United States - English - NLM (National Library of Medicine)

dr.reddy's laboratories inc., - treprostinil (unii: rum6k67esg) (treprostinil - unii:rum6k67esg) - treprostinil injection is indicated for the treatment of pulmonary arterial hypertension (pah; who group 1) to diminish symptoms associated with exercise. studies establishing effectiveness included patients with nyha functional class ii-iv symptoms and etiologies of idiopathic or heritable pah (58%), pah associated with congenital systemic-to-pulmonary shunts (23%), or pah associated with connective tissue diseases (19%) [see clinical studies (14.1)] . in patients with pah requiring transition from epoprostenol, treprostinil injection is indicated to diminish the rate of clinical deterioration. consider the risks and benefits of each drug prior to transition. none risk summary limited case reports of treprostinil use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. however, there are risks to the mother and the fetus associated with pulmonary arterial hypertension (see clinical considerations) . in animal studies, no adverse reproductive and developmental

United States - English - NLM (National Library of Medicine)

teva parenteral medicines, inc. - treprostinil (unii: rum6k67esg) (treprostinil - unii:rum6k67esg) - treprostinil injection is indicated for the treatment of pulmonary arterial hypertension (pah; who group 1) to diminish symptoms associated with exercise. studies establishing effectiveness included patients with nyha functional class ii-iv symptoms and etiologies of idiopathic or heritable pah (58%), pah associated with congenital systemic-to-pulmonary shunts (23%), or pah associated with connective tissue diseases (19%) [see clinical studies (14.1)] . in patients with pah requiring transition from epoprostenol, treprostinil injection is indicated to diminish the rate of clinical deterioration. consider the risks and benefits of each drug prior to transition. none risk summary limited case reports of treprostinil use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. however, there are risks to the mother and the fetus associated with pulmonary arterial hypertension (see clinical considerations) . in animal studies, no adverse reproductive and developmental

United States - English - NLM (National Library of Medicine)

par pharmaceutical, inc. - treprostinil (unii: rum6k67esg) (treprostinil - unii:rum6k67esg) - treprostinil is indicated for the treatment of pulmonary arterial hypertension (pah; who group 1) to diminish symptoms associated with exercise. studies establishing effectiveness included patients with nyha functional class ii-iv symptoms and etiologies of idiopathic or heritable pah (58%), pah associated with congenital systemic-to -pulmonary shunts (23%), or pah associated with connective tissue diseases (19%) [see clinical studies (14.1) ]. in patients with pah requiring transition from epoprostenol, treprostinil is indicated to diminish the rate of clinical deterioration. consider the risks and benefits of each drug prior to transition. none risk summary limited case reports of treprostinil use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. however, there are risks to the mother and the fetus associated with pulmonary arterial hypertension (see clinical considerations) . in animal studies, no adverse reproductive and developmental effects were seen

Canada - English - Health Canada

dr reddy's laboratories ltd - treprostinil (treprostinil sodium) - solution - 1mg - treprostinil (treprostinil sodium) 1mg

Canada - English - Health Canada

dr reddy's laboratories ltd - treprostinil (treprostinil sodium) - solution - 2.5mg - treprostinil (treprostinil sodium) 2.5mg

Canada - English - Health Canada

dr reddy's laboratories ltd - treprostinil (treprostinil sodium) - solution - 5mg - treprostinil (treprostinil sodium) 5mg

Canada - English - Health Canada

dr reddy's laboratories ltd - treprostinil (treprostinil sodium) - solution - 10mg - treprostinil (treprostinil sodium) 10mg

United States - English - NLM (National Library of Medicine)

sandoz inc - treprostinil (unii: rum6k67esg) (treprostinil - unii:rum6k67esg) - treprostinil injection is indicated for the treatment of pulmonary arterial hypertension (pah; who group 1) to diminish symptoms associated with exercise. studies establishing effectiveness included patients with nyha functional class ii-iv symptoms and etiologies of idiopathic or heritable pah (58%), pah associated with congenital systemic-to-pulmonary shunts (23%), or pah associated with connective tissue diseases (19%) [see clinical studies (14.1)] . in patients with pah requiring transition from epoprostenol, treprostinil injection is indicated to diminish the rate of clinical deterioration. consider the risks and benefits of each drug prior to transition. none risk summary limited case reports of treprostinil use in pregnant women are insufficient to inform a drug- associated risk of adverse developmental outcomes. however, there are risks to the mother and the fetus associated with pulmonary arterial hypertension (see clinical considerations) . in animal studies, no adverse reproductive and developmenta

United States - English - NLM (National Library of Medicine)

alembic pharmaceuticals inc. - treprostinil (unii: rum6k67esg) (treprostinil - unii:rum6k67esg) - treprostinil injection is indicated for the treatment of pulmonary arterial hypertension (pah; who group 1) to diminish symptoms associated with exercise. studies establishing effectiveness included patients with nyha functional class ii-iv symptoms and etiologies of idiopathic or heritable pah (58%), pah associated with congenital systemic-to-pulmonary shunts (23%), or pah associated with connective tissue diseases (19%) [see clinical studies (14.1)]. in patients with pah requiring transition from epoprostenol, treprostinil injection is indicated to diminish the rate of clinical deterioration. consider the risks and benefits of each drug prior to transition. none risk summary limited case reports of treprostinil use in pregnant women are insufficient to inform a drug- associated risk of adverse developmental outcomes. however, there are risks to the mother and the fetus associated with pulmonary arterial hypertension (see clinical considerations ). in animal studies, no adverse reproductive and developmen

