AmBisome

Name: AmBisome

Amphotericin B Liposomal Interactions

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Other drugs may interact with amphotericin B liposomal, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Proper Use of Ambisome

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For the treatment of infection caused by fungus or protozoa
    • For injection dosage form:
      • Adults and children: 3 to 6 milligrams (mg) per kilogram (1.36 to 2.73 mg per pound) of body weight once a day, injected slowly into a vein. The number of days that you receive this treatment depends on the medical problem for which you are receiving amphotericin B liposomal complex.

Ambisome Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

More common
  • Chills
  • fever
  • irregular heartbeat
  • muscle cramps or pain
  • unusual tiredness or weakness
Less common
  • Back pain
  • chest pain
  • dark urine
  • difficulty in breathing
  • headache
  • yellowing of eyes or skin
Rare
  • Difficulty in swallowing
  • hives
  • itching, especially of feet or hands
  • reddening of skin, especially around ears
  • swelling of eyes, face, or inside of nose
  • unusual tiredness or weakness (sudden and severe)

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Abdominal pain
  • cough
  • diarrhea
  • dizziness
  • nausea
  • vomiting
Less common
  • Skin rash

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

What are some things I need to know or do while I take AmBisome?

  • Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
  • This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take AmBisome.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.

Principal Display Panel

AmBisome 
amphotericin b injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0469-3051
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMPHOTERICIN B (AMPHOTERICIN B) AMPHOTERICIN B 50 mg  in 12.5 mL
Packaging
# Item Code Package Description
1 NDC:0469-3051-30 12.5 mL in 1 VIAL, SINGLE-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050740 08/11/1997
Labeler - Astellas Pharma US, Inc. (605764828)
Revised: 05/2012   Astellas Pharma US, Inc.

What is amphotericin b liposomal (ambisome)?

Amphotericin B liposomal is an antifungal antibiotic that fights infections caused by fungus.

Amphotericin B liposomal is used to treat serious, life-threatening fungal infections including leishmaniasis, and a certain form of meningitis in people infected with HIV (human immunodeficiency virus). Amphotericin B liposomal is not for treating a minor fungal infection such as a yeast infection of the mouth, esophagus, or vagina.

Amphotericin B liposomal may also be used for purposes not listed in this medication guide.

What happens if I miss a dose?

Since AmBisome is usually given while you are in the hospital, you are not likely to miss a dose.

If you are receiving AmBisome in an outpatient clinic, call your doctor if you will miss an appointment for your injection.

Usual Adult Dose for Aspergillosis - Invasive

Systemic fungal infections: 3 to 5 mg/kg IV once a day

Doses as high as 10 mg/kg have been used in patients with documented Aspergillus infection.

The addition of flucytosine 25 to 37.5 mg/kg orally every 6 hours may be considered in HIV-infected patients with invasive candidiasis.

The total dose administered or duration of therapy will vary and depend on the nature and severity of the infection and the patient's tolerance to amphotericin B liposomal.

Usual Pediatric Dose for Cryptococcal Meningitis - Immunosuppressed Host

1 month or older:
HIV-infected patient: 6 mg/kg IV once a day

The addition of flucytosine 25 mg/kg orally every 6 hours may be considered.

The total dose administered or duration of therapy will vary and depend on the nature and severity of the infection and the patient's tolerance to amphotericin B liposomal.

Usual Pediatric Dose for Leishmaniasis

1 month or older:
Visceral leishmaniasis:
Immunocompetent patient: 3 mg/kg IV once a day on day 1 through 5, day 14, and day 21
Immunocompromised patient: 4 mg/kg IV once a day on day 1 through 5, day 10, day 17, day 24, day 31, and day 38

If the immunocompetent patient does not achieve parasitic clearance, a repeat course of therapy may be effective. If the immunocompromised patient does not achieve parasitic clearance or experiences a relapse, expert advice regarding future treatment is recommended.

