Amphotericin B Liposomal Injection

Amphotericin B liposomal injection is used to treat fungal infections such as cryptococcal meningitis (a fungal infection of the lining of the spinal cord and brain) and visceral leishmaniasis (a parasitic disease that usually affects spleen, liver, and bone marrow) in certain people. It is also used to treat certain fungal infections in people who cannot receive conventional amphotericin B therapy. Amphotericin B liposomal injection is in a class of medications called antifungals. It works by slowing the growth of fungi that cause infection.

Amphotericin B liposomal injection comes as a suspension (liquid) to be injected intravenously (into a vein). It is usually infused intravenously once daily, or for the treatment of leishmaniasis on specific days, over a period of 2 hours. If previous doses are tolerated, this medication may be given over a period of 1 hour. The length of your treatment depends on your general health, how you tolerate the medication, and the type of infection you have.

You may experience a reaction while you receive a dose of amphotericin B liposomal complex injection. These reactions usually happen 1 to 3 hours after starting your infusion and are more severe with the first few doses. Your health care provider may prescribe other medications to decrease these side effects. Tell your doctor immediately if you experience any of these symptoms while you receive amphotericin B liposomal complex injection: fever, chills, nausea, vomiting, flushing, back pain with or without chest tightness, chest pain, shortness of breath, breathing problems, or a fast, irregular, or pounding heartbeat.

You may receive amphotericin B liposomal injection in a hospital or you may use the medication at home. If you will be using amphotericin B liposomal injection at home, your healthcare provider will show you how to infuse the medication. Be sure that you understand these directions, and ask your healthcare provider if you have any questions. Ask your healthcare provider what to do if you have any problems infusing amphotericin B liposomal injection.

If your symptoms do not improve or get worse while receiving amphotericin B liposomal injection, tell your doctor. If you still have symptoms of infection after you finish amphotericin B liposomal injection, tell your doctor.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before receiving amphotericin B liposomal injection,

• tell your doctor and pharmacist if you are allergic to amphotericin B, any other medications, or any of the ingredients in amphotericin B liposomal injection. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: aminoglycoside antibiotics such as amikacin, gentamicin, or tobramycin (Bethkis, Kitabis Pak, Tobi); antifungals such as clotrimazole, fluconazole (Diflucan), itraconazole (Onmel, Sporanox), ketoconazole (Extina, Nizoral, Xolegel), and miconazole (Oravig, Monistat); medications for the treatment of cancer; corticotropin (H.P. Acthar Gel); cyclosporine (Gengraf, Neoral, Sandimmune); digoxin (Lanoxin); flucytosine (Ancobon); and steroids taken orally such as dexamethasone, methylprednisolone (Medrol), and prednisone (Rayos). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you are receiving leukocyte (white blood cell) transfusions.
• tell your doctor if you have or have ever had kidney disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while receiving amphotericin B liposomal injection, call your doctor. Do not breast-feed while receiving amphotericin B liposomal injection.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are receiving amphotericin B liposomal injection.

Unless your doctor tells you otherwise, continue your normal diet.

Amphotericin B liposomal injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• stomach pain
• heartburn
• diarrhea
• constipation
• loss of appetite
• redness or swelling at the injection site
• pale skin
• shortness of breath
• dizziness
• headache
• coldness in the hands and feet

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• rash
• hives
• difficulty breathing
• itching
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• chest pain or tightness
• black and tarry stools
• decreased urination
• blood in the urine

Amphotericin B liposomal injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests during your treatment to check your body's response to amphotericin B liposomal injection.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are receiving amphotericin B liposomal injection.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• AmBisome^®