Vyndamax 61 mg Soft Capsules

国家: 马来西亚

语言: 英文

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

有效成分:

Tafamidis

可用日期:

PFIZER (MALAYSIA) SDN. BHD.

INN（国际名称）:

Tafamidis

每包单位数:

30 Capsules

厂商:

Catalent Pharma Solutions, LLC

资料单张

Not Applicable.

产品特点

1
1.
NAME OF THE MEDICINAL PRODUCT
Vyndamax
®
61 mg soft capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each soft capsule contains 61 mg of micronized tafamidis.
Excipient with known effect
Each soft capsule contains no more than 44 mg of sorbitol (E 420).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Soft capsule.
Reddish brown, opaque, oblong (approximately 21 mm) capsule printed
with “VYN 61” in white.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Vyndamax is indicated for the treatment of wild-type or hereditary
transthyretin amyloidosis in adult
patients with cardiomyopathy (ATTR-CM).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated under the supervision of a physician
knowledgeable in the management of
patients with amyloidosis or cardiomyopathy.
When there is a suspicion in patients presenting with specific medical
history or signs of heart failure or
cardiomyopathy, etiologic diagnosis must be done by a physician
knowledgeable in the management of
amyloidosis or cardiomyopathy to confirm ATTR-CM and exclude AL
amyloidosis before starting
tafamidis, using appropriate assessment tools such as: bone
scintigraphy and blood/urine assessment,
and/or histological assessment by biopsy, and transthyretin (TTR)
genotyping to characterise as wild-type
or hereditary.
Posology
The recommended dose is one capsule of Vyndamax 61 mg (tafamidis)
orally once daily (see section 5.1).
Vyndamax should be started as early as possible in the disease course
when the clinical benefit on disease
progression could be more evident. Conversely, when amyloid-related
cardiac damage is more advanced,
such as in NYHA Class III, the decision to start or maintain treatment
should be taken at the discretion of
a physician knowledgeable in the management of patients with
amyloidosis or cardiomyopathy (see
section 5.1). There are limited clinical data in patients with NYHA
Class IV.
2
If vomiting occurs after dosing, and the intact Vyndamax capsule is
identified, then an addit