciferase reporter gene in in vitro drug screening.
2005 Sep
Amphotericin B-induced severe hypertension in a young patient: case report and review of the literature.
2006
Role of plasma lipids and lipoproteins in predicting amphotericin B-induced nephrotoxicity in pediatric oncology patients.
2006 Jan
Invasive fungal infection of the maxilla following dental extractions in a patient with chronic obstructive pulmonary disease.
2006 Mar
[Acute adverse effects following administration of liposomal amphotericin B].
2006 May
Patents

Patents

04195172
3
JP2001500477A
122
JP2003528821A
36
JP2004166676A
3
JP2011526918A
3
JPH09241168A
3
US20130123205
3

Sample Use Guides

In Vivo Use Guide
Curator's Comment: Description was created based on several sources, including: http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a0a54943-9ce4-4f3e-b681-a1a9144c16ce
The recommended concentration for intravenous infusion is 0.1 mg/mL (1mg/10mL). Amphotericin B for Injection should no be given in doses greater than 1.5 mg/kg.
Route of Administration: Intravenous
In Vitro Use Guide
Curator's Comment: Amphotericin B exhibited species-specific concentration-dependent activity, with 50% effective concentrations (EC50s) ranging from 0.10 to 0.12 mg/ml for A. fumigatus, 0.36 to 0.53 mg/ml for A. terreus, 0.27 to ≥32 mg/ml for F. solani, 0.41 to 0.55 mg/ml for F. oxysporum, and 0.97 and 0.65 mg/ml for S. apiospermum and S. prolificans, respectively. http://www.ncbi.nlm.nih.gov/pubmed/15728887
The best fungicidal activity is for Candida albicans, (MFC90 1 ug/ml) and the lowest for C.parapsilosis, C.tropicalis and C.glabrata (MFC90 16 ug/ml). Amphotericin B spectrum of activity in clinically important candidas (MIC90(mg/L)): 0.25 - 2. Amphotericin B spectrum of activity in clinically important moulds (MIC90(mg/L)): 0.25 - >16.
Name Type Language
Amphotericin B
EP   HSDB   INN   MART.   MI   ORANGE BOOK   USP   USP-RS   VANDF   WHO-DD   WHO-IP  
INN  
Official Name English
AMPHOTERICIN
Common Name English
AMPHOTEC
Brand Name English
AMPHOTERICIN B LIPOSOME [VANDF]
Common Name English
Amphotericin b [WHO-DD]
Common Name English
Amphotericin b, liposome [WHO-DD]
Common Name English
AMBISOME
Brand Name English
AMPHOTERICIN B LIPID COMPLEX [MI]
Common Name English
AMPHO-MORONAL
Brand Name English
AMBIL
Brand Name English
FUNGILIN
Brand Name English
AMPHOTERICIN B LIPOSOME
VANDF  
Common Name English
AMPHOTERICIN B [VANDF]
Common Name English
ABELCET, LIPOSOMAL AMPHOTERICIN B
Common Name English
AMPHOTERICIN B [USP MONOGRAPH]
Common Name English
ABELCET
Common Name English
AMPHOTERICIN B [ORANGE BOOK]
Common Name English
ABLC
Common Name English
AMPHOTERICIN B [MART.]
