ABELCET (Page 3 of 4)

Carcinogenesis, Mutagenesis, and Impairment of Fertility:

No long-term studies in animals have been performed to evaluate the carcinogenic potential of ABELCET ®. The following in vitro (with and without metabolic activation) and in vivo studies to assess ABELCET ® for mutagenic potential were conducted: bacterial reverse mutation assay, mouse lymphoma forward mutation assay, chromosomal aberration assay in CHO cells, and in vivo mouse micronucleus assay. ABELCET ® was found to be without mutagenic effects in all assay systems. Studies demonstrated that ABELCET ® had no impact on fertility in male and female rats at doses up to 0.32 times the recommended human dose (based on body surface area considerations).

Pregnancy:

There are no reports of pregnant women having been treated with ABELCET ®. Teratogenic Effects. Reproductive studies in rats and rabbits at doses of ABELCET ® up to 0.64 times the human dose revealed no harm to the fetus. Because animal reproductive studies are not always predictive of human response, and adequate and well-controlled studies have not been conducted in pregnant women, ABELCET ® should be used during pregnancy only after taking into account the importance of the drug to the mother.

Nursing Mothers:

It is not known whether ABELCET ® is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in breast-fed infants from ABELCET ® , a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use:

One hundred eleven children (2 were enrolled twice and counted as separate patients), age 16 years and under, of whom 11 were less than 1 year, have been treated with ABELCET ® at 5 mg/kg/day in two open-label studies and one small, prospective, single-arm study. In one single-center study, 5 children with hepatosplenic candidiasis were effectively treated with 2.5 mg/kg/day of ABELCET ®. No serious unexpected adverse events have been reported.

Geriatric Use:

Forty-nine elderly patients, age 65 years or over, have been treated with ABELCET ® at 5 mg/kg/day in two open-label studies and one small, prospective, single-arm study. No serious unexpected adverse events have been reported.

ADVERSE REACTIONS

The total safety data base is composed of 921 patients treated with ABELCET ® (5 patients were enrolled twice and counted as separate patients), of whom 775 were treated with 5 mg/kg/day. Of these 775 patients, 194 patients were treated in four comparative studies; 25 were treated in open-label, non-comparative studies; and 556 patients were treated in an open-label, emergency-use program. Most had underlying hematologic neoplasms, and many were receiving multiple concomitant medications. Of the 556 patients treated with ABELCET ® , 9% discontinued treatment due to adverse events regardless of presumed relationship to study drug.

In general, the adverse events most commonly reported with ABELCET ® were transient chills and/or fever during infusion of the drug.

Adverse Events a with an Incidence of ≥3% (N=556)

Adverse Event

Percentage (%) of Patients

Chills

18

Fever

14

Increased Serum Creatinine

11

Multiple Organ Failure

11

Nausea

9

Hypotension

8

Respiratory Failure

8

Vomiting

8

Dyspnea

7

Sepsis

7

Diarrhea

6

Headache

6

Cardiac Arrest

6

Hypertension

5

Hypokalemia

5

Infection

5

Kidney Failure

5

Pain

5

Thrombocytopenia

5

Anemia

4

Hyperbilirubinemia

4

Gastrointestinal Hemorrhage

4

Leukopenia

4

Rash

4

Respiratory Disorder

4

Chest Pain

3

Nausea and Vomiting

3

a The causal association between these adverse events and ABELCET ® is uncertain.

The following adverse events have also been reported in patients using ABELCET ® in open-label, uncontrolled clinical studies. The causal association between these adverse events and ABELCET ® is uncertain.

Body as a whole: malaise, weight loss, deafness, injection site reaction including inflammation

Allergic: bronchospasm, wheezing, asthma, anaphylactoid and other allergic reactions

Cardiopulmonary: cardiac failure, pulmonary edema, shock, myocardial infarction, hemoptysis, tachypnea, thrombophlebitis, pulmonary embolus, cardiomyopathy, pleural effusion, arrhythmias including ventricular fibrillation.

Dermatological: maculopapular rash, pruritus, exfoliative dermatitis, erythema multiforme

Gastrointestinal: acute liver failure, hepatitis, jaundice, melena, anorexia, dyspepsia, cramping, epigastric pain, veno-occlusive liver disease, diarrhea, hepatomegaly, cholangitis, cholecystitis

Hematologic: coagulation defects, leukocytosis, blood dyscrasias including eosinophilia

Musculoskeletal: myasthenia, including bone, muscle, and joint pains

Neurologic: convulsions, tinnitus, visual impairment, hearing loss, peripheral neuropathy, transient vertigo, diplopia, encephalopathy, cerebral vascular accident, extrapyramidal syndrome and other neurologic symptoms

Urogenital: oliguria, decreased renal function, anuria, renal tubular acidosis, impotence, dysuria

Serum electrolyte abnormalities: hypomagnesemia, hyperkalemia, hypocalcemia, hypercalcemia

Liver function test abnormalities: increased AST, ALT, alkaline phosphatase, LDH

Renal function test abnormalities: increased BUN

Other test abnormalities: acidosis, hyperamylasemia, hypoglycemia, hyperglycemia, hyperuricemia, hypophosphatemia

To report SUSPECTED ADVERSE REACTIONS, contact Leadiant Biosciences, Inc. at 1-888-393-4584 or by email at drugsafety@leadiant.com or contact the FDA at 1-800-FDA-1088 or www.fda.gov/safety/medwatch.

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