Renal Dose Adjustments

Data not available

Dialysis

Data not available

Usual Adult Dose for Ocular Fungal Infection

5 to 10 micrograms INTRAVITREALLY
-Use with systemic voriconazole.


Comments:
-Local drug concentration is lower if injected at the end of a pars plana vitrectomy, reducing retinal toxicity concerns.

Use(s): Aspergillus endophthalmitis

Usual Adult Dose for Aspergillosis - Invasive

**VERIFY PRODUCT NAME AND DOSAGE, ESPECIALLY IF DOSE EXCEEDS 1.5 MG/KG**

Test dose: 1 mg in 20 mL dextrose, slow IV over 20 to 30 minutes, with monitoring for 2 to 4 hours afterward.
Initial dose (patients with good cardio-renal function and well tolerated test dose): 0.25 mg/kg slow IV daily
Initial dose (severe and rapidly progressive infection): 0.3 mg/kg slow IV daily
Initial dose (patients with impaired cardio-renal function OR severe reaction to test dose): use smaller doses (e.g. 5 to 10 mg)
-Gradually increase dose by 5 to 10 mg/day to a final daily dose of 0.5 to 0.7 mg/kg IV once a day depending on cardio-renal status.

Maximum dose: 1.5 mg/kg total daily dose - UNDER NO CIRCUMSTANCES SHOULD THIS DOSE BE EXCEEDED

Cumulative dose: Up to 3.6 grams
Duration of therapy: Up to 11 months

Comments:
-Administer primarily for progressive, potentially life-threatening fungal infections.
-Excess dosage can lead to potentially fatal cardiac or cardiopulmonary arrest.
-Administer by slow IV infusion, over approximately 2 to 6 hours, depending on dose.
-The recommended concentration for infusion is 0.1 mg/mL.
-Patient tolerance varies greatly; individualize dose based on patient clinical status (e.g. site and severity of infection, cardio-renal function).
-A single test dose is preferred; monitor temperature, pulse, respiration, and blood pressure every 30 minutes for 2 to 4 hours.
-Optimal daily doses and ideal treatment durations are unknown.

Usual Adult Dose for Blastomycosis

**VERIFY PRODUCT NAME AND DOSAGE, ESPECIALLY IF DOSE EXCEEDS 1.5 MG/KG**

Test dose: 1 mg in 20 mL dextrose, slow IV over 20 to 30 minutes, with monitoring for 2 to 4 hours afterward.
Initial dose (patients with good cardio-renal function and well tolerated test dose): 0.25 mg/kg slow IV daily
Initial dose (severe and rapidly progressive infection): 0.3 mg/kg slow IV daily
Initial dose (patients with impaired cardio-renal function OR severe reaction to test dose): use smaller doses (e.g. 5 to 10 mg)
-Gradually increase dose by 5 to 10 mg/day to the final daily dose.

Pulmonary blastomycosis (moderately severe to severe): 0.7 to 1 mg/kg IV once a day for 1 to 2 weeks or until improvement is noted
-Follow with oral itraconazole.

Disseminated extrapulmonary blastomycosis(moderately severe to severe): 0.7 to 1 mg/kg IV once a day for 1 to 2 weeks or until improvement is noted
-Follow with oral itraconazole.

Immunocompromised patients with blastomycosis: 0.7 to 1 mg/kg IV once a day for 1 to 2 weeks or until improvement is noted

Maximum dose: 1.5 mg/kg total daily dose - UNDER NO CIRCUMSTANCES SHOULD THIS DOSE BE EXCEEDED

Comments:
-Administer primarily for progressive, potentially life-threatening fungal infections.
-Excess dosage can lead to potentially fatal cardiac or cardiopulmonary arrest.
-Administer by slow IV infusion, over approximately 2 to 6 hours, depending on dose.
-The recommended concentration for infusion is 0.1 mg/mL.
-Patient tolerance varies greatly; individualize dose based on patient clinical status (e.g. site and severity of infection, cardio-renal function).
-A single test dose is preferred; monitor temperature, pulse, respiration, and blood pressure every 30 minutes for 2 to 4 hours.
-Optimal daily doses and ideal treatment durations are unknown.

