Vyndaqel tafamidis meglumine 20 mg Capsule, Liquid Filled — NDC 0069-1975-40 (Billing 00069-1975-40)
This is a package of Vyndaqel tafamidis meglumine 20 mg Capsule, Liquid Filled from Pfizer Laboratories Div Pfizer Inc, marketed since May 2019 and currently FDA-listed, this package's marketing is listed to end Jul 2027. It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 0069-1975-40 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 0069 labeler · 1975 product · 40 package
- Package marketed since
- May 16, 2019
- Package marketing ended
- Jul 31, 2027
- Sample package
- No — commercial package
- Barcode (UPC-A, from the NDC)
- 3 0069197540 4
- FDA record last changed
- Oct 1, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 073210
- GCN: 37584
- GPI-14 (Medi-Span): 40550080200120
- HICL (First Databank): 041631
- AHFS class code: 24:04.92.00
- RxCUI (RxNorm): 2168534
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 8, 2026
RxNorm drug class
This medicine belongs to the Other nervous system drugs class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- ATTR-CM stands for transthyretin-mediated amyloidosis cardiomyopathy. It's a condition where a protein called transthyretin — which your body makes naturally — breaks apart and clu...
- What exactly is ATTR-CM and why do I need this medication?
- They do contain the same active ingredient, tafamidis, but they are not interchangeable dose for dose. Vyndaqel and Vyndamax are different formulations, and the milligram amounts o...
- Can I take Vyndaqel and Vyndamax interchangeably — they seem like the same drug?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Tafamidis Meglumine — tap one for details:
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 8, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 00069-1975-40 You're viewing this Main listing | 4 CARTON in 1 CARTON / 30 BLISTER PACK in 1 CARTON / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK | 2019-05-16 | Jul 31, 2027 | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Vyndaqel 20 mgthis 00069-1975-40 | Pfizer | 1 capsule | — | — | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file
Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 7214696 ↗ | Method of use | U-2524 | Dec 19, 2026 |
| US 7214695 ↗ | Drug substance | — | Dec 19, 2026 |
| Code | What it grants | Expires |
|---|---|---|
| ODE-237 | Orphan Drug Exclusivity (7-year) | May 3, 2026 |
Is there a generic version of VYNDAQEL 20 MG CAPSULE?
The FDA approved a generic — why can’t I get it at my pharmacy yet?
Why do different websites show different generic release dates?
What does “FDA listed” mean?
What does a patent or protection date mean here?
What does “current Orange Book estimate” mean?
Can a generic come out before the last patent expires?
Can a generic come out after the listed dates?
What is the difference between patents and exclusivity?
Why are there multiple patent dates?
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 6, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
🧪 Avoiding an ingredient? See Tafamidis inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 5138Q19F1X
Ammonia is a colorless gas made from nitrogen and hydrogen. It's used in medicines as a pH buffer to maintain the correct acidity level and help keep the product stable.
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UNII H3R47K3TBD
FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
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UNII EX438O2MRT
Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
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UNII 2G86QN327L
Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
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UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
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UNII 07XHK4SAV6
A synthetic red colorant derived from chemical compounds. It's added to medicines to color tablets, capsules, or coatings so products are visually identifiable and easier to distinguish from one another.
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UNII B697894SGQ
Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
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UNII 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
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UNII 58QVG85GW3
A synthetic polymer made from vinyl acetate and phthalic acid. It coats tablets and capsules to control when and where the medicine dissolves in the digestive system, protecting the contents from stomach acid.
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UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
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UNII 06XEA2VD56
Sorbitan oleate is an emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together and keeps them from separating in the medicine.
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UNII 506T60A25R
Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
13 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 6, 2026
- FDA openFDA NDC Directory · synced Oct 8, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Pfizer Laboratories Div Pfizer Inc labeler code 00069
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- Caduet amlodipine besylate and atorvastatin calcium 5 mg; 80 mg Tablet, Film Coated NDC 0069-2260-30
- Vizimpro dacomitinib 45 mg Tablet, Film Coated NDC 0069-2299-30
- Abrysvo Respiratory Syncytial Virus Vaccine .06 mg/.5mL; .06 mg/.5mL Injection, Powder, Lyophilized, For Solution NDC 0069-2465-01
- Comirnaty COVID-19 Vaccine, mRNA .0158 mg/.48mL Injection, Suspension NDC 0069-2501-10
- Elrexfio elranatamab-bcmm 44 mg/1.1mL Injection, Solution NDC 0069-2522-02
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 8, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 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 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 and 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 )
2.1Recommended 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) ] .
