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

alnylam pharmaceuticals, inc. - patisiran sodium (unii: wo0ym16lkg) (patisiran - unii:50fkx8cb2y) - onpattro is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to onpattro during pregnancy. physicians are encouraged to enroll pregnant patients, or pregnant women may register themselves in the program by calling 1-877-256-9526 or by contacting alnylampregnancyprogram@iqvia.com. risk summary there are no available data on onpattro use in pregnant women to inform a drug-associated risk of adverse developmental outcomes. onpattro treatment leads to a decrease in serum vitamin a levels, and vitamin a supplementation is advised for patients taking onpattro. vitamin a is essential for normal embryofetal development; however, excessive levels of vitamin a are associated with adverse developmental effects. the effects on the fetus of a reduction in maternal serum ttr caused by onpattro and of vitamin a supplementation are unknown [see

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

alnylam pharmaceuticals, inc. - givosiran sodium (unii: 5xe21e41rt) (givosiran - unii:rov204583w) - givlaari is indicated for the treatment of adults with acute hepatic porphyria (ahp). givlaari is contraindicated in patients with known severe hypersensitivity to givosiran. reactions have included anaphylaxis [see warnings and precautions (5.1)]. risk summary in animal reproduction studies, subcutaneous administration of givosiran to pregnant rabbits during the period of organogenesis resulted in adverse developmental outcomes at doses that produced maternal toxicity (see data). there are no available data with givlaari use in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. consider the benefits and risks of givlaari for the mother and potential adverse effects to the fetus when prescribing givlaari to a pregnant woman. the estimated background risk of major birth defects and miscarriage in the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. gene

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

alnylam pharmaceuticals, inc. - lumasiran (unii: rzt8c352o1) (lumasiran - unii:rzt8c352o1) - oxlumo is indicated for the treatment of primary hyperoxaluria type 1 (ph1) to lower urinary and plasma oxalate levels in pediatric and adult patients [see clinical pharmacology (12.1), clinical studies (14.1, 14.2, 14.3)] . none. risk summary there are no available data with the use of oxlumo in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. no adverse effects on pregnancy or embryo-fetal development related to oxlumo were observed in rats at 45 times and in rabbits at 90 times the maximum recommended human dose in women (see data ). the estimated background risk of major birth defects and miscarriage in the indicated population 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. data animal data in an emb

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

alnylam pharmaceuticals, inc. - vutrisiran (unii: gb4i2ji8ui) (vutrisiran - unii:gb4i2ji8ui) - amvuttra is indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults. none. risk summary there are no available data on amvuttra use in pregnant women to inform a drug-associated risk of adverse developmental outcomes. amvuttra treatment leads to a decrease in serum vitamin a levels, and vitamin a supplementation is advised for patients taking amvuttra. vitamin a is essential for normal embryofetal development; however, excessive levels of vitamin a are associated with adverse developmental effects. the effects on the fetus of a reduction in maternal serum ttr caused by amvuttra and of vitamin a supplementation are unknown [see warnings and precautions (5.1) and clinical pharmacology (12.2)] . in animal studies, subcutaneous administration of vutrisiran to pregnant rats resulted in developmental toxicity (reduced fetal body weight and embryofetal mortality) at doses associated with maternal toxicity (see data) . in the u.s. general population, the estimated

Israel - English - Ministry of Health

medison pharma ltd - patisiran as sodium - concentrate for solution for infusion - patisiran as sodium 2 mg / 1 ml - patisiran - onpattro is indicated for the treatment of hereditary transthyretin-mediated amyloidosis (hattr amyloidosis) in adult patients with stage 1 or stage 2 polyneuropathy

Israel - English - Ministry of Health

medison pharma ltd - givosiran as sodium - solution for injection - givosiran as sodium 189 mg / 1 ml - givosiran - givlaari is indicated for the treatment of acute hepatic porphyria (ahp) in adults and adolescents aged 12 years and older

Israel - English - Ministry of Health

medison pharma ltd - lumasiran as sodium - solution for injection - lumasiran as sodium 189 mg / 1 ml - lumasiran - oxlumo is indicated for the treatment of primary hyperoxaluria type 1 (ph1) in all age groups.

Australia - English - Department of Health (Therapeutic Goods Administration)

alnylam australia pty ltd - givosiran sodium, quantity: 200 mg (equivalent: givosiran, qty 189 mg) - injection, solution - excipient ingredients: phosphoric acid; sodium hydroxide; water for injections - givlaari is indicated for the treatment of acute hepatic porphyria (ahp) in adults and adolescents aged 12 years and older.

New Zealand - English - Medsafe (Medicines Safety Authority)

sanofi-aventis new zealand limited - prenylamine lactate 60mg - tablet - 60 mg - active: prenylamine lactate 60mg

New Zealand - English - Medsafe (Medicines Safety Authority)

sanofi-aventis new zealand limited - gallamine triethiodide 40 mg/ml - solution for injection - 40 mg/ml - active: gallamine triethiodide 40 mg/ml