Usual Adult Dose for Candida Urinary Tract Infection

**VERIFY PRODUCT NAME AND DOSAGE, ESPECIALLY IF DOSE EXCEEDS 1.5 MG/KG**

Test dose: 1 mg in 20 mL dextrose, slow IV over 20 to 30 minutes, with monitoring for 2 to 4 hours afterward.
Initial dose (patients with good cardio-renal function and well tolerated test dose): 0.25 mg/kg slow IV daily
Initial dose (severe and rapidly progressive infection): 0.3 mg/kg slow IV daily
Initial dose (patients with impaired cardio-renal function OR severe reaction to test dose): use smaller doses (e.g. 5 to 10 mg)
-Gradually increase dose by 5 to 10 mg/day to the final daily dose.

Patients undergoing urologic procedures: 0.3 to 0.6 mg/kg IV once a day for several days before and after the procedure

Fluconazole-resistant candida glabrata: 0.3 to 0.6 mg/kg IV once a day for 1 to 7 days

Symptomatic ascending candida pyelonephritis from fluconazole-resistant candida glabrata: 0.3 to 0.6 mg/kg IV once a day for 1 to 7 days
-Use with or without flucytosine

Symptomatic ascending candida pyelonephritis from fluconazole-resistant candida kryseu: 0.3 to 0.6 mg/kg IV once a day for 1 to 7 days

Maximum IV dose: 1.5 mg/kg total daily dose - UNDER NO CIRCUMSTANCES SHOULD THIS DOSE BE EXCEEDED


Cystitis due to fluconazole-resistant species: 50 mg/mL in sterile water as a bladder irrigation once a day for 5 days

Candida urinary tract infection with fungus balls in patients with nephrostomy tubes: 25 to 50 mg in 200 to 500 mL sterile water IRRIGATED THROUGH the nephrostomy tubes


Comments:
-Administer primarily for progressive, potentially life-threatening fungal infections.
-Excess dosage can lead to potentially fatal cardiac or cardiopulmonary arrest.
-Administer by slow IV infusion, over approximately 2 to 6 hours, depending on dose.
-The recommended concentration for infusion is 0.1 mg/mL.
-Patient tolerance varies greatly; individualize dose based on patient clinical status (e.g. site and severity of infection, cardio-renal function).
-A single test dose is preferred; monitor temperature, pulse, respiration, and blood pressure every 30 minutes for 2 to 4 hours.
-Optimal daily doses and ideal treatment durations are unknown.
-Four week induction therapy is reserved for meningoencephalitis without neurological complications and cerebrospinal fluid yeast cultures that are negative after 2 weeks of treatment.
-In patients with neurological complications, consider using 6 weeks of induction therapy.
-If flucytosine is not given or treatment is interrupted, consider lengthening induction treatment at least 2 weeks.
-Patients at low risk of therapeutic failure (e.g. early diagnosis, no uncontrolled underlying disease, not immunocompromised, and excellent clinical response) consider decreasing induction treatment to 2 weeks.

Use(s): Candiduria

Usual Adult Dose for Coccidioidomycosis

**VERIFY PRODUCT NAME AND DOSAGE, ESPECIALLY IF DOSE EXCEEDS 1.5 MG/KG**

Test dose: 1 mg in 20 mL dextrose, slow IV over 20 to 30 minutes, with monitoring for 2 to 4 hours afterward.
Initial dose (patients with good cardio-renal function and well tolerated test dose): 0.25 mg/kg slow IV daily
Initial dose (severe and rapidly progressive infection): 0.3 mg/kg slow IV daily
Initial dose (patients with impaired cardio-renal function OR severe reaction to test dose): use smaller doses (e.g. 5 to 10 mg)
-Gradually increase dose by 5 to 10 mg/day to the final daily dose.

