amphotericin B liposomal (Rx)

Brand and Other Names:AmBisome
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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

Candida auris (Off-label)

The CDC recommends considering a switch to liposomal amphotericin B if the patient is clinically unresponsive to echinocandin treatment or has persistent fungemia for >5 days

5 mg/kg IV qDay

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

Candida auris (Off-label)

Neonates and infants <2 months

  • The CDC recommends considering a switch to liposomal amphotericin B if unresponsive to amphotericin B deoxycholate
  • 5 mg/kg/day IV

≥2 months

  • The CDC recommends considering a switch to liposomal amphotericin B if the patient is clinically unresponsive to echinocandin treatment or has persistent fungemia for >5 days
  • 5 mg/kg IV qDay
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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 neutrophil counts

Acute pulmonary toxicity reported with simultaneous leukocyte transfusions

Therapy should be administered by medically trained personnel; during initial dosing period, patients should be under close clinical observation; this drug has been shown to be significantly less toxic than amphotericin B deoxycholate; however, adverse events may still occur

Drug interaction overview

  • Concurrent use of antineoplastic agents may enhance potential for renal toxicity, bronchospasm, and hypotension; antineoplastic agents should be given concomitantly with caution
  • Concurrent use of corticosteroids and ACTH may potentiate hypokalemia, which could predispose patient to cardiac dysfunction; if used concomitantly, serum electrolytes and cardiac function should be closely monitored
  • Concurrent use with digitalis glycosides may induce hypokalemia and may potentiate digitalis toxicity; when administered concomitantly, serum potassium levels should be closely monitored
  • Concurrent use of flucytosine may increase toxicity of flucytosine by possibly increasing its cellular uptake and/or impairing its renal excretion
  • In vitro and in vivo animal studies of combination of amphotericin B and imidazoles suggest that imidazoles may induce fungal resistance to amphotericin B; combination therapy should be administered with caution, especially in immunocompromised patients
  • Acute pulmonary toxicity has been reported in patients simultaneously receiving intravenous amphotericin B and leukocyte transfusions
  • Concurrent use of amphotericin B and other nephrotoxic medications may enhance potential for drug-induced renal toxicity; intensive monitoring of renal function is recommended in patients requiring any combination of nephrotoxic medications
  • Amphotericin B-induced hypokalemia may enhance curariform effect of skeletal muscle relaxants (eg tubocurarine) due to hypokalemia; when administered concomitantly, serum potassium levels should be closely monitored.

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Pregnancy & Lactation

Pregnancy

There have been no adequate and well-controlled studies in pregnant women; systemic fungal infections have been successfully treated in pregnant women with amphotericin B deoxycholate, but the number of cases reported has been small

Animal data

  • Studies in both rats and rabbits have concluded that this dosage form had no teratogenic potential in these species; in rats, maternal non-toxic dose of this drug was estimated to be 5 mg/kg (equivalent to 0.16 to 0.8 times the recommended human clinical dose range of 1 to 5 mg/kg) and in rabbits, 3 mg/kg (equivalent to 0.2 to 1 times the recommended human clinical dose range), based on body surface area correction
  • Rabbits receiving the higher doses, (equivalent to 0.5 to2 times the recommended human dose) of this dosage form experienced a higher rate of spontaneous abortions than did the control groups
  • Use during pregnancy if possible benefits to be derived outweigh potential risks involved

Lactation

Many drugs are excreted in human milk; however, it is not known whether this dosage form is excreted in human milk; due to potential for serious adverse reactions in

breastfed infants, a decision should be made whether to discontinue nursing or whether to discontinue the drug, taking into account importance of the drug to the mother

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: 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

BRAND FORM. UNIT PRICE PILL IMAGE
AmBisome intravenous
-
50 mg vial

Copyright © 2010 First DataBank, Inc.

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Patient Handout

Patient Education
amphotericin B liposome intravenous

AMPHOTERICIN/LIPID COMPLEX - INJECTION

(AM-foe-TER-i-sin/LIP-id)

COMMON BRAND NAME(S): Abelcet, Ambisome, Amphotec

USES: This medication is used to treat a variety of serious fungal infections. It is often used in patients who cannot tolerate or who do not respond to the regular amphotericin treatment. It works by stopping the growth of fungi.

HOW TO USE: This medication is usually given by injection into a vein as directed by your doctor, usually once a day. It should be injected slowly over 2 hours. Dosage is based on your medical condition, weight, and response to therapy.If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.It may be necessary to continue this medication for several weeks to several months in order to treat certain infections. Stopping the medication too early may result in a return of the infection.Tell your doctor if your condition lasts or gets worse.

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 (including acetaminophen, diphenhydramine, corticosteroids such as hydrocortisone) may be necessary to prevent or relieve these side effects. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor 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, signs of kidney problems (such as change in the amount of urine, painful urination), numbness/tingling of arms/legs, vision changes, hearing changes (such as 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 (such as sore throat that doesn't go away, fever), mental/mood changes, seizures, black stools, vomit that looks like coffee grounds.A very serious allergic reaction to this drug is rare. However, get medical help right away 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 or at www.fda.gov/medwatch.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 (such as 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.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: anti-cancer drugs (such as mechlorethamine, nitrogen mustard), azole antifungals (such as ketoconazole, itraconazole), cidofovir, digoxin, flucytosine, medications that affect the kidneys (including pentamidine, tacrolimus, aminoglycosides such as gentamicin), muscle relaxants (such as tubocurarine), zidovudine.This medication may interfere with certain laboratory tests (including phosphate levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Lab and/or medical tests (such as kidney/liver function, potassium/magnesium levels, complete blood counts) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.

STORAGE: Consult the product instructions and your pharmacist for storage details. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised December 2022. Copyright(c) 2022 First Databank, Inc.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
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  • Compare formulary status to other drugs in the same class.
  • Access your plan list on any device – mobile or desktop.

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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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.