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

novo nordisk - semaglutide (unii: 53axn4nnhx) (semaglutide - unii:53axn4nnhx) - semaglutide 1.34 mg in 1 ml - ozempic is indicated: limitations of use ozempic is contraindicated in patients with: risk summary there are limited data with semaglutide use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. there are clinical considerations regarding the risks of poorly controlled diabetes in pregnancy (see clinical considerations) . based on animal reproduction studies, there may be potential risks to the fetus from exposure to semaglutide during pregnancy. ozempic should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. in pregnant rats administered semaglutide during organogenesis, embryofetal mortality, structural abnormalities and alterations to growth occurred at maternal clinical exposure based on auc. in rabbits and cynomolgus monkeys administered semaglutide during organogenesis, early pregnancy losses or structural abnormalities were observed at clinical exposure (rabbit) and ≥2-fold the mrhd (monkey). these findings coincided wi

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

novo nordisk - semaglutide (unii: 53axn4nnhx) (semaglutide - unii:53axn4nnhx) - wegovy is indicated in combination with a reduced calorie diet and increased physical activity: limitations of use wegovy is contraindicated in the following conditions: pregnancy exposure registry there will be a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to semaglutide during pregnancy. pregnant women exposed to wegovy and healthcare providers are encouraged to contact novo nordisk at 1-877-390-2760 or www.wegovypregnancyregistry.com. risk summary based on animal reproduction studies, there may be potential risks to the fetus from exposure to semaglutide during pregnancy. additionally, weight loss offers no benefit to a pregnant patient and may cause fetal harm. when a pregnancy is recognized, advise the pregnant patient of the risk to a fetus, and discontinue wegovy (see clinical considerations) . available pharmacovigilance data and data from clinical trials with wegovy use in pregnant patients are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. in pregnant rats administered semaglutide during organogenesis, embryofetal mortality, structural abnormalities and alterations to growth occurred at maternal exposures below the maximum recommended human dose (mrhd) based on auc. in rabbits and cynomolgus monkeys administered semaglutide during organogenesis, early pregnancy losses and structural abnormalities were observed at below the mrhd (rabbit) and greater than or equal to 2-fold the mrhd (monkey). these findings coincided with a marked maternal body weight loss in both animal species (see data).   the estimated background risk of major birth defects and miscarriage for the indicated population are 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. clinical considerations disease-associated maternal and/or embryo/fetal risk appropriate weight gain based on pre-pregnancy weight is currently recommended for all pregnant patients, including those who already have overweight or obesity, because of the obligatory weight gain that occurs in maternal tissues during pregnancy. data animal data in a combined fertility and embryofetal development study in rats, subcutaneous doses of 0.01, 0.03 and 0.09 mg/kg/day (0.04-, 0.1-, and 0.4-fold the mrhd) were administered to males for 4 weeks prior to and throughout mating and to females for 2 weeks prior to mating, and throughout organogenesis to gestation day 17. in parental animals, pharmacologically mediated reductions in body weight gain and food consumption were observed at all dose levels. in the offspring, reduced growth and fetuses with visceral (heart blood vessels) and skeletal (cranial bones, vertebra, ribs) abnormalities were observed at the human exposure. in an embryofetal development study in pregnant rabbits, subcutaneous doses of 0.0010, 0.0025 or 0.0075 mg/kg/day (0.01-, 0.1-, and 0.9-fold the mrhd) were administered throughout organogenesis from gestation day 6 to 19. pharmacologically mediated reductions in maternal body weight gain and food consumption were observed at all dose levels. early pregnancy losses and increased incidences of minor visceral (kidney, liver) and skeletal (sternebra) fetal abnormalities were observed at greater than or equal to 0.0025 mg/kg/day, at clinically relevant exposures. in an embryofetal development study in pregnant cynomolgus monkeys, subcutaneous doses of 0.015, 0.075, and 0.15 mg/kg twice weekly (0.4-, 2-, and 6-fold the mrhd) were administered throughout organogenesis, from gestation day 16 to 50. pharmacologically mediated, marked