Busulfex, illustration of injection vial form (not a photo of the actual pack)

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Busulfex

Busulfan

Prescription required

$551.00

60mg · 1 vial

BrandBranded medicine· By Otsuka America Pharmaceutical

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FDA boxed warningMyelosuppression

BUSULFEX (busulfan) Injection causes severe and prolonged myelosuppression at the recommended dosage. Hematopoietic progenitor cell transplantation is required to prevent potentially fatal complications of the prolonged myelosuppression.

Read this with the rest of the clinical information

About Busulfex

Overview

Busulfex contains busulfan, an alkylating medicine supplied in a vial for intravenous use after dilution. It is used with cyclophosphamide to prepare patients with chronic myelogenous leukemia (CML) for a blood-forming stem cell transplant from a donor. It works by damaging DNA, which is thought to account for much of its cell-killing effect.

What it treats

Used with cyclophosphamide to prepare patients with chronic myelogenous leukemia (CML) for a blood-forming stem cell transplant from a donor.

Safety information

Side effects

Common side effects include reduced blood cell production (bone marrow suppression), nausea, mouth inflammation or sores, vomiting, loss of appetite, diarrhoea, difficulty sleeping, fever, abdominal pain, anxiety and headache. Low magnesium, low potassium and high blood sugar are also common. Serious side effects that require prompt medical attention include bone marrow suppression, seizures, blockage of small veins in the liver (hepatic veno-occlusive disease), pressure on the heart from fluid around it (cardiac tamponade), lung damage (bronchopulmonary dysplasia) and abnormal changes in cells (cellular dysplasia). Contact your doctor promptly about these problems; seek immediate medical help for a seizure. Treatment to prevent seizures is started before Busulfex, and daily liver blood tests are needed during treatment. Busulfex can harm an unborn baby. Effective contraception is needed; contact your doctor promptly if you become pregnant during treatment.

FDA boxed warning

Myelosuppression

BUSULFEX (busulfan) Injection causes severe and prolonged myelosuppression at the recommended dosage. Hematopoietic progenitor cell transplantation is required to prevent potentially fatal complications of the prolonged myelosuppression.

A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.

When to call your doctor

- Seek medical attention immediately if you have a seizure. - Seek medical attention immediately if you develop a fever.

If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.

Before taking this medicine

Busulfex must not be used if you have a history of an allergic reaction to busulfan or any of its components. Extra caution and monitoring are needed if you have a history of seizures or head injury, or take medicines that can trigger seizures. Medicine to prevent seizures should be started before Busulfex treatment. Busulfex can cause hepatic veno-occlusive disease, a serious liver complication. The risk increases with higher drug exposure, and daily liver blood tests are required. Busulfex can harm an unborn baby. Effective contraception is advised. Tell your treating team if you are pregnant or could be pregnant. Do not breastfeed during treatment.

Interactions

Metronidazole, itraconazole, iron-chelating medicines and acetaminophen can slow the clearance of Busulfex from the body. Phenytoin can increase its clearance. Tell your doctor if you take any of these medicines.

Using Busulfex

Dosing

Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.

Storage

Store in the original carton below 25°C, protected from light, unless the pack states refrigeration. Do not freeze. Keep all medicines out of the sight and reach of children.

Clinical information on this page is summarised from the US FDA label BUSULFEX (BUSULFAN) INJECTION [OTSUKA AMERICA PHARMACEUTICAL, INC.] (DailyMed, retrieved 19 September 2026).

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