Promacta

Promacta is used for:

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Treating low blood platelets in certain patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP).

Promacta is a thrombopoietin (TPO) receptor agonist. It works by causing the bone marrow to produce more clot-forming cells (platelets).

Do NOT use Promacta if:

• you are allergic to any ingredient in Promacta

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

Before using Promacta :

Some medical conditions may interact with Promacta . 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 a history of liver or kidney problems, other bleeding problems, or bone marrow problems (eg, blood cancer, myelodysplastic syndrome), or if you have had surgery to remove your spleen
• if you have a blood clot, a history of blood clots, or a condition that may increase your risk for getting a blood clot (eg, ATIII deficiency, antiphospholipid syndrome)
• if you take a blood thinner (eg, warfarin) or an antiplatelet medicine (eg, clopidogrel)
• if you have a history of cataracts or use tobacco products

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

• Ciprofloxacin, fluvoxamine, gemfibrozil, omeprazole, rifampin, or trimethoprim because they may increase the risk of Promacta 's side effects
• Acetaminophen, HMG-CoA reductase inhibitors (eg, atorvastatin, rosuvastatin), meglitinides (eg, nateglinide), methotrexate, narcotic pain medications (eg, codeine), or nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen) because the risk of their side effects may be increased by Promacta

This may not be a complete list of all interactions that may occur. Ask your health care provider if Promacta 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 Promacta :

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

• Promacta comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Promacta refilled.
• Take Promacta by mouth on an empty stomach at least 1 hour before or 2 hours after a meal.
• Take Promacta at least 4 hours before or 4 hours after you take certain other medicines (eg, antacids), calcium-rich foods (eg, dairy products, calcium fortified juices), or supplements that contain iron, calcium, aluminum, magnesium, selenium, or zinc.
• Do not suddenly stop taking Promacta . You may have an increased risk of severe low platelets and bleeding. If you need to stop Promacta or add a new medicine, your doctor will need to monitor your condition.
• If you miss a dose of Promacta , skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. Do not take more than 1 dose in 1 day.

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

Important safety information:

• The number of clot-forming cells (platelets) in your blood may be reduced, especially if you stop taking Promacta . Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding.
• Tell your doctor or dentist that you take Promacta before you receive any medical or dental care, emergency care, or surgery.
• Lab tests, including liver function, complete blood cell counts, and eye exams, may be performed while you use Promacta and for at least 4 weeks after you stop Promacta . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Promacta with caution in East Asian patients (eg, Chinese, Japanese, Taiwanese, Korean) and in patients who have moderate to severe liver problems. They may be more sensitive to the medicine and may require a lower dose than other patients. Discuss any questions or concerns with your doctor.
• Use Promacta with caution in the ELDERLY; they may be more sensitive to its effects.
• Promacta should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: It is not known if Promacta can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Promacta while you are pregnant. It is not known if Promacta is found in breast milk. Do not breast-feed while taking Promacta .

Possible side effects of Promacta :

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:

Indigestion; menstrual changes; minor muscle aches or pain; nausea; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bleeding of the eye or eyelid; chest pain; coughing; dark urine; new or worsening vision problems (eg, cloudy vision); pain, redness, or swelling in the legs; severe or persistent nausea, vomiting, or stomach pain; stroke symptoms (eg, confusion, slurred speech, sudden vision changes, one-sided weakness); trouble breathing; unusual bruising or bleeding; unusual burning, itching, numbness or tingling of the skin; unusual tiredness or weakness; yellowing of the skin or eyes.

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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org), or emergency room immediately. Symptoms may include bleeding; chest pain; confusion; coughing; dark urine; one-sided weakness; pain, redness, tenderness or warmth in the legs; slurred speech; trouble breathing; unusual tiredness or weakness; vision problems; yellowing of the skin or eyes.

Store Promacta at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Keep Promacta out of the reach of children and away from pets.

General information:

• If you have any questions about Promacta , please talk with your doctor, pharmacist, or other health care provider.
• Promacta 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.

This information is a summary only. It does not contain all information about Promacta . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

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