VYNDAQEL 7 Warnings and Precautions

tafamidis meglumine

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General

No studies have been conducted in organ transplant patients. The efficacy and safety of VYNDAQEL in organ transplant patients has not been established.  Tafamidis is not recommended in these patients.

Carcinogenesis and Mutagenesis

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 18‑times the human AUC at the clinical dose of 80 mg tafamidis meglumine (see 16 NON-CLINICAL TOXICOLOGY).

Mutagenesis: There was no evidence of mutagenicity or clastogenicity in vitro, and an in vivo rat micronucleus study was negative.

Driving and Operating Machinery

VYNDAQEL has not been shown to influence the ability to drive and use machines.

Hepatic/Biliary/Pancreatic

VYNDAQEL has not been studied in patients with severe hepatic impairment and use is not recommended in these patients.

Renal

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 (see 16 NON-CLINICAL TOXICOLOGY). The potential risk for humans is unknown. VYNDAQEL should not be used during pregnancy.

Women of childbearing potential should use appropriate contraception when taking VYNDAQEL 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 VYNDAQEL in pregnant women. Studies in animals have shown developmental toxicity (see 16 NON-CLINICAL TOXICOLOGY).  The potential risk for humans is unknown. VYNDAQEL should not be used during pregnancy.

7.1.2 Breast-feeding

There are no clinical data available to support the presence of tafamidis in human breast milk. Nonclinical data demonstrates 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 VYNDAQEL 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 breastfed infant, VYNDAQEL should not be used by nursing women.

7.1.3 Pediatrics

Pediatrics (<18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.

7.1.4 Geriatrics

Geriatrics (≥65 years of age): Safety and efficacy were demonstrated in this population.

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7 Warnings and Precautions

General

No studies have been conducted in organ transplant patients. The efficacy and safety of VYNDAQEL in organ transplant patients has not been established.  Tafamidis is not recommended in these patients.

Carcinogenesis and Mutagenesis

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 18‑times the human AUC at the clinical dose of 80 mg tafamidis meglumine (see 16 NON-CLINICAL TOXICOLOGY).

Mutagenesis: There was no evidence of mutagenicity or clastogenicity in vitro, and an in vivo rat micronucleus study was negative.

Driving and Operating Machinery

VYNDAQEL has not been shown to influence the ability to drive and use machines.

Hepatic/Biliary/Pancreatic

VYNDAQEL has not been studied in patients with severe hepatic impairment and use is not recommended in these patients.

Renal

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 (see 16 NON-CLINICAL TOXICOLOGY). The potential risk for humans is unknown. VYNDAQEL should not be used during pregnancy.

Women of childbearing potential should use appropriate contraception when taking VYNDAQEL 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 VYNDAQEL in pregnant women. Studies in animals have shown developmental toxicity (see 16 NON-CLINICAL TOXICOLOGY).  The potential risk for humans is unknown. VYNDAQEL should not be used during pregnancy.

7.1.2 Breast-feeding

There are no clinical data available to support the presence of tafamidis in human breast milk. Nonclinical data demonstrates 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 VYNDAQEL 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 breastfed infant, VYNDAQEL should not be used by nursing women.

7.1.3 Pediatrics

Pediatrics (<18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.

7.1.4 Geriatrics

Geriatrics (≥65 years of age): Safety and efficacy were demonstrated in this population.

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