Agrylin

Agrylin Special Precautions

anagrelide

Manufacturer:

Takeda

Distributor:

Zuellig
/
Firma Chun Cheong
Full Prescribing Info
Special Precautions
Laboratory Tests: Anagrelide therapy requires close clinical supervision of the patient. While the platelet count is being lowered (usually during the first 2 weeks of treatment), blood counts (hemoglobin, white blood cells), liver function (SGOT, SGPT) and renal function (serum creatinine, BUN) should be monitored.
In 9 subjects receiving a single 5-mg dose of anagrelide, standing blood pressure fell an average of 22/15 mm Hg, usually accompanied by dizziness. Only minimal changes in blood pressure were observed following a dose of 2 mg.
Cessation of Agrylin Treatment: In general, interruption of anagrelide treatment is followed by an increase in platelet count. After sudden stoppage of anagrelide therapy, the increase in platelet count can be observed within 4 days.
Carcinogenicity, Mutagenicity & Impairment of Fertility: No long-term studies in animals have been performed to evaluate carcinogenic potential of anagrelide HCl. Anagrelide HCl was not genotoxic in the Ames test, the mouse lymphoma cell (L5178Y, TK±) forward mutation test, the human lymphocyte chromosome aberration test or the mouse micronucleus test. Anagrelide HCl at oral doses up to 240 mg/kg/day (1440 mg/m2/day, 195 times the recommended maximum human dose based on body surface area) was found to have no effect on fertility and reproductive performance of male rats. However, in female rats, at oral doses of 60 mg/kg/day (360 mg/m2/day, 49 times the recommended maximum human dose based on body surface area) or higher, it disrupted implantation when administered in early pregnancy and retarded or blocked parturition when administered in late pregnancy.
Use in pregnancy: Teratogenic Effects: Teratology studies have been performed in pregnant rats at oral doses up to 900 mg/kg/day (5400 mg/m2/day, 730 times the recommended maximum human dose based on body surface area) and in pregnant rabbits at oral doses up to 20 mg/kg/day (240 mg/m2/day, 32 times the recommended maximum human dose based on body surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to anagrelide HCl.
Nonteratogenic Effects: A fertility and reproductive performance study performed in female rats revealed that anagrelide HCl at oral doses of 60 mg/kg/day (360 mg/m2/day, 49 times the recommended maximum human dose based on body surface area) or higher disrupted implantation and exerted adverse effect on embryo/fetal survival.
A perinatal and postnatal study performed in female rats revealed that anagrelide HCl at oral doses of 60 mg/kg/day (360 mg/m2/day, 49 times the recommended maximum human dose based on body surface area) or higher produced delay or blockage of parturition, deaths of nondelivering pregnant dams and their fully developed fetuses and increased mortality in the pups born. Five women became pregnant while on anagrelide treatment at doses of 1-4 mg/day. Treatment was stopped as soon as it was realized that they were pregnant. All delivered normal, healthy babies. There are no adequate and well-controlled studies in pregnant women. Anagrelide HCl should be used during pregnancy only it the potential benefit justifies the potential risk to the fetus. Anagrelide is not recommended in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus. Women of childbearing potential should be instructed that they must not be pregnant and that they should use contraception while taking anagrelide. Anagrelide may cause fetal harm when administered to a pregnant woman.
Use in lactation: It is not known whether Agrylin is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reaction in nursing infants from anagrelide HCl, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Use in children: The safety and efficacy of anagrelide in patients <16 years have not been established. Myeloproliferative disorders are uncommon in pediatric patients. Anagrelide has been used successfully in 12 pediatric patients (age range 6.8-17.4 years; 6 male and 6 female), including 8 patients with ET, 2 patients with CML, 1 patient with PV and 1 patient with OMPD. Patients were started on therapy with 0.5 mg 4 times daily to a maximum daily dose of 10 mg. The median duration of treatment was 18.1 months with a range of 3.1-92 months. Three patients received treatment for >3 years.
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