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

eli lilly and company - dulaglutide (unii: wtt295hsy5) (dulaglutide - unii:wtt295hsy5) - dulaglutide 0.75 mg in 0.5 ml - trulicity® is indicated: - as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. - 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 who have established cardiovascular disease or multiple cardiovascular risk factors. limitations of use trulicity: - has not been studied in patients with a history of pancreatitis [see warnings and precautions (5.2)] . consider other antidiabetic therapies in patients with a history of pancreatitis. - should not be used in patients with type 1 diabetes mellitus. - has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis and is therefore not recommended in these patients [see warnings and precautions (5.6)] . trulicity is contraindicated in patients with: - personal or family history of medullary thyroid carcino

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

eli lilly australia pty ltd - dulaglutide -

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

eli lilly australia pty ltd - dulaglutide, quantity: 1.5 mg - injection, solution - excipient ingredients: citric acid; water for injections; mannitol; polysorbate 80; sodium citrate dihydrate - type 2 diabetes mellitus: glycaemic control - trulicity is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus: ? as monotherapy. ? in combination with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see section 5.1 for data with respect to different combinations).,type 2 diabetes mellitus: reduction in risk of major adverse cardiovascular events - trulicity is indicated as an adjunct to standard of care therapy to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus who have: ? established cardiovascular disease or ? multiple cardiovascular risk factors

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

a-s medication solutions - dulaglutide (unii: wtt295hsy5) (dulaglutide - unii:wtt295hsy5) - trulicity® is indicated: - as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. - 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 who have established cardiovascular disease or multiple cardiovascular risk factors. limitations of use trulicity: - has not been studied in patients with a history of pancreatitis [see warnings and precautions (5.2)] . consider other antidiabetic therapies in patients with a history of pancreatitis. - should not be used in patients with type 1 diabetes mellitus. - has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis and is therefore not recommended in these patients [see warnings and precautions (5.6)] . trulicity is contraindicated in patients with: - personal or family history of medullary thyroid carcinoma (mtc) or in patients with multiple endocrine neoplasia syndrome type 2 (men 2) [see warnings and precautions (5.1)] . - serious hypersensitivity reaction to dulaglutide or to any of the product components. serious hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with trulicity [see warnings and precautions (5.4)] . risk summary limited data with trulicity in pregnant women are not sufficient to determine 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]. based on animal reproduction studies, there may be risks to the fetus from exposure to dulaglutide during pregnancy. trulicity should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. in pregnant rats administered dulaglutide during organogenesis, early embryonic deaths, fetal growth reductions, and fetal abnormalities occurred at systemic exposures at least 6-times human exposure at the maximum recommended human dose (mrhd) of 4.5 mg/week. in pregnant rabbits administered dulaglutide during organogenesis, major fetal abnormalities occurred at 5-times human exposure at the mrhd. adverse embryo/fetal effects in animals occurred in association with decreased maternal weight and food consumption attributed to the pharmacology of dulaglutide [see data] . the estimated background risk of major birth defects is 6–10% in women with pre-gestational diabetes with an hba1c >7% and has been reported to be as high as 20–25% in women with an hba1c >10%. the estimated background risk of 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. clinical considerations disease-associated maternal and/or embryo/fetal risk poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery and delivery complications. poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia-related morbidity. data animal data pregnant rats given subcutaneous doses of 0.49, 1.63, or 4.89 mg/kg dulaglutide every 3 days during organogenesis had systemic exposures 2-, 6-, and 18-times human exposure at the maximum recommended human dose (mrhd) of 4.5 mg/week, respectively, based on plasma area under the time-concentration curve (auc) comparison. reduced fetal weights associated with decreased maternal food