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

novo nordisk - liraglutide (unii: 839i73s42a) (liraglutide - unii:839i73s42a) - liraglutide 6 mg in 1 ml - victoza is indicated: infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease. limitations of use : victoza should not be used in patients with type 1 diabetes mellitus. victoza contains liraglutide and should not be coadministered with other liraglutide-containing products. victoza is contraindicated in patients with a: risk summary based on animal reproduction studies, there may be risks to the fetus from exposure to victoza during pregnancy. victoza should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. animal reproduction studies identified increased adverse developmental outcomes from exposure during pregnancy. liraglutide exposure was associated with early embryonic deaths and an imbalance in some fetal abnormalities in pregnant rats administered liraglutide during organogenesis at doses that approximate clinical exposures at the maximum recommended human dose (mrhd) of 1.8 mg/day. in pregnant rab

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

novo nordisk - liraglutide (unii: 839i73s42a) (liraglutide - unii:839i73s42a) - liraglutide 6 mg in 1 ml - saxenda is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in: limitations of use saxenda is contraindicated in: risk summary saxenda is contraindicated during pregnancy because weight loss offers no potential benefit to a pregnant woman and may result in fetal harm [see clinical considerations] . there are no available data with liraglutide in pregnant women to inform a drug associated risk for major birth defects and miscarriage. saxenda should not be used during pregnancy. if a patient wishes to become pregnant, or pregnancy occurs, treatment with saxenda should be discontinued. animal reproduction studies identified increased adverse embryofetal developmental outcomes from exposure during pregnancy. liraglutide exposure was associated with early embryonic deaths and an imbalance in some fetal abnormalities in pregnant rats administered liraglutide during organogenesis at doses that approximate clinical exposures at the maximum recommended hum

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

novo nordisk pharmaceuticals pty ltd - liraglutide, quantity: 6 mg/ml - injection, solution - excipient ingredients: phenol; hydrochloric acid; water for injections; propylene glycol; dibasic sodium phosphate dihydrate; sodium hydroxide - saxenda is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial body mass index (bmi) of:,- greater than or equal to 30 kg/m2 (obese) or,- greater than or equal to 27 kg/m2 to <30 kg/m2 (overweight) in the presence of at least one weight related comorbidity, such as dysglycaemia (pre-diabetes and type 2 diabetes mellitus), hypertension, dyslipidaemia, or obstructive sleep apnoea.,treatment with saxenda should be discontinued after 12 weeks on the 3.0 mg/day dose if a patient has not lost at least 5% of their initial body weight.

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

novo nordisk pharmaceuticals pty ltd - liraglutide, quantity: 6 mg/ml - injection, solution - excipient ingredients: phenol; hydrochloric acid; water for injections; propylene glycol; dibasic sodium phosphate dihydrate; sodium hydroxide - glycaemic control,victoza is indicated as an adjunct to diet and exercise for treatment of adults with type 2 diabetes mellitus to achieve glycaemic control:,- as monotherapy when metformin is contraindicated or is not tolerated,- in combination with other glucose lowering medicines.,prevention of cardiovascular events,in patients where victoza is indicated to improve glycaemic control, victoza is indicated to reduce the risk of cardiovascular events in those at high cardiovascular risk, as an adjunct to standard of care therapy (see clinical trials).

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

novo nordisk - insulin degludec (unii: 54q18076qb) (insulin degludec - unii:54q18076qb), liraglutide (unii: 839i73s42a) (liraglutide - unii:839i73s42a) - insulin degludec 100 [iu] in 1 ml - xultophy 100/3.6 is a combination of insulin degludec and liraglutide and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitations of use: xultophy 100/3.6 is contraindicated: risk summary based on animal reproduction studies, there may be risks to the fetus from exposure to liraglutide during pregnancy. xultophy 100/3.6 should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. there are no available data with xultophy 100/3.6, insulin degludec or liraglutide in pregnant women to inform a drug associated risk for major birth defects and miscarriage. there are clinical considerations regarding the risks of poorly controlled diabetes in pregnancy [see clinical considerations]. for insulin degludec, rats and rabbits were exposed in animal reproduction studies at 5 times (rat) and 10 times (rabbit) the human exposure at a dose of 0.75 u/kg/day. no adverse outcomes were observed for pregnant ani

