(30 capsules total)
Store VYNDAQEL and VYNDAMAX at controlled room temperature 20excursions permitted to 15°C to 30°C (5912“wins” divided by number of pairs of placebo patient “wins.” Analyses of 6MWT and KCCQrelative to placebo within each subgroup.
and Components of Primary Analysis
variant transthyretin amyloid, ATTRwt = wild type transthyretin amyloid, F-S = Finkelstein Schoenfeldcause mortality and frequency of cardiovascular hospitalization)
devices treated as death.
6MWT at Month 30 and KCCQ-OS at Month 30 were statistically significantVYNDAQEL vs. placebo, with similar results for both doses.
HOW SUPPLIED/STORAGE AND HANDLING(tafamidis meglumine) soft gelatin capsules are yellow, opaque, oblong,supplied in the following package configurations:
VYNDAQEL Capsules
Strength
20 mg NDC 0069ft gelatin capsules are reddish brown, opaque, oblong, andin the following package configurations:
VYNDAMAX Capsules
Strength
cards. Each blister card 61 mg NDC 0069at controlled room temperature 20°C to 25°C (6830°C (59°F to 86°F) [see USP Controlled Room Temperature]
Analyses of 6MWT and KCCQ-OS also favoredFinkelstein Schoenfeld, CI = Confidencewere statistically significantvs. placebo, with similar results for both doses.
yellow, opaque, oblong, and printed withNDC
NDC 0069-1975-40
ft gelatin capsules are reddish brown, opaque, oblong, and printed with
NDC
NDC 0069-8730-30
25°C (68°F to 77°F)
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 1reproductive potential of the potential risk to a fetus. Advise females to inform their healthcare provider of a
known or suspected pregnancy [see Use iLactation
Advise females not to breastfeed during treatment with VYNDAQEL
Populations (8.2)].
Transthyretin Amyloidosis Outcome Survey
Advise all patients prescribed VYNDAQEL
Amyloidosis Outcome Survey (THAOS) registry, that their participation is voluntary, and may involvelong-term follow-up. THAOS is an international disease registry designed to assess disease progression,genotype/phenotype relationships, and the impact of interventions, including VYNDAQELon disease progression. For information regarding the registry, visitThis product’s label may have been updated. For full prescribing information, please visitLAB-0497-1.013
PATIENT COUNSELING INFORMATION
approved patient labeling (Patient Information).
Report pregnancies to the Pfizer reporting line at 1-800-438-1985. Advise pregnant women and females ofreproductive potential of the potential risk to a fetus. Advise females to inform their healthcare provider of a[see Use in Specific Populations (8.1)].
females not to breastfeed during treatment with VYNDAQEL or VYNDAMAX
Transthyretin Amyloidosis Outcome Survey (THAOS)
Advise all patients prescribed VYNDAQEL or VYNDAMAX of the availability of the TransthyretinAmyloidosis Outcome Survey (THAOS) registry, that their participation is voluntary, and may involveup. THAOS is an international disease registry designed to assess disease progression,notype/phenotype relationships, and the impact of interventions, including VYNDAQELon disease progression. For information regarding the regist |