intake and decreased weight gain attributed to the pharmacology of dulaglutide were observed at ≥1.63 mg/kg. irregular skeletal ossifications and increases in post-implantation loss also were observed at 4.89 mg/kg. in pregnant rabbits given subcutaneous doses of 0.04, 0.12, or 0.41 mg/kg dulaglutide every 3 days during organogenesis, systemic exposures in pregnant rabbits were 0.5-, 2-, and 5-times human exposure at the mrhd, based on plasma auc comparison. fetal visceral malformation of lung lobular agenesis and skeletal malformations of the vertebrae and/or ribs were observed in conjunction with decreased maternal food intake and decreased weight gain attributed to the pharmacology of dulaglutide at 0.41 mg/kg. in a prenatal-postnatal study in f0 maternal rats given subcutaneous doses of 0.2, 0.49, or 1.63 mg/kg every third day from implantation through lactation, systemic exposures in pregnant rats were 1-, 2-, and 7-times human exposure at the mrhd, based on plasma auc comparison. f1 pups from f0 maternal rats given 1.63 mg/kg dulaglutide had statistically significantly lower mean body weight from birth through postnatal day 63 for males and postnatal day 84 for females. f1 offspring from f0 maternal rats receiving 1.63 mg/kg dulaglutide had decreased forelimb and hindlimb grip strength and males had delayed balano-preputial separation. females had decreased startle response. these physical findings may relate to the decreased size of the offspring relative to controls as they appeared at early postnatal assessments but were not observed at a later assessment. f1 female offspring of the f0 maternal rats given 1.63 mg/kg of dulaglutide had a longer mean escape time and a higher mean number of errors relative to concurrent control during 1 of 2 trials in the memory evaluation portion of the biel water maze. these findings occurred in conjunction with decreased f0 maternal food intake and decreased weight gain attributed to the pharmacologic activity at 1.63 mg/kg. the human relevance of these memory deficits in the f1 female rats is not known. risk summary there are no data on the presence of dulaglutide in human milk, the effects on the breastfed infant, or the effects on milk production. the presence of dulaglutide in milk of treated lactating animals was not determined. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for trulicity and any potential adverse effects on the breastfed infant from trulicity or from the underlying maternal condition. the safety and effectiveness of trulicity as an adjunct to diet and exercise to improve glycemic control in pediatric patients 10 years of age and older with type 2 diabetes mellitus have been established. use of trulicity for this indication is supported by a 26-week, multicenter, randomized, double-blind, parallel arm, placebo-controlled trial in 154 pediatric patients 10 years of age and older with type 2 diabetes mellitus [see clinical studies (14.6)] . trulicity-treated pediatric patients reported a higher incidence of injection site-related reactions compared to trulicity-treated adults [see adverse reactions (6.1)] . the safety and effectiveness of trulicity have not been established in pediatric patients less than 10 years of age. in the adult glycemic control trials [see clinical studies (14.2, 14.3)] , 620 (19%) of trulicity-treated patients were 65 years of age or older and 65 (2%) of trulicity-treated patients were 75 years of age or older at baseline. in the trulicity 1.5 mg treatment arm of the rewind trial (cardiovascular outcomes trial in adults with type 2 diabetes mellitus and cardiovascular disease or multiple cardiovascular risk factors) [see clinical studies (14.5)] , 2,619 (53%) patients were 65 years of age or older, and 484 (10%) patients were 75 years of age or older at baseline. no overall differences in safety or effectiveness for trulicity have been observed between patients 65 years of age and older and younger adult patients. trulicity has been studied in patients with varying degrees of renal function, including a dedicated clinical trial in patients with moderate to severe chronic kidney disease. no overall differences in safety or effectiveness were observed in these studies according to renal function [see clinical studies (14.2, 14.3, 14.4)] . in a clinical pharmacology study in patients with renal impairment, including end-stage renal disease (esrd), no clinically relevant change in dulaglutide pharmacokinetics (pk) was observed. in the 52-week trial in patients with type 2 diabetes and moderate to severe renal impairment, the pk behavior of trulicity 0.75 mg and 1.5 mg once weekly was similar to that demonstrated in previous clinical studies [see clinical pharmacology (12.3)] . no dose adjustment is recommended in patients with renal impairment including end-stage renal disease (esrd). monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions. use trulicity