Product Description.:
S, 063
capsule , white , oblong oblong
Black ink
Name: AGRYLIN? (anagrelide hydrochloride)
Dosage Form: 0.5 mg capsules for oral administration
Active Ingredient: AGRYLIN? Capsules contain 0.5 mg of anagrelide base (as anagrelide hydrochloride).
Inactive Ingredients: Anhydrous Lactose NF, Crospovidone NF, Lactose Monohydrate NF, Magnesium stearate NF, Microcrystalline cellulose NF, Povidone USP.
Pharmacological Classification: Platelet-reducing agent.
Chemical Name: 6,7-dichloro-1,5-dihydroimidazo[2,1-b]quinazolin-2(3H)-one monohydrochloride monohydrate.
INDICATIONS
AGRYLIN? Capsules are indicated for the treatment of patients with thrombocythemia, secondary to myeloproliferative disorders, 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
Treatment with AGRYLIN? Capsules should be initiated under close medical supervision. The recommended starting dosage of AGRYLIN? for adult patients is 0.5 mg qid or 1 mg bid (2 capsules of 0.5 mg twice a day), which should be maintained for at least one week. Starting doses in pediatric patients have ranged from 0.5 mg per day 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 SUPPLIED
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.
