Vyndaqel 20 mg/1
tafamidis meglumine · CAPSULE, LIQUID FILLED · Pfizer Laboratories Div Pfizer Inc
Vyndaqel (tafamidis meglumine) is an oral medication taken as a capsule that is used to treat a rare condition called transthyretin amyloidosis, which affects the heart and nervous system. It works by stabilizing a protein in the body that would otherwise accumulate and cause organ damage.
Key Facts
- Brand Name
- Vyndaqel
- Generic Name
- tafamidis meglumine
- NDC Code (Product)
0069-1975- Manufacturer
- Pfizer Laboratories Div Pfizer Inc
- Strength
- 20 mg/1
- Dosage Form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Marketing Status
- Application #
- NDA211996
- Marketing Start
- 05/16/2019
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & 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 cardiovascular-related hospitalization. VYNDAQEL and VYNDAMAX are transthyretin stabilizers indicated for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization. ( 1 )
Dosage & Administration
2. DOSAGE AND ADMINISTRATION The recommended dosage is either: • VYNDAQEL 80 mg orally once daily, or • VYNDAMAX 61 mg orally once daily ( 2.1 ) • VYNDAMAX and VYNDAQEL are not substitutable on a per mg basis. ( 2.1 ) 2.1 Recommended Dosage The recommended dosage is either VYNDAQEL 80 mg (four 20-mg tafamidis meglumine capsules) orally once daily or VYNDAMAX 61 mg (one 61-mg tafamidis capsule) orally once daily. VYNDAMAX and VYNDAQEL are not substitutable on a per mg basis [see Clinical Pharmacology (12.3) ] . 2.2 Administration Instructions The capsules should be swallowed whole and not crushed or cut. If a dose is missed, instruct patients to take the dose as soon as remembered or to skip the missed dose and take the next dose at the regularly scheduled time. Do not double the dose.
Contraindications
4. CONTRAINDICATIONS None. None. ( 4 )
Drug Interactions
7. DRUG INTERACTIONS 7.1 BCRP Substrates Tafamidis inhibits breast cancer resistant protein (BCRP) in humans [see Clinical Pharmacology (12.3) ] . Coadministration of tafamidis and drugs that are BCRP substrates may increase the exposure of substrates of this transporter (e.g., methotrexate, rosuvastatin, imatinib) and the risk of the substrate-related toxicities. Monitor for signs of BCRP substrate-related toxicities and modify dosage of the substrate if appropriate.
Adverse Reactions
6. ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data reflect exposure of 377 ATTR-CM patients to 20 mg or 80 mg (administered as four 20-mg capsules) of VYNDAQEL administered daily for an average of 24.5 months (ranging from 1 day to 111 months). Adverse events were assessed from ATTR-CM clinical trials with VYNDAQEL, primarily a 30-month placebo-controlled trial [see Clinical Studies (14) ] . The frequency of adverse events in patients treated with VYNDAQEL 20 mg (n=88) or 80 mg (n=176; administered as four 20-mg capsules) was similar to that with placebo (n=177). In the 30-month placebo-controlled trial, similar proportions of VYNDAQEL-treated patients and placebo-treated patients discontinued the study drug because of an adverse event: 12 (7%), 5 (6%), and 11 (6%) from the VYNDAQEL 80-m…
Frequently Asked Questions
What is Vyndaqel used for?
Vyndaqel (tafamidis meglumine) is an oral medication taken as a capsule that is used to treat a rare condition called transthyretin amyloidosis, which affects the heart and nervous system. It works by stabilizing a protein in the body that would otherwise accumulate and cause organ damage.
Is Vyndaqel a controlled substance?
Vyndaqel is not classified as a controlled substance by the DEA.
What is the generic name for Vyndaqel?
The generic name for Vyndaqel is tafamidis meglumine. There are no other listed brand versions of tafamidis meglumine.
What is the NDC code for Vyndaqel 20 mg/1?
The NDC (National Drug Code) for Vyndaqel 20 mg/1 is 0069-1975, listed by Pfizer Laboratories Div Pfizer Inc.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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