Decreased sperm counts have been observed in patients taking endothelin receptor antagonists and in animal fertility studies with ambrisentan.Pulmonary edema with pulmonary veno-occlusive disease (PVOD): Consider PVOD in patients who develop acute pulmonary edema during Letairis initiation and discontinue Letairis if PVOD is confirmed.There have also been postmarketing reports of fluid retention occurring within weeks after starting Letairis that required a diuretic, fluid management, or hospitalization for decompensating heart failure
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In clinical studies, peripheral edema was more common with Letairis than with placebo (most edema was mild to moderate in severity) and with Letairis plus tadalafil than with either drug alone.
Further evaluate patients who develop clinically significant fluid retention to determine the cause and possible need for edema treatment or to discontinue Letairis. Peripheral edema: Peripheral edema is a known class effect of endothelin receptor antagonists, and is also a clinical consequence of PAH and worsening PAH.Pharmacies must be certified with the program and must dispense to female patients who are authorized to receive Letairisįurther information is available at or 1-86.Male patients are not enrolled in the program.All female patients, regardless of reproductive potential, must enroll in the Letairis REMS Program.Prescribers must be certified with the program by enrolling in and completing training.Embryo-fetal toxicity and Letairis REMS Program requirements:.Idiopathic Pulmonary Fibrosis (IPF), including IPF patients with pulmonary hypertension (WHO Group 3).Pregnancy: Letairis can cause fetal harm.Because of the risk of embryo-fetal toxicity, females can only receive Letairis through a restricted program called the Letairis REMS program.Obtain monthly pregnancy tests during treatment and 1 month after discontinuation of treatment Females of reproductive potential must use acceptable methods of contraception during treatment with Letairis and for one month after treatment. Exclude pregnancy before the initiation of treatment with Letairis.Letairis is very likely to produce serious birth defects if used by pregnant females, as this effect has been seen consistently when it is administered to animals Do not administer Letairis to a pregnant female because it may cause fetal harm.
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