Safety-Related Labeling Changes

"Multiple safety updates including; Medication overuse headache, nausea, dyspnoea Recommendations against use in patients with severe hepatic impairment, end-stage renal disease (CLcr < 15 ml/min), or concomitant use with strong or moderate inducers of CYP3A4 enzyme Interactions with CYP3A4 inhibitors/ inducers and P-gp and BCRP only inhibitors Animal studies did not demonstrate teratogenic potential and were only observed at at exposure levels associated with maternal toxicity (approximately 200 times greater than clinical exposures)"

Trade Name

Nurtec

Updated Section

"4.4 Special Warnings and Special Precautions for Use 4.5. Interactions with other medicinal products 4.6. Fertility, pregnancy and lactation 4.8 Undesirable effects"

Month

Jul, 2024