United States - English - NLM (National Library of Medicine)

united therapeutics corporation - treprostinil (unii: rum6k67esg) (treprostinil - unii:rum6k67esg) - treprostinil 0.125 mg - orenitram is indicated for the treatment of pulmonary arterial hypertension (pah) (who group 1) to delay disease progression and to improve exercise capacity. the studies that established effectiveness included predominately patients with who functional class ii-iii symptoms and etiologies of idiopathic or heritable pah (66%) or pah associated with connective tissue disease (26%). severe hepatic impairment (child pugh class c) [see use in specific populations (8.6) and clinical pharmacology (12.3)] . risk summary limited published data from case reports with orenitram use in pregnant women are not sufficient to assess for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. there are risks to the mother and the fetus associated with pulmonary arterial hypertension (see clinical considerations) . animal reproductive studies with treprostinil diolamine administered orally have shown an adverse effect on the fetus. in rats, administration of treprostinil to pregnant rats during the period of organogenesis at doses ≥10 mg/kg/day (approximately 15 times the human exposure at the dose of 3.5 mg bid on an auc basis) resulted in decreased pregnancy rate, increased post-implantation loss, and decreased fetal viability and growth. in rabbits, teratogenicity and decreased fetal viability and growth were observed at doses ≥1.5 mg/kg/day (approximately 7 times the human exposure at the dose of 3.5 mg bid on an auc basis) (see animal data) . the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. clinical considerations disease-associated maternal and embryo-fetal risk pulmonary arterial hypertension in pregnancy increases the risk of maternal heart failure, stroke and death, preterm delivery, low birth weight, and stillbirth. data animal data in pregnant rats, reversible, dose-dependent decreases in body weight gain and food consumption were observed during the first four days of dosing in animals administered 10, 20, and 30 mg/kg/day treprostinil diolamine. in a dose range-finding study, there was a 17% decrease in the pregnancy rate in the animals administered 20 and 30 mg/kg/day. one dam in each of the 20 and 30 mg/kg/day had litters with no viable fetuses. in the definitive study (0, 5, 10, and 20 mg/kg/day), there were four treatment-related deaths, and a 32% decrease in the pregnancy rate for rats administered 20 mg/kg/day. there was an 8% decrease in the pregnancy rate in the animals administered 10 mg/kg/day. across both studies, an increase in post-implantation loss was observed in animals administered 10 to 30 mg/kg/day, and a significant decrease in the mean number of live births was seen at dose levels ≥10 mg/kg/day. the no observed adverse effect level was 5 mg/kg/day (maternal, fetal viability and growth), and 20 mg/kg/day (teratogenicity), the highest dose tested in the definitive study. the exposures at 5 and 20 mg/kg/day doses represent 8 and 33 times, respectively, the human exposure at the dose of 3.5 mg bid on an auc basis. for f1 progeny, a decreased copulation index was observed at the 5 and 10 mg/kg/day treprostinil diolamine dose levels in rats. the no observed effect levels for physical development, reflex development, exploratory behavior, learning and memory, and sexual maturation was 10 mg/kg/day. the no observed effect level for f1 progeny general development (based on body weight) was 10 mg/kg/day for females and ≤2.5 mg/kg/day for males; the no observed effect level for f1 reproductive performance was 2.5 mg/kg/day (approximately 4 times the human exposure at the dose of 3.5 mg bid on an auc basis). in pregnant rabbits, the primary maternal adverse effect was gastrointestinal disturbance; dose-dependent decreases in mean body weight, body weight gain, and food consumption were observed. during the post-dose phase, the effect was reversed. in a dose range-finding study, there was a 17% decrease in the pregnancy rate for animals administered 4 mg/kg/day. a dose-dependent increase in post-implantation loss was observed. two dams administered 4 mg/kg/day had litters with no viable fetuses; the mean fetal weight was slightly decreased in animals administered 4 mg/kg/day. in the definitive study, mean fetal weights were significantly decreased in animals administered 0.5 to 3 mg/kg/day of treprostinil diolamine. at doses of 1.5 and 3 mg/kg/day, external fetal and soft tissue malformations were observed in a few fetuses, and the total fetal skeletal malformations were significantly increased. the no observed adverse effect level was less than 0.5 mg/kg/day (maternal), 1.5 mg/kg/day (fetal viability and growth), and 0.5 mg/kg/day (teratogenicity). the 0.5 mg/kg/day dose represents about 3 times the human exposure at the dose of 3.5 mg bid on an auc basis. risk summary there are no data on the presence of treprostinil in human milk, the effects on the breastfed infant, or the effects on milk production. safety and effectiveness in pediatric patients have not been established. use of orenitram in patients aged 65 years and over demonstrated slightly higher absolute and relative adverse event rates compared to younger patients. in general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic or cardiac function, and of concomitant disease or other drug therapy. there is a marked increase in the systemic exposure to treprostinil in hepatically impaired patients [see dosage and administration (2.3), contraindications (4), and clinical pharmacology (12.3)] . no dose adjustments are required in patients with renal impairment. orenitram is not removed by dialysis [see clinical pharmacology (12.3)] .