Common Name English
AMPHOTERICIN B LIPOSOMAL
Common Name English
amphotericin b [INN]
Common Name English
AMPHOTERICIN B [EP MONOGRAPH]
Common Name English
FUNGIZONE
Brand Name English
AMPHOTOCERIN
Common Name English
AMPHOTERICIN B LIPOSOMAL COMPLEX [MI]
Common Name English
AMPHOTERICIN B [JAN]
Common Name English
AMPHOTERICIN B LIPID COMPLEX
MI   VANDF  
Common Name English
AMPHOTERICIN B [WHO-IP]
Common Name English
AMPHOTERICIN B [MI]
Common Name English
AMPHOTERICIN B LIPOSOMAL COMPLEX
MI  
Common Name English
NSC-527017
Code English
AMPHOTERICIN B [HSDB]
Common Name English
AMPHOTERICIN B LIPID COMPLEX [VANDF]
Common Name English
HALIZON
Common Name English
AMPHOTERICINUM B [WHO-IP LATIN]
Common Name English
AMPHOTERICIN B [USP-RS]
Common Name English
Classification Tree Code System Code
WHO-VATC QJ02AA01
Created by admin on Fri Dec 15 15:02:58 GMT 2023 , Edited by admin on Fri Dec 15 15:02:58 GMT 2023
NDF-RT N0000175498
Created by admin on Fri Dec 15 15:02:58 GMT 2023 , Edited by admin on Fri Dec 15 15:02:58 GMT 2023
FDA ORPHAN DRUG 315310
Created by admin on Fri Dec 15 15:02:58 GMT 2023 , Edited by admin on Fri Dec 15 15:02:58 GMT 2023
WHO-ESSENTIAL MEDICINES LIST 6.5.2
Created by admin on Fri Dec 15 15:02:58 GMT 2023 , Edited by admin on Fri Dec 15 15:02:58 GMT 2023
WHO-ATC G01AA03
Created by admin on Fri Dec 15 15:02:58 GMT 2023 , Edited by admin on Fri Dec 15 15:02:58 GMT 2023
FDA ORPHAN DRUG 416113
Created by admin on Fri Dec 15 15:02:58 GMT 2023 , Edited by admin on Fri Dec 15 15:02:58 GMT 2023
WHO-VATC QG01AA03
Created by admin on Fri Dec 15 15:02:58 GMT 2023 , Edited by admin on Fri Dec 15 15:02:58 GMT 2023
NDF-RT N0000175510
Created by admin on Fri Dec 15 15:02:58 GMT 2023 , Edited by admin on Fri Dec 15 15:02:58 GMT 2023
WHO-ATC J02AA01
Created by admin on Fri Dec 15 15:02:58 GMT 2023 , Edited by admin on Fri Dec 15 15:02:58 GMT 2023
FDA ORPHAN DRUG 99496
Created by admin on Fri Dec 15 15:02:58 GMT 2023 , Edited by admin on Fri Dec 15 15:02:58 GMT 2023
WHO-VATC QA07AA07
Created by admin on Fri Dec 15 15:02:58 GMT 2023 , Edited by admin on Fri Dec 15 15:02:58 GMT 2023
FDA ORPHAN DRUG 210805
Created by admin on Fri Dec 15 15:02:58 GMT 2023 , Edited by admin on Fri Dec 15 15:02:58 GMT 2023
FDA ORPHAN DRUG 57891
Created by admin on Fri Dec 15 15:02:58 GMT 2023 , Edited by admin on Fri Dec 15 15:02:58 GMT 2023
WHO-ATC A07AA07
Created by admin on Fri Dec 15 15:02:58 GMT 2023 , Edited by admin on Fri Dec 15 15:02:58 GMT 2023
FDA ORPHAN DRUG 99696
Created by admin on Fri Dec 15 15:02:58 GMT 2023 , Edited by admin on Fri Dec 15 15:02:58 GMT 2023
FDA ORPHAN DRUG 97796
Created by admin on Fri Dec 15 15:02:58 GMT 2023 , Edited by admin on Fri Dec 15 15:02:58 GMT 2023
WHO-ATC A01AB04
Created by admin on Fri Dec 15 15:02:58 GMT 2023 , Edited by admin on Fri Dec 15 15:02:58 GMT 2023
FDA ORPHAN DRUG 97396
Created by admin on Fri Dec 15 15:02:58 GMT 2023 , Edited by admin on Fri Dec 15 15:02:58 GMT 2023
WHO-VATC QA01AB04
Created by admin on Fri Dec 15 15:02:58 GMT 2023 , Edited by admin on Fri Dec 15 15:02:58 GMT 2023
FDA ORPHAN DRUG 97696
