Tafamidis
VYNDAQEL, VYNDAMAX
Pronunciation: ta-FAM-id-is (VIN-da-max)
“Taffy Vender Max”
stabilizing a TTR tetramer
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
Available strengths
- cap 61 mg
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
Cost
| Strength | #/mo | generic $/mo | CostPlus | |
|---|---|---|---|---|
| 61 mg | cap | 30 qd | not offered |
Generic entry2031 (settlement)
NO BOXED WARNINGS
Principal riskBenefit takes many months; extreme cost
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.
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