Severe, non-meningeal infection: 0.7 to 1 mg/kg/day IV
Duration of therapy: Until clinical improvement
-Follow with a triazole.

Maximum dose: 1.5 mg/kg total daily dose - UNDER NO CIRCUMSTANCES SHOULD THIS DOSE BE EXCEEDED

Comments:
-Administer primarily for progressive, potentially life-threatening fungal infections.
-Excess dosage can lead to potentially fatal cardiac or cardiopulmonary arrest.
-Administer by slow IV infusion, over approximately 2 to 6 hours, depending on dose.
-The recommended concentration for infusion is 0.1 mg/mL.
-Patient tolerance varies greatly; individualize dose based on patient clinical status (e.g. site and severity of infection, cardio-renal function).
-A single test dose is preferred; monitor temperature, pulse, respiration, and blood pressure every 30 minutes for 2 to 4 hours.
-Optimal daily doses and ideal treatment durations are unknown.

Use(s): Coccidioidomycosis

Usual Pediatric Dose for Cryptococcal Meningitis - Immunosuppressed Host

**VERIFY PRODUCT NAME AND DOSAGE, ESPECIALLY IF DOSE EXCEEDS 1.5 MG/KG**

Test dose: 1 mg in 20 mL dextrose, slow IV over 20 to 30 minutes, with monitoring for 2 to 4 hours afterward.
Initial dose (patients with good cardio-renal function and well tolerated test dose): 0.25 mg/kg slow IV daily
Initial dose (severe and rapidly progressive infection): 0.3 mg/kg slow IV daily
Initial dose (patients with impaired cardio-renal function OR severe reaction to test dose): use smaller doses (e.g. 5 to 10 mg)
-Gradually increase dose by 5 to 10 mg/day to the final daily dose.

Induction dose: 0.7 to 1 mg/kg IV once a day - with concomitant fluconazole or flucytosine
Duration of therapy: 5 to 7 days

Maximum dose: 1.5 mg/kg total daily dose - UNDER NO CIRCUMSTANCES SHOULD THIS DOSE BE EXCEEDED


Comments:
-Administer primarily for progressive, potentially life-threatening fungal infections.
-Excess dosage can lead to potentially fatal cardiac or cardiopulmonary arrest.
-Administer by slow IV infusion, over approximately 2 to 6 hours, depending on dose.
-The recommended concentration for infusion is 0.1 mg/mL.
-Patient tolerance varies greatly; individualize dose based on patient clinical status (e.g. site and severity of infection, cardio-renal function).
-A single test dose is preferred; monitor temperature, pulse, respiration, and blood pressure every 30 minutes for 2 to 4 hours.
-Optimal daily doses and ideal treatment durations are unknown.

Use(s): HIV-infected patients or organ transplant recipients with cryptococcal disease (meningeal and disseminated non-meningeal)

Liver Dose Adjustments

Data not available

Other Comments

Administration advice:
- VERIFY PRODUCT NAME AND DOSAGE, ESPECIALLY IF DOSE EXCEEDS 1.5 MG/KG
-Whenever therapy is interrupted for 7 days or longer, resume therapy at the lowest dosage level and increase as outlined in dosage guidelines.

Storage requirements:
-Refrigerate; protect from light.

Monitoring:
-Monitor renal function frequently during therapy.
-Regularly monitor liver function, serum electrolytes (particularly potassium and magnesium), blood counts, and hemoglobin concentrations.
-Use lab test results to guide dose adjustments.

Amphotericin b Pregnancy Warnings

Animal studies showed no evidence of fetal harm, however one animal model showed a higher rate of spontaneous abortions. There are no controlled data in human pregnancy. This drug crosses the placenta, with cord blood to maternal serum ratios ranging from 0.38 to 1. A small number of systemic fungal infections have been successfully treated with the injectable form of this medication without obvious fetal effects. AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus. AU TGA pregnancy category: B3 US FDA pregnancy category: B

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