2.2Administration 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.
💊 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: • tafamidis 61 mg: reddish brown, opaque, oblong capsule, printed with "VYN 61" in white. Capsules: Tafamidis meglumine 20 mg and tafamidis 61 mg. ( 3 )
⛔ Contraindications ▾
4. CONTRAINDICATIONS None. None. ( 4 )
🤒 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 .
6.1Clinical 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. DRUG INTERACTIONS
7.1BCRP 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.
👥 Use in Specific Populations ▾
8. USE IN SPECIFIC POPULATIONS • Pregnancy: Based on animal studies, may cause fetal harm. ( 8.1 ) • Lactation: Advise not to breastfeed. ( 8.2 )
8.1Pregnancy Risk Summary Based on findings from animal studies, VYNDAQEL and VYNDAMAX may cause fetal harm when administered to a pregnant woman. However, limited available human data with VYNDAQEL use in pregnant women (at a dose of 20 mg per day) have not identified any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes. 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 approximately 9 times the human exposure (AUC) at the maximum recommended human dose (MRHD) of VYNDAQEL (80 mg), and increased incidence of fetal skeletal variation at a dosage providing equivalent human exposure (AUC) at the MRHD.
Postnatal mortality, growth retardation, and impaired learning and memory were observed in offspring of pregnant rats administered tafamidis meglumine during gestation and lactation at a dosage approximately 2 times the MRHD based on body surface area (mg/m 2 ) (see Data ) . Advise pregnant women of the potential risk to a fetus. Report pregnancies to the Pfizer reporting line at 1-800-438-1985.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Data Animal Data In pregnant rats, oral administration of tafamidis meglumine (0, 15, 30, and 45 mg/kg/day) throughout organogenesis resulted in decreased fetal body weights at ≥30 mg/kg/day (approximately 10 times the human exposure at the MRHD based on AUC). The no-observed-adverse-effect-level (NOAEL) for embryofetal development in rats was 15 mg/kg/day (approximately 7 times the human exposure at the MRHD based on AUC). In pregnant rabbits, oral administration of tafamidis meglumine (0, 0.5, 2, and 8 mg/kg/day) throughout organogenesis resulted in increased embryofetal mortality, reduced fetal body weights, and an increased incidence of fetal malformations at 8 mg/kg/day (approximately 9 times the human exposure at the MRHD based on AUC), which was also maternally toxic.
Increased incidences of fetal skeletal variations were observed at doses ≥0.5 mg/kg/day (approximately equivalent to the human exposure at the MRHD based on AUC). In the pre- and postnatal study, pregnant rats received oral administration of tafamidis meglumine at doses of 0, 5, 15, or 30 mg/kg/day throughout pregnancy and lactation (Gestation Day 7 to Lactation Day 20). Decreased survival and body weights, delayed male sexual maturation and neurobehavioral effects (learning and memory impairment) were observed in the offspring of dams treated at 15 mg/kg/day (approximately 2 times the MRHD on a mg/m 2 basis).
The NOAEL for pre- and postnatal development in rats was 5 mg/kg/day (approximately equivalent to the MRHD on a mg/m 2 basis).
8.2Lactation Risk Summary There are no available data on the presence of tafamidis in human milk, the effect on the breastfed infant, or the effect on milk production. Tafamidis is present in rat milk (see Data ) . When a drug is present in animal milk, it is likely the drug will be present in human milk.
Based on findings from animal studies which suggest the potential for serious adverse reactions in the breastfed infant, advise patients that breastfeeding is not recommended during treatment with VYNDAQEL or VYNDAMAX. Data Pregnant and lactating female rats were administered repeated daily oral doses of tafamidis meglumine (15 mg/kg/day) followed by a single oral gavage… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Based on findings from animal studies, VYNDAQEL and VYNDAMAX may cause fetal harm when administered to a pregnant woman. However, limited available human data with VYNDAQEL use in pregnant women (at a dose of 20 mg per day) have not identified any drug-associated risks for major birth defects, miscarriage, or adverse maternal or fetal outcomes. 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 approximately 9 times the human exposure (AUC) at the maximum recommended human dose (MRHD) of VYNDAQEL (80 mg), and increased incidence of fetal skeletal variation at a dosage providing equivalent human exposure (AUC) at the MRHD.
