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VYNDAQEL® OR VYNDAMAX™ (tafamidis meglumine or tafamidis)
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
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
Indications and Usage
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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Dosage and Administration
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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Dosage Forms and Strengths
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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Adverse Reactions
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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Drug Interactions
7. DRUG INTERACTIONS
7.1 BCRP Substrates
Tafamidis inhibits breast cancer resistant protein (BCRP) in humans [see Clinical...
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Use in Specific Populations
8. USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Based on findings...
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Overdosage
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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Description
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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Clinical Pharmacology
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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Nonclinical Toxicology
13. NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
...
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Clinical Studies
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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How Supplied/Storage and Handling
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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Medication Guide
17. PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Pregnancy...
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Resources
Report Adverse Event
To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at(800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.