AGRYLIN 0.5MG CAPSULES

País: Malàisia

Idioma: anglès

Font: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

ingredients actius:

ANAGRELIDE HYDROCHLORIDE MONOHYDRATE

Disponible des:

Takeda Malaysia Sdn Bhd

Designació comuna internacional (DCI):

ANAGRELIDE HYDROCHLORIDE MONOHYDRATE

Unidades en paquete:

100capsule Capsules

Fabricat per:

Patheon Manufacturing Services LLC

Fitxa tècnica

1
Agrylin® capsules 0.5 mg
Anagrelide (as hydrochloride)
1. NAME OF THE MEDICINAL PRODUCT
Agrylin capsules 0.5 mg
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 0.5 mg anagrelide (as 0.61 mg anagrelide
hydrochloride).
Excipient(s) with known effect
Each hard capsule contains lactose monohydrate (53.7 mg) and anhydrous
lactose (65.8 mg).
For a full list of excipients see section 6.1.
3. PHARMACEUTICAL FORM
Hard capsule.
An opaque white hard capsule imprinted with S 063.
4. CLINICAL PARTICULARS
4.1 THERAPEUTICAL INDICATIONS
Agrylin capsules are indicated for the reduction of elevated platelet
counts in at risk essential
thrombocythaemia (ET) patients who are intolerant to their current
therapy or whose elevated
platelet counts are not reduced to an acceptable level by their
current therapy.
_An at-risk patient: _
An at-risk essential thrombocythaemia patient is defined by one or
more of
the following features:
• >60 years of age or
• A platelet count >1000 x 109/L or
• A history of thrombo-haemorrhagic events.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Agrylin capsules should be initiated by a clinician
with experience in the
management of essential thrombocythaemia.
_Posology _
The recommended starting dosage of anagrelide is 1 mg/day, which
should be administered
orally in two divided doses (0.5 mg/dose).
The starting dose should be maintained for at least one week. After
one week the dose may be
titrated, on an individual basis, to achieve the lowest effective dose
required to reduce and/or
maintain a platelet count below 600 x 109/L and ideally at levels
between 150 x 109/L and
TAKEDA
Package insert
2
400 x 109/L. The dose increment must not exceed more than 0.5 mg/day
in any one week and
the recommended maximum single dose should not exceed 2.5 mg (see
section 4.9). During
clinical development doses of 10 mg/day have been used.
The effects of treatment with anagrelide must be monitored on a
regular basis (see section 4.4).
If the starting dose is >1 mg/day platelet