Busulfex (Busulfan, Myleran)

Class of Drugs: Bifunctional alkylating agent

Manufacturer:
Orphan Drug Company - Busulfex
Glaxo Wellcome - Myleran

Information on Patient Assistance Program:

The Partnership for Prescription Assistance -1-888-4PPA-NOW (1-888-477-2669)

Description:  Busulfan injection is intended for intravenous administration. It is supplied as a clear, colorless, sterile, solution and should be diluted with '0.9% Sodium Chloride Injection, USP' or '5% Dextrose Injection, USP' prior to intravenous infusion. The solution should be clear with no floating particles. If there is "particulate matter" in the solution, it should not be used.

Myleran is dispensed as white scored tablets imprinted with 'MYLERAN' and "K2A on each tablet.

Ingredient: Busulfan is a white crystalline powder.

Use: Often used in bone marrow and stem cell transplants. Busulfan seems to act by interfering with the functioning of the DNA in bone marrow cells. Since the growth of normal body cells may also be affected by busulfan, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects may not be serious but may cause concern. Some effects may not occur for months or years after the medicine is used.

Warnings[LINK REQUIRES ADOBE ACROBAT READER]: All patients should be premedicated with phenytoin since busulfan is known to cross the blood brain barrier and cause seizures. In cases where other anticonvulsants are used, plasma busulfan exposure should be monitored. Antiemetics should be administered prior to the first dose of Busulfan and continued through administration of Busulfan.

Busulfan may cause fetal harm when administered to a pregnant woman.

There is increased risk of a second malignancy associated with the use of this drug. Busulfan is a presumed human carcinogen.

Side Effects: Busulfan may cause cellular damage in many organs. Cellular abnormalities have been reported in lymph nodes, pancreas, thyroid, adrenal glands, liver, lungs and bone marrow. This may be severe enough to cause difficulty in interpretation of biopsies of the lungs, bladder, breast and the uterine cervix.

Sterility, severly reduced sperm counts and testicular atrophy have been reported in male patients. Ovarian suppression and amenorrhea commonly occur in premenopausal women.

Treatment with Busulfan at the recommended dose and schedule will result in profound myelosuppression in 100% of patients. This includes granulocytopenia, thrombocytopenia, anemia, or a combined loss of formed elements of the blood. One result of this is severe impairment of the immune system. Care should be taken to avoid any contagious situation or any damage to the skin. Dental treatments should be avoided, if possible. If dental work is necessarry, tell the dentist that Busulfan is being administered so appropriate caution can be exercised.

Call your medical professional immediately if you notice black, tarry stools; blood in urine or stools; cough or hoarseness; fever or chills; inflammation of the mouth; lower back or side pain; painful or difficult urination; pinpoint red spots on skin; unusual bleeding or bruising. These are common side effects of this treatment and may be serious.

Less common, but equally serious side effects are chest pain; dizziness; fast or irregular breathing; joint pain; light-headedness; puffiness or swelling around the face; rapid heartbeat; shortness of breath; sudden, severe decrease in blood pressure; sweating; swelling of fingers, hands, arms, lower legs, or feet; sweating; tingling in lower legs, hands, or feet; blurred vision; difficulty swallowing; heartburn; severe upper abdominal and back pain; vomiting blood.

If you notice any other side effects, check with your doctor.

References: Busulfex - (Busulfan, Myleran)

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This information is intended as reference and not as medical advice. All treatment decisions should be made with your team of medical professionals and prescriptions must be given by your doctor. See TERMS AND CONDITIONS.