with caution in patients with esrd [see warning and precautions (5.5), clinical pharmacology (12.3)] . in a clinical pharmacology study in patients with varying degrees of hepatic impairment, no clinically relevant change in dulaglutide pk was observed [see clinical pharmacology (12.3)] . however, there is limited clinical experience in patients with mild, moderate, or severe hepatic impairment; therefore, use trulicity with caution in these patient populations. dulaglutide slows gastric emptying. trulicity has not been studied in patients with preexisting gastroparesis. use trulicity with caution in patients with gastroparesis. - trulicity single-dose pen (pen) is a disposable, prefilled medicine delivery device. each pen contains 1 dose of trulicity (0.75 mg/0.5 ml). each pen should only be used 1 time. - trulicity is used 1 time each week. make sure the pen is locked . - pull the base cap straight off and throw it away in your household trash. do not put the base cap back on — this could damage the needle. do not touch the needle. - place the clear base flat and firmly against your skin at the injection site. unlock by turning the lock ring. unlock by turning the lock ring. - press and hold the green injection button. you will hear a loud click. continue holding the clear base firmly against your skin until you hear a second click. this happens when the needle starts retracting in about 5-10 seconds. continue holding the clear base firmly against your skin until you hear a second click. this happens when the needle starts retracting in about 5-10 seconds. - remove the pen from your skin. - put your used pens in a fda-cleared sharps disposal container right away after use. do not throw away (dispose of) pens in your household trash. - if you do not have a fda-cleared sharps disposal container, you may use a household container that is: - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. - 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 information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal. - do not recycle your used sharps disposal container. - store your pen in the refrigerator between 36°f to 46°f (2°c to 8°c). - you may store your pen at room temperature below 86°f (30°c) for up to a total of 14 days. - do not freeze your pen. if the pen has been frozen, throw the pen away and use a new pen. - storage of your pen in the original carton is recommended. protect your pen from direct heat and light. - the pen has glass parts. handle it carefully. if you drop it on a hard surface, do not use it. use a new pen for your injection. - keep your trulicity pen and all medicines out of the reach of children. - if you have vision problems, do not use your pen without help from a person trained to use the trulicity pen. - if you have any questions or problems with your trulicity single-dose pen, contact lilly at 1-800-lilly-rx (1-800-545-5979) or call your healthcare provider. - for more information about trulicity single-dose pen, visit our website at: www.trulicity.com. - trulicity single-dose pen (pen) is a disposable, prefilled medicine delivery device. each pen contains 1 dose of trulicity (1.5 mg/0.5 ml). each pen should only be used 1 time. - trulicity is used 1 time each week. make sure the pen is locked . - pull the base cap straight off and throw it away in your household trash. do not put the base cap back on — this could damage the needle. do not touch the needle. - place the clear base flat and firmly against your skin at the injection site. unlock by turning the lock ring. unlock by turning the lock ring. - press and hold the green injection button. you will hear a loud click. continue holding the clear base firmly against your skin until you hear a second click. this happens when the needle starts retracting in about 5-10 seconds. continue holding the clear base firmly against your skin until you hear a second click. this happens when the needle starts retracting in about 5-10 seconds. - remove the pen from your skin. - put your used pens in a fda-cleared sharps disposal container right away after use. do not throw away (dispose of) pens in your household trash. - if you do not have a fda-cleared sharps disposal container, you may use a household container that is: - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. - 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 information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal. - do not recycle your used sharps disposal container. - store your pen in the refrigerator between 36°f to 46°f (2°c to 8°c). - you may store your pen at room temperature below 86°f (30°c) for up to a total of 14 days. - do not freeze your pen. if the pen has been frozen, throw the pen away and use a new pen. - storage of your pen in the original carton is recommended. protect your pen from direct heat and light. - the pen has glass parts. handle it carefully. if you drop