Abelcet

• It is used to treat fungal infections.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• Some people have had side effects within a few hours of the start of the infusion. Tell your doctor if you have any bad effects during this time.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Abelcet while you are pregnant.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Upset stomach or throwing up.
• Loose stools (diarrhea).
• Headache.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Pharmacokinetics

The assay used to measure amphotericin B in the blood after the administration of Abelcet® does not distinguish amphotericin B that is complexed with the phospholipids of Abelcet® from amphotericin B that is uncomplexed.

The pharmacokinetics of amphotericin B after the administration of Abelcet® are nonlinear. Volume of distribution and clearance from blood increase with increasing dose of Abelcet®, resulting in less than proportional increases in blood concentrations of amphotericin B over a dose range of 0.6-5 mg/kg/day. The pharmacokinetics of amphotericin B in whole blood after the administration of Abelcet® and amphotericin B desoxycholate are:

 a Data from patients with mucocutaneous leishmaniasis. Infusion rate was 0.25 mg/kg/h.

b Data from studies in patients with cytologically proven cancer being treated with chemotherapy or neutropenic patients with
presumed or proven fungal infection. Infusion rate was 2.5 mg/kg/h.

c Data from patients with mucocutaneous leishmaniasis. Infusion rate was 4 mg/kg/h.

d Percentage of dose excreted in 24 hours after last dose.

The large volume of distribution and high clearance from blood of amphotericin B after the admistration of Abelcet® probably reflect uptake by tissues. The long terminal elimination half-life probably reflects a slow redistribution from tissues. Although amphotericin B is excreted slowly, there is little accumulation in the blood after repeated dosing. AUC of amphotericin B increased approximately 34% from day 1 after the administration of Abelcet® 5 mg/kg/day for 7 days. The effect of gender or ethnicity on the pharmacokinetics of Abelcet® has not been studied.

Tissue concentrations of amphotericin B have been obtained at autopsy from one heart transplant patient who received three doses of Abelcet® at 5.3 mg/kg/day:

 This pattern of distribution is consistent with that observed in preclinical studies in dogs in which greatest concentrations of amphotericin B after Abelcet® administration were observed in the liver, spleen, and lung; however, the relationship of tissue concentrations of amphotericin B to its biological activity when administered as Abelcet® is unknown.

Special Populations

Hepatic Impairment: The effect of hepatic impairment on the disposition of Abelcet® is not known.

Renal Impairment: The effect of renal impairment on the disposition of Abelcet® is not known. The effect of dialysis on the elimination of Abelcet® has not been studied; however, amphotericin B is not removed by hemodialysis when administered as amphotericin B desoxycholate.

Pediatric and Elderly Patients:  The pharmacokinetics and pharmacodynamics of pediatric patients (≤16 years of age) and elderly patients (≥65 years of age) have not been studied.

Abelcet® is contraindicated in patients who have shown hypersensitivity to amphotericin B or any other component in the formulation.

Amphotericin B desoxycholate overdose has been reported to result in cardio-respiratory arrest. Fifteen patients have been reported to have received one or more doses of Abelcet® between 7-13 mg/kg. None of these patients had a serious acute reaction to Abelcet®. If an overdose is suspected, discontinue therapy, monitor the patient’s clinical status, and administer supportive therapy as required. Abelcet® is not hemodialyzable.

NDC 57665-101-41

100 mg

Abelcet®

(amphotericin B Lipid Complex Injection)

Lipid

Formulation

For Intravenous Use Only

5 mg/mL

Contents:
One 100 mg vial
One filter needle

Manufactured by Sigma-Tau PharmaSource, Inc.
Indianapolis, IN 46268

Distributed by Sigma-Tau Pharmaceuticals, Inc.
Gaithersburg, MD 20878

U.S. PATENT NOS. 4,973,465 5,616,334 6,406,713

Lot:
Exp:

C-101-41-US-L

Each mL of Abelcet contains:
Amphotericin B USP 5 mg
L-α-dimyristoylphosphatidylcholine (DMPC) 3.4 mg
L-α-dimyristoylphosphatidylglycerol (DMPG) 1.5 mg
Sodium Chloride USP 9 mg
Water for Injection USP, q.s. 1 mL

Preparation

Abelcet must be added to 5% Dextrose Injection USP before intravenous infusion.
See package insert for complete directions.

Dosage

See package insert for dosage and administration information.

Storage

Store between 2° and 8°C (36° to 46° F).
Do not freeze. Protect from light. Single-use vial.

Rx Only.

Carton Label

Abelcet is part of the drug class:

• Systemic Antibiotic Antifungals

Applies to amphotericin b lipid complex: powder for solution, suspension

Along with its needed effects, amphotericin b lipid complex (the active ingredient contained in Abelcet) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur while taking amphotericin b lipid complex:

• Chills and fever
• headache
• nausea and vomiting

• Difficulty in breathing
• sore throat and fever
• unusual bleeding or bruising
• unusual tiredness and weakness

• Increased or decreased urination

Some side effects of amphotericin b lipid complex may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Diarrhea
• loss of appetite
• stomach pain

There are no data on the excretion of amphotericin B lipid complex into human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from amphotericin B lipid complex, 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.