Omacetaxine Injection

IMPORTANT NOTICE:

Omacetaxine is no longer commercially available in the U.S. See the FDA website (https://www.accessdata.fda.gov/scripts/cder/daf/) for information on drugs that have been discontinued.

Because this drug is no longer available in the U.S. market, the material in this section is no longer updated by AHFS DI. If this drug is used in countries other than the U.S., it is essential that the manufacturers' labeling be consulted for more recently available information.

WHY is this medicine prescribed?

Omacetaxine injection is used to treat adults with chronic myelogenous leukemia (CML; a type of cancer of the white blood cells) who have already been treated with at least two other medications for CML and can no longer benefit from these medications or cannot take these medications due to side effects. Omacetaxine injection is in a class of medications called protein synthesis inhibitors. It works by slowing the growth of cancer cells.

Are there OTHER USES for this medicine?

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

HOW should this medicine be used?

Omacetaxine injection comes as a liquid to be injected under the skin by a healthcare provider in a medical facility or you may be given the medication to use at home. At the beginning of treatment, it is usually given twice a day for the first 14 days of a 28-day cycle. Once your doctor finds that you are responding to omacetaxine injection, it is usually given twice a day for the first 7 days of a 28-day cycle.

If you will be using omacetaxine injection at home, your healthcare provider will show you or your caregiver how to store, inject, dispose of the medication and supplies. Be sure that you understand these directions, and ask your healthcare provider if you have any questions. Ask your healthcare provider what to do if you have any problems using omacetaxine injection.

If you are receiving this medication at home, you or your caregiver must use disposable gloves and protective eye wear when handling omacetaxine injection. Before putting the gloves on and after taking them off, wash your hands. Do not eat or drink while handling omacetaxine. Omacetaxine must be given in a location away from food or food preparation areas (e.g., kitchen), children, and pregnant women.

You can inject omacetaxine injection anywhere on the front of your thighs (upper leg) or abdomen (stomach) except your navel and the area 2 inches (5 centimeters) around it. If a caregiver injects the medication, the back of the upper arm may also be used. To reduce the chances of soreness or redness, use a different site for each injection. Do not inject into an area where the skin is tender, bruised, red, hard, or where there are scars or stretch marks.

Be careful not to get omacetaxine injection on your skin or in your eyes. If omacetaxine does get on your skin. wash the skin with soap and water. If omacetaxine gets into your eyes, flush the eye with water. After washing or flushing, call your healthcare provider as soon as possible.

Your doctor may delay the start of a treatment cycle or may decrease the number of days that you receive omacetaxine injection during a treatment cycle if you experience serious side effects of the medication or if blood tests show a decrease in the number of blood cells you have. Be sure to talk to your doctor about how you are feeling during your treatment.

What SPECIAL PRECAUTIONS should I follow?

Before taking omacetaxine injection,

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

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, or herbal products you are taking or plan to take. Be sure to mention any of the following: anticoagulants (blood thinners) such as warfarin (Coumadin, Jantoven) or nonsteroidal anti-inflammatory drugs (NSAIDs) such as aspirin, ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you or anyone in your family has or has ever had diabetes, if you are overweight, and if you have or have ever had low HDL (high density lipoprotein; 'good cholesterol' that may lower the risk of heart disease), high triglycerides (fatty substances in the blood), or high blood pressure.

• tell your doctor if you are pregnant or plan to become pregnant, or if you plan to father a child. You or your partner should not become pregnant while you are receiving omacetaxine injection. You may need to have a pregnancy test before starting treatment. If you are female, you should use birth control to prevent pregnancy during your treatment and for 6 months after your final dose. If you are male, you and your female partner should use birth control during your treatment and for 3 months after your final dose. If you or your partner become pregnant while receiving omacetaxine injection, call your doctor immediately. Omacetaxine injection can harm the fetus.

• tell your doctor if you are breastfeeding. Do not breastfeed while receiving this medication or for 2 weeks after your final dose.

• you should know that this medication may decrease fertility in men. Talk to your doctor about the risks of receiving omacetaxine injection.

• you should know that omacetaxine injection may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

If you miss a dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

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

• diarrhea
• constipation
• stomach pain
• nausea
• vomiting
• loss of appetite
• redness, pain, itching, or swelling at the injection site
• rash
• weakness
• headache
• difficulty falling asleep or staying asleep
• pain in the joints, back, arms, or legs
• hair loss

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• unusual bruising or bleeding
• nosebleed
• blood in urine
• bright red blood in stool
• black or tarry stool
• confusion
• slurred speech
• vision changes
• sore throat, fever, chills, cough, and other signs of infection
• shortness of breath
• excessive tiredness
• excessive hunger or thirst
• frequent urination

Omacetaxine injection 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 (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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:

• nausea
• vomiting
• constipation
• diarrhea
• stomach pain
• unusual bruising or bleeding
• bleeding gums
• sore throat, fever, chills, and other signs of infection
• hair loss

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to omacetaxine injection.

Ask your pharmacist any questions you have about omacetaxine injection.

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.