Omacetaxine

Omacetaxine is a prescription medication used to treat chronic myeloid leukemia (cancer of the white blood cells) in adults. Omacetaxine belongs to a group of drugs called protein synthesis inhibitors, which slow the growth of cancer cells.

This medication comes in an injectable form to be given just under the skin twice daily for 14 days of a 28-day cycle.

Common side effects include diarrhea and a decrease in platelets, red blood cells, and white blood cells. Omacetaxine can cause drowsiness.

Omacetaxine is a prescription medication used to treat adults with chronic or accelerated phase chronic myeloid leukemia (CML) who have previously received at least two other medications for CML.

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

Omacetaxine may be found in some form under the following brand names:

• Synribo

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.

No omacetaxine drug interactions have been identified, however, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

If, while receiving omacetaxine, your platelet count is abnormally low, your doctor may tell you to avoid aspirin, NSAIDs (such as ibuprofen, and naproxen), and "blood thinners" such as warfarin (Coumadin). These medications increase the risk of bleeding.

Omacetaxine may cause serious side effects.

• Omacetaxine may cause abnormally low blood platelet counts which can lead to serious bleeding. Tell your doctor immediately if you have any signs of bleeding including bruising easily, blood in urine or stool, confusion, slurred speech, or a change in your vision.
• By suppressing the activity of the bone marrow, this medication may cause a decrease in red and white blood cells, as well as platelets. Red blood cells are responsible for carrying oxygen. Tell your doctor if you experience shortness of breath or extreme tiredness. White blood cells are responsible for immunity. Tell your doctor right away if you develop a fever or other signs and symptoms of infection.
• Careful monitoring of blood glucose (sugar) is important for people with diabetes who are receiving omacetaxine as this medication may cause hyperglycemia (high blood glucose levels).
• You may develop a skin rash while receiving omacetaxine. Tell your doctor right away if a rash becomes severe or causes itchiness.
• Omacetaxine may cause tiredness. Avoid driving any vehicle or operating any machinery that requires mental alertness until you know how omacetaxine affects you.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of omacetaxine there are no specific foods that you must exclude from your diet when receiving this medication.

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.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if omacetaxine is excreted in human breast milk. Because this medication may harm your nursing baby, you should not breastfeed while receiving omacetaxine.

Omacetaxine comes in an injectable form and should be prepared in a healthcare facility and administered by a healthcare professional. It is injected subcutaneously (just under the skin) twice daily. To start, you will receive two injections daily for 14 days every 28 days, until the desired response is seen. The cycle is repeated every 28 days.

You will likely have weekly blood tests to monitor your complete blood counts (CBCs). In addition, your blood glucose (sugar) levels will be monitored, especially if you have diabetes.

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 usually administered by a healthcare provider in a medical setting making it unlikely for an overdose to occur. However, if overdose is suspected, seek emergency medical attention.