In the U.S.—

In Canada—

• Platelet count–reducing agent

Anagrelide ( an-AG-re-lide) is used to decrease the risk of blood clots in patients who have too many platelet cells in their blood.

This medicine is available only with your doctor's prescription, in the following dosage form:

Oral
• Capsules (U.S. and Canada)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For anagrelide, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to anagrelide. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Anagrelide has not been studied in pregnant women. This medicine has been found to cause toxic or harmful effects in animals, but was not found to cause birth defects.

It is best to use some kind of birth control while you are taking anagrelide. Tell your doctor right away if you think you have become pregnant while taking anagrelide.

Breast-feeding—It is not known whether anagrelide passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.

Children—Studies on this medicine have been done only on adult patients, and there is no specific information comparing use of anagrelide in children with use in other age groups.

• Heart disease (known or suspected)—Anagrelide can cause unwanted effects on the heart
• Kidney disease—Anagrelide rarely causes unwanted effects on the kidney
• Liver disease—Blood levels of anagrelide may be increased, possibly increasing the chance of side effects. Also, this medicine sometimes causes unwanted effects on the liver

Dosing—

The dose of anagrelide will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of anagrelide. If your dose is different, do not change it unless your doctor tells you to do so.

The number of capsules that you take depends on the strength of the medicine.

• For oral dosage form (capsules):
  • For too many platelets in the blood:
    • Adults—0.5 milligrams (mg) four times a day, or 1 mg two times a day, for at least one week. After that, the dose is adjusted to the dose that keeps the number of platelets normal.
    • Children—Use and dose must be determined by your doctor.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

Anagrelide can cause unwanted effects on the heart, including a heart attack. Check with your doctor and/or get emergency help immediately if you experience any signs or symptoms of a heart attack.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor and/or get emergency help immediately if any of the following side effects occur:

• Less common
  • Sudden severe headache or weakness;  symptoms of a heart attack, which may include anxiety, cold sweating, increased heart rate, nausea or vomiting, severe pain or pressure in the chest and/or the jaw, neck, back, or arms, and shortness of breath 
  
  

Check with your doctor as soon as possible if any of the following side effects occur:

• More common
  • Abdominal or stomach pain;  dizziness ;  irregular heartbeat;  weakness 
  
  

• Less common
  • Blood in urine;  blurred or double vision ;  difficulty in breathing;  faintness;  flushing;  numbness or tingling in hands or feet;  painful or difficult urination;  swelling of feet or lower legs;  unusual bleeding or bruising;  unusual tiredness 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common
  • Diarrhea;  gas or bloating of stomach ;  headache;  heartburn;  pain 
  
  

• Less common or rare
  • Back pain;  canker sore;  confusion;  constipation;  fever or chills;  general feeling of discomfort or illness;  joint pain;  leg cramps;  loss of appetite;  mental depression;  muscle pain;  nervousness;  ringing in the ears;  skin rash or itching;  sleepiness;  stuffy or runny nose;  trouble in sleeping;  unusual sensitivity to light 
  
  

Anagrelide may cause a temporary loss of hair in some people.

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.