- Approval Id
- 07026737855f63e3
- Drug Name
- VYNDAMAX SOFT GELATIN CAPSULE 61MG
- Product Name
- VYNDAMAX SOFT GELATIN CAPSULE 61MG
- Approval Number
- SIN15894P
- Approval Date
- 2020-02-27
- Registrant
- PFIZER PRIVATE LIMITED
- Licence Holder
- PFIZER PRIVATE LIMITED
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- CAPSULE
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p><u>Posology</u></p>
<p>The recommended dose of VYNDAMAX is 61 mg tafamidis orally once daily (see Section 5.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p>VYNDAMAX can be taken with or without food.</p>
<p><u>Special populations</u></p>
<p><em>Paediatric</em><br>
VYNDAMAX should not be prescribed in the paediatric population as transthyretin amyloidosis is not a disease present in this population.</p>
<p>Elderly<br>
No dosage adjustment is required for elderly patients (≥65 years) (see Section 5.2 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><em>Renal or hepatic impairment</em><br>
No dosage adjustment is required for patients with renal impairment, or mild or moderate hepatic impairment. VYNDAMAX has not been studied in patients with severe hepatic impairment.</p>
<p><u>Method of administration</u></p>
<p>Oral use.</p>
<p>The capsule(s) should be swallowed whole and not crushed or cut. VYNDAMAX may be taken with or without food.</p>
<p>If a dose is missed, the patient should take the dose as soon as remembered. If it is almost time for the next dose, the patient should skip the missed dose and take the next dose at the regularly scheduled time. Do not double the dose.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p>VYNDAMAX is indicated for the treatment of transthyretin amyloidosis in adult patients with wild-type or hereditary cardiomyopathy to reduce all-cause mortality and cardiovascular-related hospitalisation.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<p>Hypersensitivity to the active substance or to any of the excipients of VYNDAMAX (see Section 6.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
- Atc Code
- N07XX08
- Atc Item Name
- tafamidis
- Pharma Manufacturer Name
- PFIZER PRIVATE LIMITED
- Company Detail Path
- /organization/pfizer-private-limited
