Tafamidis
VYNDAQEL, VYNDAMAX
What it isTransthyretin stabilizer; ATTR cardiomyopathy.
Why this oneIt reduces mortality and hospitalization in ATTR cardiomyopathy, the first therapy to do so.
What limits itIt inhibits BCRP; monitor for toxicity from substrates such as rosuvastatin, methotrexate, and imatinib. Cost remains a major barrier.
FDA-approved for
- transthyretin amyloid cardiomyopathy (2019)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| ATTR cardiomyopathy — Vyndaqel (tafamidis meglumine) | Adults | 80 mg QD | 80 mg QD | 80 mg QD |
| ATTR cardiomyopathy — Vyndamax (tafamidis) | Adults | 61 mg QD | 61 mg QD | 61 mg QD |
Renal Undefined
Hepatic Undefined
Instructions
- Swallow capsules whole; do not crush or cut
- Vyndamax 61 mg and Vyndaqel 80 mg are NOT substitutable on a per-mg basis
- Missed dose: take when remembered or skip; do not double
Cautions
- May reduce serum thyroxine binding (per class); monitor clinically as indicated
Adverse reactions
- No adverse reactions occurred at a frequency different from placebo in ATTR-CM trials
Pregnancy May cause fetal harm (animal data: embryofetal mortality, reduced weight, malformation); limited human data at 20 mg/day not identifying risk
Lactation No human data; present in rat milk; advise not to breastfeed
NO BOXED WARNINGS
Principal riskBenefit takes many months; extreme cost
Cost, est. cash$15,000–$40,000/month
Generic entry2031 (settlement)
Classes and tags
Clinical profile
Legacy pregnancy categoryNot assigned — PLLR-era drug
Defining liabilityGenerally tolerated at therapeutic doses; clinically important risks are agent-specific and increase with interactions or organ impairment.
Mechanism of action: Tafamidis ballicule
Open Tafamidis in the interactive console ↗
Memory aids: mascots and interaction avatars
stabilizing a TTR tetramer