initial maternal body weight loss and reductions in body weight gain and food consumption coincided with the occurrence of sporadic abnormalities (vertebra, sternebra, ribs) at greater than or equal to 0.075 mg/kg twice weekly (greater than or equal to 2 times human exposure). in a pre- and postnatal development study in pregnant cynomolgus monkeys, subcutaneous doses of 0.015, 0.075, and 0.15 mg/kg twice weekly (0.2-, 1-, and 3-fold the mrhd) were administered from gestation day 16 to 140. pharmacologically mediated marked initial maternal body weight loss and reductions in body weight gain and food consumption coincided with an increase in early pregnancy losses and led to delivery of slightly smaller offspring at greater than or equal to 0.075 mg/kg twice weekly (greater than or equal to 1-time human exposure). risk summary there are no data on the presence of semaglutide or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. semaglutide was present in the milk of lactating rats. when a drug is present in animal milk, it is likely that the drug will be present in human milk (see data ). the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for wegovy and any potential adverse effects on the breastfed infant from wegovy or from the underlying maternal condition. data in lactating rats, semaglutide was detected in milk at levels 3-12-fold lower than in maternal plasma. because of the potential for fetal harm, discontinue wegovy in patients at least 2 months before they plan to become pregnant to account for the long half-life of semaglutide [see use in specific populations (8.1 )] . the safety and effectiveness of wegovy as an adjunct to a reduced calorie diet and increased physical activity for weight reduction and long-term maintenance have been established in pediatric patients aged 12 years and older with obesity. use of wegovy for this indication is supported by a 68-week, double-blind, placebo-controlled clinical trial in 201 pediatric patients aged 12 years and older with a bmi corresponding to ≥95th percentile for age and sex and from studies in adult patients with obesity [see clinical studies (14.3) ] . adverse reactions with wegovy treatment in pediatric patients aged 12 years and older were generally similar to those reported in adults. pediatric patients aged 12 years and older treated with wegovy had greater incidences of cholelithiasis, cholecystitis, hypotension, rash, and urticaria compared to adults treated with wegovy [see adverse reactions (6.1)] . there are insufficient data in pediatric patients with type 2 diabetes treated with wegovy for obesity to determine if there is an increased risk of hypoglycemia with wegovy treatment similar to that reported in adults. inform patients of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia. in pediatric patients aged 12 years and older with type 2 diabetes, monitor blood glucose prior to starting wegovy and during wegovy treatment. when initiating wegovy in pediatric patients aged 12 years and older with type 2 diabetes, consider reducing the dose of concomitantly administered insulin secretagogue (such as sulfonylureas) or insulin to reduce the risk of hypoglycemia [see warnings and precautions (5.4)] . the safety and effectiveness of wegovy have not been established in pediatric patients less than 12 years of age. in the wegovy clinical trials for weight reduction and long-term maintenance, 233 (9%) wegovy-treated patients were aged 65 to 75 years and 23 (1%) wegovy-treated patients were aged 75 years and older [see clinical studies (14.2)] . in a cardiovascular outcomes trial, 2656 (30%) wegovy-treated patients were aged 65 to 75 years and 703 (8%) wegovy-treated patients were aged 75 years and older [see clinical studies (14.1)] . no overall difference in effectiveness was observed between patients aged 65 years and older and younger adult patients. in the cardiovascular outcomes trial, patients aged 75 years and older reported more fractures of the hip and pelvis on wegovy than on placebo. patients aged 75 years and older (wegovy-treated and placebo-treated) reported more serious adverse reactions overall compared to younger adult patients [see adverse reactions (6.1)]. no dose adjustment of wegovy is recommended for patients with renal impairment. in a study in patients with renal impairment, including end-stage renal disease, no clinically relevant change in semaglutide pharmacokinetics was observed [see clinical pharmacology (12.3 )] . no dose adjustment of wegovy is recommended for patients with hepatic impairment. in a study in patients with different degrees of hepatic impairment, no clinically relevant change in semaglutide pharmacokinetics was observed [see clinical pharmacology (12.3 )] . instructions for use wegovy® (semaglutide) injection wegovy comes in five strengths: before you use your wegovy pen for the first time, talk to your healthcare provider or your caregiver about how to prepare and inject wegovy correctly. important information read this instructions for use before you start using wegovy. this information does not replace talking to your healthcare provider about your medical condition or treatment. · your wegovy pen is for 1 time use only . the wegovy pen is for subcutaneous (under the skin) use only. · the dose of wegovy is already set on your pen. · the needle is covered by the needle cover and the needle will not be seen. · do not remove the pen cap until you are ready to inject. · do not touch or push on the needle cover. you could get a needle stick injury. · your wegovy injection will start when the needle cover is pressed firmly against your skin. · do not remove the pen from your skin before the yellow bar in the pen window has stopped moving. the medicine may appear on the skin or squirt from the needle and you may not get your full dose of wegovy if: · if the yellow bar does not start moving or stops during the injection, contact your healthcare provider or novo nordisk at startwegovy.com or call novo nordisk inc. at 1-833-934-6891. · the needle cover will lock when the pen is removed from your skin. you cannot stop the injection and restart it later. · people who are blind or have vision problems should not use the wegovy pen without help from a person trained to use the wegovy pen. how do i store wegovy? · store the wegovy pen in the refrigerator between 36°f to 46°f (2°c to 8°c). · if needed, before removing the pen cap, wegovy can be stored from 46°f to 86°f (8°c to 30°c) in the original carton for up to 28 days. · keep wegovy in the original carton to protect it from light. · do not freeze . · throw away the pen if wegovy has been frozen, has been exposed to light or temperatures above 86°f (30°c), or has been out of the refrigerator for 28 days or longer. keep wegovy and all medicines out of the reach of children. how to use your wegovy pen do not use your wegovy pen without receiving training from your healthcare provider. make sure that you or your caregiver know how to give an injection with the pen before you start your treatment. read and follow the instructions so that you use your wegovy pen correctly: preparation step 1. prepare for your injection. contact novo nordisk at 1-833-934-6891 if your wegovy pen fails any of these checks. step 2. choose your injection site. • your healthcare provider can help you choose the injection site that is best for you • do not inject into an area where the skin is tender, bruised, red, or hard. avoid injecting into areas with scars or stretch marks. • you may inject in the same body area each week, but make sure it is not in the same spot each time. clean the injection site with an alcohol swab or soap and water. do not touch the injection site after cleaning. allow the skin to dry before injecting. injection step 3. remove pen cap. • pull the pen cap straight off your pen. step 4. inject wegovy. • push the pen firmly against your skin and keep applying pressure until the yellow bar has stopped moving. if the yellow bar does not start moving, press the pen more firmly against your skin. throw away pen step 5. throw away (dispose of) pen. safely dispose of the wegovy pen right away after each use. see “how do i throw away (dispose of) wegovy pens?” • what if blood appears after injection? if blood appears at the injection site, press the site lightly with a gauze pad or cotton ball. how do i throw away (dispose of) wegovy pens? put the used wegovy pen in an fda-cleared sharps disposal container right away after use. do not throw away (dispose of) the pen in your household trash. if you do not have an fda-cleared sharps disposal container, you may use a household container that is: when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific sharps disposal in the state that you live in, go to the fda’s website at http://www.fda.gov/safesharpsdisposal. important: keep your wegovy pen, sharps disposal container and all medicines out of the reach of children. how do i care for my pen? protect your pen manufactured by: novo nordisk a/s novo allé dk-2880 bagsvaerd, denmark for information about wegovy, go to startwegovy.com or contact: novo nordisk inc. 800 scudders mill road plainsboro, nj 08536 1-833-wegovy-1 version: 2 wegovy ® is a registered trademark of novo nordisk a/s. patent information: http://novonordisk-us.com/products/product-patents.html © 2022 novo nordisk this instructions for use has been approved by the u.s. food and drug administration. revised: august 2022

