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ButtonLoadingButtonLoading AboutAbout ATTR-CMUrgencySuspectDetectDiagnostic flowchartAbout ATTR-PNUrgencyAwarenessPartnershipStudy DesignStudy DesignAbout ATTR-PNUrgencyAwarenessPartnershipEfficacy & SafetyPivotal efficacyLong-term survivalSubgroup analysisKey secondary endpointsEarly efficacy measuresSafety profileATTR-PNPivotal efficacyPivotal efficacy ALTLong-term efficacyMutations efficacyLong-term survivalSafety profileDosingATTR-CM dosingATTR-PNPivotal efficacyPivotal efficacy ALTLong-term efficacyMutations efficacyLong-term survivalSafety profileMOD/MOARole of TTRATTR-CM MODATTR-CM MOAATTR-PNATTR-PN MODATTR-PN MOASupport & ResourcesMaterialsVideosATTR-PNATTR-PN MODATTR-PN MOA

Prescribing Information

ATTR-PNATTR-PN MODATTR-PN MOA

Vyndaqel 61mg is indicated for the treatment of wild‑type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy
(ATTR-CM).1

▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. Refer to section 4.8 of the SmPC for how to report adverse reactions.

[SELECT APPROPRIATE DOSAGE PAGE PER COUNTRY’S LOCAL LABEL.]

Oral VYNDAQEL 61 mg for ATTR-CM A convenient, once-daily, single-dose capsule that’s simple for patients to take at home1

VYNDAQEL dose for ATTR-CM

Prescribe VYNDAQEL 61 mg once daily

Vyndaqel (tafamidis) 61 mg capsule imprinted with “VYN 61” in white.​​​​​​​

Capsule shown is not actual size.

Simple for patients to take at home  

Can be taken with or without food1

Capsules should be swallowed whole – do not crush or cut capsules1

Requires no premedication or administration by a healthcare professional

A single VYNDAQEL (tafamidis) 61-mg capsule corresponds to VYNDAQEL (tafamidis meglumine) 80 mg (four 20-mg capsules) and is not interchangeable on a per-mg basis.1,2BioequivalenceA study demonstrated the bioequivalence of VYNDAQEL 61 mg to 80 mg of VYNDAQEL2A single VYNDAQEL 61-mg capsule corresponds to VYNDAQEL 80 mg (four 20-mg capsules) and is not interchangeable on a per-mg basis.1,2

VYNDAQEL (tafamidis)

Free acid formulation

Vyndaqel (tafamidis) 61 mg capsule imprinted with “VYN 61” in white.​​​​​​​

arrow​​​​​​​

VYNDAQEL (tafamidis meglumine)

Meglumine salt formulation

4 Vyndaqel (tafamidis meglumine) 20 mg capsules imprinted with “VYN 20” in red.​​​​​​​

tablets​​​​​​​

In a phase 1, open-label, randomized, 2-period, 2-sequence, crossover, multiple-dose bioequivalence study, fasted healthy individuals (n=30) received VYNDAQEL 61 mg once daily or VYNDAQEL 80 mg once daily.2† 

The study compared the area under the concentration-time profiles from time 0 to time tau (AUCtau) and the maximum observed concentration (Cmax) at steady state.2

Approval of VYNDAQEL 61 mg was based on ATTR-ACT, which evaluated pooled 20-mg and 80-mg (4 × 20 mg) doses of VYNDAQEL. The relative bioavailability of 61 mg of VYNDAQEL (tafamidis) is similar to 80 mg of VYNDAQEL at steady state.2

After a twice-daily loading dose on days 1 and 2 to reduce the time to reach steady state, patients switched to a once-daily dose for days 3-7.2Capsules shown are not actual size.
As determined by the predefined 90% confidence interval criteria of 80%-125% bioequivalence limits for tafamidis for area under curve (AUC) and peak plasma concentration (Cmax) after repeated oral daily dosing for 7 days.2 ​​​​​​​ATTR-CM=transthyretin amyloid cardiomyopathy. 
Explore MorePivotal and 5-year data for ATTR-CM
 View the Body of Evidence
References:VYNDAQEL Summary of Product CharacteristicsLockwood PA, Le VH, O'Gorman MT, et al. The bioequivalence of tafamidis 61 mg free acid capsules and tafamidis meglumine 4 × 20-mg capsules in healthy volunteers. Clin Pharmacol Drug Dev. 2020;9(7):849-854. doi:10.1002/cpdd.789
VYNDAQEL Prescribing InformationLoading
Dosing

Legal Category: S1A.Further information available upon request

 

PP-VYN-IRL-0180. November 2022

Adverse events should be reported.

If you wish to make a medical information inquiry or report an adverse event please contact Pfizer on 1800 633 363 
or email Pfizer at [email protected] or visit www.PfizerMedicalInformation.ie

Report an adverse event to your national reporting system (HPRA Pharmacovigilance)

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PP-UNP-IRL-0891. February 2025
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