it on a hard surface, do not use it. use a new pen for your injection. - keep your trulicity pen and all medicines out of the reach of children. - if you have vision problems, do not use your pen without help from a person trained to use the trulicity pen. - if you have any questions or problems with your trulicity single-dose pen, contact lilly at 1-800-lilly-rx (1-800-545-5979) or call your healthcare provider. - for more information about trulicity single-dose pen, visit our website at: www.trulicity.com. information about trulicity single-dose pen please read this instructions for use and the medication guide carefully and completely before using your trulicity single-dose pen. talk to your healthcare provider about how to inject trulicity the right way. - trulicity single-dose pen (pen) is a disposable, prefilled medicine delivery device. each pen contains 1 dose of trulicity (3 mg/0.5 ml). each pen should only be used 1 time. - trulicity is used 1 time each week. you may want to mark your calendar to remind you when to take your next dose. before you get started choose your injection site your healthcare provider can help you choose the injection site that is best for you. step 1 uncap the pen make sure the pen is locked . - pull the base cap straight off and throw it away in your household trash. do not put the base cap back on — this could damage the needle. do not touch the needle. - place the clear base flat and firmly against your skin at the injection site. unlock by turning the lock ring. - press and hold the green injection button. you will hear a loud click. continue holding the clear base firmly against your skin until you hear a second click. this happens when the needle starts retracting in about 5-10 seconds. press and hold the green injection button. you will hear a loud click. continue holding the clear base firmly against your skin until you hear a second click. this happens when the needle starts retracting in about 5-10 seconds. - remove the pen from your skin. important information disposal of pen storage and handling commonly asked questions other information where to learn more - put your used pens in a fda-cleared sharps disposal container right away after use. do not throw away (dispose of) pens in your household trash. - if you do not have a fda-cleared sharps disposal container, you may use a household container that is: - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. - 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 information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal. - do not recycle your used sharps disposal container. storage and handling - store your pen in the refrigerator between 36°f to 46°f (2°c to 8°c). - you may store your pen at room temperature below 86°f (30°c) for a total of 14 days. - do not freeze your pen. if the pen has been frozen, throw the pen away and use a new pen. - storage of your pen in the original carton is recommended. protect your pen from direct heat and light. - the pen has glass parts. handle it carefully. if you drop it on a hard surface, do not use it. use a new pen for your injection. - keep your trulicity pen and all medicines out of the reach of children. commonly asked questions what if i see air bubbles in my pen? air bubbles are normal. what if i unlock the pen and press the green injection button before pulling off the base cap? do not remove the base cap. throw away the pen and get a new pen. what if there is a drop of liquid on the tip of the needle when i remove the base cap? a drop of liquid on the tip of the needle is normal. do i need to hold the injection button down until the injection is complete? this is not necessary, but it may help you keep the pen steady and firm against your skin. i heard more than 2 clicks during my injection—2 louder clicks and 1 soft one. did i get my complete injection? some people may hear a soft click right before the second loud click. that is the normal operation of the pen. do not remove the pen from your skin until you hear the second louder click. what if there is a drop of liquid or blood on my skin after my injection? this is normal. i am not sure if my pen worked the right way. check to see if you have received your dose. your dose was delivered the right way if the gray plunger is visible (see step 3) . also contact lilly at 1-800-lilly-rx (1-800-545-5979) for further instructions. until then, store your pen safely to avoid an accidental needle stick. other information - if you have vision problems, do not use your pen without help from a person trained to use the trulicity pen. where to learn more - if you have any questions or problems with your trulicity single-dose pen, contact lilly at 1-800-lilly-rx (1-800-545-5979) or call your healthcare provider. - for more information about trulicity single-dose pen, visit our website at: www.trulicity.com. this instructions for use has been approved