"The U.S. Food and Drug Administration yesterday approved Obizur [Antihemophilic Factor (Recombinant), Porcine Sequence] for the treatment of bleeding episodes in adults with acquired hemophilia A (acquired Factor VIII [FVII] deficiency).
AGRYLIN Capsules are 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 [see Clinical Studies, DOSAGE AND ADMINISTRATION].
DOSAGE AND ADMINISTRATION
Adults: The recommended starting dosage of AGRYLIN is 0.5 mg four times daily or 1 mg twice daily.
Pediatric Patients: The recommended starting dosage of AGRYLIN is 0.5 mg daily.
Continue the starting dose for at least one week and then titrate to reduce and maintain the platelet count below 600,000/μL, and ideally between 150,000/μL and 400,000/μL. The dose increment should not exceed 0.5 mg/day in any one week. Dosage should not exceed 10 mg/day or 2.5 mg in a single dose [see WARNINGS AND PRECAUTIONS]. Most patients will experience an adequate response at a dose of 1.5 to 3.0 mg/day. Monitor platelet counts weekly during titration then monthly or as necessary.
Dose Modifications For Hepatic Impairment
In patients with moderate hepatic impairment (Child Pugh score 7-9) start AGRYLIN therapy at a dose of 0.5 mg/day and monitor frequently for cardiovascular events [see WARNINGS AND PRECAUTIONS, Use in Specific Populations and CLINICAL PHARMACOLOGY]. Patients with moderate hepatic impairment who have tolerated AGRYLIN therapy for one week may have their dose increased. The dose increase increment should not exceed 0.5 mg/day in any one week. Avoid use of AGRYLIN in patients with severe hepatic impairment.
AGRYLIN therapy requires clinical monitoring, including complete blood counts, assessment of hepatic and renal function, and electrolytes.
To prevent the occurrence of thrombocytopenia, monitor platelet counts every two days during the first week of treatment and at least weekly thereafter until the maintenance dosage is reached. Typically, platelet counts begin to respond within 7 to 14 days at the proper dosage. In the clinical trials, the time to complete response, defined as platelet count ≤ 600,000/μL, ranged from 4 to 12 weeks. In the event of dosage interruption or treatment withdrawal, the rebound in platelet count is variable, but platelet counts typically will start to rise within 4 days and return to baseline levels in one to two weeks, possibly rebounding above baseline values. Monitor platelet counts frequently.
Dosage Forms And Strengths
White, opaque capsule, containing 0.5 mg anagrelide (as anagrelide hydrochloride), imprinted with “ S 063” in black ink.
Storage And Handling
AGRYLIN is available as:
0.5 mg, opaque, white capsules imprinted “ S 063” in black ink: NDC 54092-063-01 = bottle of 100 Store at 25°C (77°F) excursions permitted to 15-30°C (59-86°F), [See USP Controlled Room Temperature]. Store in a light resistant container.
Manufactured for Shire US Inc., 725 Chesterbrook Blvd., Wayne, PA 19087, USA 1-800-828-2088. Revised: Oct 2014
Last reviewed on RxList: 11/14/2014
This monograph has been modified to include the generic and brand name in many instances.
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