Drug Detail:Vyndamax (Tafamidis [ ta-fam-id-is ])
Drug Class: Transthyretin stabilizers
Usual Adult Dose for Amyloidogenic Transthyretin Amyloidosis
Tafamidis meglumine (Vyndaqel): 80 mg orally once a day (Four 20 mg capsules/day)
OR
Tafamidis (Vyndamax): 61 mg orally once a day (One 61 mg capsule/day)
Comments:
- Tafamidis and tafamidis meglumine products are not substitutable on a per mg basis.
Use: For the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization.
Renal Dose Adjustments
No adjustment recommended
Liver Dose Adjustments
Mild to moderate liver dysfunction: No adjustment recommended
Severe liver dysfunction: Use with caution
Precautions
CONTRAINDICATIONS: None
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Administration advice:
- Tafamidis and tafamidis meglumine are not interchangeable on a per mg basis.
- Take orally once a day with or without food; the capsules should be swallowed whole, not crushed or chewed.
Missed Dose: If a dose is missed, take the dose as soon as remembered or skip the missed dose and take the next dose at the regularly scheduled time; do not double the dose
General:
- For patients with wild type or hereditary transthyretin-mediated amyloidosis, there is an international disease registry called the Transthyretin Amyloidosis Outcome Survey (THAOS), designed to assess disease progression, genotype/phenotype relationships, and the impact of interventions, including this drug, on disease progression; participation is voluntary, and may involve long-term follow-up. For information regarding the registry, visit www.thaos.net.
Patient advice:
- Patients should be instructed to read the US FDA-approved patient labeling (Patient Information).
- Patients should be advised of the availability of the Transthyretin Amyloidosis Outcome Survey (THAOS) international voluntary registry designed to assess disease progression, genotype/phenotype relationships, and the impact of interventions.
- Advise pregnant women and females of reproductive potential of the potential risk to a fetus and to inform of a known or suspected pregnancy; pregnancy should be reported to Pfizer reporting line at 1-800-438-1985.
- Advise females not to breastfeed during treatment.
Frequently asked questions
- How long does it take Vyndamax to work?
- How long does it take for Vyndaqel to start working?
