ABELCET® (amphotericin b) is a sterile, pyrogen-free suspension for intravenous infusion. ABELCET® consists of amphotericin B complexed with two phospholipids in a 1:1 drug-to-lipid molar ratio. The two phospholipids, L-?-dimyristoylphosphatidylcholine (DMPC) and L-?-dimyristoylphosphatidylglycerol (DMPG), are present in a 7:3 molar ratio. ABELCET® (amphotericin b) is yellow and opaque in appearance, with a pH of 5 - 7.

NOTE: Liposomal encapsulation or incorporation in a lipid complex can substantially affect a drug's functional properties relative to those of the unencapsulated or nonlipid-associated drug. In addition, different liposomal or lipid-complexed products with a common active ingredient may vary from one another in the chemical composition and physical form of the lipid component. Such differences may affect functional properties of these drug products.

Amphotericin B is a polyene, antifungal antibiotic produced from a strain of Streptomyces nodosus. Amphotericin B is designated chemically as [1R-(1R*, 3S*, 5R*, 6R*, 9R*, 11R*, 15S*, 16R*, 17R*, 18S*, 19E, 21E, 23E, 25E, 27E, 29E, 31E, 33R*, 35S*, 36R*, 37S*)]-33-[(3-Amino-3, 6-dideoxy-?-D-mannopyranosyl) oxy]-1,3,5,6,9,11,17,37-octahydroxy-15,16,18-trimethyl-13-oxo-14,39-dioxabicy-clo[33.3.1] nonatriaconta-19, 21, 23, 25, 27, 29, 31-heptaene-36-carboxylic acid.

It has a molecular weight of 924.09 and a molecular formula of C₄₇H₇₃NO₁₇. The structural formula is:

ABELCET® (amphotericin b) is provided as a sterile, opaque suspension  in 20 mL glass, single-use vials. Each 20 mL vial contains 100 mg of amphotericin B (see DOSAGE AND ADMINISTRATION), and each mL of ABELCET® contains:

Amphotericin B USP.......................................5 mgL-?-dimyristoylphosphatidylcholine (DMPC).......................................3.4 mg
L-?-dimyristoylphosphatidylglycerol (DMPG).......................................1.5 mg
Sodium Chloride USP.......................................9 mg
Water for Injection USP, q.s. 1 mL

SIDE EFFECTS: Fever, shaking, chills, flushing, loss of appetite, dizziness, nausea, vomiting, headache, shortness of breath, or fast breathing may occur 1 to 2 hours after the infusion is started. In some cases, other medications (e.g., acetaminophen, diphenhydramine, corticosteroids such as hydrocortisone) may be necessary to prevent or relieve these side effects. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: swelling/pain at injection site, muscle/joint pain, unusual tiredness, weakness, muscle cramping, change in the amount of urine, painful urination, numbness/tingling of arms/legs, vision changes, hearing changes (e.g., ringing in the ears), dark urine, severe stomach/abdominal pain, yellowing eyes/skin, swelling ankles/feet, fast/slow/irregular heartbeat, cold sweats, blue lips, easy bruising/bleeding, other signs of infection (e.g., fever, persistent sore throat), mental/mood changes, seizures, black stools, vomit that looks like coffee grounds.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using amphotericin/lipid complex, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: white blood cell (leukocyte) transfusions, heart disease (e.g., irregular heartbeat, congestive heart failure), liver disease, kidney disease.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.