Postnatal mortality, growth retardation, and impaired learning and memory were observed in offspring of pregnant rats administered tafamidis meglumine during gestation and lactation at a dosage approximately 2 times the MRHD based on body surface area (mg/m 2 ) (see Data ) . Advise pregnant women of the potential risk to a fetus. Report pregnancies to the Pfizer reporting line at 1-800-438-1985.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Data Animal Data In pregnant rats, oral administration of tafamidis meglumine (0, 15, 30, and 45 mg/kg/day) throughout organogenesis resulted in decreased fetal body weights at ≥30 mg/kg/day (approximately 10 times the human exposure at the MRHD based on AUC). The no-observed-adverse-effect-level (NOAEL) for embryofetal development in rats was 15 mg/kg/day (approximately 7 times the human exposure at the MRHD based on AUC). In pregnant rabbits, oral administration of tafamidis meglumine (0, 0.5, 2, and 8 mg/kg/day) throughout organogenesis resulted in increased embryofetal mortality, reduced fetal body weights, and an increased incidence of fetal malformations at 8 mg/kg/day (approximately 9 times the human exposure at the MRHD based on AUC), which was also maternally toxic.
Increased incidences of fetal skeletal variations were observed at doses ≥0.5 mg/kg/day (approximately equivalent to the human exposure at the MRHD based on AUC). In the pre- and postnatal study, pregnant rats received oral administration of tafamidis meglumine at doses of 0, 5, 15, or 30 mg/kg/day throughout pregnancy and lactation (Gestation Day 7 to Lactation Day 20). Decreased survival and body weights, delayed male sexual maturation and neurobehavioral effects (learning and memory impairment) were observed in the offspring of dams treated at 15 mg/kg/day (approximately 2 times the MRHD on a mg/m 2 basis).
The NOAEL for pre- and postnatal development in rats was 5 mg/kg/day (approximately equivalent to the MRHD on a mg/m 2 basis).
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of VYNDAQEL and VYNDAMAX have not been established in pediatric patients.
🧓 Geriatric Use ▾
8.5Geriatric Use No dosage adjustment is required for elderly patients (≥65 years) [see Clinical Pharmacology (12.3) ] . Of the total number of patients in the clinical study (n=441), 90.5% were 65 and over, with a median age of 75 years.
🆘 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 given to healthy volunteers in a clinical trial was 480 mg as a single dose. There was one reported adverse event of mild hordeolum at this dose.
🧬 Clinical Pharmacology ▾
12. CLINICAL PHARMACOLOGY
12.1Mechanism of Action Tafamidis is a selective stabilizer of TTR. Tafamidis binds to TTR at the thyroxine binding sites, stabilizing the tetramer and slowing dissociation into monomers, the rate-limiting step in the amyloidogenic process.
12.2Pharmacodynamics A proprietary TTR stabilization assay was utilized as a pharmacodynamic marker and assessed the stability of the TTR tetramer ex vivo. The TTR stabilization assay quantifies immunoturbidimetric measurement of the stable TTR tetramer in plasma pre- and post-treatment with 2-day in vitro denaturation with urea. Using this proprietary assay, a dose-dependent trend for greater TTR tetramer stabilization is observed for VYNDAQEL 80-mg compared to VYNDAQEL 20-mg.
However, the clinical relevance of a higher TTR tetramer stabilization towards cardiovascular outcomes is not known. VYNDAQEL stabilized both the wild-type TTR tetramer and the tetramers of 14 TTR variants tested clinically after once-daily dosing. Tafamidis also stabilized the TTR tetramer for 25 variants tested ex vivo.
VYNDAQEL and VYNDAMAX may decrease serum concentrations of total thyroxine, without an accompanying change in thyroid stimulating hormone (TSH). This reduction in total thyroxine values is probably the result of reduced thyroxine binding to or displacement from transthyretin (TTR) due to the high binding affinity of tafamidis to the TTR thyroxine receptor. No corresponding clinical findings consistent with hypothyroidism have been observed.
Biomarkers associated with heart failure (NT-proBNP and Troponin I) favored VYNDAQEL over placebo. Cardiac Electrophysiology At approximately 2.2 times the steady state peak plasma concentration (C max ) at the recommended dose, tafamidis does not prolong the QTc interval to any clinically relevant extent.
