Omacetaxine, Injection

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KEY POINTS

• This medicine is given by injection (shot) to treat certain kinds of chronic myeloid leukemia.
• You may get infections more easily when you are taking this medicine.
• This medicine increases your risk of bleeding. Be careful while shaving, cutting fingernails or toenails, or when using sharp objects.
• Keep all appointments for tests to see how this medicine affects you.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: antineoplastic (anticancer)

Generic and brand names: omacetaxine, injection; Synribo

What is this medicine used for?

This medicine is given by injection (shot) to treat certain kinds of chronic myeloid leukemia.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Bleeding problems
• Diabetes
• Kidney problems
• Liver disease

Also, tell your healthcare provider if you are scheduled to have any dental or surgical procedures.

Females of childbearing age: This medicine is not usually given to pregnant women because it can harm the baby. If you are pregnant, tell your healthcare provider. Do not become pregnant during treatment with this medicine. If you become pregnant, contact your healthcare provider right away. Do not breast-feed while you are receiving this medicine.

How do I use it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a treatment or refill.

This medicine is given by injection, usually every 12 hours. These injections are usually given by your healthcare provider. You will be monitored closely while receiving this medicine. Keep all your appointments.

Sometimes you or someone at home can give this medicine to you. Follow your healthcare provider's instructions carefully. Also, follow the detailed instructions for use included with your medicine. If you are not sure how to use this medicine, ask your healthcare provider for help.

Check with your healthcare provider before using this medicine in children under age 18.

If you or your caregiver get this medicine on your skin, wash the area with soap and water. If you or your caregiver get this medicine in your eyes, flush your eyes with water and call your healthcare provider right away

What if I miss a dose?

If you miss a dose, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: nausea, vomiting, diarrhea, unusual bruising or bleeding.

What should I watch out for?

You will need to have blood tests regularly to see how this medicine affects you. Keep all appointments for these tests.

This medicine may lower the number of certain types of blood cells in your body. You may get infections or bleed more easily when you are taking this medicine. Stay away from people with colds, flu, or other infections. Do not have any vaccines without getting your healthcare provider's approval first. Use a soft brush to brush your teeth. Be careful while shaving or using sharp objects. Aspirin, ibuprofen, and other NSAIDs may increase the risk of bleeding. Do not drink alcohol or take other prescription medicines, nonprescription medicines, or natural remedies unless your healthcare provider approves. If you develop a fever or other signs of infection, or have any unusual bruising or bleeding, contact your healthcare provider right away

This medicine may make you tired or dizzy. Do not drive or operate machinery unless you are fully alert.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you have received this medicine.

If you have diabetes: This medicine may affect your blood sugar level and change the amount of insulin or other diabetes medicines you may need. Talk to your healthcare provider about this.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat); sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking; confusion.

Serious (Report these to your healthcare provider right away.): Severe nausea or vomiting; severe diarrhea; severe pain, sores, or peeling at the site of injection; severe or worsening rash or itching; unusual bruising or bleeding; unusual tiredness or weakness; fever; chills; sore throat; cough; black, tarry bowel movements; bloody urine; chest pain; trouble breathing; severe dizziness or fainting; unexplained swelling in the hands or feet; unusual increase in hunger or thirst; increased urination.

Other: Loss of appetite, nausea, vomiting, diarrhea, constipation, stomach pain, mild irritation where the shot was given, mild headache, dizziness, tiredness, trouble sleeping, weakness, muscle or joint pain, hair loss.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Aspirin and other salicylates
• Medicines to treat or prevent blood clots such as clopidogrel (Plavix), dabigatran (Pradaxa), dipyridamole (Persantine), fondaparinux (Arixtra), prasugrel (Effient), rivaroxaban (Xarelto), and warfarin (Coumadin)
• Natural remedies such as alfalfa, arnica, bilberry, bladderwrack, cat's claw, chamomile, cranberry, dong quai, evening primrose, fenugreek, feverfew, garlic, ginger, ginkgo biloba, ginseng, goldenseal, horse chestnut, licorice, red clover, SAMe, sweet clover, and willow
• Nonsteroidal anti-inflammatory medicines (NSAIDs) such as celecoxib (Celebrex), diclofenac (Cambia, Voltaren, Zipsor), ibuprofen (Advil, Motrin), indomethacin (Indocin), ketoprofen, ketorolac, nabumetone (Relafen), naproxen (Aleve, Anaprox, Naprelan), oxaprozin (Daypro), piroxicam (Feldene), and sulindac (Clinoril)

Do not have any vaccines without getting your healthcare provider's approval first. Do not drink alcohol while you are taking this medicine unless your healthcare provider approves.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this unopened vials of this medicine at room temperature. Keep the container tightly closed and in the original carton. Protect it from heat, high humidity, and bright light.

Store medicine syringes in a refrigerator and use them within 6 days from when they were mixed. If stored at room temperature, use the syringes within 12 hours from when they were mixed.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.