Generic Name and Formulations:
Anagrelide (as HCl) 0.5mg; caps.
Shire US, Inc.
Indications for AGRYLIN:
Treatment of thrombocythemia, secondary to myeloproliferative neoplasms, to reduce elevated platelet count and the risk of thrombosis and to improve symptoms.
Initially 0.5mg four times daily or 1mg twice daily for ≥1 week. May increase dose by 0.5mg/day weekly to maintain normal platelet count; max 10mg/day or 2.5mg/dose. Moderate hepatic impairment: initially 0.5mg/daily.
Initially 0.5mg daily. May increase dose by 0.5mg/day weekly to maintain normal platelet count; max 10mg/day or 2.5mg/dose.
Congenital long QT syndrome, acquired QTc prolongation, hypokalemia: not recommended. Obtain baseline cardiovascular exam and monitor during treatment. Monitor for QTc prolongation and other cardiovascular events in those with hepatic impairment. Heart failure, bradyarrhythmias, electrolyte abnormalities; consider periodic ECG monitoring. Evaluate for underlying cardiopulmonary disease prior to initiation and during therapy. Discontinue and evaluate if pulmonary toxicity is suspected. Monitor CBCs, electrolytes, renal and liver function before initiating and during therapy. Obtain platelet counts every 2 days during 1st week of treatment, then weekly until maintenance dose reached. Cessation may cause platelet count to rise within 4 days. Severe hepatic impairment: not recommended. Pregnancy (Cat.C). Nursing mothers: not recommended.
Concomitant drugs that can prolong the QT interval (eg, chloroquine, clarithromycin, haloperidol, methadone, moxifloxacin, amiodarone, disopyramide, procainamide, pimozide), inotropes, other PDE3 inhibitors (eg, cilostazol, milrinone): not recommended. Concomitant anticoagulants, PDE3 inhibitors, NSAIDs, antiplatelet agents, SSRIs; monitor for bleeding. Potentiated by fluvoxamine, ciprofloxacin or other CYP1A2 inhibitors. Antagonized by omeprazole or other CYP1A2 inducers; may need to adjust dose. May affect CYP1A2 substrates (eg, theophylline, fluvoxamine, ondansetron).
Platelet-reducing agent (PDE3 inhibitor).
Headache, palpitations, diarrhea, asthenia, edema, nausea, abdominal pain, dizziness, pain, dyspnea, flatulence, vomiting, fever, rash, chest pain, anorexia, tachycardia, malaise, cough, paresthesia, back pain, pruritus, dyspepsia; cardiovascular effects (eg, torsades de pointes, ventricular tachycardia, CHF), pulmonary hypertension, interstitial lung disease.