HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to useVYNDAQEL and VYNDAMAX safely and effectively. See fullprescribing information for VYNDAQEL and VYNDAMAX.
VYNDAQEL(tafamidis meglumine) capsules, for oral administration
Initial U.S. Approval: 2019
VYNDAMAXTM (tafamidis) capsules, for oral administration
Initial U.S. Approval: 2019
INDICATIONS AND USAGE
VYNDAQEL and VYNDAMAX are transthyretin stabilizers indicated for thetreatment of the cardiomyopathy of wild type or hereditarytransthyretin-mediated amyloidosis in adults to reduce cardiovascularmortality and cardiovascular-related hospitalization. (1)
DOSAGE AND ADMINISTRATION
The recommended dosage is either:
VYNDAQEL 80 mg orally once daily, orVYNDAMAX 61 mg orally once daily
VYNDAMAX and VYNDAQEL are not substitutable on a per mg basis.
DOSAGE FORMS AND STRENGTHS
Capsules: Tafamidis meglumine 20 mg and tafamidis 61 mg. (3)
CONTRAINDICATIONS
None. (4)
To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
Pregnancy: Based on animal studies, may cause fetal harm. (8.1)
Lactation: Advise not to breastfeed. (8.2)
See 17 for PATIENT COUNSELING INFORMATION andFDA-approved patient labeling.
Revised: 05/2019
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FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage
2.2 Administration Instructions
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
7 DRUG INTERACTIONS
7.1 BCRP Substrates
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.3 Females and Males of Reproductive Potential
8.4 Pediatric Use
8.5 Geriatric Use
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
*Sections or subsections omitted from the full prescribing information are notlisted.
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FULL PRESCRIBING INFORMATION
1. INDICATIONS AND USAGE
VYNDAQEL and VYNDAMAX are indicated for the treatment of the cardiomyopathy of wild type orhereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality andcardiovascular-related hospitalization.
2. DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage
The recommended dosage is either VYNDAQEL 80 mg (four 20-mg tafamidis meglumine capsules) orallyonce 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 takethe next dose at the regularly scheduled time. Do not double the dose.
3. DOSAGE FORMS AND STRENGTHS
VYNDAQ