12.3Pharmacokinetics No clinically significant differences in steady state C max and area under the plasma concentration over time curve (AUC) of tafamidis were observed for VYNDAMAX 61-mg capsule compared to VYNDAQEL administered as four 20-mg capsules. Tafamidis exposure increases proportionally over single (up to 480 mg) or multiple (up to 80 mg) (1 to 6 times the approved recommended dosage) once daily dosing. The apparent clearance were similar after single and repeated administration of VYNDAQEL 80 mg.
Absorption Median tafamidis peak concentrations occurred within 4 hours following dosing. Effect of Food No clinically significant differences in the pharmacokinetics of tafamidis were observed following administration of a high fat, high calorie meal. Distribution The apparent steady state volume of distribution of tafamidis meglumine is 16 liters and 18.5 liters for tafamidis.
Plasma protein binding of tafamidis is >99% in vitro. Tafamidis primarily binds to TTR. Elimination The mean half-life of tafamidis is approximately 49 hours.
The apparent oral clearance of tafamidis meglumine is 0.228 L/h (0.263 L/h for tafamidis). The degree of drug accumulation at steady state after repeated tafamidis daily dosing is approximately 2.5-fold greater than that observed after a single dose. Metabolism The metabolism of tafamidis has not been fully characterized.
However, glucuronidation has been observed. Excretion After a single oral dose of tafamidis meglumine 20 mg, approximately 59% of the dose was recovered in feces (mostly as the unchanged drug) and approximately 22% of the dose was recovered in urine (mostly as the glucuronide metabolite). Specific Populations No clinically significant differences in the pharmacokinetics of tafamidis were observed based on age, race/ethnicity (Caucasian and Japanese) or renal impairment.
Patients with Hepatic Impairment Patients with moderate hepatic impairment (Child-Pugh Score of 7 to 9) had decreased systemic exposure (approximately 40%) and increased clearance (approximately 68%) of tafamidis compared to healthy subjects. As TTR levels are lower in subjects with moderate hepatic impairment than… [Excerpted — this section continues on DailyMed.]
🧬 Mechanism of Action ▾
12.1Mechanism of Action Tafamidis is a selective stabilizer of TTR. Tafamidis binds to TTR at the thyroxine binding sites, stabilizing the tetramer and slowing dissociation into monomers, the rate-limiting step in the amyloidogenic process.
📦 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: 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] .
📦 Storage and 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] .
📋 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-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
💬 Information for Patients ▾
17. PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Pregnancy Report pregnancies to the Pfizer reporting line at 1-800-438-1985.
Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females to inform their healthcare provider of a known or suspected pregnancy [see Use in Specific Populations (8.1) ]. Lactation Advise females not to breastfeed during treatment with VYNDAQEL or VYNDAMAX [see Use in Specific Populations (8.2) ] .
This product's label may have been updated. For full prescribing information, please visit www.pfizer.com . For medical information about VYNDAQEL or VYNDAMAX, please visit www.pfizermedinfo.com or call 1‑800‑438‑1985.
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics No clinically significant differences in steady state C max and area under the plasma concentration over time curve (AUC) of tafamidis were observed for VYNDAMAX 61-mg capsule compared to VYNDAQEL administered as four 20-mg capsules. Tafamidis exposure increases proportionally over single (up to 480 mg) or multiple (up to 80 mg) (1 to 6 times the approved recommended dosage) once daily dosing. The apparent clearance were similar after single and repeated administration of VYNDAQEL 80 mg.
Absorption Median tafamidis peak concentrations occurred within 4 hours following dosing. Effect of Food No clinically significant differences in the pharmacokinetics of tafamidis were observed following administration of a high fat, high calorie meal. Distribution The apparent steady state volume of distribution of tafamidis meglumine is 16 liters and 18.5 liters for tafamidis.
Plasma protein binding of tafamidis is >99% in vitro. Tafamidis primarily binds to TTR. Elimination The mean half-life of tafamidis is approximately 49 hours.
The apparent oral clearance of tafamidis meglumine is 0.228 L/h (0.263 L/h for tafamidis). The degree of drug accumulation at steady state after repeated tafamidis daily dosing is approximately 2.5-fold greater than that observed after a single dose. Metabolism The metabolism of tafamidis has not been fully characterized.
However, glucuronidation has been observed. Excretion After a single oral dose of tafamidis meglumine 20 mg, approximately 59% of the dose was recovered in feces (mostly as the unchanged drug) and approximately 22% of the dose was recovered in urine (mostly as the glucuronide metabolite). Specific Populations No clinically significant differences in the pharmacokinetics of tafamidis were observed based on age, race/ethnicity (Caucasian and Japanese) or renal impairment.
