Busulfex

Busulfex is a prescription medication is used treat a certain type of chronic myelogenous leukemia (CML). It is used to destroy bone marrow and cancer cells prior to a bone marrow transplant. Busulfex belongs to a group of drugs called alkylating agents. These work by slowing or stopping the growth of cancer cells in your body.

This medication comes in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Common side effects include nausea, fever, diarrhea, and loss of appetite.

Oral:

Busulfan is a prescription medication used to treat a certain type of chronic myelogenous leukemia, or CML. CML is a type of cancer of the white blood cells.

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

Injectable: 

Busulfan is a prescription medication used in combination with other medications to destroy bone marrow and cancer cells in preparation for a bone marrow transplant in patients with chronic myelogenous leukemia, or CML. CML is a type of cancer of the white blood cells.

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

• ESP Pharma, Inc.

• Otsuka America Pharmaceutical, Inc.

• Otsuka America Pharmaceuticals, Inc.

• PDL BioPharma, Inc.

Oral/Injectable:

Common side effects of busulfan include:

• nausea
• diarrhea
• loss of appetite
• weight loss
• constipation
• sores in the mouth and throat
• dry mouth
• headache
• difficulty falling asleep or staying asleep
• feeling unusually anxious or worried
• dizziness
• swelling of the face, arms, hands, feet, ankles or lower legs
• chest pain
• joint, muscle or back pain
• rash
• itching and dry skin
• darkened skin
• hair loss
• black, tarry stools
• red urine
• vomiting

This is not a complete list of busulfan side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• itraconazole (Sporanox)
• acetaminophen (Tylenol)
• phenytoin (Dilantin, Phenytek)

This is not a complete list of busulfan drug interactions. Ask your doctor or pharmacist for more information.

Oral/Injectable:

Serious side effects have been reported with busulfan including the following:

• A severe decrease in the number of blood cells in your bone marrow. Tell your doctor and pharmacist about all the medications you are taking. If you receive busulfan with other medications that may cause a low blood count, the side effects of the medications may be more severe. If you experience any of the following symptoms, call your doctor immediately: fever, sore throat, ongoing cough and congestion, or other signs of infection; unusual bleeding or bruising.
• Liver complications (hepatic veno-occlusive disease)
• Heart complications (cardiac tamponade)
• Seizures
• Lung complications (pulmonary fibrosis)
• Interference with the normal menstrual cycle (period) in women
• Lowered sperm production in men
• Infertility (difficulty becoming pregnant)
• An increased risk of developing other cancers
• Report any signs of abrupt weakness, unusual fatigue, anorexia, weight loss, nausea and vomiting, skin hyperpigmentation (discoloring), drug hypersensitivity, dryness of the mucous membranes, and cataract formation.

Do not take busulfan if you are allergic to busulfan or to any of its ingredients.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of busulfan, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking busulfan, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to busulfan or to any of its ingredients
• have previously received radiation therapy or treatment with other chemotherapy medications or if you have or have ever had seizures or a head injury
• have taken busulfan before, but your cancer did not respond to the medication
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category D. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Busulfan has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from busulfan, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

Oral:

This medication comes in tablet form and is taken once a day, with or without food.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of busulfan at the same time.

Injectable:

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Take busulfan exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

Oral:

• The usual adult dose range is 4 to 8 mg, total dose, daily.
• Dosing on a weight basis is the same for both pediatric patients and adults, approximately 60 mcg/kg of body weight or 1.8 mg/m2 of body surface, daily.
• Daily doses exceeding 4 mg per day should be reserved for patients with the most compelling symptoms.

Injectable:

This medication is also available in an injectable form to be dosed by a healthcare professional.

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Oral:

• Store at room temperature.
• Dispense in a tight container.
• Keep this and all other medications out of the reach of children.

Injectable:

• Unopened vials of busulfan must be stored under refrigerated conditions between 2°-8°C (36°-46°F).
• Busulfan diluted in 0.9% Sodium Chloride or 5% Dextrose is stable at room temperature (25°C) for up to 8 hours but the infusion must be completed within that time.
• Busulfan diluted in 0.9% Sodium Chloride is stable at refrigerated conditions (2°-8°C) for up to 12 hours but the infusion must be completed within that time.

Oral:

Busulfan is a potent drug. It should not be used unless a diagnosis of chronic myelogenous leukemia has been adequately established and the responsible physician is knowledgeable in assessing response to chemotherapy.

Busulfan can induce severe bone marrow hypoplasia. Reduce or discontinue the dosage immediately at the first sign of any unusual depression of bone marrow function as reflected by an abnormal decrease in any of the formed elements of the blood. A bone marrow examination should be performed if the bone marrow status is uncertain.

Injectable:

Busulfan is a potent cytotoxic drug that causes profound myelosuppression at the recommended dosage. It should be administered under the supervision of a qualified physician who is experienced in allogeneic hematopoietic stem cell transplantation, the use of cancer chemotherapeutic drugs and the management of patients with severe pancytopenia. Appropriate management of therapy and complications is only possible when adequate diagnostic and treatment facilities are readily available.