Created by admin on Fri Dec 15 15:02:58 GMT 2023 , Edited by admin on Fri Dec 15 15:02:58 GMT 2023
FDA ORPHAN DRUG 97096
Created by admin on Fri Dec 15 15:02:58 GMT 2023 , Edited by admin on Fri Dec 15 15:02:58 GMT 2023
WHO-ESSENTIAL MEDICINES LIST 6.3
Created by admin on Fri Dec 15 15:02:58 GMT 2023 , Edited by admin on Fri Dec 15 15:02:58 GMT 2023
FDA ORPHAN DRUG 96996
Created by admin on Fri Dec 15 15:02:58 GMT 2023 , Edited by admin on Fri Dec 15 15:02:58 GMT 2023
NCI_THESAURUS C514
Created by admin on Fri Dec 15 15:02:58 GMT 2023 , Edited by admin on Fri Dec 15 15:02:58 GMT 2023
FDA ORPHAN DRUG 703119
Created by admin on Fri Dec 15 15:02:58 GMT 2023 , Edited by admin on Fri Dec 15 15:02:58 GMT 2023
NDF-RT N0000007672
Created by admin on Fri Dec 15 15:02:58 GMT 2023 , Edited by admin on Fri Dec 15 15:02:58 GMT 2023
FDA ORPHAN DRUG 99596
Created by admin on Fri Dec 15 15:02:58 GMT 2023 , Edited by admin on Fri Dec 15 15:02:58 GMT 2023
LIVERTOX NBK548141
Created by admin on Fri Dec 15 15:02:58 GMT 2023 , Edited by admin on Fri Dec 15 15:02:58 GMT 2023
Code System Code Type Description
RXCUI
236594
Created by admin on Fri Dec 15 15:02:58 GMT 2023 , Edited by admin on Fri Dec 15 15:02:58 GMT 2023
ALTERNATIVE
RXCUI
2001759
Created by admin on Fri Dec 15 15:02:58 GMT 2023 , Edited by admin on Fri Dec 15 15:02:58 GMT 2023
ALTERNATIVE
ECHA (EC/EINECS)
215-742-2
Created by admin on Fri Dec 15 15:02:58 GMT 2023 , Edited by admin on Fri Dec 15 15:02:58 GMT 2023
PRIMARY
NSC
527017
Created by admin on Fri Dec 15 15:02:58 GMT 2023 , Edited by admin on Fri Dec 15 15:02:58 GMT 2023
PRIMARY
DRUG CENTRAL
197
Created by admin on Fri Dec 15 15:02:58 GMT 2023 , Edited by admin on Fri Dec 15 15:02:58 GMT 2023
PRIMARY
WIKIPEDIA
AMPHOTERICIN B
Created by admin on Fri Dec 15 15:02:58 GMT 2023 , Edited by admin on Fri Dec 15 15:02:58 GMT 2023
PRIMARY
RXCUI
732
Created by admin on Fri Dec 15 15:02:58 GMT 2023 , Edited by admin on Fri Dec 15 15:02:58 GMT 2023
PRIMARY
WHO INTERNATIONAL PHARMACOPEIA
AMPHOTERICIN B
Created by admin on Fri Dec 15 15:02:58 GMT 2023 , Edited by admin on Fri Dec 15 15:02:58 GMT 2023
PRIMARY Description: A yellow to orange powder; odourless or almost odourless. Solubility: Practically insoluble in water, ethanol (~750 g/l) TS, toluene R and ether R; soluble in 200 parts of dimethylformamide R and in 20 parts of dimethyl sulfoxide R, slightly soluble in methanol R. Category: Antifungal drug. Storage: Amphotericin B should be kept in a tightly closed container, protected from light, and stored at a temperature between 2 and 8 ?C. Labelling: The designation Amphotericin B for parenteral use indicates that the substance complies with the altered and additional requirements for Amphotericin B and may be used for parenteral administration. Additional information: Even in the absence of light, Amphotericin B is gradually degraded on exposure to a humid atmosphere, the decomposition being faster at higher temperatures. In diluted solutions it is sensitive to light and is inactivated at low pH values. Definition: Amphotericin B contains not less than 750 μg per mg, calculated with reference to the dried substance.
