Abelcet

Name: Abelcet

Before Using Abelcet

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

This medicine has been tested in children and, in effective doses, has not been shown to cause different side effects or problems than it does in adults.

Geriatric

This medicine has been tested in a limited number of patients 65 years of age or older and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

Pregnancy Category Explanation
All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Cyclosporine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Blood transfusion—Amphotericin B lipid complex may cause side effects affecting the lungs
  • Kidney disease—Amphotericin B lipid complex may make your kidney problems worse

How do I store and/or throw out Abelcet?

  • If you need to store Abelcet at home, talk with your doctor, nurse, or pharmacist about how to store it.

Warnings

Anaphylaxis has been reported with amphotericin B desoxycholate and other amphotericin B-containing drugs. Anaphylaxis has been reported with Abelcet® with an incidence rate of <0.1%. If severe respiratory distress occurs, the infusion should be immediately discontinued. The patient should not receive further infusions of Abelcet®.

Precautions

General:

As with any amphotericin B-containing product, during the initial dosing of Abelcet®, the drug should be administered under close clinical observation by medically trained personnel.

Acute reactions including fever and chills may occur 1 to 2 hours after starting an intravenous infusion of Abelcet®. These reactions are usually more common with the first few doses of Abelcet® and generally diminish with subsequent doses. Infusion has been rarely associated with hypotension, bronchospasm, arrhythmias, and shock.

Laboratory Tests:

Serum creatinine should be monitored frequently during Abelcet® therapy (see ADVERSE REACTIONS). It is also advisable to regularly monitor liver function, serum electrolytes (particularly magnesium and potassium), and complete blood counts.

Drug Interactions:

No formal clinical studies of drug interactions have been conducted with Abelcet®. However, when administered concomitantly, the following drugs are known to interact with amphotericin B; therefore, the following drugs may interact with Abelcet®:

Antineoplastic agents: Concurrent use of antineoplastic agents and amphotericin B may enhance the potential for renal toxicity, bronchospasm, and hypotension. Antineoplastic agents should be given concomitantly with Abelcet® with great caution.

Corticosteroids and corticotropin (ACTH): Concurrent use of corticosteroids and corticotropin (ACTH) with amphotericin B may potentiate hypokalemia which could predispose the patient to cardiac dysfunction. If used concomitantly with Abelcet®, serum electrolytes and cardiac function should be closely monitored.

Cyclosporin A: Data from a prospective study of prophylactic Abelcet® in 22 patients undergoing bone marrow transplantation suggested that concurrent initiation of cyclosporin A and Abelcet® within several days of bone marrow ablation may be associated with increased nephrotoxicity.

Digitalis glycosides: Concurrent use of amphotericin B may induce hypokalemia and may potentiate digitalis toxicity. When administered concomitantly with Abelcet®, serum potassium levels should be closely monitored.

Flucytosine: Concurrent use of flucytosine with amphotericin B-containing preparations may increase the toxicity of flucytosine by possibly increasing its cellular uptake and/or impairing its renal excretion. Flucytosine should be given concomitantly with Abelcet® with caution. 

Imidazoles (e.g., ketoconazole, miconazole, clotrimazole, fluconazole, etc.): Antagonism between amphotericin B and imidazole derivatives such as miconazole and ketoconazole, which inhibit ergosterol synthesis, has been reported in both in vitro and in vivo animal studies. The clinical significance of these findings has not been determined. 

Leukocyte transfusions: Acute pulmonary toxicity has been reported in patients receiving intravenous amphotericin B and leukocyte transfusions. Leukocyte transfusions and Abelcet® should not be given concurrently.

Other nephrotoxic medications: Concurrent use of amphotericin B and agents such as aminoglcosides and pentamidine may enhance the potential for drug-induced renal toxicity. Aminoglycosides and pentamidine should be used concomitantly with Abelcet® only with great caution. Intensive monitoring of renal function is recommended in patients requiring any combination of nephrotoxic medications.

Skeletal muscle relaxants: Amphotericin B-induced hypokalemia may enhance the curariform effect of skeletal muscle relaxants (e.g., tubocurarine) due to hypokalemia. When administered concomitantly with Abelcet®, serum potassium levels should be closely monitored.

Zidovudine: Increased myelotoxicity and nephrotoxicity were observed in dogs when either Abelcet® (at doses 0.16 or 0.5 times the recommended human dose) or amphotericin B desoxycholate (at 0.5 times the recommended human dose) were administered concomitantly with zidovudine for 30 days. If zidovudine is used concomitantly with Abelcet®, renal and hematologic function should be closely monitored.

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. Pregnancy Category B: 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.

How is Abelcet Supplied

Single-use vials along with 5-micron filter needles are individually packaged.

100 mg of Abelcet® in 20 mL of suspension NDC 57665-101-41

Storage

Prior to admixture, Abelcet® should be stored at 2° to 8°C (36° to 46°F) and protected from exposure to light. Do not freeze. Abelcet® should be retained in the carton until time of use.

The admixed Abelcet® and 5% Dextrose Injection may be stored for up to 48 hours at 2° to 8°C (36° to 46°F) and an additional 6 hours at room temperature. Do not freeze. Any unused material should be discarded.

U.S. Patent Nos. 4,973,465

5,616,334

6,406,713

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

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

Revised 03/2013

Manufacturer

  • Sigma-Tau Pharmaceuticals, Inc.

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