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AGRYLIN
Miscellaneous hematological agents
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Drug Name:

AGRYLIN Rx

Generic Name and Formulations:
Anagrelide (as HCl) 0.5mg; caps.

Company:
Shire US, Inc.

Therapeutic Use:

Indications for AGRYLIN:

Treatment of thrombocythemia, secondary to myeloproliferative disorders, to reduce elevated platelet count and the risk of thrombosis and to improve symptoms.

Adult:

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.

Children:

Initially 0.5mg daily. May increase dose by 0.5mg/day weekly to maintain normal platelet count; max 10mg/day or 2.5mg/dose.

Warnings/Precautions:

Congenital or 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 monitoring ECGs. 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. Discontinue and evaluate if pulmonary toxicity is suspected. Severe hepatic impairment: not recommended. Pregnancy (Cat.C). Nursing mothers: not recommended.

Interactions:

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 potentiate aspirin, theophylline, ondansetron, other CYP1A2 substrates.

Pharmacological Class:

Platelet-reducing agent (PDE3 inhibitor).

Adverse Reactions:

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), interstitial lung disease.

How Supplied:

Caps—100

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