VYNDAQEL
(+1 other brands)
Drug Facts
Composition & Profile
Identifiers & Packaging
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: VYNDAQEL Capsules Package Configuration Strength NDC Carton of 4 intermediary cartons. Each intermediary carton contains 3 blister cards. Each blister card contains 10 capsules. (120 total capsules) 20 mg NDC 0069-1975-40 VYNDAMAX 61-mg (tafamidis) soft gelatin capsules are reddish brown, opaque, oblong, and printed with "VYN 61" in white and supplied in the following package configurations: VYNDAMAX Capsules Package Configuration Strength NDC Carton of 3 blister cards. Each blister card contains 10 capsules. (30 capsules total) 61 mg NDC 0069-8730-30 Store VYNDAQEL and VYNDAMAX at controlled room temperature 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] .; PRINCIPAL DISPLAY PANEL - 20 mg Capsule Blister Card NDC 0069-1975-12 Vyndaqel ® (tafamidis meglumine) capsules 20 mg per capsule Pfizer Labs. LOT/EXP PEEL & PUSH PRINCIPAL DISPLAY PANEL - 20 mg Capsule Blister Card; PRINCIPAL DISPLAY PANEL - 20 mg Capsule Blister Card Carton Vyndaqel ® (tafamidis meglumine) capsules 20 mg per capsule* Attention Pharmacist: Vyndaqel is NOT substitutable on a per mg basis with other tafamidis products. NOT FOR INDIVIDUAL RESALE Pfizer Contains: A total of 30 capsules per carton. Each carton contains 3 blister cards. Each blister card contains 10 capsules. Rx only PRINCIPAL DISPLAY PANEL - 20 mg Capsule Blister Card Carton; PRINCIPAL DISPLAY PANEL - 20 mg Capsule Blister Card Carton Carton NDC 0069-1975-40 Vyndaqel ® (tafamidis meglumine) capsules 20 mg per capsule* Attention Pharmacist: Vyndaqel is NOT substitutable on a per mg basis with other tafamidis products. Pfizer Contains: A total of 120 capsules per carton. Each carton contains 4 intermediary cartons. Each intermediary carton contains 3 blister cards. Each blister card contains 10 capsules. Rx only PRINCIPAL DISPLAY PANEL - 20 mg Capsule Blister Card Carton Carton; PRINCIPAL DISPLAY PANEL - 61 mg Capsule Blister Card NDC 0069-8730-01 Vyndamax™ (tafamidis) capsules 61 mg per capsule Pfizer Labs. LOT/EXP PEEL & PUSH PRINCIPAL DISPLAY PANEL - 61 mg Capsule Blister Card; PRINCIPAL DISPLAY PANEL - 61 mg Capsule Blister Card Carton NDC 0069-8730-30 Vyndamax™ (tafamidis) capsules 61 mg per capsule Attention Pharmacist: Vyndamax is NOT substitutable on a per mg basis with tafamidis meglumine products. Pfizer Contains: A total of 30 capsules per carton. Each carton contains 3 blister cards. Each blister card contains 10 capsules. Rx only PRINCIPAL DISPLAY PANEL - 61 mg Capsule Blister Card Carton
- 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: VYNDAQEL Capsules Package Configuration Strength NDC Carton of 4 intermediary cartons. Each intermediary carton contains 3 blister cards. Each blister card contains 10 capsules. (120 total capsules) 20 mg NDC 0069-1975-40 VYNDAMAX 61-mg (tafamidis) soft gelatin capsules are reddish brown, opaque, oblong, and printed with "VYN 61" in white and supplied in the following package configurations: VYNDAMAX Capsules Package Configuration Strength NDC Carton of 3 blister cards. Each blister card contains 10 capsules. (30 capsules total) 61 mg NDC 0069-8730-30 Store VYNDAQEL and VYNDAMAX at controlled room temperature 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] .
