Anagrelide

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 thrombo-hemorrhagic events.

The precise mechanism by which anagrelide reduces blood platelet count is unknown. In cell culture studies, anagrelide suppressed expression of transcription factors including GATA-1 and FOG-1 required for megakaryocytopoiesis, ultimately leading to reduced platelet production.

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.

None. None.

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.

The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Cardiovascular Toxicity Pulmonary Hypertension Bleeding Risk Pulmonary Toxicity The most common adverse reactions (incidence ≥ 5%) are headache, palpitations, diarrhea, asthenia, edema, nausea, abdominal pain, dizziness, pain, dyspnea, cough, flatulence, vomiting, fever, peripheral edema, rash, chest pain, anorexia, tachycardia, malaise, paresthesia, back pain, pruritus, and dyspepsia.

Other PDE3 inhibitors: Exacerbation of inotropic effects. Aspirin and Drugs that Increase Bleeding Risk: Increased risk of bleeding with concomitant use.

Store at 25°C (77°F) excursions permitted to 15°C to 30°C (59°F to 86°F),. Store in a light resistant container.