Omacetaxine

Contraindications

None

Cautions

Monitor CBC panel for myelosuppression

Grade 3/4 neutropenia, thrombocytopenia and anemia commonly occur; avoid use of anticoagulants, aspirin, and NSAIDs when platelet count is <50,000/ mm³

Therapy may induce glucose intolerance; monitor glucose levels frequently, especially in patients with diabetes or with risk factors for diabetes; avoid use in patients with poorly controlled diabetes; may initiate after glycemic control established

Avoid pregnancy

Administration

Inject subcutaneously

Follow institutional guidelines for preparing, administering, and disposal of chemotherapy

Preparation

• Reconstitute with 1 mL of 0.9% NaCl
• After addition of the diluent, gently swirl until a clear solution obtained
• Lyophilized powder should be completely dissolved in <1 minute
• Resulting solution concentration is 3.5 mg/mL
• Does not contain antimicrobial preservatives

Home administration

Provide training on proper handling, storage conditions, administration, disposal, and clean-up of accidental spillage of the product

Ensure that patients receive the necessary supplies for home administration. at minimum these should include:

• Reconstituted omacetaxine with patient-specific dose in syringe with a capped needle for SC injection
• Protective eyewear
• Gloves
• An appropriate biohazard container
• Absorbent pad(s) for placement of administration materials and for accidental spillage
• Alcohol swabs
• Gauze pads
• Ice packs or cooler for transportation of reconstituted syringes

Storage

Reconstituted solution: Use within 12 hr when stored at room temperature and within 6 days if refrigerated between 2- 8 °C (36-46°F)

Protect reconstituted solution from light

During clinical trials, the most common side effects of omacetaxine therapy included:

• an abnormal decrease in the number of platelets, red blood cells, and white blood cells 
• diarrhea
• upset stomach
• extreme tiredness
• weakness
• injection site reaction
• fever
• infection

Other side effects include:

• increased blood sugar (hyperglycemia)
• stomach pain
• constipation
• vomiting
• rash
• hair loss

If any side effect is bothersome or does not go away, contact your doctor. This is not a complete list of omacetaxine side effects. Ask your doctor or pharmacist for more information.

Tell your doctor about all of your medical conditions before receiving omacetaxine. Especially tell your doctor if you:

• have diabetes
• are pregnant or breastfeeding

Tell your doctor about all of the medicines you take including prescription and non-prescription medicines, vitamines, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Omacetaxine falls into category D. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used only if the potential benefits to the mother outweigh the potential risks to the unborn child.

The recommended starting schedule for induction is 1.25 mg/m² administered subcutaneously twice daily for 14 consecutive days every 28 days, over a 28-day cycle. Cycles should be repeated every 28 days.

The recommended maintenance schedule is 1.25 mg/m² administered subcutaneously twice daily for 7 consecutive days every 28 days, over a 28-day cycle. Treatment should continue as long as patients are clinically benefiting from therapy.

Omacetaxine is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Omacetaxine is used to treat chronic myeloid leukemia (CML).

Omacetaxine is usually given after other cancer medications have been tried without success.

Omacetaxine may also be used for purposes not listed in this medication guide.

You should not use omacetaxine if you are allergic to it.

To make sure omacetaxine is safe for you, tell your doctor if you have:

• diabetes;

• a bleeding or blood clotting disorder; or

• if you are pregnant or may become pregnant.

Do not use omacetaxine if you are pregnant. It could harm the unborn baby. Use effective birth control to avoid pregnancy during your treatment with omacetaxine. Follow your doctor's instructions about how long to prevent pregnancy after your treatment ends.

It is not known whether omacetaxine passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

• Most of the time, this medicine will be given in a hospital or doctor's office. If stored at home, follow how to store as you were told by the doctor.
• Be sure you know how long you can store omacetaxine if stored in a refrigerator or at room temperature.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Data not available