tafamidis meglumine (Rx)

Brand and Other Names:Vyndaqel
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Dosing & Uses

AdultPediatric

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

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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            Warnings

            Contraindications

            None

            Cautions

            Drug interactions overview

            • Breast cancer-resistant protein (BCRP) substrates
              • Tafamidis inhibits BCRP in vitro and may increase exposure of BCRP substrates (eg, methotrexate, rosuvastatin, imatinib) if coadministered; dosage adjustment may be necessary
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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 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)

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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

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

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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
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
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            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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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.