by the u.s. food and drug administration. eli lilly and company indianapolis, in 46285, usa us license number 1891 trulicity is a registered trademark of eli lilly and company. copyright © 2020, 2023, eli lilly and company. all rights reserved. the trulicity pen meets the current dose accuracy and functional requirements of iso 11608-1:2012 and 11608-5:2012. implemented: 04/2023 tru3mg-0002-ifu-20230407 information about trulicity single-dose pen please read this instructions for use and the medication guide carefully and completely before using your trulicity single-dose pen. talk to your healthcare provider about how to inject trulicity the right way. - trulicity single-dose pen (pen) is a disposable, prefilled medicine delivery device. each pen contains 1 dose of trulicity (4.5 mg/0.5 ml). each pen should only be used 1 time. - trulicity is used 1 time each week. you may want to mark your calendar to remind you when to take your next dose. before you get started choose your injection site your healthcare provider can help you choose the injection site that is best for you. step 1 uncap the pen make sure the pen is locked . - pull the base cap straight off and throw it away in your household trash. do not put the base cap back on — this could damage the needle. do not touch the needle. - place the clear base flat and firmly against your skin at the injection site . place the clear base flat and firmly against your skin at the injection site . unlock by turning the lock ring. - press and hold the green injection button. you will hear a loud click. continue holding the clear base firmly against your skin until you hear a second click. this happens when the needle starts retracting in about 5-10 seconds. press and hold the green injection button. you will hear a loud click. continue holding the clear base firmly against your skin until you hear a second click. this happens when the needle starts retracting in about 5-10 seconds. - remove the pen from your skin. important information disposal of pen storage and handling commonly asked questions other information where to learn more - put your used pens in a fda-cleared sharps disposal container right away after use. do not throw away (dispose of) pens in your household trash. - if you do not have a fda-cleared sharps disposal container, you may use a household container that is: - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. - 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 information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal. - do not recycle your used sharps disposal container. storage and handling - store your pen in the refrigerator between 36°f to 46°f (2°c to 8°c). - you may store your pen at room temperature below 86°f (30°c) for a total of 14 days. - do not freeze your pen. if the pen has been frozen, throw the pen away and use a new pen. - storage of your pen in the original carton is recommended. protect your pen from direct heat and light. - the pen has glass parts. handle it carefully. if you drop it on a hard surface, do not use it. use a new pen for your injection. - keep your trulicity pen and all medicines out of the reach of children. commonly asked questions what if i see air bubbles in my pen? air bubbles are normal. what if i unlock the pen and press the green injection button before pulling off the base cap? do not remove the base cap. throw away the pen and get a new pen. what if there is a drop of liquid on the tip of the needle when i remove the base cap? a drop of liquid on the tip of the needle is normal. do i need to hold the injection button down until the injection is complete? this is not necessary, but it may help you keep the pen steady and firm against your skin. i heard more than 2 clicks during my injection—2 louder clicks and 1 soft one. did i get my complete injection? some people may hear a soft click right before the second loud click. that is the normal operation of the pen. do not remove the pen from your skin until you hear the second louder click. what if there is a drop of liquid or blood on my skin after my injection? this is normal. i am not sure if my pen worked the right way. check to see if you have received your dose. your dose was delivered the right way if the gray plunger is visible (see step 3) . also contact lilly at 1-800-lilly-rx (1-800-545-5979) for further instructions. until then, store your pen safely to avoid an accidental needle stick. other information - if you have vision problems, do not use your pen without help from a person trained to use the trulicity pen. where to learn more - if you have any questions or problems with your trulicity single-dose pen, contact lilly at 1-800-lilly-rx (1-800-545-5979) or call your healthcare provider. - for more information about trulicity single-dose pen, visit our website at: www.trulicity.com. this instructions for use has been approved by the u.s. food and drug administration. eli lilly and company indianapolis, in 46285, usa us license number 1891 trulicity is a registered trademark of eli lilly and company. copyright © 2020, 2023, eli lilly and company. all rights reserved. the trulicity pen meets the current dose accuracy and functional requirements of iso 11608-1:2012 and 11608-5:2012. implemented: 04/2023 tru4.5mg-0002-ifu-20230407

