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amphotericin B liposomal (Rx)Brand and Other Names:AmBisome

 
 
 

Dosing & Uses

AdultPediatric

Dosing Form & Strengths

powder for injection

  • 50mg/vial

Fungal Infection, Empiric Therapy

Indicated for empiric therapy for presumed fungal infection in febrile, neutropenic patients

3 mg/kg IV qDay  

Systemic Fungal Infections

Indicated for treatment of Aspergillus species, Candida species, and/or Cryptococcus species infections refractory to amphotericin B deoxycholate, or if renal impairment or unacceptable toxicity precludes use of amphotericin B deoxycholate

3-5 mg/kg IV qDay  

Cryptococcal Meningitis

Indicated for treatment of Cryptococcal meningitis in HIV-infected patients

6 mg/kg IV qDay  

Visceral Leishmaniasis

Indicated for treatment of visceral leishmaniasis

Note: relapse rate high with amphotericin B liposomal following initial clearance of parasites in patients who are immunocompromised

Immunocompetent patients

  • 3 mg/kg IV qDay on days 1-5, 14, and 21  
  • May repeat course of therapy if parasitic clearance not achieved

Immunocompromised patients

  • 4 mg/kg IV qDay on days 1-5, 10, 17, 24, 31, and 38
  • If parasitic clearance not achieved, consult infectious disease specialist for further treatment

Histoplasmosis (Orphan)

Orphan indication sponsor

  • Fujisawa USA, Inc; 3 Parkway North Center; Deerfield, IL 60015

Dosing Form & Strengths

powder for injection

  • 50mg/vial

Fungal Infection, Empiric Therapy

Indicated for empiric therapy for presumed fungal infection in febrile, neutropenic patients

As adults; 3 mg/kg IV qDay  

Systemic Fungal Infections

Indicated for treatment of Aspergillus species, Candida species, and/or Cryptococcus species infections refractory to amphotericin B deoxycholate, or if renal impairment or unacceptable toxicity precludes use of amphotericin B deoxycholate

As adults; 3-5 mg/kg IV qDay  

Cryptococcal Meningitis

Indicated for treatment of Cryptococcal meningitis in HIV-infected patients

As adults; 6 mg/kg IV qDay  

Visceral Leishmaniasis

Indicated for treatment of visceral leishmaniasis

Note: relapse rate high with amphotericin B liposomal following initial clearance of parasites in patients who are immunocompromised

Immunocompetent patients

  • As adults; 3 mg/kg IV qDay on days 1-5, 14, and 21  
  • May repeat course of therapy if parasitic clearance not achieved

Immunocompromised patients

  • As adults; 4 mg/kg IV qDay on days 1-5, 10, 17, 24, 31, and 38
  • If parasitic clearance not achieved, consult infectious disease specialist for further treatment
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Adverse Effects

>10%

Hypokalemia (31-51%)

Hypomagnesemia (15-50%)

Chills (29-48%)

Anemia (27-48%)

Nephrotoxicity (14-47%)

Nausea (16-40%)

Vomiting (11-32%)

Diarrhea (11-30%)

Rash (5-25%)

Dyspnea (18-23%)

Hyperglycemia (8-23%)

Insomnia (17-22%)

Alkaline phosphatase increase (7-22%)

Infusion reaction (4-21%)

Headache (9-20%)

Hypertension (8-20%)

Abdominal pain (7-20%)

Tachycardia (9-19%)

Lung disorder (14-18%)

Blood transfusion reaction (9-18%)

Hypocalcemia (5-18%)

Cough (2-18%)

Bilirubinemia (<18%)

Leukopenia (15-17%)

ALT increased (15%)

Constipation (15%)

Peripheral edema (15%)

Pain (14%)

Anorexia (10-14%)

Anxiety (7-14%)

Hypotension (7-14%)

Sepsis (7-14%)

AST increased (13%)

Pleural effusion (13%)

Confusion (9-13%)

Thrombocytopenia (6-13%)

Weakness (6-13%)

Back pain (12%)

Edema (10-12%)

Hyponatremia (9-12%)

Chest pain (8-12%)

Hypervolemia (8-12%)

Pruritus (11%)

Rhinitis (11%)

Phlebitis (9-11%)

1-10%

Abnormal thinking

Acidosis

Agitation

Alopecia

Arthralgia

Asthma

Bruising

Cardiovascular abnormalities

Coagulation disorder

Cellulitis

Depression

Dizziness

Electrolyte abnormalities

Fluid overload

Gastrointestinal hemorrhage

Hallucinations

Hyperventilation

Injection site reaction

Malaise

Mucositis

Petechia

Rash

Renal function abnormalities

Respiratory acidosis

Respiratory failure

Seizure

Stomatitis

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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

Caution when coadministration with other drugs that cause hypokalemia (eg, corticosteroids, digoxin)

Acute pulmonary toxicity reported with simultaneously leukocyte transfusions

Caution with other nephrotoxic medications

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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.

more...
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Pharmacology

Half-Life: 7-10 hr (at 24 hr); terminal half-life range 10-153 hr

Vd: 0.1-0.4 L/kg

AUC: 27-555 mcg•h/mL

Peak Plasma Concentration: 7.3-83 mcg/mL

Clearance: 11-51 mL/hr/kg

Mechanism of Action

Acts by binding to sterols in fungal cell membrane, leading to alterations in cell permeability and cell death

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Administration

IV Incompatibilities

Solution: NaCl solutions or electrolyte solutions

IV Compatibilities

Solution: dextrose solutions

Y-site: anidulafungin

IV Preparation

Reconstitute by adding 12 mL sterile water for injection to 50 mg-vial (resulting concentration 4 mg/mL); do not use fluids containing NaCl or bacteriostatic agent

Do not admix with other drugs or electrolytes

Shake vial vigorously for 30 seconds

Dilute further by withdrawing appropriate amount of reconstituted solution and adding to D5W to provide a final concentration of 1-2 mg/mL; lower concentrations (0.2-0.5 mg/mL) may be appropriate for infants and small children

IV Administration

May be infused through in-line filter provided pore diameter >1 micron

May be administered through existing IV line; if doing so, flush line with D5W prior to infusion, otherwise use separate line

Infuse over at least 2 hr using controlled infusion device; if well tolerated, infusion time may be reduced to 1 hr

Infusion time may need to be increase if discomfort during infusion occurs

Withdraw dosage amount into a syringe and inject through a 5-micron filter into appropriate amount of D5W

Use a controlled infusion device and an inline filter (with a mean pore diameter >1 micron)

Storage

Refrigerate unopened drug at 36-46°F (2-8°C)

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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