Dosing & Uses
Dosage Forms & Strengths
capsule
- 20mg
Transthyretin Amyloid Cardiomyopathy
Indicated for cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization
80 mg PO qDay
Dosage Modifications
Hepatic impairment
- Mild (Child Pugh Score 5-6): No dosage adjustment necessary
- Moderate (Child Pugh Score of 7-9): Decreased systemic exposure (~40%) and increased clearance (~68%) of tafamidis compared to healthy subjects
- Severe (Child Pugh >9): Unknown
Dosing Considerations
Tafamidis (Vyndamax) and tafamidis meglumine (Vyndaqel) are not substitutable on a per mg basis
Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (3)
- alpelisib
tafamidis meglumine will increase the level or effect of alpelisib by Other (see comment). Avoid or Use Alternate Drug. Coadministration of alpelisib (BCRP substrate) with a BCRP inhibitor may increase alpelisib concentration, which may increase the risk of toxicities. If unable to avoid or use alternant drugs, closely monitor for increased adverse reactions.
- ozanimod
tafamidis meglumine increases toxicity of ozanimod by Other (see comment). Avoid or Use Alternate Drug. Comment: Coadministration of ozanimod (a BCRP substrate) with BCRP inhibitors increases the exposure of the minor (RP101988, RP101075) and major active metabolites (CC112273, CC1084037) of ozanimod, which may increase the risk of ozanimod adverse reactions. .
- rimegepant
tafamidis meglumine will increase the level or effect of rimegepant by Other (see comment). Avoid or Use Alternate Drug. Avoid coadministration of rimegepant (a BCRP substrate) with inhibitors of BCRP.
Monitor Closely (33)
- atorvastatin
tafamidis meglumine will increase the level or effect of atorvastatin by Other (see comment). Use Caution/Monitor. Tafamidis inhibits breast cancer resistant protein (BCRP) in vitro and may increase exposure of BCRP substrates following tafamidis or tafamidis meglumine administration. Dosage adjustment of these BCRP substrates may be necessary.
- berotralstat
tafamidis meglumine increases levels of berotralstat by Other (see comment). Modify Therapy/Monitor Closely. Comment: Reduced dose of berotralstat (a BCRP substrate) to 110 mg/day when coadministered with BCRP inhibitors.
- chlorothiazide
tafamidis meglumine will increase the level or effect of chlorothiazide by Other (see comment). Use Caution/Monitor. Tafamidis inhibits breast cancer resistant protein (BCRP) in vitro and may increase exposure of BCRP substrates following tafamidis or tafamidis meglumine administration. Dosage adjustment of these BCRP substrates may be necessary.
- cimetidine
tafamidis meglumine will increase the level or effect of cimetidine by Other (see comment). Use Caution/Monitor. Tafamidis inhibits breast cancer resistant protein (BCRP) in vitro and may increase exposure of BCRP substrates following tafamidis or tafamidis meglumine administration. Dosage adjustment of these BCRP substrates may be necessary.
- daunorubicin
tafamidis meglumine will increase the level or effect of daunorubicin by Other (see comment). Use Caution/Monitor. Tafamidis inhibits breast cancer resistant protein (BCRP) in vitro and may increase exposure of BCRP substrates following tafamidis or tafamidis meglumine administration. Dosage adjustment of these BCRP substrates may be necessary.
- dipyridamole
tafamidis meglumine will increase the level or effect of dipyridamole by Other (see comment). Use Caution/Monitor. Tafamidis inhibits breast cancer resistant protein (BCRP) in vitro and may increase exposure of BCRP substrates following tafamidis or tafamidis meglumine administration. Dosage adjustment of these BCRP substrates may be necessary.
- doxorubicin
tafamidis meglumine will increase the level or effect of doxorubicin by Other (see comment). Use Caution/Monitor. Tafamidis inhibits breast cancer resistant protein (BCRP) in vitro and may increase exposure of BCRP substrates following tafamidis or tafamidis meglumine administration. Dosage adjustment of these BCRP substrates may be necessary.
