In order to be eligible for enrolment in the VYNDAMAX Patient Assistance Program, the patient must be or have:
- 18 years of age or older
- Wild-type or hereditary transthyretin amyloid cardiomyopathy (ATTR-CM)
- Evidence of cardiac involvement by echocardiography with an end-diastolic interventricular septal wall thickness ≥ 12 mm
- Documentation that AL amyloidosis has been evaluated and ruled out
- New York Heart Association (NYHA) Heart Failure Functional Classification I or II
The full name of the specialist medical practitioner consulted and the date of consultation must be recorded in the patient’s notes and is required for enrolment in the VYNDAMAX Patient Assistance Program. Please note: treatment with VYNDAMAX may only be initiated and maintained under the supervision of a physician knowledgeable in the management of patients with ATTR-CM.
The results of the following tests† must be recorded at the time of enrolment and during the time that the patient remains enrolled in this Program. Prescribers must confirm all tests† have been conducted as follows:
- Renal function (initiation, month 1 and then every 6 months thereafter)
- Liver function (initiation, month 1 and then every 6 months thereafter)
- Cardiac markers: Troponin (initiation, 6 monthly), NT-pro BNP level (initiation, 12 monthly)
- Echo (initiation, 12 monthly)
† Please note: any costs associated with the above tests will not be reimbursed under the Program.
VYNDAMAX Patient Assistance Program patient exclusion criteria
Patients with the following conditions will not be eligible for the VYNDAMAX Patient Assistance Program:
- Transthyretin amyloid of a predominantly polyneuropathy phenotype
- Hypersensitivity to tafamidis or to any of the excipients in the capsules
- Organ transplant recipient
- Severe renal impairment (creatinine clearance ≤30 mL/min)
- Severe liver impairment (transaminase levels >2.0 x ULN)
- Pregnancy
- Women of childbearing potential not using contraception
- Women who are breastfeeding
- Paediatric patients (aged <18 years)
- Implanted cardiac ventricular assist device (not including pacemakers or implantable cardioverter-defibrillators)
- New York Heart Association (NYHA) Heart Failure Functional Classification III or IV