Omacetaxine injection

Generic Name: omacetaxine (OH-ma-se-TAX-een)
Brand Name: Synribo

Omacetaxine injection is used for:

Treating certain types of chronic myelogenous leukemia (CML) in certain patients. It may also be used for other conditions as determined by your doctor.

Omacetaxine injection is an antineoplastic product. It works by preventing the growth of cancer cells.

Do NOT use omacetaxine injection if:

  • you are allergic to any ingredient in omacetaxine injection
  • you have poorly controlled diabetes

Contact your doctor or health care provider right away if any of these apply to you.

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Before using omacetaxine injection:

Some medical conditions may interact with omacetaxine injection. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have bone marrow problems (eg, low blood platelet levels, low white blood cell levels, anemia)
  • if you have a history of bleeding in the brain or bleeding or clotting problems
  • if you have a history of diabetes or high blood sugar, or if a family member has a history of diabetes

Some MEDICINES MAY INTERACT with omacetaxine injection. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Anticoagulants (eg, warfarin), aspirin, or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen, naproxen) because the risk of bleeding may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if omacetaxine injection may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use omacetaxine injection:

Use omacetaxine injection as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Omacetaxine injection comes with extra patient information sheets called a Medication Guide and Instructions for Use. Read them carefully. Read them again each time you get omacetaxine injection refilled.
  • Omacetaxine injection is usually given as an injection at your doctor's office, hospital, or clinic. Ask your doctor, nurse, or pharmacist any questions that you may have about omacetaxine injection.
  • If you will be using omacetaxine injection at home, a health care provider will teach you how to use it. Be sure you understand how to use omacetaxine injection. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
  • Avoid contact with the eyes and skin. If omacetaxine injection comes into contact with your skin, wash it off right away with soap and water. If you get it in your eyes, flush right away with cool water.
  • Do not use omacetaxine injection if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
  • Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
  • If you miss a dose of omacetaxine injection, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use omacetaxine injection.

Important safety information:

  • Dizziness or tiredness may occur while you take omacetaxine injection. These effects may be worse if you take it with alcohol or certain medicines. Use omacetaxine injection with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not stop using omacetaxine injection without checking with your doctor.
  • Tell your doctor or dentist that you take omacetaxine injection before you receive any medical or dental care, emergency care, or surgery.
  • Omacetaxine injection may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.
  • Omacetaxine injection may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
  • If you may become pregnant, you must use an effective form of birth control while you take omacetaxine injection. If you have questions about effective birth control, talk with your doctor.
  • Omacetaxine injection may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
  • Diabetes patients-Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Lab tests, including complete blood cell counts and blood glucose levels, may be performed while you use omacetaxine injection. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use omacetaxine injection with caution in the ELDERLY; they may be more sensitive to its effects, especially blood problems.
  • PREGNANCY and BREAST-FEEDING: Omacetaxine injection may cause harm to the fetus. Do not become pregnant while you are using it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using omacetaxine injection while you are pregnant. It is not known if omacetaxine injection is found in breast milk. Do not breast-feed while taking omacetaxine injection.

Possible side effects of omacetaxine injection:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; cough; diarrhea; hair loss; headache; joint, arm, leg, muscle, or back pain; loss of appetite; mild nosebleeds; mild stomach pain; nausea; redness, pain, or swelling at the injection site; tiredness; trouble sleeping; weakness; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine; bloody or black, tarry stools; burning, numbness, or tingling; chest pain; confusion; coughing up blood; fainting; fast, slow, or irregular heartbeat; mental or mood changes; one-sided weakness; ringing in the ears; seizures; severe or persistent dizziness or headache; severe or persistent redness, pain, or swelling at the injection site; severe or persistent tiredness or weakness; severe stomach pain; shortness of breath; slurred speech; swelling of the hands, ankles, or feet; swelling or soreness of the mouth or tongue; symptoms of infection (eg, fever; chills; persistent sore throat or cough; increased, difficult, or painful urination; warm, red, or swollen skin); unusual bruising or bleeding; vision changes (eg, blurred vision); vomit that looks like coffee grounds.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of omacetaxine injection:

Omacetaxine injection is usually handled and stored by a health care provider. If you are using omacetaxine injection at home, store omacetaxine injection as directed by your pharmacist or health care provider. Keep omacetaxine injection out of the reach of children and away from pets.

General information:

  • If you have any questions about omacetaxine injection, please talk with your doctor, pharmacist, or other health care provider.
  • Omacetaxine injection is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take omacetaxine injection or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about omacetaxine injection. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to omacetaxine injection. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using omacetaxine injection.

Issue Date: December 3, 2014
Database Edition 14.4.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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