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VYNDAQEL® OR VYNDAMAX™ (tafamidis meglumine or tafamidis)

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Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

VYNDAQEL® OR VYNDAMAX™ Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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1. INDICATIONS AND USAGE

VYNDAQEL and VYNDAMAX are indicated for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality and...

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2. DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

The recommended dosage is either VYNDAQEL 80 mg (four 20-mg tafamidis meglumine capsules) orally once daily or...

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3. DOSAGE FORMS AND STRENGTHS

VYNDAQEL is available as:

  • tafamidis meglumine 20 mg: yellow, opaque, oblong capsule, printed with "VYN 20" in red.

VYNDAMAX is available as:

...
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4. CONTRAINDICATIONS

None.

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6. ADVERSE REACTIONS

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the...

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7. DRUG INTERACTIONS

7.1 BCRP Substrates

Tafamidis inhibits breast cancer resistant protein (BCRP) in humans [see Clinical...

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8. USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Based on findings from...

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10. OVERDOSAGE

There is minimal clinical experience with overdose. During clinical trials, two patients accidentally ingested a single VYNDAQEL dose of 160 mg without adverse events. The highest dose of tafamidis meglumine...

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11. DESCRIPTION

VYNDAQEL (tafamidis meglumine) and VYNDAMAX (tafamidis) contain tafamidis as the active moiety, which is a selective stabilizer of transthyretin.

The chemical name of tafamidis meglumine is 2-(3,5-...

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12. CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Tafamidis is a selective stabilizer of TTR. Tafamidis binds to TTR at the thyroxine binding sites, stabilizing the...

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13. NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

...

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14. CLINICAL STUDIES

Efficacy was demonstrated in a multicenter, international, randomized, double-blind, placebo-controlled study in 441 patients with wild-type or hereditary ATTR-CM (NCT01994889).

Patients were...

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16. HOW SUPPLIED/STORAGE AND HANDLING

VYNDAQEL 20-mg (tafamidis meglumine) soft gelatin capsules are yellow, opaque, oblong, and printed with "VYN 20" in red and supplied in the following package configurations:

...
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17. PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Pregnancy...

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