y to 0.5 mg qid. As there are limited data on the appropriate starting dose for pediatric patients, an initial dose of 0.5 mg per day is recommended. In both adult and pediatric patients, dosage should then be adjusted to the lowest effective dosage required to reduce and maintain platelet count below 600,000/µL, and ideally to the normal range. The dosage should be increased by not more than 0.5 mg/day in any one week. Maintenance dosing is not expected to be different between adult and pediatric patients. Dosage should not exceed 10 mg/day or 2.5 mg in a single dose (see PRECAUTIONS).
There are no special requirements for dosing the geriatric population.
It is recommended that patients with moderate hepatic impairment start anagrelide therapy at a dose of 0.5 mg/day and be maintained for a minimum of one week with careful monitoring of cardiovascular effects. The dosage increment must not exceed more than 0.5 mg/day in any one-week. The potential risks and benefits of anagrelide therapy in a patient with mild or moderate impairment of hepatic function should be assessed before treatment is commenced. Use of anagrelide in patients with severe hepatic impairment has not been studied. Use of anagrelide in patients with severe hepatic impairment is contraindicated (see CONTRAINDICATIONS).
To monitor the effect of anagrelide and prevent the occurrence of thrombocytopenia, platelet counts should be performed every two days during the first week of treatment and at least weekly thereafter until the maintenance dosage is reached.
Typically, platelet count begins to respond within 7 to 14 days at the proper dosage. The time to complete response, defined as platelet count ≤ 600,000/µL, ranged from 4 to 12 weeks. Most patients will experience an adequate response at a dose of 1.5 to 3.0 mg/day. Patients with known or suspected heart disease, renal insufficiency, or hepatic dysfunction should be monitored closely.
HOW SUPPLIEDAGRYLIN ® is available as:
0.5 mg, opaque, white capsules imprinted “S063″ 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
© 2013 Shire US Inc.
Rev. 07/13
063 0117 020Printed in USA
NDC 54092-063-01 — 0.5 mg bottle of 100 capsules
(click image for full-size original) AGRYLIN anagrelide hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54092-063
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ANAGRELIDE HYDROCHLORIDE (ANAGRELIDE) ANAGRELIDE 0.5 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
CROSPOVIDONE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONES
Product Characteristics
Color WHITE (white) Score no score
Shape CAPSULE (CAPSULE) Size 14mm
Flavor Imprint Code S063
Contains
Packaging
Item Code Package Description Multilevel Packaging
1 NDC:54092-063-01 100 CAPSULE (100 CAPSULE) in 1 BOTTLE None
Marketing Information
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