No studies have been conducted in organ transplant patients. The efficacy and safety of VYNDAMAX (tafamidis) in organ transplant patients have not been established. VYNDAMAX is not recommended in these patients.
Carcinogenesis and Mutagenesis
There was no evidence of an increased incidence of neoplasia in the transgenic (Tg)‑rasH2 mouse following repeated daily administration of tafamidis meglumine 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 18‑times the human Area Under Curve (AUC) at the clinical dose of 61 mg tafamidis (see 16 NON-CLINICAL TOXICOLOGY).
There was no evidence of mutagenicity or clastogenicity in vitro, and an in vivo rat micronucleus study was negative.
Driving and Operating Machinery
VYNDAMAX has not been shown to influence the ability to drive and use machines.
VYNDAMAX has not been studied in patients with severe hepatic impairment and use is not recommended in these patients.
Limited data are available in patients with severe renal impairment (creatinine clearance less than or equal to 30 mL/min).
Reproductive Health: Female and Male Potential
- Teratogenic Risk
Studies in animals have shown developmental toxicity. The potential risk for humans is unknown. VYNDAMAX should not be used during pregnancy (see 16 NON-CLINICAL TOXICOLOGY).
Women of childbearing potential should use appropriate contraception when taking VYNDAMAX and continue to use contraception for 1‑month after stopping treatment.
7.1 Special Populations
7.1.1 Pregnant Women
There are no adequate and well-controlled clinical studies with the use of VYNDAMAX in pregnant women. Studies in animals have shown developmental toxicity. The potential risk for humans is unknown. VYNDAMAX should not be used during pregnancy.
There are no clinical data available to support the presence of tafamidis in human breast milk. Nonclinical data demonstrate that tafamidis is secreted in the milk of lactating rats (see 16 NON-CLINICAL TOXICOLOGY). When a drug is present in animal milk, it is likely the drug will be present in human milk. The effect of VYNDAMAX on nursing infants after administration to the mother has not been studied. Based on findings from animal studies which suggest the potential for serious adverse reactions in the breast-fed infant, VYNDAMAX should not be used by nursing women.
Pediatrics (<18 years of age): VYNDAMAX is not indicated and should not be prescribed in the pediatric population.
Geriatrics (≥65 years of age): Safety and efficacy were demonstrated in this population.