Anagrelide

Anagrelide is a prescription medication used to treat a condition where the body produces excess platelets in the blood. (Thrombocythemia or Thrombocytosis). 

• Anagrelide is available under the following different brand names: Agrylin

Common side effects of Anagrelide 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 the hands or feet,
• fever,
• cough,
• feeling unwell,
• back pain,
• rash, and
• itching

Serious side effects of Anagrelide include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• easy bruising,
• unusual bleeding (nosebleeds, bleeding gums),
• bloody or tarry stools,
• coughing up blood,
• vomit that looks like coffee grounds,
• chest pain or pressure,
• fast or pounding heartbeats,
• fluttering in the chest,
• sudden dizziness,
• shortness of breath,
• swelling in the lower legs, and
• blue-colored lips or skin

Rare side effects of Anagrelide include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Capsule

• 0.5mg
• 1mg

Thrombocythemia

Adult dosage

• 0.5 orally every 6 hours or 1 mg every 12 hours; increase as needed not more frequently than 0.5 mg/day/week
• Not to exceed 10 mg/day or 2.5 mg/dose
• Platelet count responds typically in 7-14 days; the time to complete response is 4 to 12 weeks

Pediatric dosage

• Children below 7 years
  • Safety and efficacy not established
• Children above 7 years
  • 0.5 mg/day to 0.5 mg orally every 6 hours; adjust the dose as needed no more frequently than 0.5 mg/day/week
  • Platelet count responds typically in 7-14 days; the time to complete response is 4 to 12 weeks

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Anagrelide has severe interactions with the following drugs:
  • abrocitinib
  • goserelin
  • histrelin
  • leuprolide
  • triptorelin
• Anagrelide has serious interactions with at least 51 other drugs.
• Anagrelide has moderate interactions with at least 42 other drugs.
• Anagrelide has minor interactions with the following drugs:
  • devil's claw
  • food
  • ginger
  • Ginkgo Biloba
  • horse chestnut seed
  • sucralfate
  • verteporfin

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Severe hepatic impairment 

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Anagrelide?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Anagrelide?”

Cautions

• Caution in heart disease, renal impairment, mild-moderate hepatic impairment
• Torsades de pointes and ventricular tachycardia were reported; obtain pre-treatment cardiovascular exam, including EKG, in all patients
• Hepatic impairment increases anagrelide exposure and could increase the risk of QTc prolongation; monitor patients with hepatic impairment for QTc prolongation and other cardiovascular adverse reactions
• Increases QTc interval and heart rate in healthy volunteers; should not be used in patients with known risk factors for QT interval prolongation, such as congenital long QT syndrome, a known history of acquired QTc prolongation, medicinal products that can prolong QTc interval, and hypokalaemia
• In patients with cardiac disease, use only when benefits outweigh risks
• In patients with heart failure, bradyarrhythmia, or electrolyte abnormalities, consider periodic ECG monitoring
• Orthostatic hypotension was reported with higher doses; minimal BP changes were observed following 2 mg/dose
• Coadministration with aspirin increases the risk for major hemorrhagic event
• Cases of pulmonary hypertension reported; evaluate patients for signs and symptoms of underlying cardiopulmonary disease before initiating and during anagrelide therapy
• Interstitial lung diseases (including allergic alveolitis, eosinophilic pneumonia, and interstitial pneumonitis) were reported to be associated with the use of anagrelide in post-marketing reports; most cases presented with progressive dyspnea with lung infiltrations; time of onset ranged from 1 week to several years after initiating anagrelide; discontinue anagrelide if it occurs and evaluates; symptoms may improve after discontinuation
• Monitor platelets, Hgb, WBC, LFTs, Cr, and BUN for at least the first 2 weeks
• May induce high output heart failure by PDE4 inhibition (may be reversible upon discontinuation)

Pregnancy & Lactation

• Available data from case reports in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes; in animal embryo-fetal studies, delayed fetal development (delayed skeletal ossification and reduced body weight) was observed in rats administered anagrelide hydrochloride during organogenesis at doses approximately 97 times the maximum clinical dose (10 mg/day) based on body surface area; there are adverse effects on maternal and fetal outcomes associated with thrombocythemia in pregnancy
• Thrombotic events, such as stroke, deep vein thrombosis, or myocardial infarction, can be complications of thrombocythemia; thrombocythemia in pregnancy is associated with an increased risk for miscarriage, stillbirth, and other maternal outcomes, such as preeclampsia

Infertility

• Based on findings from animal studies, therapy may impair female fertility

Lactation

• There is no information regarding the presence of the drug in human milk, its effect on the breastfed child, or milk production; the drug or its metabolites have been detected in the milk of lactating rats; because of the potential for serious adverse reactions, including thrombocytopenia, in a breastfed child, advise patients that breastfeeding is not recommended during treatment, and for one week following the last dose