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

Details

Stereochemistry ABSOLUTE
Molecular Formula C47H72NO17.Na
Molecular Weight 946.0608
Optical Activity UNSPECIFIED
Defined Stereocenters 19 / 19
E/Z Centers 0
Charge 0

SHOW SMILES / InChI
Structure of CORIFUNGIN

SMILES

[Na+].[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=MTSXPVSZJVNPBE-OCOINPOZSA-M
InChI=1S/C47H73NO17.Na/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);/q;+1/p-1/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
LETHAL TOXICITY AND DOSE-RELATED AZOTEMIA DUE TO AMPHOTERICIN B IN DOGS.
1963 Oct
The influence of Myrj 59 on the solubility, toxicity and activity of amphotericin B.
1991 May
Antifungal activity of HWA-138 and amphotericin B in experimental systemic candidiasis.
1991 Oct
Non-nephrotoxic empiric antimicrobial therapy in febrile neutropenic cancer patients.
1992
Rapid intravenous infusion of amphotericin B: a pilot study.
1992 Aug
Acute and chronic effects of flucytosine on amphotericin B nephrotoxicity in rats.
1992 Dec
In-vivo and in-vitro studies on the effect of amphotericin B on endothelin release.
1992 Jan
Risk of ventricular dysrhythmias during 1-hour infusions of amphotericin B in patients with preserved renal function.
1992 Nov
Amphotericin B-associated leukoencephalopathy.
1992 Oct
Bradycardia due to anthracyclines.
1992 Oct 3
Recent strategies for the chemotherapy of visceral leishmaniasis.
1999 Dec
Fatal fat embolism following amphotericin B lipid complex injection.
2004 Dec
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
Heat-treated Fungizone retains amphotericin B antifungal activity without renal toxicity in rats infected with Aspergillus fumigatus.
2004 Sep
Assessment of nephrotoxicity in patients receiving amphotericin B lipid complex: a pharmacosurveillance study in Spain.
2004 Sep
Caspofungin versus liposomal amphotericin B for empirical antifungal therapy in patients with persistent fever and neutropenia.
2004 Sep 30
N-acetylcysteine ameliorates amphotericin-induced nephropathy in rats.
2005
Efficacy and safety of amphotericin B lipid complex in 548 children and adolescents with invasive fungal infections.
2005 Feb
Recent Developments in Leishmaniasis: Epidemiology, Diagnosis, and Treatment.
2005 Jan
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
Refractoriness to the treatment of sodium stibogluconate in Indian kala-azar field isolates persist in in vitro and in vivo experimental models.
2005 Jun
Amphotericin B-induced nephrogenic diabetes insipidus in a case of cryptococcemia.
2005 May
Reversible dilated cardiomyopathy associated with amphotericin B treatment.
2005 May
Study of renal safety in amphotericin B lipid complex-treated patients.
2005 May 1
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
Disseminated invasive aspergillosis in a patient with acute leukaemia.
2006
Amphotericin B-induced severe hypertension in a young patient: case report and review of the literature.
2006
Amphotericin B-related nephrotoxicity in low-risk patients.
2006 Apr
Prospective study of amphotericin B formulations in immunocompromised patients in 4 European countries.
2006 Aug 15
Amphotericin B blunts erythropoietin response to hypoxia by reinforcing FIH-mediated repression of HIF-1.
2006 Feb 1
An unusual presentation of rhinofacial zygomycosis due to Cunninghamella sp. in an immunocompetent patient: a case report and literature review.
2006 Jan
Role of plasma lipids and lipoproteins in predicting amphotericin B-induced nephrotoxicity in pediatric oncology patients.
2006 Jan
Visceral leishmaniasis (kala-azar)--the Bihar (India) perspective.
2006 Jul
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
Symptomatic relapse of HIV-associated cryptococcal meningitis after initial fluconazole monotherapy: the role of fluconazole resistance and immune reconstitution.
2006 Oct 15
Invasive aspergillosis: is treatment with "inexpensive" amphotericin B cost saving if "expensive" voriconazole is only used on demand?
2006 Sep 30
Hypokalemic rhabdomyolysis in a child due to amphotericin B therapy.
2007 Feb
Treatment of Bolivian mucosal leishmaniasis with miltefosine.
2007 Feb 1
Discovery of novel indazole-linked triazoles as antifungal agents.
2007 Jun 15
Injectable paromomycin for Visceral leishmaniasis in India.
2007 Jun 21
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
CORIFUNGIN
Common Name English
AMPHOTERICIN B SODIUM
Common Name English
AMPHOTERICIN B, MONOSODIUM SALT
Common Name English
SODIUM AMPHOTERICIN B
Common Name English
Classification Tree Code System Code
FDA ORPHAN DRUG 348811
Created by admin on Sat Dec 16 05:03:31 GMT 2023 , Edited by admin on Sat Dec 16 05:03:31 GMT 2023
FDA ORPHAN DRUG 342211
Created by admin on Sat Dec 16 05:03:31 GMT 2023 , Edited by admin on Sat Dec 16 05:03:31 GMT 2023
Code System Code Type Description
EVMPD
SUB126971
Created by admin on Sat Dec 16 05:03:31 GMT 2023 , Edited by admin on Sat Dec 16 05:03:31 GMT 2023
ALTERNATIVE
DRUG BANK
DBSALT002275
Created by admin on Sat Dec 16 05:03:31 GMT 2023 , Edited by admin on Sat Dec 16 05:03:31 GMT 2023
PRIMARY
CAS
41610-51-9
Created by admin on Sat Dec 16 05:03:31 GMT 2023 , Edited by admin on Sat Dec 16 05:03:31 GMT 2023
PRIMARY
FDA UNII
L26BTK4791
Created by admin on Sat Dec 16 05:03:31 GMT 2023 , Edited by admin on Sat Dec 16 05:03:31 GMT 2023
PRIMARY
PUBCHEM
16218873
Created by admin on Sat Dec 16 05:03:31 GMT 2023 , Edited by admin on Sat Dec 16 05:03:31 GMT 2023
PRIMARY
EPA CompTox
DTXSID00194438
Created by admin on Sat Dec 16 05:03:31 GMT 2023 , Edited by admin on Sat Dec 16 05:03:31 GMT 2023
PRIMARY
SUBSTANCE RECORD
Structure of CORIFUNGIN
NIH
NCATS
PRIVACY ACT
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DISCLAIMER
HHS VULNERABILITY DISCLOSURE
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