Amphotericin B Injection

Amphotericin B injection comes as a solid powder cake to be made into a solution and then injected intravenously (into a vein) by a nurse or a doctor. Amphotericin B injection is usually infused (injected slowly) intravenously over a period of 2 to 6 hours once daily. Before you receive your first dose, you may receive a test dose over 20 to 30 minutes to see if you can tolerate the medication. 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 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 injection: fever, chills, loss of appetite, nausea, vomiting, dizziness, breathing problems, or headache.

You may receive amphotericin B injection in a hospital or you may use the medication at home. If you will be using amphotericin B 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 injection.

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

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

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

• stomach pain or cramping
• heartburn
• diarrhea
• weight loss
• bone, muscle, or joint pain
• lack of energy
• 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
• blisters or hives
• flushing
• wheezing
• difficulty breathing
• itching
• yellowing of the skin or eyes
• decreased urination

Amphotericin B 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 (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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 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.

The total safety data base is composed of 921 patients treated with ABELCET® (amphotericin b) (5 patients were enrolled twice and counted as separate patients), of whom 775 were treated with 5 mg/kg/day. Of these 775 patients, 194 patients were treated in four comparative studies; 25 were treated in open-label, non-comparative studies; and 556 patients were treated in an open-label, emergency-use program. Most had underlying hematologic neoplasms, and many were receiving multiple concomitant medications. Of the 556 patients treated with ABELCET® (amphotericin b) , 9% discontinued treatment due to adverse events regardless of presumed relationship to study drug.

In general, the adverse events most commonly reported with ABELCET® (amphotericin b) were transient chills and/or fever during infusion of the drug.

Adverse Eventsa with an Incidence of ≥ 3% (N=556)

The following adverse events have also been reported in patients using ABELCET® (amphotericin b) in open-label, uncontrolled clinical studies. The causal association between these adverse events and ABELCET® (amphotericin b) is uncertain.

Body as a whole: malaise, weight loss, deafness, injection site reaction including inflammation

Allergic: bronchospasm, wheezing, asthma, anaphylactoid and other allergic reactions

Cardiopulmonary:cardiac failure, pulmonary edema, shock, myocardial infarction, hemoptysis, tachypnea, thrombophlebitis, pulmonary embolus, cardiomyopathy, pleural effusion, arrhythmias including ventricular fibrillation.

Dermatological: maculopapular rash, pruritus, exfoliative dermatitis, erythema multiforme

Gastrointestinal:acute liver failure, hepatitis, jaundice, melena, anorexia, dyspepsia, cramping, epigastric pain, veno-occlusive liver disease, diarrhea, hepatomegaly, cholangitis, cholecystitis

Hematologic:coagulation defects, leukocytosis, blood dyscrasias including eosinophilia

Musculoskeletal: myasthenia, including bone, muscle, and joint pains

Neurologic: convulsions, tinnitus, visual impairment, hearing loss, peripheral neuropathy, transient vertigo, diplopia, encephalopathy, cerebral vascular accident, extrapyramidal syndrome and other neurologic symptoms

Urogenital: oliguria, decreased renal function, anuria, renal tubular acidosis, impotence, dysuria

Serum electrolyte abnormalities: hypomagnesemia, hyperkalemia, hypocalcemia, hypercalcemia

Liver function test abnormalities: increased AST, ALT, alkaline phosphatase, LDH

Renal function test abnormalities: increased BUN

Other test abnormalities: acidosis, hyperamylasemia, hypoglycemia, hyperglycemia, hyperuricemia, hypophosphatemia

Amphotericin B desoxycholate overdose has been reported to result in cardio-respiratory arrest. Fifteen patients have been reported to have received one or more doses of ABELCET® (amphotericin b) between 7-13 mg/kg. None of these patients had a serious acute reaction to ABELCET® (amphotericin b) . If an overdose is suspected, discontinue therapy, monitor the patient's clinical status, and administer supportive therapy as required. ABELCET® (amphotericin b) is not hemodialyzable.

See also Warning section.

This medication is used to treat a variety of serious, possibly fatal fungal infections. It works by stopping the growth of fungi.

How to use Amphotericin B Vial

This medication is usually given by injection into a vein as directed by your doctor, usually given once a day or every other day. It should be injected slowly over 2 to 6 hours. Your doctor may give you a smaller dose first to test your response to the medication. Dosage is based on your medical condition, weight, response to the test dose, and response to therapy. If this medication is stopped for 7 days or longer, then it should be restarted at the lowest dose and slowly increased.

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 persists or worsens.

Fever, shaking, chills, flushing, loss of appetite, dizziness, nausea, vomiting, headache, shortness of breath, or fast breathing may occur 1 to 3 hours after the infusion is started. In some cases, other medications (e.g., acetaminophen, diphenhydramine, corticosteroids such as hydrocortisone) may be necessary to prevent or relieve these side effects. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she 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 (e.g., 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 (e.g., fever, persistent sore throat), mental/mood changes, seizures, black stools, vomit that looks like coffee grounds.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention 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.

Before using amphotericin, 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 (e.g., 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.