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Agrylin (Anagrelide Hydrochloride) - Summary

 
 



AGRYLIN SUMMARY

AGRYLIN®
(anagrelide hydrochloride)
Capsules

Rx only

AGRYLIN® (anagrelide hydrochloride) reduces blood platelet count.

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).


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NEWS HIGHLIGHTS

Published Studies Related to Agrylin (Anagrelide)

Pharmacokinetics, bioequivalence, tolerability, and effects on platelet counts of two formulations of anagrelide in healthy volunteers and patients with thrombocythemia associated with chronic myeloproliferation. [2009.02]
BACKGROUND: Anagrelide hydrochloride is an anti-thrombotic agent indicated for the treatment of essential thrombocythemia (ET). In various previously published clinical trials of 2 branded formulations of anagrelide in patients with ET at high risk for thrombohemorrhagic events, the rates of adverse events and discontinuation were strikingly divergent between brands. Because the formulations and manufacturers differed, the differences in tolerability, as well as platelet counts, might have been related to differences in pharmacokinetic properties between the 2 formulations. OBJECTIVES: The present series of investigations (1) determined the pharmacokinetic profile of anagrelide and its metabolites; (2) compared the pharmacokinetic profiles of the test and reference formulations of anagrelide; (3) investigated the in vitro release of anagrelide as a marker of intragastric anagrelide release of the test and reference formulations; and (4) compared the platelet-reducing effects of the test and reference formulations in patients with thrombocythemia in 2 longitudinal studies over 4 weeks... CONCLUSIONS: The pharmacokinetic properties, adverse event rates, and in vitro dissolution profile differed between the test and reference anagrelide formulations in these healthy volunteers. In patients with ET or thrombocythemia associated with CMPD, platelet counts did not differ significantly from baseline at 4 weeks when subjects were switched from the reference to the test anagrelide formulation.

Hydroxyurea compared with anagrelide in high-risk essential thrombocythemia. [2005.07.07]
BACKGROUND: We conducted a randomized comparison of hydroxyurea with anagrelide in the treatment of essential thrombocythemia... CONCLUSIONS: Hydroxyurea plus low-dose aspirin is superior to anagrelide plus low-dose aspirin for patients with essential thrombocythemia at high risk for vascular events. Copyright 2005 Massachusetts Medical Society.

Anagrelide for the treatment of thrombocythaemia in daily clinical practice: a post-marketing observational survey on efficacy and safety performed in Germany. [2010]
BACKGROUND: Myeloproliferative diseases - in particular essential thrombocythaemia (ET) - may be associated with increases in platelet count which put patients at risk of life-threatening complications such as thromboses and severe bleedings... CONCLUSION: Anagrelide was effective in lowering the platelet count and was also well tolerated when used in daily clinical practice. (c) 2010 S. Karger AG, Basel.

Management of refractory essential thrombocythemia with anagrelide in a patient undergoing hemodialysis. [2009.11]
BACKGROUND: Management of essential thrombocythemia (ET) in high-risk patients is difficult because high platelet numbers can lead to vascular occlusive events and bleeding. Therapeutic interventions in ET are limited to hydroxyurea and anagrelide; however, in Europe, anagrelide is contraindicated in patients with chronic renal disease...

Atypical Takotsubo syndrome during anagrelide therapy. [2009.07]
Anagrelide is a phosphodiesterase III inhibitor utilized in the treatment of essential thrombocythemia... To our knowledge, this is one of the first reports of an association between anagrelide therapy and Takotsubo cardiomyopathy.

more studies >>

Clinical Trials Related to Agrylin (Anagrelide)

Fed Study of Anagrelide Hydrochloride Capsules 1 mg to AgrylinŽ Capsules 1 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's anagrelide HCl 1 mg capsules to Shire US's AgrylinŽ 1 mg capsules following a single, oral 1 mg (1 x 1 mg) dose administration under fed conditions.

Fasting Study of Anagrelide Hydrochloride Capsules 1 mg to AgrylinŽ Capsules 1 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's anagrelide HCl 1 mg capsules to Shire US's AgrylinŽ 1 mg capsules following a single, oral 1 mg (1 x 1 mg) dose administration under fasting conditions.

A Phase II Study of the Pharmacokinetics of Anagrelide in Elderly and Young ET Patients [Recruiting]
Age related differences in response to a drug could arise from variation in PK and/or pharmacodynamic (PD) profiles between age groups. Whilst the efficacy and safety profile of anagrelide is well established through a well-documented clinical trial programme in patients of all ages, no formal studies have been carried out to investigate whether the PK profile of anagrelide and its metabolites is altered with age.

This study is designed to allow comparisons to be made in terms of pharmacokinetics of anagrelide and its metabolites between elderly (>65 years) and young (18-50 years) ET patients

A Study of Anagrelide and Hydroxyurea in High-Risk Essential Thrombocythemia Patients [Recruiting]
Essential thrombocythaemia is a disorder of bone marrow, which causes too many platelets to be produced. Platelets are small cells carried around in the blood, which help form blood clots. When patients have too many platelets, there is a risk of blood clots forming unnecessarily and excessive bleeding. The aim of this study is to gain additional information on the safety profile of Anagrelide (Xagrid(r)) and Hydroxyurea (also known as hydroxycarbamide).

Long-term Safety of SPD422 in Japanese Adults With Essential Thrombocythaemia [Recruiting]
The purpose of this study is to provide SPD422 to subjects who completed Study SPD422 308 and, in the opinion of the Investigator, will continue to benefit from treatment.

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Reports of Suspected Agrylin (Anagrelide) Side Effects

Intentional Overdose (2)Drug Diversion (2)Gastrointestinal Haemorrhage (1)Pain (1)Mucous Stools (1)Headache (1)Haematemesis (1)Tunnel Vision (1)Overdose (1)Chest Pain (1)more >>


Page last updated: 2010-10-05

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