- fluvastatin
tafamidis meglumine will increase the level or effect of fluvastatin by Other (see comment). Use Caution/Monitor. Tafamidis inhibits breast cancer resistant protein (BCRP) in vitro and may increase exposure of BCRP substrates following tafamidis or tafamidis meglumine administration. Dosage adjustment of these BCRP substrates may be necessary.
- glyburide
tafamidis meglumine will increase the level or effect of glyburide by Other (see comment). Use Caution/Monitor. Tafamidis inhibits breast cancer resistant protein (BCRP) in vitro and may increase exposure of BCRP substrates following tafamidis or tafamidis meglumine administration. Dosage adjustment of these BCRP substrates may be necessary.
- imatinib
tafamidis meglumine will increase the level or effect of imatinib by Other (see comment). Use Caution/Monitor. Tafamidis inhibits breast cancer resistant protein (BCRP) in vitro and may increase exposure of BCRP substrates following tafamidis or tafamidis meglumine administration. Dosage adjustment of these BCRP substrates may be necessary.
- irinotecan
tafamidis meglumine will increase the level or effect of irinotecan by Other (see comment). Use Caution/Monitor. Tafamidis inhibits breast cancer resistant protein (BCRP) in vitro and may increase exposure of BCRP substrates following tafamidis or tafamidis meglumine administration. Dosage adjustment of these BCRP substrates may be necessary.
- lapatinib
tafamidis meglumine will increase the level or effect of lapatinib by Other (see comment). Use Caution/Monitor. Tafamidis inhibits breast cancer resistant protein (BCRP) in vitro and may increase exposure of BCRP substrates following tafamidis or tafamidis meglumine administration. Dosage adjustment of these BCRP substrates may be necessary.
- ledipasvir/sofosbuvir
tafamidis meglumine will increase the level or effect of ledipasvir/sofosbuvir by Other (see comment). Use Caution/Monitor. Tafamidis inhibits breast cancer resistant protein (BCRP) in vitro and may increase exposure of BCRP substrates following tafamidis or tafamidis meglumine administration. Dosage adjustment of these BCRP substrates may be necessary.
- leflunomide
tafamidis meglumine will increase the level or effect of leflunomide by Other (see comment). Use Caution/Monitor. Tafamidis inhibits breast cancer resistant protein (BCRP) in vitro and may increase exposure of BCRP substrates following tafamidis or tafamidis meglumine administration. Dosage adjustment of these BCRP substrates may be necessary.
- lenvatinib
tafamidis meglumine will increase the level or effect of lenvatinib by Other (see comment). Use Caution/Monitor. Tafamidis inhibits breast cancer resistant protein (BCRP) in vitro and may increase exposure of BCRP substrates following tafamidis or tafamidis meglumine administration. Dosage adjustment of these BCRP substrates may be necessary.
- methotrexate
tafamidis meglumine will increase the level or effect of methotrexate by Other (see comment). Use Caution/Monitor. Tafamidis inhibits breast cancer resistant protein (BCRP) in vitro and may increase exposure of BCRP substrates following tafamidis or tafamidis meglumine administration. Dosage adjustment of these BCRP substrates may be necessary.
- mitoxantrone
tafamidis meglumine will increase the level or effect of mitoxantrone by Other (see comment). Use Caution/Monitor. Tafamidis inhibits breast cancer resistant protein (BCRP) in vitro and may increase exposure of BCRP substrates following tafamidis or tafamidis meglumine administration. Dosage adjustment of these BCRP substrates may be necessary.
- nitrofurantoin
tafamidis meglumine will increase the level or effect of nitrofurantoin by Other (see comment). Use Caution/Monitor. Tafamidis inhibits breast cancer resistant protein (BCRP) in vitro and may increase exposure of BCRP substrates following tafamidis or tafamidis meglumine administration. Dosage adjustment of these BCRP substrates may be necessary.