Patients with Hepatic Impairment Patients with moderate hepatic impairment (Child-Pugh Score of 7 to 9) had decreased systemic exposure (approximately 40%) and increased clearance (approximately 68%) of tafamidis compared to healthy subjects. As TTR levels are lower in subjects with moderate hepatic impairment than in healthy subjects, the exposure of tafamidis relative to the amount of TTR is sufficient to maintain stabilization of the TTR tetramer in these patients. No clinically significant differences in the pharmacokinetics of tafamidis were observed in patients with mild hepatic impairment (Child Pugh Score of 5 to 6) compared to healthy subjects.
The effect of severe hepatic impairment on tafamidis is unknown. Drug Interaction Studies Clinical Studies CYP3A4 substrates: No clinically significant differences in the pharmacokinetics of midazolam (a CYP3A4 substrate) or on the formation of its active metabolite (1-hydroxymidazolam) were observed when a single 7.5-mg dose of midazolam was administered prior to and after a 14-day regimen of VYNDAQEL 20-mg once daily. BCRP substrates: Tafamidis inhibits breast cancer resistant protein (BCRP).
In a clinical study in healthy participants, AUC inf and C max of the BCRP substrate rosuvastatin increased by 96.75% and 85.59%, respectively following multiple doses of VYNDAMAX 61 mg daily dosing. In Vitro Studies Cytochrome P450 Enzymes : Tafamidis induces CYP2B6 and CYP3A4 and does not induce CYP1A2. Tafamidis does not inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP3A4/5 or CYP2D6.
UDP glucuronosyltransferase (UGT) : Tafamidis inhibits intestinal activities of UGT1A1 but neither induces nor inhibits other UDP glucuronosyltransferase (UGT) systemically. Transporter Systems : In vitro studies and model predictions show that tafamidis has a low potential to inhibit organic anion transporters OAT1 and OAT3 at clinically relevant concentrations. Tafamidis did not show a potential to inhibit Multi-Drug Resistant Protein (MDR1) (also known as P-glycoprotein; P-gp), organic cation transporter OCT2, multidrug and toxin extrusion transporters MATE1 and MATE2K and, orga… [Excerpted — this section continues on DailyMed.]
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics A proprietary TTR stabilization assay was utilized as a pharmacodynamic marker and assessed the stability of the TTR tetramer ex vivo. The TTR stabilization assay quantifies immunoturbidimetric measurement of the stable TTR tetramer in plasma pre- and post-treatment with 2-day in vitro denaturation with urea. Using this proprietary assay, a dose-dependent trend for greater TTR tetramer stabilization is observed for VYNDAQEL 80-mg compared to VYNDAQEL 20-mg.
However, the clinical relevance of a higher TTR tetramer stabilization towards cardiovascular outcomes is not known. VYNDAQEL stabilized both the wild-type TTR tetramer and the tetramers of 14 TTR variants tested clinically after once-daily dosing. Tafamidis also stabilized the TTR tetramer for 25 variants tested ex vivo.
VYNDAQEL and VYNDAMAX may decrease serum concentrations of total thyroxine, without an accompanying change in thyroid stimulating hormone (TSH). This reduction in total thyroxine values is probably the result of reduced thyroxine binding to or displacement from transthyretin (TTR) due to the high binding affinity of tafamidis to the TTR thyroxine receptor. No corresponding clinical findings consistent with hypothyroidism have been observed.
Biomarkers associated with heart failure (NT-proBNP and Troponin I) favored VYNDAQEL over placebo. Cardiac Electrophysiology At approximately 2.2 times the steady state peak plasma concentration (C max ) at the recommended dose, tafamidis does not prolong the QTc interval to any clinically relevant extent.
🔬 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 randomized in a 1:2:2 ratio to receive VYNDAQEL 20 mg (n=88), VYNDAQEL 80 mg (administered as four 20-mg VYNDAQEL capsules) (n=176), or matching placebo (n=177) once daily for 30 months, in addition to standard of care (e.g., diuretics).
Treatment assignment was stratified by the presence or absence of a variant TTR genotype as well as baseline disease severity (NYHA Class). Transplant patients were excluded from this study. Table 1 describes the patient demographics and baseline characteristics.
