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amphotericin B phospholipid complex (Rx)Brand and Other Names:Abelcet

 
 
 

Dosing & Uses

AdultPediatric

Dosing Form & Strengths

injectable, lipid complex

  • 5mg/mL

Systemic Fungal Infection

Indicated for invasive fungal infection refractory to conventional amphotericin B desoxycholate therapy or when renal impairment or unacceptable toxicity precludes use conventional amphotericin B

5 mg/kg IV qDay; infuse IV at rate of 2.5 mg/hr  

Renal Impairment

CrCl <10 mL/min: 5 mg/kg IV q24-36hr

Other Indications & Uses

Activity shown in vitro for Aspergillus and Candida species

Activity shown in animal models for Cryptococcus sp, Coccidioidomyces sp, Histoplasma sp, and Blastomyces sp

Dosing Form & Strengths

injectable, lipid complex

  • 5mg/mL

Systemic Fungal Infection

Indicated for invasive fungal infection refractory to conventional amphotericin B desoxycholate therapy or when renal impairment or unacceptable toxicity precludes use conventional amphotericin B

As adults; 5 mg/kg IV qDay; infuse IV at rate of 2.5 mg/hr  

Renal Impairment

CrCl <10 mL/min: 5 mg/kg IV q24-36hr

Other Indications & Uses

Activity shown in vitro for Aspergillus and Candida species

Activity shown in animal models for Cryptococcus sp, Coccidioidomyces sp, Histoplasma sp, and Blastomyces sp

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Adverse Effects

>10%

Chills (18%)

Fever (14%)

Multiple organ failure (11%)

Serum creatinine increased (11%)

1-10%

Nausea (9%)

Hypotension (8%)

Respiratory Failure (8%)

Vomiting (8%)

Dyspnea (7%)

Sepsis (7%)

Diarrhea (6%)

Headache (6%)

Heart Arrest (6%)

Hypertension (5%)

Hypokalemia (5%)

Infection (5%)

Kidney Failure (5%)

Pain (5%)

Thrombocytopenia (5%)

Abdominal Pain (4%)

Anemia (4%)

Bilirubinemia (4%)

Gastrointestinal Hemorrhage (4%)

Leukopenia (4%)

Rash (4%)

Respiratory Disorder (4%)

Chest Pain (3%)

Nausea (3%)

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Warnings

Contraindications

Hypersensitivity

Cautions

Indicated for patients with progressive and potentially fatal fungal infections

Do not use for noninvasive fungal infections (eg, oral thrush, vaginal candidiasis, esophageal candidiasis) in patients with normal neurophil counts

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Pregnancy & Lactation

Pregnancy Category: B

Lactation: Unknown whether distributed in breast milk, caution advised

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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Pharmacology

Half-Life: 173.4 hr

Vd: 131 L/kg

AUC: 14 mcg•h/mL

Peak Plasma Concentration: 1.7 mcg/mL

Trough Plasma Concentration: 0.6 mcg/mL

Clearance: 436 mL/hr•kg

Mechanism of Action

Acts by binding to sterols in fungal cell membrane

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Administration

IV Incompatibilities

Solution: NaCl solutions or electrolyte solutions

IV Compatibilities

Solution: Dextrose solutions

Y-site: anidulafungin

IV Preparation

Shake vial gently until no yellow sediment visible at bottom

Withdraw dose from vial(s) into 1 or more 20 mL syringes using 18-gauge needle

Remove needle from syringe and attach 5-micron filter needle provided; 1 filter may be used for up to 4 vials

Insert filter needle into D5W IV bag of appropriate volume for dose and empty contents

Final concentration should not exceed 1 mg/mL; concentration of 2 mg/mL may be appropriate for children or fluid restricted patients

Do not use NaCl or electrolyte-containing fluids

Do not admix with other drugs or electrolytes

Do not use if precipitate or foreign matter present

IV Administration

Administer using separate infusion line; if an existing IV line is used, flush with D5W before infusion

Do not use inline filter during administration

Infusion rate: 2.5 mg/kg/hr

Prior to infusion initiation, gently shake IV container of diluted drug until contents are thoroughly mixed; infusion container should then be shaken every 2 hr if infusion time >2 hr

Do not mix with 0.9% NaCl or infuse in same IV line as other drugs

Storage

Prior to admixture, store refrigerated at 36-46°F (2- 8°C) and protected from light

Admixed with D5W, stable up to 48 hr when refrigerated at 36-46°F (2- 8°C) or up to 6 hr at room temp

Do not freeze

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Images

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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