omacetaxine (Synribo)

Brand Names: Synribo

Generic Name: omacetaxine

• What is omacetaxine (Synribo)?
• What are the possible side effects of omacetaxine (Synribo)?
• What is the most important information I should know about omacetaxine (Synribo)?
• What should I discuss with my healthcare provider before using omacetaxine (Synribo)?
• How is omacetaxine given (Synribo)?
• What happens if I miss a dose (Synribo)?
• What happens if I overdose (Synribo)?
• What should I avoid while using omacetaxine (Synribo)?
• What other drugs will affect omacetaxine (Synribo)?
• Where can I get more information (Synribo)?

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.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum);
• confusion, vision changes, slurred speech;
• blood in your urine, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• severe skin rash;
• high blood sugar--increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss; or
• low blood cell counts--fever, chills, flu-like symptoms, swollen gums, mouth sores, skin sores, rapid heart rate, pale skin, easy bruising, unusual bleeding, feeling light-headed.

Common side effects may include:

• stomach pain, nausea, vomiting;
• diarrhea, constipation;
• fever, infections;
• bruising or bleeding;
• hair loss;
• weakness, tired feeling; or
• pain, swelling, or irritation where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Omacetaxine can lower blood cells that help your body fight infections and help your blood to clot. You may get an infection or bleed more easily. Call your doctor if you have unusual bruising or bleeding, or signs of infection (fever, chills, swollen glands, cold or flu symptoms).

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.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Omacetaxine is injected under the skin, usually every 12 hours. You may be shown how to use injections at home. Do not self-inject this medicine if you do not understand how to give the injection and properly dispose of used needles and syringes.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Your care provider will show you the best places on your body to inject omacetaxine. Use a different place each time you give an injection. Do not inject into the same place two times in a row.

Your injection will be prepared at the pharmacy and you will receive the medicine in prefilled syringes. Store these syringes in the refrigerator, do not freeze. If you need to transport the medicine, place the syringes in a cooler with ice packs.

Do not allow this medicine to come into contact with food or drinks inside your refrigerator.

The omacetaxine mixture does not contain a preservative. You must use a prefilled syringe within 6 days of when it was mixed at the pharmacy.

If a prefilled syringe reaches room temperature, you must use it within 12 hours after it was mixed.

Each single-use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

If this medicine accidentally gets on your skin, wash it thoroughly with soap and warm water. Anyone handling this medicine or giving you an injection should wear protective gloves and safety glasses.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

If you need surgery or dental work, tell the surgeon ahead of time that you are using omacetaxine. You may need to stop using the medicine for a short time.

Omacetaxine can lower blood cells that help your body fight infections and help your blood to clot. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests.

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Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

If you are receiving this medicine in a clinic or cancer center, call your doctor for instructions if you miss an appointment for your omacetaxine injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

If this medication gets in your eyes, rinse with water and call your doctor right away.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection. Avoid activities that may increase your risk of bleeding or injury. Use extra care to prevent bleeding while shaving or brushing your teeth.

Omacetaxine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

This medicine can pass into body fluids (urine, feces, vomit). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Other drugs may interact with omacetaxine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Your pharmacist can provide more information about omacetaxine.

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