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

a-s medication solutions - liraglutide (unii: 839i73s42a) (liraglutide - unii:839i73s42a) - victoza is indicated: infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease [see clinical studies ( 14.3 )] . limitations of use : victoza should not be used in patients with type 1 diabetes mellitus. victoza contains liraglutide and should not be coadministered with other liraglutide-containing products. victoza is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (mtc) or in patients with multiple endocrine neoplasia syndrome type 2 (men 2). victoza is contraindicated in patients with a serious hypersensitivity reaction to liraglutide or to any of the excipients in victoza. serious hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with victoza [see warnings and precautions (5.6)]. risk summary based on animal reproduction studies, there may be risks to the fetus from exposure to victoza during pregnancy. victoza should be used during pregnancy only if the potentia

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

a-s medication solutions - liraglutide (unii: 839i73s42a) (liraglutide - unii:839i73s42a) - victoza is indicated: infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease [see clinical studies ( 14.3 )] . limitations of use : victoza should not be used in patients with type 1 diabetes mellitus. victoza contains liraglutide and should not be coadministered with other liraglutide-containing products. victoza is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (mtc) or in patients with multiple endocrine neoplasia syndrome type 2 (men 2). victoza is contraindicated in patients with a serious hypersensitivity reaction to liraglutide or to any of the excipients in victoza. serious hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with victoza [see warnings and precautions (5.6)]. risk summary based on animal reproduction studies, there may be risks to the fetus from exposure to victoza during pregnancy. victoza should be used during pregnancy only if the potentia

Israel - English - Ministry of Health

novo nordisk ltd., israel - liraglutide - solution for injection - liraglutide 6.0 mg/ml - liraglutide - liraglutide - victoza is indicated for:• treatment of adults, adolescents and children aged 10 years and above with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:1. as monotherapy when metformin is considered inappropriate due to intolerance or contraindications2. in addition to other medicinal products for the treatment of diabetes.• to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with type 2 diabetes mellitus and established cardiovascular disease

Canada - English - Health Canada

novo nordisk canada inc - liraglutide - solution - 6mg - liraglutide 6mg - incretin mimetics