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

a-s medication solutions - dulaglutide (unii: wtt295hsy5) (dulaglutide - unii:wtt295hsy5) - trulicity® is indicated: - as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. - 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 who have established cardiovascular disease or multiple cardiovascular risk factors. limitations of use trulicity: - has not been studied in patients with a history of pancreatitis [see warnings and precautions (5.2)] . consider other antidiabetic therapies in patients with a history of pancreatitis. - should not be used in patients with type 1 diabetes mellitus. - has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis and is therefore not recommended in these patients [see warnings and precautions (5.6)] . trulicity is contraindicated in patients with: - personal or family history of medullary thyroid carcinoma (mtc) or in patients with multiple endocrine neoplasia syndrome type 2 (men 2) [see warnings and precautions (5.1)] . - serious hypersensitivity reaction to dulaglutide or to any of the product components. serious hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with trulicity [see warnings and precautions (5.4)] . risk summary limited data with trulicity in pregnant women are not sufficient to determine 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]. based on animal reproduction studies, there may be risks to the fetus from exposure to dulaglutide during pregnancy. trulicity should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. in pregnant rats administered dulaglutide during organogenesis, early embryonic deaths, fetal growth reductions, and fetal abnormalities occurred at systemic exposures at least 6-times human exposure at the maximum recommended human dose (mrhd) of 4.5 mg/week. in pregnant rabbits administered dulaglutide during organogenesis, major fetal abnormalities occurred at 5-times human exposure at the mrhd. adverse embryo/fetal effects in animals occurred in association with decreased maternal weight and food consumption attributed to the pharmacology of dulaglutide [see data] . the estimated background risk of major birth defects is 6–10% in women with pre-gestational diabetes with an hba1c >7% and has been reported to be as high as 20–25% in women with an hba1c >10%. the estimated background risk of 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. clinical considerations disease-associated maternal and/or embryo/fetal risk poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery and delivery complications. poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia-related morbidity. data animal data pregnant rats given subcutaneous doses of 0.49, 1.63, or 4.89 mg/kg dulaglutide every 3 days during organogenesis had systemic exposures 2-, 6-, and 18-times human exposure at the maximum recommended human dose (mrhd) of 4.5 mg/week, respectively, based on plasma area under the time-concentration curve (auc) comparison. reduced fetal weights associated with decreased maternal food intake and decreased weight gain attributed to the pharmacology of dulaglutide were observed at ≥1.63 mg/kg. irregular skeletal ossifications and increases in post-implantation loss also were observed at 4.89 mg/kg. in pregnant rabbits given subcutaneous doses of 0.04, 0.12, or 0.41 mg/kg dulaglutide every 3 days during organogenesis, systemic exposures in pregnant rabbits were 0.5-, 2-, and 5-times human exposure at the mrhd, based on plasma auc comparison. fetal visceral malformation of lung lobular agenesis and skeletal malformations of the vertebrae and/or ribs were observed in conjunction with decreased maternal food intake and decreased weight gain attributed to the pharmacology of dulaglutide at 0.41 mg/kg. in a prenatal-postnatal study in f0 maternal rats given subcutaneous doses of 0.2, 0.49, or 1.63 mg/kg every third day from implantation through lactation, systemic exposures in pregnant rats were 1-, 2-, and 7-times human exposure at the mrhd, based on plasma auc comparison. f1 pups from f0 maternal rats given 1.63 mg/kg dulaglutide had statistically significantly lower mean body weight from birth through postnatal day 63 for males and postnatal day 84 for females. f1 offspring from f0 maternal rats receiving 1.63 mg/kg dulaglutide had decreased forelimb and hindlimb grip strength and males had delayed balano-preputial separation. females had decreased startle response. these physical findings may relate to the decreased size of the offspring