Table 1: Patient Demographics and Baseline Characteristics Characteristic Pooled Tafamidis N=264 Placebo N=177 Abbreviations: ATTRm = variant transthyretin amyloid, ATTRwt = wild-type transthyretin amyloid Age — years Mean (standard deviation) 74.5 (7.2) 74.1 (6.7) Median (minimum, maximum) 75 (46, 88) 74 (51, 89) Sex — number (%) Male 241 (91.3) 157 (88.7) Female 23 (8.7) 20 (11.3) TTR Genotype — number (%) ATTRm 63 (23.9) 43 (24.3) ATTRwt 201 (76.1) 134 (75.7) NYHA Class — number (%) NYHA Class I 24 (9.1) 13 (7.3) NYHA Class II 162 (61.4) 101 (57.1) NYHA Class III 78 (29.5) 63 (35.6) The primary analysis used a hierarchical combination applying the method of Finkelstein-Schoenfeld (F-S) to all-cause mortality and frequency of cardiovascular-related hospitalizations, which was defined as the number of times a subject was hospitalized (i.e., admitted to a hospital) for cardiovascular-related morbidity.
The method compared each patient to every other patient within each stratum in a pair-wise manner that proceeded in a hierarchical fashion using all-cause mortality followed by frequency of cardiovascular-related hospitalizations when patients could not be differentiated based on mortality. This analysis demonstrated a significant reduction (p=0.0006) in all-cause mortality and frequency of cardiovascular-related hospitalizations in the pooled VYNDAQEL 20-mg and 80-mg groups versus placebo (Table 2). Table 2: Primary Analysis Using Finkelstein-Schoenfeld (F-S) Method of All-Cause Mortality and Frequency of Cardiovascular-Related Hospitalizations Primary Analysis Pooled VYNDAQEL N=264 Placebo N=177 Number (%) of Subjects Alive Heart transplantation and cardiac mechanical assist device implantation are considered indicators of approaching end stage.
As such, these subjects are treated in the analysis as equivalent to death. Therefore, such subjects are not included in the count of "Number of Subjects Alive at Month 30" even if such subjects are alive based on 30 month vital status follow-up assessment. at Month 30 186 (70.5) 101 (57.1) Mean Number of Cardiovascular-related Hospitalizations During 30 months (per patient per year) Among Those Alive at Month 30 0.297 0.455 p-value from F-S Method 0.0006 Analysis of the individual components of the primary analysis (all-cause mortality and cardiovascular-related hospitalization) also demonstrated significant reductions for VYNDAQEL versus placebo.
The hazard ratio from the all-cause mortality Cox-proportional hazard model for pooled VYNDAQEL versus placebo was 0.70 (95% confidence interval [CI] 0.51, 0.96), indicating a 30% relative reduction in the risk of death relative to the placebo group (p=0.026). Approximately 80% of total deaths were cardiovascular-related in both treatment groups. A Kaplan-Meier plot of time to event all-cause mortality is presented in Figure 1.
Figure 1: All-Cause Mortality Heart transplants and cardiac mechanical assist devices treated as death. Hazard ratio from Cox proportional hazards model with treatment, TTR genotype (variant and wild-type), and NYHA baseline classification (NYHA Classes I and II combined and NYHA Class III) as factors. There were significantly fewer cardiovascular-related hospitalizations with VYNDAQEL compared with placebo with a re… [Excerpted — this section continues on DailyMed.]
🧪 Nonclinical Toxicology ▾
13. NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis There was no evidence of an increased incidence of neoplasia in the transgenic (Tg)-rasH2 mouse following repeated daily administration for 26 weeks at daily doses of 0, 10, 30 or 90 mg/kg. There was no evidence of increased incidence of neoplasia in a 2-year carcinogenicity study in rats at exposures up to 18 times the AUC at the MRHD. Mutagenesis There was no evidence of mutagenicity or clastogenicity in vitro, and an in vivo rat micronucleus study was negative.
Impairment of Fertility There were no effects of tafamidis meglumine on fertility, reproductive performance, or mating behavior in the rat at any dose. Rats were dosed daily (0, 5, 15, and 30 mg/kg/day) prior to cohabitation (for at least 15 days for females and 28 days for males), throughout the cohabitation period to the day prior to termination of males and through to implantation of females (Gestation Day 7). No adverse effects were noted on male and female rats in toxicity, fertility, and mating behavior at any dose.
