Anagrelide

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

Call your doctor at once if you have:

• headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats, fluttering in your chest;
• sudden breathing problems, wheezing, dry cough or hack;
• shortness of breath with mild exertion, swelling, rapid weight gain;
• easy bruising or bleeding (nosebleeds, bleeding gums);
• chest pain spreading to your jaw or shoulder, with sweating or general ill feeling;
• sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance; or
• severe pain in your upper stomach spreading to your back, with nausea or vomiting.

Common side effects may include:

• headache, weakness, dizziness;
• flushing (warmth, redness, or tingly feeling);
• stomach pain, gas, indigestion, loss of appetite;
• nausea, vomiting, diarrhea;
• swelling in your hands or feet;
• fever, cough;
• 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.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking anagrelide,

• tell your doctor and pharmacist if you are allergic to anagrelide or any other medications.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: atazanavir (Reyataz); cilostazol (Pletal); cimetidine (Tagamet); clozapine (Clozaril); cyclobenzaprine (Flexeril); fluoroquinolone antibiotics including ciprofloxacin (Cipro), gatifloxacin (Tequin), levofloxacin (Levaquin), norfloxacin (Noroxin), ofloxacin (Floxin), others; fluvoxamine (Luvox); imipramine (Tofranil); inamrinone; mexiletine (Mexitil); milrinone (Primacor); naproxen (Aleve, Naprosyn, in Prevacid NapraPAC); riluzole (Rilutek); sucralfate (Carafate); tacrine (Cognex);theophylline (Elixophyllin, Theo-24, Theolair, others); and ticlopidine (Ticlid). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had bleeding problems; high or low blood pressure; lactose intolerance (inability to digest dairy products) or heart, kidney, or liver disease.
• do not take anagrelide if you are pregnant or plan to become pregnant.You should use an effective form of birth control to prevent pregnancy during your treatment with anagrelide. Talk to your doctor about types of birth control that are right for you. If you become pregnant while taking anagrelide, call your doctor immediately. Do not breast-feed while you are taking anagrelide.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking anagrelide.
• you should know that anagrelide may make you dizzy, especially when you first start taking the medication. Do not drive a car or operate machinery until you know how this medication affects you.
• you should know that anagrelide may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start taking anagrelide. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
• plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. Anagrelide may make your skin sensitive to sunlight.

Anagrelide is a prescription medication used to treat a condition where the blood makes too many platelets. Anagrelide belongs to a group of drugs called platelet-reducing agents. These work by slowing the production of platelets in the body.

Anagrelide comes as a capsule to take by mouth. It is usually taken with or without food 2 to 4 times a day.

Common side effects of anagrelide include headache, irregular heart beats, diarrhea, weakness, and nausea. Anagrelide can also cause dizziness. Do not drive or operate heavy machinery until you know how this medication affects you.

Anagrelide lowers platelets (blood-clotting cells) in the body, which helps prevent blood clots from forming.

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.

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 pain, cold, allergy, or sleep medication. Aspirin (sometimes abbreviated as ASA) is contained in many combination medicines. Check the label to see if a medicine contains aspirin or ASA.

Ask your doctor before using anagrelide if you take an antidepressant such as citalopram, escitalopram, fluoxetine (Prozac), fluvoxamine, paroxetine, sertraline (Zoloft), trazodone, or vilazodone. Taking any of these medicines with anagrelide may cause you to bruise or bleed easily.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about anagrelide, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. 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 anagrelide. 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 the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using anagrelide.

Review Date: October 4, 2017

Anagrelide capsules are indicated for the treatment of patients with thrombocythemia, secondary to myeloproliferative neoplasms, to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms including thrombo-hemorrhagic events [see Clinical Studies (14), Dosage and Administration (2)].

None.

• Agrylin

6 to 24 hours; upon discontinuation, platelet count begins to rise within 4 days

Half-Life Elimination

Anagrelide: 1.5 hours, similar data reported in pediatric patients 7-14 years; 3-hydroxy anagrelide: 2.5 hours

Moderate impairment (Child-Pugh score 7 to 9): Initial: 0.5 mg once daily; maintain for at least 1 week with careful monitoring of cardiovascular status; the dose must not be increased by >0.5 mg per day in any 1 week.

Severe impairment (Child-Pugh score ≥10): Avoid use.

May be administered without regard to food.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

• Deep Vein Thrombosis (DVT, Blood Clot in the Legs)

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.

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.

Moderate hepatic impairment: Single 1 mg dose showed an 8-fold increase in total exposure (AUC) to anagrelide
Severe renal impairment (creatinine clearance less than 30 mL/min): Single 1 mg dose showed no significant effects on the pharmacokinetics of anagrelide