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

a-s medication solutions - semaglutide (unii: 53axn4nnhx) (semaglutide - unii:53axn4nnhx) - ozempic is indicated: limitations of use ozempic is contraindicated in patients with: risk summary there are limited data with semaglutide use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. there are clinical considerations regarding the risks of poorly controlled diabetes in pregnancy (see clinical considerations) . based on animal reproduction studies, there may be potential risks to the fetus from exposure to semaglutide during pregnancy. ozempic should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. in pregnant rats administered semaglutide during organogenesis, embryofetal mortality, structural abnormalities and alterations to growth occurred at maternal exposures below the maximum recommended human dose (mrhd) based on auc. in rabbits and cynomolgus monkeys administered semaglutide during organogenesis, early pregnancy losses and structural abnormalities were observed at below the mrhd (rabbit) and ≥5-fold the mrhd

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

a-s medication solutions - semaglutide (unii: 53axn4nnhx) (semaglutide - unii:53axn4nnhx) - ozempic is indicated: limitations of use ozempic is contraindicated in patients with: risk summary there are limited data with semaglutide use in pregnant women to inform a drug-associated risk for adverse developmental outcomes. there are clinical considerations regarding the risks of poorly controlled diabetes in pregnancy (see clinical considerations) . based on animal reproduction studies, there may be potential risks to the fetus from exposure to semaglutide during pregnancy. ozempic should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. in pregnant rats administered semaglutide during organogenesis, embryofetal mortality, structural abnormalities and alterations to growth occurred at maternal exposures below the maximum recommended human dose (mrhd) based on auc. in rabbits and cynomolgus monkeys administered semaglutide during organogenesis, early pregnancy losses and structural abnormalities were observed at below the mrhd (rabbit) and ≥5-fold the mrhd

Israel - English - Ministry of Health

novo nordisk ltd., israel - semaglutide - solution for injection - semaglutide 1.34 mg / 1 ml - semaglutide - ozempic is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise• as monotherapy when metformin is considered inappropriate due to intolerance or contraindications• in addition to other medicinal products for the treatment of diabetes.

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

remedyrepack inc. - semaglutide (unii: 53axn4nnhx) (semaglutide - unii:53axn4nnhx) - ozempic is indicated: - as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus [see clinical studies ( 14.1)] . - 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 [see clinical studies ( 14.4 ) ]. limitations of use - ozempic has not been studied in patients with a history of pancreatitis. consider other antidiabetic therapies in patients with a history of pancreatitis [see warnings and precautions ( 5.2)] . - ozempic is not indicated for use in patients with type 1 diabetes mellitus. ozempic 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)

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

novo nordisk pharma (malaysia) sdn. bhd. - semaglutide -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

novo nordisk pharma (malaysia) sdn. bhd. - semaglutide -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

novo nordisk pharma (malaysia) sdn. bhd. - semaglutide -

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

a-s medication solutions - semaglutide (unii: 53axn4nnhx) (semaglutide - unii:53axn4nnhx) - wegovy is indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in: limitation of use wegovy is contraindicated in the following conditions: pregnancy exposure registry there will be a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to semaglutide during pregnancy. pregnant women exposed to wegovy and healthcare providers are encouraged to contact novo nordisk at 1-800-727-6500. risk summary based on animal reproduction studies, there may be potential risks to the fetus from exposure to semaglutide during pregnancy. additionally, weight loss offers no benefit to a pregnant patient and may cause fetal harm. when a pregnancy is recognized, advise the pregnant patient of the risk to a fetus, and discontinue wegovy (see clinical considerations) . available pharmacovigilance data and data from clinical trials with wegovy use in pregnant patients are insufficient to establish a drug-associated risk of major birth defects, misca