AGRYLIN (anagrelide hydrochloride) is a platelet-reducing agent. Its chemical name is 6,7-dichloro-1,5-dihydroimidazo[2,1-b]quinazolin-2(3H)-one monohydrochloride monohydrate. The molecular formula is C 10 H 7 Cl 2 N 3 O∙HCl∙H 2 O which corresponds to a molecular weight of 310.55. The structural formula is: Anagrelide hydrochloride is an off-white powder. It is very slightly soluble in water and sparingly soluble in dimethyl sulfoxide and dimethylformamide. AGRYLIN is supplied as capsules for oral a...

Read more

AGRYLIN is 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. AGRYLIN is a platelet reducing agent indicated for the treatment of thrombocythemia, secondary to myeloproliferative neoplasms, to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms including thr...

Read more

The starting dose for adults is 0.5 mg four times a day or 1 mg twice a day. The starting dose for pediatric patients is 0.5 mg per day. Maintain the starting dose for at least one week and then titrate to maintain target platelet counts. Do not exceed a dose increment of 0.5 mg/day in any one week. Do not exceed 10 mg/day or 2.5 mg in a single dose. Moderate hepatic impairment: Start with 0.5 mg per day. 2.1 Recommended Starting Dosage Adults: The recommended starting dosage of AGRYLIN is 0.5 mg four...

Read more

At higher than recommended doses, AGRYLIN has been shown to cause hypotension. There have been postmarketing case reports of intentional overdose with AGRYLIN. Reported symptoms include sinus tachycardia and vomiting. Symptoms resolved with supportive management. Platelet reduction from AGRYLIN therapy is dose-related; therefore, thrombocytopenia, which can potentially cause bleeding, is expected from overdosage. In case of overdosage, stop AGRYLIN dosing and monitor platelet counts for thrombocytop...

Read more

Cardiovascular Toxicity: QT prolongation and ventricular tachycardia have been reported with AGRYLIN. Obtain a pre-treatment cardiovascular examination including an ECG in all patients. Monitor patients for cardiovascular effects. Pulmonary Hypertension: Assess underlying cardiopulmonary disease prior to initiating therapy. Bleeding Risk: Monitor patients for bleeding, including those receiving concomitant therapy with other drugs known to cause bleeding. 5.1 Cardiovascular Toxicity Torsades de point...

Read more

Other PDE3 inhibitors: Exacerbation of inotropic effects. Aspirin and Drugs that Increase Bleeding Risk : Increased risk of bleeding with concomitant use. 7.1 Drugs that Prolong QT Avoid use of AGRYLIN in patients taking medications that may prolong QT interval (including, but not limited to, chloroquine, clarithromycin, haloperidol, methadone, moxifloxacin, amiodarone, disopyramide, procainamide, and pimozide) . 7.2 PDE3 Inhibitors AGRYLIN is a phosphodiesterase 3 (PDE3) inhibitor. Avoid use of dr...

Read more

Available data from case reports with AGRYLIN use 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 eff...

Read more