- PRINCIPAL DISPLAY PANEL - 20 mg Capsule Blister Card NDC 0069-1975-12 Vyndaqel ® (tafamidis meglumine) capsules 20 mg per capsule Pfizer Labs. LOT/EXP PEEL & PUSH PRINCIPAL DISPLAY PANEL - 20 mg Capsule Blister Card
- PRINCIPAL DISPLAY PANEL - 20 mg Capsule Blister Card Carton Vyndaqel ® (tafamidis meglumine) capsules 20 mg per capsule* Attention Pharmacist: Vyndaqel is NOT substitutable on a per mg basis with other tafamidis products. NOT FOR INDIVIDUAL RESALE Pfizer Contains: A total of 30 capsules per carton. Each carton contains 3 blister cards. Each blister card contains 10 capsules. Rx only PRINCIPAL DISPLAY PANEL - 20 mg Capsule Blister Card Carton
- PRINCIPAL DISPLAY PANEL - 20 mg Capsule Blister Card Carton Carton NDC 0069-1975-40 Vyndaqel ® (tafamidis meglumine) capsules 20 mg per capsule* Attention Pharmacist: Vyndaqel is NOT substitutable on a per mg basis with other tafamidis products. Pfizer Contains: A total of 120 capsules per carton. Each carton contains 4 intermediary cartons. Each intermediary carton contains 3 blister cards. Each blister card contains 10 capsules. Rx only PRINCIPAL DISPLAY PANEL - 20 mg Capsule Blister Card Carton Carton
- PRINCIPAL DISPLAY PANEL - 61 mg Capsule Blister Card NDC 0069-8730-01 Vyndamax™ (tafamidis) capsules 61 mg per capsule Pfizer Labs. LOT/EXP PEEL & PUSH PRINCIPAL DISPLAY PANEL - 61 mg Capsule Blister Card
- PRINCIPAL DISPLAY PANEL - 61 mg Capsule Blister Card Carton NDC 0069-8730-30 Vyndamax™ (tafamidis) capsules 61 mg per capsule Attention Pharmacist: Vyndamax is NOT substitutable on a per mg basis with tafamidis meglumine products. Pfizer Contains: A total of 30 capsules per carton. Each carton contains 3 blister cards. Each blister card contains 10 capsules. Rx only PRINCIPAL DISPLAY PANEL - 61 mg Capsule Blister Card Carton
Overview
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-dichlorophenyl)-1,3-benzoxazole-6-carboxylic acid mono (1-deoxy-1-methylamino-D-glucitol). The molecular formula is C 14 H 7 Cl 2 NO 3 C 7 H 17 NO 5 , and the molecular weight is 503.33 g/mol. The structural formula is: Tafamidis meglumine 20-mg soft gelatin capsule for oral use contains a white to pink colored suspension of tafamidis meglumine 20 mg (equivalent to 12.2 mg of tafamidis free acid), and the following inactive ingredients: ammonium hydroxide 28%, brilliant blue FCF, carmine, gelatin, glycerin, iron oxide (yellow), polyethylene glycol 400, polysorbate 80, polyvinyl acetate phthalate, propylene glycol, sorbitan monooleate, sorbitol, and titanium dioxide. The chemical name of tafamidis is 2-(3,5-dichlorophenyl)-1,3-benzoxazole-6-carboxylic acid. The molecular formula is C 14 H 7 Cl 2 NO 3 , and the molecular weight is 308.12 g/mol. The structural formula is: Tafamidis 61-mg soft gelatin capsule for oral use contains a white to pink colored suspension of tafamidis 61 mg and the following inactive ingredients: ammonium hydroxide 28%, butylated hydroxytoluene, gelatin, glycerin, iron oxide (red), polyethylene glycol 400, polysorbate 20, povidone (K-value 90), polyvinyl acetate phthalate, propylene glycol, sorbitol, and titanium dioxide. Chemical Structure Chemical Structure
Indications & 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
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.
Warnings & Precautions
No warnings available yet.
Contraindications
None. None. ( 4 )
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-mg, VYNDAQEL 20-mg, and placebo groups, respectively.
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.
Storage & Handling
Store VYNDAQEL and VYNDAMAX at controlled room temperature 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature] .
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