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General Information

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IMPORTANT NOTICE:

Omacetaxine is no longer commercially available in the U. S. See the FDA website (http://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Because this drug is no longer available in the U. S. market, the material in this section is no longer updated by AHFS DI.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.

Use

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.

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.

Are there OTHER USES for this medication?

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

Special

What SPECIAL PRECAUTIONS should I follow?

Before taking omacetaxine injection,

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.

Side Effects

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:

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

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

Overdose

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 http://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:

Miscellaneous

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.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS® Patient Medication Information Copyright, 2025. The American Society of Health-System Pharmacists®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: July 20, 2024.