tafamidis (Rx)

Brand and Other Names:Vyndamax
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule

  • 61mg

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

61 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

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Interactions

Interaction Checker

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            Contraindicated (0)

              Serious - Use Alternative (3)

              • alpelisib

                tafamidis 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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)

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                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
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                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.

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                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

                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)

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                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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                Formulary

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                The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                Tier Description
                1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                NC NOT COVERED – Drugs that are not covered by the plan.
                Code Definition
                PA Prior Authorization
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                QL Quantity Limits
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                Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.