The paternal and maternal no observed adverse effect level for reproductive toxicity of tafamidis meglumine is 30 mg/kg/day, approximately 4 times the MRHD on a mg/m 2 basis.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis There was no evidence of an increased incidence of neoplasia in the transgenic (Tg)-rasH2 mouse following repeated daily administration for 26 weeks at daily doses of 0, 10, 30 or 90 mg/kg. There was no evidence of increased incidence of neoplasia in a 2-year carcinogenicity study in rats at exposures up to 18 times the AUC at the MRHD. Mutagenesis There was no evidence of mutagenicity or clastogenicity in vitro, and an in vivo rat micronucleus study was negative.
Impairment of Fertility There were no effects of tafamidis meglumine on fertility, reproductive performance, or mating behavior in the rat at any dose. Rats were dosed daily (0, 5, 15, and 30 mg/kg/day) prior to cohabitation (for at least 15 days for females and 28 days for males), throughout the cohabitation period to the day prior to termination of males and through to implantation of females (Gestation Day 7). No adverse effects were noted on male and female rats in toxicity, fertility, and mating behavior at any dose.
The paternal and maternal no observed adverse effect level for reproductive toxicity of tafamidis meglumine is 30 mg/kg/day, approximately 4 times the MRHD on a mg/m 2 basis.
📄 Patient Package Insert ▾
This Patient Information has been approved by the U.S. Food and Drug Administration Issued: 10/2023 PATIENT INFORMATION VYNDAQEL ® (VIN-duh-kel) (tafamidis meglumine) capsules VYNDAMAX™ (VIN-dah-max) (tafamidis) capsules What is VYNDAQEL and VYNDAMAX? VYNDAQEL and VYNDAMAX are prescription medicines used to treat adults with cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) to reduce death and hospitalization related to heart problems.
It is not known if VYNDAQEL and VYNDAMAX are safe and effective in children. Before taking VYNDAQEL or VYNDAMAX, tell your healthcare provider about all your medical conditions, including if you: • have liver problems. • are pregnant or plan to become pregnant. VYNDAQEL and VYNDAMAX may harm your unborn baby.
Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with VYNDAQEL or VYNDAMAX. You may also report your pregnancy by calling the Pfizer reporting line at 1-800-438-1985. • are breastfeeding or plan to breastfeed. It is not known if VYNDAQEL or VYNDAMAX passes into your breast milk.
You should not breastfeed during treatment with VYNDAQEL or VYNDAMAX. Talk to your healthcare provider about the best way to feed your baby during treatment with VYNDAQEL or VYNDAMAX. Tell your healthcare provider about all the medicines you take including any prescription or over-the-counter medicines, vitamins, and herbal supplements.
How should I take VYNDAQEL or VYNDAMAX? • Take either VYNDAQEL or VYNDAMAX exactly as your healthcare provider tells you to. • Take either VYNDAQEL or VYNDAMAX capsule(s) 1 time a day. • VYNDAQEL or VYNDAMAX capsule(s) should be swallowed whole and not crushed or cut. • If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the next dose at your regularly scheduled time. Do not take 2 doses at the same time.
What are the possible side effects of VYNDAQEL and VYNDAMAX? There were no known side effects that happened during treatment with VYNDAQEL or VYNDAMAX in people with cardiomyopathy of transthyretin-mediated amyloidosis. You may report side effects to FDA at 1-800-FDA-1088.
How should I store VYNDAQEL and VYNDAMAX? • Store VYNDAQEL and VYNDAMAX capsules at room temperature between 68°F to 77°F (20°C to 25°C). • Keep VYNDAQEL and VYNDAMAX and all medicines out of the reach of children. General information about the safe and effective use of VYNDAQEL and VYNDAMAX. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.
Do not use VYNDAQEL or VYNDAMAX for a condition for which it was not prescribed. Do not give VYNDAQEL or VYNDAMAX to other people, even if they have the same symptoms you have. It may harm them.
You can ask your healthcare provider or pharmacist for information about VYNDAQEL or VYNDAMAX that is written for healthcare professionals. What are the ingredients in VYNDAQEL and VYNDAMAX? VYNDAQEL: Active ingredient: tafamidis meglumine 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 VYNDAMAX: Active ingredient : tafamidis 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 LAB-0573-5.0 For more information, go to www.vyndaqel.com or call 1-800-438-1985. logo
📄 Package Label / Principal Display Panel ▾
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
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