AmBisome is given through an intravenous (IV) injection into the veins. Due to its potentially severe side effects, it is only prescribed when a fungal or parasitic infection is so severe that few other treatment options are available.
What Is AmBisome Used for?
The Food and Drug Administration (FDA) approved AmBisome to treat severe and potentially life-threatening fungal infections, such as:
Brand Name: AmBisome
Drug Availability: Prescription
Therapeutic Classification: Antifungal
Available Generically: Yes
Controlled Substance: N/A
Administration Route: Injection
Active Ingredient: Amphotericin B liposome
Dosage Form: Powder for solution
Invasive Aspergillus Presumed fungal infection in people with febrile neutropenia, which is a persistent drop in a type of white blood cell called neutrophils that causes fever and leaves a person vulnerable to opportunistic infections Invasive Candidiasis Cryptococcal meningitis in people with human immunodeficiency virus (HIV)
People who are severely immunocompromised, such as those with advanced HIV, are at a high risk of opportunistic fungal infections.
AmBisome is also used to treat a parasitic infection known as visceral leishmaniasis.
Leishmaniasis is a tropical disease spread by the bite of certain sandflies. It can cause severe ulcers of the skin, mouth, and nose. Visceral leishmaniasis occurs when the parasite spreads to internal organs such as the spleen, liver, and bone marrow. If left untreated, visceral leishmaniasis will almost always lead to death.
How to Take AmBisome
AmBisome is given by IV infusion, usually in a hospital but sometimes in a home care setting by a nurse.
Each vial of AmBisome contains 50 milligrams (mg) of amphotericin B in powdered form, reconstituted with sterile water. Once reconstituted, the health provider will insert a needle into a vein in your arm and slowly administer the drug through a controlled IV drip.
The dose is delivered at a slow, steady pace over two hours to reduce the risk of an adverse reaction. As a precaution, the first dose may be administered for 10 minutes and then stopped for 30 minutes. If there is no reaction, the rest of the drug can be administered.
In people who have tolerated a previous dose of AmBisome, the infusion time may be decreased to one hour.
Storage
AmBisome vials are stored by the healthcare provider at room temperature (about 77 degrees Fahrenheit).
Off-Label Uses
AmBisome is sometimes used off-label for other severe systemic fungal infections, including:
BlastomycosisCoccidiomycosisHistoplasmosisMucormycosis
It has also been used to treat amoebic meningoencephalitis, a severe infection caused when one-celled amoebas invade the brain, spinal cord, and meningeal membranes of the central nervous system.
Off-label use means a drug is prescribed for conditions that the FDA has not approved to treat but has demonstrated benefits for.
What Are the Side Effects of AmBisome?
This is not a complete list of side effects and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 800-FDA-1088.
AmBisome is used with caution when the benefits of treatment outweigh the risks. Side effects are common, some of which can be severe.
Common Side Effects
The list of AmBisome side effects is extensive, ranging in severity from mild to life-threatening. Although AmBisome is well tolerated in some people, many have some form of a side effect.
Common side effects of AmBisome include:
Flu-like symptoms, such as chills, cough, headache, and sneezing or nasal congestion Gastrointestinal-related effects like diarrhea or heartburn Insomnia (trouble sleeping) Blood in urine Cold hands or feet Swelling of the ankles or feet Nosebleed Pale skin Dizziness Rapid heartbeat Weakness Muscle, bone, or joint pain Anxiety Itchiness
The risk of side effects is mainly dose-dependent, meaning that higher doses translate to a greater risk of side effects.
Premarket studies (performed before the drug is available for sale) suggest that teenagers and children under the age of 16 tend to tolerate AmBisome better than adults.
Severe Side Effects
A potentially life-threatening, whole-body allergy known as anaphylaxis can occur in some people who received AmBisome. Amphotericin B hypersensitivity occurs within three hours of the infusion, although the most severe reactions often occur within the first 15 minutes of an infusion.
Even so, hypersensitive reactions to AmBisome are considered rare and are more likely to occur with conventional, non-liposomal forms of amphotericin B.
Signs of a severe hypersensitive reaction to amphotericin B include:
Severe flu-like symptoms, such as high fever or headacheSkin reactions like rashes or hivesGastrointestinal effects such as nausea or vomitingDrowsinessGeneralized weaknessShortness of breath, wheezing, or shallow, rapid breathingDizziness or fainting
In addition to drug hypersensitivity, amphotericin B has been known to cause acute kidney injury in rare instances. Although the risk is highest in people with preexisting kidney disease, amphotericin B has been known to cause harm in those with no history of kidney problems.
Call your healthcare provider immediately if you have serious side effects after using AmBisome. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency. These include symptoms of acute kidney failure, such as:
Decreased urine output or no urination Shortness of breath Chest pain or pressure Extreme fatigue Nausea or vomiting Swelling of the legs, feet, or ankles Irregular heartbeat Confusion Seizures
Long-Term Side Effects
AmBisome is generally not used on a long-term basis. If used consistently over time, AmBisome can interfere with the production of erythropoietin (EPO), a hormone produced by the kidneys that plays a key role in the synthesis of red blood cells. This, in turn, can lead to a form of anemia called normocytic anemia, which can be relieved with an injection of Epogen (synthetic EPO).
