Abelcet (amphotericin B lipid complex) Injection is an antifungalantibiotic used to treat a variety of serious fungal infections. Abelcet is available in generic form.
fast breathing 1 to 2 hours after the infusion is started
Dosage for Abelcet
The recommended dosage of Abelcet is 5 mg/kg.
What Drugs, Substances, or Supplements Interact with Abelcet?
Anti-cancer drugs, azole antifungals, cidofovir, digoxin, flucytosine, medications that affect the kidneys, medications that lower potassium levels, muscle relaxants, and zidovudine may interact with Abelcet.
Abelcet During Pregnancy and Breastfeeding
Tell your doctor all medications you use. Before taking Abelcet tell your doctor if you have had white blood cell transfusions or have heart, liver, or kidney disease. If you are pregnant only take Abelcet if clearly needed. Talk to your doctor about taking Abelcet if you are breastfeeding.
Additional Information
Our Abelcet (amphotericin B lipid complex) Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Abelcet Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Some side effects may occur during the injection. Tell your caregiver right away if you feel feverish, light-headed, or short of breath.
Call your doctor at once if you have:
new or worsening cough, wheezing, trouble breathing;
blue lips, blue colored fingers or toes;
easy bruising, unusual bleeding, purple or red spots under your skin;
kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath; or
low calcium level--muscle spasms or contractions, numbness or tingling;
low magnesium--dizziness, irregular heartbeats, feeling jittery, muscle cramps, muscle spasms, cough or choking feeling; or
low potassium level--leg cramps, constipation, fluttering in your chest, increased thirst or urination, muscle weakness or limp feeling.
Common side effects may include:
fever, chills;
nausea, vomiting; or
abnormal kidney function tests.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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, noncomparative
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 Eventsa 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
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 [email protected] or contact the FDA at 1-800-FDA-1088 or
www.fda.gov/safety/medwatch.
&Copy; Abelcet Patient Information is supplied by Cerner Multum, Inc. and Abelcet Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