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

a-s medication solutions - liraglutide (unii: 839i73s42a) (liraglutide - unii:839i73s42a) - saxenda is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in: limitations of use saxenda is contraindicated in: risk summary saxenda is contraindicated during pregnancy because weight loss offers no potential benefit to a pregnant woman and may result in fetal harm [see clinical considerations] . there are no available data with liraglutide in pregnant women to inform a drug associated risk for major birth defects and miscarriage. saxenda should not be used during pregnancy. if a patient wishes to become pregnant, or pregnancy occurs, treatment with saxenda should be discontinued. animal reproduction studies identified increased adverse embryofetal developmental outcomes from exposure during pregnancy. liraglutide exposure was associated with early embryonic deaths and an imbalance in some fetal abnormalities in pregnant rats administered liraglutide during organogenesis at doses that approximate clinical exposures at the maximum recommended human dose (mrhd) of 3 mg/day. in pregnant rabbits administered liraglutide during organogenesis, decreased fetal weight and an increased incidence of major fetal abnormalities were seen at exposures below the human exposures at the mrhd [see animal data] . the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage of clinically recognized pregnancies is 2-4% and 15-20%, respectively. clinical considerations disease-associated maternal and/or embryofetal risk a minimum weight gain, and no weight loss, is recommended for all pregnant women, including those who are already overweight or obese, due to the necessary weight gain that occurs in maternal tissues during pregnancy. animal data liraglutide has been shown to be teratogenic in rats at or above 0.8-times systemic exposures in obese humans resulting from the maximum recommended human dose (mrhd) of 3 mg/day based on plasma area under the time-concentration curve (auc) comparison. liraglutide has been shown to cause reduced growth and increased total major abnormalities in rabbits at systemic exposures below exposure in obese humans at the mrhd based on plasma auc comparison. female rats given subcutaneous doses of 0.1, 0.25 and 1 mg/kg/day liraglutide beginning 2 weeks before mating through gestation day 17 had estimated systemic exposures 0.8-, 3-, and 11-times the exposure in obese humans at the mrhd based on plasma auc comparison. the number of early embryonic deaths in the 1 mg/kg/day group increased slightly. fetal abnormalities and variations in kidneys and blood vessels, irregular ossification of the skull, and a more complete state of ossification occurred at all doses. mottled liver and minimally kinked ribs occurred at the highest dose. the incidence of fetal malformations in liraglutide-treated groups exceeding concurrent and historical controls were misshapen oropharynx and/or narrowed opening into larynx at 0.1 mg/kg/day and umbilical hernia at 0.1 and 0.25 mg/kg/day. pregnant rabbits given subcutaneous doses of 0.01, 0.025 and 0.05 mg/kg/day liraglutide from gestation day 6 through day 18 inclusive, had estimated systemic exposures less than the exposure in obese humans at the mrhd of 3 mg/day at all doses, based on plasma auc comparison. liraglutide decreased fetal weight and dose-dependently increased the incidence of total major fetal abnormalities at all doses. the incidence of malformations exceeded concurrent and historical controls at 0.01 mg/kg/day (kidneys, scapula), greater than or equal to 0.01 mg/kg/day (eyes, forelimb), 0.025 mg/kg/day (brain, tail and sacral vertebrae, major blood vessels and heart, umbilicus), greater than or equal to 0.025 mg/kg/day (sternum) and at 0.05 mg/kg/day (parietal bones, major blood vessels). irregular ossification and/or skeletal abnormalities occurred in the skull and jaw, vertebrae and ribs, sternum, pelvis, tail, and scapula; and dose-dependent minor skeletal variations were observed. visceral abnormalities occurred in blood vessels, lung, liver, and esophagus. bilobed or bifurcated gallbladder was seen in all treatment groups, but not in the control group. in pregnant female rats given subcutaneous doses of 0.1, 0.25 and 1 mg/kg/day liraglutide from gestation day 6 through weaning or termination of nursing on lactation day 24, estimated systemic exposures were 0.8-, 3-, and 11-times exposure in obese humans at the mrhd of 3 mg/day, based on plasma auc comparison. a slight delay in parturition was observed in the majority of treated rats. group mean body weight of neonatal rats from liraglutide-treated dams was lower than neonatal rats from control group dams. bloody scabs and agitated behavior occurred in male rats descended from dams treated with 1 mg/kg/day liraglutide. group mean body weight from birth to postpartum day 14 trended lower in f2 generation rats descended from liraglutide-treated rats compared to f2 generation rats descended from controls, but differences did not reach statistical significance for any group. risk summary there are no data on the presence of liraglutide in human milk, the effects on the breastfed infant, or effects on milk production. liraglutide was present in the milk of lactating rats (see data ). the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for saxenda and any potential adverse effects on the breastfed infant from saxenda or from the underlying maternal condition. data in lactating rats, liraglutide was present unchanged in milk at concentrations approximately 