Omacetaxine Injection

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.

Omacetaxine injection comes as a liquid to be injected under the skin by a healthcare provider in a medical facility. 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.

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.

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

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) or non-steroidal 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, plan to become pregnant, or are breast-feeding. You should use birth control to prevent pregnancy during your treatment. If you become pregnant while receiving omacetaxine injection, call your doctor immediately. Omacetaxine injection can harm the fetus.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are 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.

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

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

• 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

• seizures

• rash

Omacetaxine injection may cause other side effects. Call your doctor if you have any unusual problems while taking 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 [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

• nausea

• vomiting

• constipation

• diarrhea

• stomach pain

• unusual bruising or bleeding

• bleeding gums

• sore throat, fever, chills, and other signs of infection

• hair loss

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.

Last Revised - 02/15/2013