CHEBI
2682
Created by admin on Fri Dec 15 15:02:58 GMT 2023 , Edited by admin on Fri Dec 15 15:02:58 GMT 2023
PRIMARY
RS_ITEM_NUM
1032007
Created by admin on Fri Dec 15 15:02:58 GMT 2023 , Edited by admin on Fri Dec 15 15:02:58 GMT 2023
PRIMARY
ChEMBL
CHEMBL267345
Created by admin on Fri Dec 15 15:02:58 GMT 2023 , Edited by admin on Fri Dec 15 15:02:58 GMT 2023
PRIMARY
FDA UNII
7XU7A7DROE
Created by admin on Fri Dec 15 15:02:58 GMT 2023 , Edited by admin on Fri Dec 15 15:02:58 GMT 2023
PRIMARY
EVMPD
SUB05486MIG
Created by admin on Fri Dec 15 15:02:58 GMT 2023 , Edited by admin on Fri Dec 15 15:02:58 GMT 2023
PRIMARY
EVMPD
SUB20545
Created by admin on Fri Dec 15 15:02:58 GMT 2023 , Edited by admin on Fri Dec 15 15:02:58 GMT 2023
PRIMARY
EPA CompTox
DTXSID9022601
Created by admin on Fri Dec 15 15:02:58 GMT 2023 , Edited by admin on Fri Dec 15 15:02:58 GMT 2023
PRIMARY
INN
869
Created by admin on Fri Dec 15 15:02:58 GMT 2023 , Edited by admin on Fri Dec 15 15:02:58 GMT 2023
PRIMARY
PUBCHEM
5280965
Created by admin on Fri Dec 15 15:02:58 GMT 2023 , Edited by admin on Fri Dec 15 15:02:58 GMT 2023
PRIMARY
EVMPD
SUB12887MIG
Created by admin on Fri Dec 15 15:02:58 GMT 2023 , Edited by admin on Fri Dec 15 15:02:58 GMT 2023
PRIMARY
DAILYMED
7XU7A7DROE
Created by admin on Fri Dec 15 15:02:58 GMT 2023 , Edited by admin on Fri Dec 15 15:02:58 GMT 2023
PRIMARY
DRUG BANK
DB00681
Created by admin on Fri Dec 15 15:02:58 GMT 2023 , Edited by admin on Fri Dec 15 15:02:58 GMT 2023
PRIMARY
EVMPD
SUB119245
Created by admin on Fri Dec 15 15:02:58 GMT 2023 , Edited by admin on Fri Dec 15 15:02:58 GMT 2023
PRIMARY
NCI_THESAURUS
C238
Created by admin on Fri Dec 15 15:02:58 GMT 2023 , Edited by admin on Fri Dec 15 15:02:58 GMT 2023
PRIMARY
MESH
D000666
Created by admin on Fri Dec 15 15:02:58 GMT 2023 , Edited by admin on Fri Dec 15 15:02:58 GMT 2023
PRIMARY
RXCUI
42527
Created by admin on Fri Dec 15 15:02:58 GMT 2023 , Edited by admin on Fri Dec 15 15:02:58 GMT 2023
ALTERNATIVE
SMS_ID
100000092100
Created by admin on Fri Dec 15 15:02:58 GMT 2023 , Edited by admin on Fri Dec 15 15:02:58 GMT 2023
PRIMARY
MERCK INDEX
m1852
Created by admin on Fri Dec 15 15:02:58 GMT 2023 , Edited by admin on Fri Dec 15 15:02:58 GMT 2023
PRIMARY Merck Index
HSDB
3008
Created by admin on Fri Dec 15 15:02:58 GMT 2023 , Edited by admin on Fri Dec 15 15:02:58 GMT 2023
PRIMARY
LACTMED
Amphotericin B
Created by admin on Fri Dec 15 15:02:58 GMT 2023 , Edited by admin on Fri Dec 15 15:02:58 GMT 2023
PRIMARY
CAS
1397-89-3
Created by admin on Fri Dec 15 15:02:58 GMT 2023 , Edited by admin on Fri Dec 15 15:02:58 GMT 2023
PRIMARY
ACTIVE MOIETY
Structure of Amphotericin B
SALT/SOLVATE (PARENT)
Structure of Amphotericin B deoxycholate
NIH
NCATS
PRIVACY ACT
ACCESSIBILITY
DISCLAIMER
HHS VULNERABILITY DISCLOSURE
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