- osimertinib
tafamidis meglumine will increase the level or effect of osimertinib by Other (see comment). Use Caution/Monitor. Tafamidis inhibits breast cancer resistant protein (BCRP) in vitro and may increase exposure of BCRP substrates following tafamidis or tafamidis meglumine administration. Dosage adjustment of these BCRP substrates may be necessary.
- pantoprazole
tafamidis meglumine will increase the level or effect of pantoprazole by Other (see comment). Use Caution/Monitor. Tafamidis inhibits breast cancer resistant protein (BCRP) in vitro and may increase exposure of BCRP substrates following tafamidis or tafamidis meglumine administration. Dosage adjustment of these BCRP substrates may be necessary.
- pazopanib
tafamidis meglumine will increase the level or effect of pazopanib by Other (see comment). Use Caution/Monitor. Tafamidis inhibits breast cancer resistant protein (BCRP) in vitro and may increase exposure of BCRP substrates following tafamidis or tafamidis meglumine administration. Dosage adjustment of these BCRP substrates may be necessary.
- pitavastatin
tafamidis meglumine will increase the level or effect of pitavastatin by Other (see comment). Use Caution/Monitor. Tafamidis inhibits breast cancer resistant protein (BCRP) in vitro and may increase exposure of BCRP substrates following tafamidis or tafamidis meglumine administration. Dosage adjustment of these BCRP substrates may be necessary.
- riociguat
tafamidis meglumine will increase the level or effect of riociguat by Other (see comment). Use Caution/Monitor. Tafamidis inhibits breast cancer resistant protein (BCRP) in vitro and may increase exposure of BCRP substrates following tafamidis or tafamidis meglumine administration. Dosage adjustment of these BCRP substrates may be necessary.
- rosuvastatin
tafamidis meglumine will increase the level or effect of rosuvastatin by Other (see comment). Use Caution/Monitor. Tafamidis inhibits breast cancer resistant protein (BCRP) in vitro and may increase exposure of BCRP substrates following tafamidis or tafamidis meglumine administration. Dosage adjustment of these BCRP substrates may be necessary.
- selexipag
tafamidis meglumine will increase the level or effect of selexipag by Other (see comment). Use Caution/Monitor. Tafamidis inhibits breast cancer resistant protein (BCRP) in vitro and may increase exposure of BCRP substrates following tafamidis or tafamidis meglumine administration. Dosage adjustment of these BCRP substrates may be necessary.
- sofosbuvir
tafamidis meglumine will increase the level or effect of sofosbuvir by Other (see comment). Use Caution/Monitor. Tafamidis inhibits breast cancer resistant protein (BCRP) in vitro and may increase exposure of BCRP substrates following tafamidis or tafamidis meglumine administration. Dosage adjustment of these BCRP substrates may be necessary.
- sulfasalazine
tafamidis meglumine will increase the level or effect of sulfasalazine by Other (see comment). Use Caution/Monitor. Tafamidis inhibits breast cancer resistant protein (BCRP) in vitro and may increase exposure of BCRP substrates following tafamidis or tafamidis meglumine administration. Dosage adjustment of these BCRP substrates may be necessary.
- talazoparib
tafamidis meglumine will increase the level or effect of talazoparib by Other (see comment). Use Caution/Monitor. Tafamidis inhibits breast cancer resistant protein (BCRP) in vitro and may increase exposure of BCRP substrates following tafamidis or tafamidis meglumine administration. Dosage adjustment of these BCRP substrates may be necessary.
- tenofovir AF
tafamidis meglumine will increase the level or effect of tenofovir AF by Other (see comment). Use Caution/Monitor. Tafamidis inhibits breast cancer resistant protein (BCRP) in vitro and may increase exposure of BCRP substrates following tafamidis or tafamidis meglumine administration. Dosage adjustment of these BCRP substrates may be necessary.
