Abelcet
- Generic Name: amphotericin b injection
- Brand Name: Abelcet
Abelcet (Amphotericin B Injection) side effects drug center
What Is Abelcet?
Abelcet (amphotericin B lipid complex) Injection is an antifungal antibiotic used to treat a variety of serious fungal infections. Abelcet is available in generic form.
What Are Side Effects of Abelcet?
Side effects of Abelcet include:
- chills,
- fever,
- shaking,
- flushing,
- loss of appetite,
- dizziness,
- nausea,
- vomiting,
- headache,
- shortness of breath, or
- 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.
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;
- slow heart rate, weak pulse, fainting, slow breathing (breathing may stop);
- 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.
Read the entire detailed patient monograph for Abelcet (Amphotericin B Injection)
SIDE EFFECTS
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
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 [email protected] or contact the FDA at 1-800-FDA-1088 or www.fda.gov/safety/medwatch.
Read the entire FDA prescribing information for Abelcet (Amphotericin B Injection)
© 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.