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Details

Stereochemistry ABSOLUTE
Molecular Formula C47H73NO17.C24H39O4.Na
Molecular Weight 1338.6328
Optical Activity UNSPECIFIED
Defined Stereocenters 29 / 29
E/Z Centers 0
Charge 0

SHOW SMILES / InChI
Structure of Amphotericin B deoxycholate

SMILES

[Na+].[H][C@@]1(CC[C@@]2([H])[C@]3([H])CC[C@]4([H])C[C@H](O)CC[C@]4(C)[C@@]3([H])C[C@H](O)[C@]12C)[C@H](C)CCC([O-])=O.[H][C@]56C[C@@H](O[C@@H]7O[C@H](C)[C@@H](O)[C@H](N)[C@@H]7O)\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]5C(O)=O)O6

InChI

InChIKey=NFHDUMMQBQTVTR-OXEBIIQQSA-M
InChI=1S/C47H73NO17.C24H40O4.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;1-14(4-9-22(27)28)18-7-8-19-17-6-5-15-12-16(25)10-11-23(15,2)20(17)13-21(26)24(18,19)3;/h5-18,27-38,40-44,46,49-54,56-58,61H,19-26,48H2,1-4H3,(H,59,60);14-21,25-26H,4-13H2,1-3H3,(H,27,28);/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+;14-,15-,16-,17+,18-,19+,20+,21+,23+,24-;/m01./s1

HIDE SMILES / InChI

Molecular Formula C24H39O4
Molecular Weight 391.5641
Charge -1
Count
Stereochemistry ABSOLUTE
Additional Stereochemistry No
Defined Stereocenters 10 / 10
E/Z Centers 0
Optical Activity UNSPECIFIED

Molecular Formula Na
Molecular Weight 22.9898
Charge 1
Count
Stereochemistry ACHIRAL
Additional Stereochemistry No
Defined Stereocenters 0 / 0
E/Z Centers 0
Optical Activity NONE

Molecular Formula C47H73NO17
Molecular Weight 924.079
Charge 0
Count
Stereochemistry ABSOLUTE
Additional Stereochemistry No
Defined Stereocenters 19 / 19
E/Z Centers 0
Optical Activity UNSPECIFIED

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

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

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

TargetsConditions

Conditions

ConditionModalityTargetsHighest PhaseProduct
Curative
Unknown

Approved Use

Unknown
Curative
Unknown

Approved Use

Unknown
Curative
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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%
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: 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: 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: 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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
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: 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: 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: 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: 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: 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: 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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
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:
unhealthy
n = 237
Health Status: unhealthy
Condition: Acute Lymphoblastic Leukemia
Population Size: 237
Sources:
Overview

Overview

CYP3A4CYP2C9CYP2D6hERG

OverviewOther

Drug as perpetrator​Drug as victim

Drug as victim

TargetModalityActivityMetaboliteClinical evidence
yes
Tox targets

Tox targets

TargetModalityActivityMetaboliteClinical evidence
PubMed

PubMed

TitleDatePubMed
Combined activity of amphotericin B and 5-fluorocytosine against Cryptococcus neoformans in vitro and in vivo in mice.
1975 Feb
Mitigation of amphotericin B nephrotoxicity by mannitol.
1975 Mar 8
[Drug-induced benign intracranial hypertension. Apropos of a case with amphotericin B. Review of the literature].
1992 Sep-Oct
Recent strategies for the chemotherapy of visceral leishmaniasis.
1999 Dec
Risk factors for amphotericin B-induced nephrotoxicity.
1999 Feb
[Hypokalemia induced by amphotericin B].
1999 Nov 15
Fluconazole vs low-dose amphotericin B for the prevention of fungal infections in patients undergoing bone marrow transplantation: a study of the North American Marrow Transplant Group.
2000 Apr
Use of amphotericin B colloidal dispersion in children.
2000 May-Jun
[Renal failure during treatment with Ambisome].
2000 Oct 7
Role of humoral mediators in, and influence of a liposomal formulation on, acute amphotericin B nephrotoxicity.
2001 Apr
[Pulmonary mucormycosis: benefit of aerosol amphotericin B?].
2001 Jun
Correlates of acute renal failure in patients receiving parenteral amphotericin B.
2001 Oct
[Radioprotective and antineoplastic activity of polyene antibiotics combined with dimethyl sulfoxide].
2002
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
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
Fatal fat embolism following amphotericin B lipid complex injection.
2004 Dec
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
Corticosteroid induced Cryptococcus meningitis.
2005 Jul
Prediction of genotoxicity of chemical compounds by statistical learning methods.
2005 Jun
Reversible dilated cardiomyopathy associated with amphotericin B treatment.
2005 May
Study of renal safety in amphotericin B lipid complex-treated patients.
2005 May 1
Use of Leishmania donovani field isolates expressing the luciferase reporter gene in in vitro drug screening.
2005 Sep
Visceral leishmaniasis (kala-azar)--the Bihar (India) perspective.
2006 Jul
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
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
In vitro efficacy of corifungin against Acanthamoeba castellanii trophozoites and cysts.
2014
Patents

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.
Substance Class Chemical
Created
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on Sat Dec 16 19:29:00 GMT 2023
Edited
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on Sat Dec 16 19:29:00 GMT 2023
Record UNII
44WG8E9MTU
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Name Type Language
Amphotericin B deoxycholate
Common Name English
Amphotericin B deoxycholate [WHO-DD]
Common Name English
Code System Code Type Description
PUBCHEM
23668620
Created by admin on Sat Dec 16 19:29:00 GMT 2023 , Edited by admin on Sat Dec 16 19:29:00 GMT 2023
PRIMARY
FDA UNII
44WG8E9MTU
Created by admin on Sat Dec 16 19:29:00 GMT 2023 , Edited by admin on Sat Dec 16 19:29:00 GMT 2023
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CAS
58501-21-6
Created by admin on Sat Dec 16 19:29:00 GMT 2023 , Edited by admin on Sat Dec 16 19:29:00 GMT 2023
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