Omacetaxine (oh-ma-se-TAX-een)

Treats chronic myeloid leukemia (CML).

Brand Name(s):

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin. It is usually given in the stomach or thigh.
• You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine.
• You may be taught how to give your medicine at home. Make sure you understand all instructions before giving yourself an injection. Do not use more medicine or use it more often than your doctor tells you to.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. Do not inject into skin areas that are tender, red, bruised, hard, or have scars or stretch marks.
• Do not recap or clip the used needle. This could cause a needle-stick injury.
• Do not eat or drink while handling this medicine. Use it in an area away from food or food preparation.
• If you get this medicine on your skin, wash the area with soap and water. If you get this medicine in your eyes, flush your eyes with water and call your doctor right away.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: If you miss a dose, skip the missed dose and give your next injection at the regularly scheduled time. Do not give 2 injections at once to make up for a missed dose. Call your doctor, home health caregiver, or treatment clinic for further instructions.
• To store syringes at home:
  • Use an ice pack or cooler to carry the syringes from your doctor's office.
  • If placed in a refrigerator, use the syringes within 6 days after you receive them. Do not allow food or drinks to touch the syringes.
  • If placed at room temperature, use the syringes within 12 hours after you receive them.
• Do not throw the used syringes, needles, or other supplies in a household trash or recycle container. Put all of the used supplies in the biohazard container and return it to your doctor for disposal.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how omacetaxine works. Tell your doctor if you are using a blood thinner (including warfarin) or an NSAID pain or arthritis medicine (including aspirin, diclofenac, ibuprofen, or naproxen).

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. Women should not get pregnant for at least 6 months after treatment ends. Men should not father a child for at least 3 months after the last dose.
• Do not breastfeed during treatment and for at least 2 weeks after the last dose of this medicine.
• Tell your doctor if you have anemia, bleeding problems, diabetes, or an infection.
• This medicine may cause the following problems:
  • Bleeding problems
  • Hyperglycemia (high blood sugar)
• This medicine may make you feel tired. Do not drive or do anything that could be dangerous until you know how this medicine affects you.
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• Tell any doctor or dentist who treats you that you are using this medicine.
• If you plan to have children, talk with your doctor before using this medicine. Some men using this medicine have become infertile (unable to have children).
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blood in the urine or stools, confusion, slurred speech, or changes in vision
• Change in how much or how often you urinate, painful or difficult urination
• Fever, chills, cough, sore throat, and body aches
• Increase in hunger or thirst
• Severe diarrhea, constipation, nausea, stomach pain, vomiting
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Hair loss
• Mild diarrhea, constipation, nausea, stomach pain, vomiting
• Pain, itching, burning, swelling, or a lump under your skin where the shot was given

If you notice other side effects that you think are caused by this medicine, tell your doctor

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