Dosage: How Much AmBisome Should I Take?
Modifications
Your AmBisome dose can change depending on body weight and the condition being treated.
If you experience a serious side effect, you or your healthcare provider may send a report to the FDA’s MedWatch Adverse Event Reporting Program or by phone (800-332-1088).
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.
The dose is not adjusted by age, kidney function, or immune status. The only exception is the use of AmBisome in treating visceral leishmaniasis. Immunocompromised people require a higher dose and longer duration of therapy than immunocompetent people.
People with kidney disease may need to undergo kidney function tests before, during, and after treatment.
Overdose: What Happens If I Take Too Much AmBisome?
There is limited information about the risk of an AmBisome overdose, given that a healthcare provider administers the drug in a controlled setting.
According to the manufacturer, there have been no reports of dose-related toxicity in clinical studies involving children given daily doses of up to 10 milligrams per kilogram (mg/kg) per day or adults given daily doses of up to 15 mg/kg per day.
What Are Reasons I Shouldn’t Take AmBisome?
People who have had a hypersensitive reaction to amphotericin B or any of the other components of the drug should not be given AmBisome unless the benefits of treatment outweigh the risks.
If someone collapses or isn’t breathing after taking AmBisome, call 911 immediately.
Nonhuman animal studies have not shown any risk of fetal harm when AmBisome is used during pregnancy but no well-controlled studies in humans are available. Careful consultation is needed to weigh the benefits and risks of treatment if you are pregnant or breastfeeding.
What Other Medications Interact With AmBisome?
A significant number of drugs are known to interact with AmBisome. The interactions don’t necessarily contraindicate the use of accompanying drugs, but intensive monitoring of kidney function is recommended.
Let your healthcare provider know if you take any of the following:
Angiotensin converting enzyme (ACE) inhibitors, like Zestril (lisinopril) and Accupril (quinapril) Ancobon (flucytosine) Antibiotics, such as penicillins, quinolones, and cephalosporins Antivirals like Zovirax (acyclovir) Calcineurin inhibitors like Prograf (tacrolimus) Chemotherapy drugs Chinese herbs Diuretics, like Lasix (furosemide) and Demadex (torsemide) Haldol (haloperidol) Nonsteroidal anti-inflammatory drugs (NSAIDs), such as Advil (ibuprofen) or Aleve (naproxen) Lithium Trexall (methotrexate) Sandimmune (cyclosporine) Proton pump inhibitors, like Prilosec (omeprazole)
A wide range of nephrotoxic drugs can increase the risk of kidney side effects when taken with AmBisome. Nephrotoxic drugs are medications that can cause damage to the kidneys. Other drugs can interact with AmBisome for different reasons, either by causing toxicities that affect the heart or lungs or reducing the effectiveness of amphotericin B.
Other drugs that interact with AmBisome include:
Azole antifungals like Diflucan (fluconazole) or Nizoral (ketoconazole) Corticosteroids like prednisone or dexamethasone Digoxin (digitalis) Leukocyte transfusions
This is not a complete drug interaction list for AmBisome. Other interactions may occur. To avoid interactions, let your healthcare provider know if you take any prescription, over-the-counter (OTC), herbal, nutritional, or recreational drugs.
What Medications Are Similar?
In addition to AmBisome, there are three other forms of amphotericin B used in the treatment of severe fungal infections:
Amphotericin B conjugated with deoxycholateAmphotericin B colloid dispersionAbelcet (amphotericin B lipid complex)
While amphotericin B conjugated with deoxycholate—often referred to as conventional amphotericin B—is highly effective in treating invasive fungal infections (particularly of the brain), the risk of acute kidney injury offsets the benefits. The risk can be reduced somewhat with colloidal dispersion formulations that require a lower dose. The risk of kidney injury is even lower with amphotericin B lipid complex.
How Can I Stay Healthy While Taking AmBisome?
Invasive fungal infections are usually the consequence of an underlying medical condition that affects how the immune system works. Without a properly working immune system, fungi that normally inhabit the body can suddenly overgrow and invade tissues throughout the body.
When an infection becomes invasive, only aggressive interventions like amphotericin B can bring it under control. At the same time, your healthcare provider will want to address the underlying condition that has compromised the immune system in the first place.
For example, if you have HIV, taking antiretroviral therapy can help suppress the virus to undetectable levels and allow your immune system to rebuild itself. Even people with life-threatening HIV-associated infections can fully recover and thrive when placed on lifelong antiretroviral drugs.
Other interventions may be needed for those with other forms of immune suppression, including organ and stem cell transplant recipients. This may include vaccination, prophylactic drugs to reduce the risk of infection, and preventive practices like handwashing, improved food hygiene, and avoiding respiratory infections.
