Novartis Animal Health Inc. - search results

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

leqvio- inclisiran injection, solution

novartis pharmaceuticals corporation - inclisiran sodium (unii: upc6btx7py) (inclisiran - unii:uow2c71pg5) - leqvio® is indicated as an adjunct to diet and statin therapy for the treatment of adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (hefh), to reduce low-density lipoprotein cholesterol (ldl-c). none. risk summary discontinue leqvio when pregnancy is recognized. alternatively, consider the ongoing therapeutic needs of the individual patient. inclisiran increases ldl-c uptake and lowers ldl-c levels in the circulation, thus decreasing cholesterol and possibly other biologically active substances derived from cholesterol; therefore, leqvio may cause fetal harm when administered to pregnant patients based on the mechanism of action [see clinical pharmacology (12.1)] . in addition, treatment of hyperlipidemia is not generally necessary during pregnancy. atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hyperlipidemia for most patients. there are no available data on the use of leqvio in pregnant patients to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. in animal reproduction studies, no adverse developmental effects were observed in rats and rabbits with subcutaneous administration of inclisiran during organogenesis at doses up to 5 to 10 times the maximum recommended human dose (mrhd) based on body surface area (bsa) comparison (see data ). no adverse developmental outcomes were observed in offspring of rats administered inclisiran from organogenesis through lactation at 5 times the mrhd based on bsa comparison (see data ). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%–4% and 15%–20%, respectively. data animal data in embryo-fetal development studies conducted in sprague-dawley rats and new zealand white rabbits, inclisiran was administered by subcutaneous injection at dose levels of 50, 100, and 150 mg/kg once daily during organogenesis (rats: gestation days 6 to 17; rabbits: gestation days 7 to 19). there was no evidence of embryo-fetal toxicity or teratogenicity at doses up to 5 and 10 times, respectively, the mrhd based on bsa comparison/dose. inclisiran crosses the placenta and was detected in rat fetal plasma at concentrations that were 65 to 154 times lower than maternal levels. in a pre- and postnatal development study conducted in sprague-dawley rats, inclisiran was administered once daily by subcutaneous injection at levels of 50, 100, and 150 mg/kg from gestation day 6 through lactation day 20. inclisiran was well-tolerated in maternal rats, with no evidence of maternal toxicity and no effects on maternal performance. there were no effects on the development of the f1 generation, including survival, growth, physical and reflexological development, behavior, and reproductive performance at doses up to 5 times the mrhd, based on bsa comparison/dose. risk summary there is no information on the presence of inclisiran in human milk, the effects on the breastfed infant, or the effects on milk production. inclisiran was present in the milk of lactating rats in all dose groups. when a drug is present in animal milk, it is likely that the drug will be present in human milk (see data ). oligonucleotide-based products typically have poor oral bioavailability; therefore, it is considered unlikely that low levels of inclisiran present in milk will adversely impact an infant’s development during lactation. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for leqvio and any potential adverse effects on the breastfed infant from leqvio or from the underlying maternal condition. data in lactating rats, inclisiran was detected in milk at mean maternal plasma:milk ratios that ranged between 0.361 and 1.79. however, there is no evidence of systemic absorption in the suckling rat neonates. the safety and effectiveness of leqvio have not been established in pediatric patients. of the 1,833 patients treated with leqvio in clinical studies, 981 (54%) patients were 65 years of age and older, while 239 (13%) patients were 75 years of age and older. no overall differences in safety or effectiveness were observed between patients 65 years of age and older and younger adult patients. no dose adjustments are necessary for patients with mild, moderate, or severe renal impairment [see clinical pharmacology (12.3)] . leqvio has not been studied in patients with end stage renal disease [see clinical pharmacology (12.3)] . no dose adjustment is necessary in patients with mild to moderate hepatic impairment. leqvio has not been studied in patients with severe hepatic impairment [see clinical pharmacology (12.3)] .

Israel - English - Ministry of Health

leqvio 284 mg

novartis israel ltd - inclisiran as sodium - solution for injection - inclisiran as sodium 189 mg/ml - inclisiran - leqvio is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non familial) or mixed dyslipidaemia, as an adjunct to diet:• in combination with a statin or statin with other lipid lowering therapies in patients unable to reach ldl c goals with the maximum tolerated dose of a statin, or• alone or in combination with other lipid lowering therapies in patients who are statin intolerant, or for whom a statin is contraindicated.

Canada - English - Health Canada

leqvio solution

novartis pharmaceuticals canada inc - inclisiran (inclisiran sodium) - solution - 284mg - inclisiran (inclisiran sodium) 284mg

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

leqvio inclisiran 284 mg /1.5 ml solution for injection in pre-filled syringe

novartis pharmaceuticals australia pty ltd - inclisiran, quantity: 284 mg - injection, solution - excipient ingredients: sodium hydroxide; phosphoric acid; water for injections - leqvio is indicated as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (ldl-c) in adults with heterozygous familial hypercholesterolaemia, atherosclerotic cardiovascular disease, or at high risk of a cardiovascular event:,? in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach ldl-c goals with the maximum tolerated dose of a statin or,,? alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant.

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

amlodipine/valsartan novartis 5/80 amlodipine 5 mg/valsartan 80 mg film-coated tablet blister pack

novartis pharmaceuticals australia pty ltd - amlodipine besilate, quantity: 6.94 mg (equivalent: amlodipine, qty 5 mg); valsartan, quantity: 80 mg - tablet, film coated - excipient ingredients: microcrystalline cellulose; magnesium stearate; crospovidone; colloidal anhydrous silica; titanium dioxide; hypromellose; purified talc; macrogol 4000; iron oxide yellow - amlodipine/valsartan novartis is indicated for the treatment of hypertension. treatment should not be initiated with this fixed dose combination.