50% of maternal plasma concentrations. the safety and effectiveness of saxenda as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management have been established in pediatric patients aged 12 years and older with body weight above 60 kg and an initial bmi corresponding to 30 kg/m2 or greater for adults (obese) by international cut-offs (see table 2). use of saxenda for this indication is supported by a 56-week double-blind, placebo-controlled clinical trial in 251 pediatric patients aged 12 to 17 years, a pharmacokinetic study in pediatric patients, and studies in adults with obesity [see clinical pharmacology (12.3), clinical studies (14.1,14.2)]. in the pediatric clinical trial, there was one death due to suicide in a saxenda-treated patient [see warnings and precautions (5.8)] ; one saxenda-treated patient had an event of pancreatitis [see warnings and precautions (5.2)] ; more episodes of hypoglycemia confirmed by self blood glucose monitoring occurred in saxenda-treated patients compared to placebo [see warnings and precautions (5.4), adverse reactions (6.1)] ; and mean increases in resting heart rate of 3 to 7 bpm from baseline were observed with saxenda-treated patients [see warnings and precautions (5.5)] . the safety and effectiveness of saxenda have not been established in patients less than 12 years of age. in the saxenda clinical trials, 232 (6.9%) of the saxenda-treated patients were 65 years of age and over, and 17 (0.5%) of the saxenda-treated patients were 75 years of age and over. no overall differences in safety or effectiveness were observed between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out. there is limited experience with saxenda in patients with mild, moderate, and severe renal impairment, including end‑stage renal disease. however, there have been postmarketing reports of acute renal failure and worsening of chronic renal failure with liraglutide, which may sometimes require hemodialysis [see warnings and precautions (5.6), adverse reactions (6.2)] . saxenda should be used with caution in this patient population [see clinical pharmacology (12.3)] . there is limited experience in patients with mild, moderate, or severe hepatic impairment. therefore, saxenda should be used with caution in this patient population [see clinical pharmacology (12.3)] . saxenda slows gastric emptying. saxenda has not been studied in patients with pre-existing gastroparesis. step 1. prepare your pen with a new needle always use a new needle for each injection. this will prevent contamination, infection, leakage of saxenda, and blocked needles leading to the wrong dose. never use a bent or damaged needle. do not attach a new needle to your pen until you are ready to take your injection. step 2. check the saxenda flow with each new pen. always make sure that a drop appears at the needle tip before you use a new pen for the first time. this makes sure that saxenda flows. if no drop appears, you will not inject any saxenda, even though the dose counter may move. this may mean that there is a blocked or damaged needle. a small drop may remain at the needle tip, but it will not be injected. only check the saxenda flow before your first injection with each new pen. step 3. select your dose always use the dose counter and the dose pointer to see how many mg you select. you will hear a “click” every time you turn the dose selector. do not set the dose by counting the number of clicks you hear. do not use the pen scale to set the dose. it does not show exactly how much saxenda is left in your pen. only doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg or 3 mg can be selected with the dose selector. the selected dose must line up exactly with the dose pointer to make sure that you get a correct dose. the dose selector changes the dose. only the dose counter and dose pointer will show how many mg you select for each dose. you can select up to 3 mg each dose. when your pen contains less than 3 mg the dose counter stops before 3 mg is shown. the dose selector clicks differently when turned forward, backwards or past the number of mg left. do not count the pen clicks. how much saxenda is left? if you need more saxenda than what is left in your pen only if trained or told by your healthcare provider, you may split your dose between your current pen and a new pen. use a calculator to plan the doses as instructed by your healthcare provider. be very careful to calculate correctly. if you are not sure how to split your dose using 2 pens, then select and inject the dose you need with a new pen. step 4. inject your dose always watch the dose counter to know how many mg you inject. hold the dose button down until the dose counter shows 0. you may see a drop of saxenda at the needle tip after injecting. this is normal and does not affect your dose. step 5. after your injection if you do not have a sharps container, follow a 1-handed needle recapping method. carefully slip the needle into the outer needle cap. dispose of the needle in a sharps container as soon as possible. never try to put the inner needle cap back on the needle. you may stick yourself with the needle. always remove the needle from your pen. this prevents contamination, infection, leakage of saxenda, and blocked needles leading to the wrong dose. if the needle is blocked, you will not inject any saxenda. always dispose of the needle after each injection . important caring for your pen how should i store my saxenda pen? this medication guide and instructions for use have been approved by the u.s. food and drug administration. december 2020