Anagrelide is used to treat a blood cell disorder called thrombocythemia (also called thrombocytosis), which occurs when your body produces too many platelet cells.

Anagrelide may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG) before and during treatment. You may also need frequent blood tests while taking anagrelide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

If you need surgery, tell the surgeon ahead of time that you are using anagrelide.

Store at room temperature away from moisture, heat, and light.

Usual Adult Dose for Thrombocythemia:

Initial: 0.5 mg orally 4 times a day, or 1 mg orally twice a day, for a minimum of 7 days.

Maintenance: titrate to the lowest effective dosage required to reduce and maintain the platelet count at less than 600,000 cells/microliter, ideally down to normal levels. Increase the dosage by no more than 0.5 mg/day in any 1 week period.

The dosage should not exceed 10 mg/day or 2.5 mg in any single dose.

Usual Pediatric Dose for Chronic Myelogenous Leukemia:

Initial dose: 0.5 mg orally daily (recommended) to 0.5 mg orally 4 times daily

Maintenance: titrate to the lowest effective dosage required to reduce and maintain the platelet count at less than 600,000 cells/microliter, ideally down to normal levels. Increase the dosage by no more than 0.5 mg/day in any 1 week period.

The dosage should not exceed 10 mg/day or 2.5 mg in any single dose.

Usual Pediatric Dose for Thrombocythemia:

Initial dose: 0.5 mg orally daily (recommended) to 0.5 mg orally 4 times daily

Maintenance: titrate to the lowest effective dosage required to reduce and maintain the platelet count at less than 600,000 cells/microliter, ideally down to normal levels. Increase the dosage by no more than 0.5 mg/day in any 1 week period.

The dosage should not exceed 10 mg/day or 2.5 mg in any single dose.

Tell your doctor if you have ever had:

• bleeding problems;

• long QT syndrome (in you or a family member);

• heart or lung problems;

• liver disease; or

• an electrolyte imbalance (such as low levels of potassium in your blood).

It is not known whether anagrelide will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

This medicine may affect fertility (your ability to have children).

You should not breastfeed while using anagrelide.

Anagrelide is not approved for use by anyone younger than 7 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

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

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light or excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medication.

Do not take aspirin unless your doctor has told you to. Follow your doctor's instructions about how much aspirin to take, and how often to take it.

Ask a doctor or pharmacist before using any medicines for pain, fever, swelling, or cold/flu symptoms. They may contain aspirin or similar ingredients (such as ibuprofen, ketoprofen, or naproxen) which can increase your risk of bleeding.

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

Anagrelide may cause serious side effects. Call your doctor at once if you have:

• easy bruising or bleeding (nosebleeds, bleeding gums);

• signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• chest pain or pressure;

• fast or pounding heartbeats, fluttering in your chest, and sudden dizziness (like you might pass out);

• shortness of breath;

• swelling in your lower legs; or

• blue colored lips or skin.

Common side effects of anagrelide may include:

• fast heartbeats, chest pain, breathing problems;

• numbness, tingling, burning pain;

• headache, weakness, dizziness;

• stomach pain, gas, indigestion, loss of appetite;

• nausea, vomiting, diarrhea;

• swelling in your hands or feet;

• fever, cough, not feeling well;

• back pain; or

• rash, itching.

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.

Anagrelide can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Tell your doctor about all your other medicines, especially:

• an antidepressant;

• medicine to improve blood flow;

• a blood thinner (such as warfarin or Coumadin) or other medicine to treat or prevent blood clots;

• NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete. Other drugs may affect anagrelide, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to anagrelide.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.