- tenofovir DF
tafamidis meglumine will increase the level or effect of tenofovir DF by Other (see comment). Use Caution/Monitor. Tafamidis inhibits breast cancer resistant protein (BCRP) in vitro and may increase exposure of BCRP substrates following tafamidis or tafamidis meglumine administration. Dosage adjustment of these BCRP substrates may be necessary.
- topotecan
tafamidis meglumine will increase the level or effect of topotecan by Other (see comment). Use Caution/Monitor. Tafamidis inhibits breast cancer resistant protein (BCRP) in vitro and may increase exposure of BCRP substrates following tafamidis or tafamidis meglumine administration. Dosage adjustment of these BCRP substrates may be necessary.
- velpatasvir
tafamidis meglumine will increase the level or effect of velpatasvir by Other (see comment). Use Caution/Monitor. Tafamidis inhibits breast cancer resistant protein (BCRP) in vitro and may increase exposure of BCRP substrates following tafamidis or tafamidis meglumine administration. Dosage adjustment of these BCRP substrates may be necessary.
- vemurafenib
tafamidis meglumine will increase the level or effect of vemurafenib by Other (see comment). Use Caution/Monitor. Tafamidis inhibits breast cancer resistant protein (BCRP) in vitro and may increase exposure of BCRP substrates following tafamidis or tafamidis meglumine administration. Dosage adjustment of these BCRP substrates may be necessary.
Minor (0)
Warnings
Contraindications
None
Cautions
Drug interactions overview
Breast cancer-resistant protein (BCRP) inhibitor
-
BCRP substrates
- Monitor for signs of BCRP substrate-related toxicities and modify dosage of substrate if appropriate
- Tafamadis increases exposure and risk of toxicities of BCRP substrates
Pregnancy
Pregnancy
Based on animal studies, fetal harm may occur when administered to a pregnant woman
Limited available human data with tafamidis meglumine use in pregnant women (at a dose of 20 mg/day) have not identified any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes
Consider pregnancy planning and prevention for females of reproductive potential
Report pregnancies to Pfizer reporting line at 1-800-438-1985
Animal data
- In animal reproductive studies, oral administration of tafamidis meglumine to pregnant rabbits during organogenesis resulted in adverse effects on development (embryofetal mortality, fetal body weight reduction, and fetal malformation) at a dosage providing ~9 times the human exposure (AUC) at the maximum recommended human dose (MRHD) of tafamidis meglumine 80 mg, and increased incidence of fetal skeletal variation at a dosage providing equivalent human exposure (AUC) at the MRHD
- Postnatal mortality, growth restriction, and impaired learning and memory were observed in offspring of pregnant rats administered tafamidis meglumine during gestation and lactation at a dosage ~2 times the MRHD based on body surface area
Lactation
No data available on the presence of tafamidis in human milk, effect on the breastfed infant, or the effect on milk production
Tafamidis is present in rat milk; drug may likely be present in human milk
Based on animal studies, which suggest the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended during treatment
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Selectively binds to transthyretin tetramer to prevent transthyretin transport protein destabilization and amyloid formation that causes ATTR-CM
Absorption
No clinically significant differences in steady state peak plasma concentration and AUC of tafamidis were observed for tafamidis (Vyndamax) 61-mg capsule compared to tafamidis meglumine (Vyndaqel) administered as four 20-mg capsules
Peak plasma time: 4 hr following dose
Distribution
Vd (steady-state): 18.5 L
Protein bound: >99%; primary binds to TTR
Metabolism
Mechanism not fully characterized; glucuronidation observed
Elimination
Half-life: ~49 hr
Oral clearance: 0.263 L/hr
Excretion: Feces (~59%; mostly unchanged); urine (~22%; mostly as glucuronide)
Administration
Oral Administration
May take with or without food
Swallow whole; do not crush or cut capsule
If a dose is missed, administer dose as soon as possible or skip the missed dose and take the next dose at the regularly scheduled time; do not double the dose
Storage
Store at room temperature (20-25°C [68-77°F]); excursions permitted to 15-30°C (59-86°F)
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