Busulfan Injection

IMPORTANT WARNING:

Busulfan injection can cause 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.

Keep all appointments with your doctor and the laboratory. Your doctor will order laboratory tests before, during and after your treatment to check your body's response to busulfan to see if your blood cells are affected by this drug.

Busulfan may increase the risk that you will develop other cancers. Talk to your doctor about the risks of receiving busulfan.

WHY is this medicine prescribed?

Busulfan injection is used to treat a certain type of chronic myelogenous leukemia (CML; a type of cancer of the white blood cells) in combination with other medications to destroy bone marrow and cancer cells in preparation for a bone marrow transplant. Busulfan is in a class of medications called alkylating agents. It works by slowing or stopping the growth of cancer cells in your body.

Are there OTHER USES for this medicine?

Busulfan injection is also used in combination with other drugs to destroy the bone marrow and cancer cells in preparation for a bone marrow transplant in people with other types of cancer.

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

HOW should this medicine be used?

Busulfan comes as a solution (liquid) to be given intravenously (into a vein) over 2 hours by a doctor or nurse in a medical facility. It is usually given every 6 hours for 4 days (for a total of 16 doses) before bone marrow transplant.

Busulfan injection may cause seizures during therapy with the medication. Your doctor will give you another medication to help prevent seizures before and during therapy with busulfan injection.

What SPECIAL PRECAUTIONS should I follow?

Before receiving busulfan injection,

• tell your doctor and pharmacist if you are allergic to busulfan, any other medications, or any of the ingredients in busulfan injection. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: acetaminophen (Tylenol); clozapine (Clozaril, FazaClo); cyclosporine (Sandimmune, Gengraf, Neoral); itraconazole (Sporanox); medications for mental illness and nausea; or meperidine (Demerol). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with busulfan, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.

• tell your doctor if you have previously received radiation therapy or other chemotherapy or have ever had seizures or a head injury.

• you should know that busulfan may interfere with the normal menstrual cycle (period) in women, may stop sperm production in men, and may cause infertility (difficulty becoming pregnant). However, you should not assume that you or your partner cannot become pregnant. Tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. You should not plan to have children while receiving chemotherapy or for a while after treatments. (Talk to your doctor for further details.) Use a reliable method of birth control to prevent pregnancy. If you become pregnant while receiving busulfan, call your doctor immediately. Busulfan may harm the fetus.

What SIDE EFFECTS can this medicine cause?

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

• 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

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• black, tarry stools
• red urine
• vomiting
• stomach pain
• unusual tiredness or weakness
• difficulty breathing
• seizures

Busulfan 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).

What should I know about STORAGE and DISPOSAL of this medication?

This medication will be stored in the hospital or medical facility where you receive each dose

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• black, tarry stools
• red urine
• unusual bruising or bleeding
• unusual tiredness or weakness

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

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.