IMPORTANT SAFETY INFORMATION
WINREVAIR® is indicated, in combination with standard PAH therapy, for the treatment of adults with WHO Group 1 PAH and FC II or III.1
Important safety information1
Clinical use:
The safety and efficacy of WINREVAIR® in pediatric patients has not been established and therefore it is not indicated for pediatric use.
Clinical studies of WINREVAIR® did not include sufficient numbers of patients aged 75 and older to determine whether they respond differently from younger patients.
Relevant warnings and precautions:
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Hematologic adverse reactions
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Increased hemoglobin; monitor before each dose for at least the first 5 doses, or longer if values are unstable, and periodically thereafter to determine if dose adjustments are required
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Severe thrombocytopenia; WINREVAIR® should not be initiated in patients with platelet count <50,000/mm3 (<50.0 x 109/L). Monitor platelet count before each dose for the first 5 doses, or longer if values are unstable, and periodically thereafter to determine whether dose adjustments are required
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Serious bleeding, advise patients about signs and symptoms of blood loss
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Teratogenic risk, embryo-fetal toxicity
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Pregnancy testing is recommended for females of reproductive potential before starting treatment
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Females of reproductive potential should use effective contraception during treatment with WINREVAIR® and for at least 4 months after the last dose if treatment is discontinued
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Advise male and female patients on the potential effects on fertility
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Advise females not to breastfeed during treatment and for 4 months after the final dose if treatment is discontinued
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Pediatrics
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Geriatrics
For more information:
Consult the WINREVAIR® Product Monograph for important information regarding adverse reactions, drug interactions, and dosing information which have not been discussed in this piece. The Product Monograph is also available by calling us at 1-800-567-2594 or by email at medinfocanada@merck.com.