Busulfex

DRUG DESCRIPTION

Busulfan is a bifunctional alkylating agent known chemically as 1,4-butanediol, dimethanesulfonate. BUSULFEX® (busulfan) Injection is intended for intravenous administration. It is supplied as a clear, colorless, sterile, solution in 10 mL single use vials. Each vial of BUSULFEX contains 60 mg (6 mg/mL) of busulfan, the active ingredient, a white crystalline powder with a molecular formula of CH3SO2O(CH2)4OSO2CH3 and a molecular weight of 246 g/mole. Busulfan is dissolved in N,N-dimethylacetamide (DMA) 33% vol/vol and Polyethylene Glycol 400, 67% vol/vol. The solubility of busulfan in water is 0.1 g/L and the pH of BUSULFEX diluted to approximately 0.5 mg/mL busulfan in 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP as recommended for infusion reflects the pH of the diluent used and ranges from 3.4 to 3.9.

BUSULFEX is intended for dilution with 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP prior to intravenous infusion.

What are the possible side effects of busulfan (Busulfex, Myleran)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • pale skin, easy bruising or bleeding (nosebleeds, bleeding gums);
  • signs of infection such as fever, chills, sore throat, flu symptoms, loss of appetite, weight loss, mouth sores, unusual weakness;
  • persistent cough, congestion, low fever, feeling short of breath (these...

Read All Potential Side Effects and See Pictures of Busulfex »

What are the precautions when taking busulfan (Busulfex)?

Before receiving busulfan, 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: blood/bone marrow disorders (such as bone marrow suppression, neutropenia, thrombocytopenia, anemia), brain disorders (such as seizures, head injury).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Busulfan can make you more likely to get infections or may worsen any...

Read All Potential Precautions of Busulfex »


Busulfex Consumer (continued)

SIDE EFFECTS: See also Warning section.

Nausea, vomiting, diarrhea, constipation, loss of appetite, mouth sores, stomach/abdominal pain, dizziness, swelling ankles/feet/hand, flushing, headache, or trouble sleeping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects.

Many people using this medication develop serious side effects. However, 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. Careful monitoring by your doctor may decrease your risk.

Tell your doctor immediately if any of these unlikely but serious side effects occur: signs of liver disease (such as persistent nausea/vomiting, severe stomach/abdominal pain, yellowing skin/eyes, dark urine), mental/mood changes (such as depression, hallucinations, anxiety, confusion), muscle cramps, increased thirst/urination, fast/irregular heartbeat, coughing up blood, bloody urine, seizures, pain/redness/swelling at injection site.

Tell your doctor immediately if any of these rare but serious side effects occur: fainting, missed menstrual periods, shrinking testicles.

Busulfan has rarely caused very serious (possibly fatal) lung disease. Tell your doctor immediately if you develop symptoms of lung disease, including chest pain, shortness of breath, persistent cough.

Busulfan may cause other cancers (such as acute leukemia, tumors). Consult your doctor for more details. Tell your doctor immediately if you notice any symptoms of cancer, including unusual lumps, sudden weight loss.

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.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before receiving busulfan, 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: blood/bone marrow disorders (such as bone marrow suppression, neutropenia, thrombocytopenia, anemia), brain disorders (such as seizures, head injury).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Busulfan can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication may make it harder for females to become pregnant or for males to father children. Discuss with your doctor for more details.

Busulfan is not recommended for use during pregnancy. It may harm an unborn baby. Discuss the use of reliable forms of birth control with your doctor. If you become pregnant or think you may be pregnant, tell your doctor immediately.

It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.


Busulfex Patient Information Including Side Effects

Brand Names: Busulfex, Myleran

Generic Name: busulfan (Pronunciation: bue SUL fan)

  • What is busulfan (Busulfex)?
  • What are the possible side effects of busulfan (Busulfex)?
  • What is the most important information I should know about busulfan (Busulfex)?
  • What should I discuss with my healthcare provider before using busulfan (Busulfex)?
  • How should I take busulfan (Busulfex)?
  • What happens if I miss a dose (Busulfex)?
  • What happens if I overdose (Busulfex)?
  • What should I avoid while using busulfan (Busulfex)?
  • What other drugs will affect busulfan (Busulfex)?
  • Where can I get more information?

What is busulfan (Busulfex)?

Busulfan is a cancer medication that interferes with the growth of cancer cells and slows their spread in the body.

Busulfan is used to treat the symptoms of chronic myelogenous leukemia (a type of blood cancer). Busulfan is not a cure for leukemia.

Busulfan may also be used for other purposes not listed in this medication guide.

What are the possible side effects of busulfan (Busulfex)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • pale skin, easy bruising or bleeding (nosebleeds, bleeding gums);
  • signs of infection such as fever, chills, sore throat, flu symptoms, loss of appetite, weight loss, mouth sores, unusual weakness;
  • persistent cough, congestion, low fever, feeling short of breath (these symptoms may occur several months or years after using busulfan);
  • weight gain, stomach swelling or tenderness, jaundice (yellowing of the skin or eyes);
  • coughing up blood;
  • stomach pain, vomiting, sharp chest pain, trouble breathing;
  • blurred vision, eye pain, or seeing halos around lights;
  • seizure (convulsions); or
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash.

Less serious side effects may include:

  • missed menstrual periods; or
  • darkened skin color.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about busulfan (Busulfex)?

You should not use busulfan if you are allergic to it.

Do not use busulfan without telling your doctor if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

Before you receive busulfan, tell your doctor if you have a weak immune system, a seizure disorder, a history of head injury or breathing problems, or if you have recently received other cancer medications or radiation treatment.

Busulfan can lower blood cells that help your body fight infections. Your blood will need to be tested on a weekly or monthly basis. Your liver function may also need to be tested on a regular basis. Busulfan can have long-lasting effects on your body. Do not miss any follow-up visits to your doctor for blood or urine tests.

Contact your doctor at once if you develop signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), weight loss, mouth sores, or unusual weakness.

Some people treated with busulfan have developed new forms of cancer. Talk to your doctor about your specific risks and benefits of using this medication.

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