relative to controls as they appeared at early postnatal assessments but were not observed at a later assessment. f1 female offspring of the f0 maternal rats given 1.63 mg/kg of dulaglutide had a longer mean escape time and a higher mean number of errors relative to concurrent control during 1 of 2 trials in the memory evaluation portion of the biel water maze. these findings occurred in conjunction with decreased f0 maternal food intake and decreased weight gain attributed to the pharmacologic activity at 1.63 mg/kg. the human relevance of these memory deficits in the f1 female rats is not known. risk summary there are no data on the presence of dulaglutide in human milk, the effects on the breastfed infant, or the effects on milk production. the presence of dulaglutide in milk of treated lactating animals was not determined. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for trulicity and any potential adverse effects on the breastfed infant from trulicity or from the underlying maternal condition. the safety and effectiveness of trulicity as an adjunct to diet and exercise to improve glycemic control in pediatric patients 10 years of age and older with type 2 diabetes mellitus have been established. use of trulicity for this indication is supported by a 26-week, multicenter, randomized, double-blind, parallel arm, placebo-controlled trial in 154 pediatric patients 10 years of age and older with type 2 diabetes mellitus [see clinical studies (14.6)] . trulicity-treated pediatric patients reported a higher incidence of injection site-related reactions compared to trulicity-treated adults [see adverse reactions (6.1)] . the safety and effectiveness of trulicity have not been established in pediatric patients less than 10 years of age. in the adult glycemic control trials [see clinical studies (14.2, 14.3)] , 620 (19%) of trulicity-treated patients were 65 years of age or older and 65 (2%) of trulicity-treated patients were 75 years of age or older at baseline. in the trulicity 1.5 mg treatment arm of the rewind trial (cardiovascular outcomes trial in adults with type 2 diabetes mellitus and cardiovascular disease or multiple cardiovascular risk factors) [see clinical studies (14.5)] , 2,619 (53%) patients were 65 years of age or older, and 484 (10%) patients were 75 years of age or older at baseline. no overall differences in safety or effectiveness for trulicity have been observed between patients 65 years of age and older and younger adult patients. trulicity has been studied in patients with varying degrees of renal function, including a dedicated clinical trial in patients with moderate to severe chronic kidney disease. no overall differences in safety or effectiveness were observed in these studies according to renal function [see clinical studies (14.2, 14.3, 14.4)] . in a clinical pharmacology study in patients with renal impairment, including end-stage renal disease (esrd), no clinically relevant change in dulaglutide pharmacokinetics (pk) was observed. in the 52-week trial in patients with type 2 diabetes and moderate to severe renal impairment, the pk behavior of trulicity 0.75 mg and 1.5 mg once weekly was similar to that demonstrated in previous clinical studies [see clinical pharmacology (12.3)] . no dose adjustment is recommended in patients with renal impairment including end-stage renal disease (esrd). monitor renal function in patients with renal impairment reporting severe adverse gastrointestinal reactions. use trulicity with caution in patients with esrd [see warning and precautions (5.5), clinical pharmacology (12.3)] . in a clinical pharmacology study in patients with varying degrees of hepatic impairment, no clinically relevant change in dulaglutide pk was observed [see clinical pharmacology (12.3)] . however, there is limited clinical experience in patients with mild, moderate, or severe hepatic impairment; therefore, use trulicity with caution in these patient populations. dulaglutide slows gastric emptying. trulicity has not been studied in patients with preexisting gastroparesis. use trulicity with caution in patients with gastroparesis. - trulicity single-dose pen (pen) is a disposable, prefilled medicine delivery device. each pen contains 1 dose of trulicity (0.75 mg/0.5 ml). each pen should only be used 1 time. - trulicity is used 1 time each week. make sure the pen is locked . - pull the base cap straight off and throw it away in your household trash. do not put the base cap back on — this could damage the needle. do not touch the needle. - place the clear base flat and firmly against your skin at the injection site. unlock by turning the lock ring. unlock by turning the lock ring. - press and hold the green injection button. you will hear a loud click. continue holding the clear base firmly against your skin until you hear a second click. this happens when the needle starts retracting in about 5-10 seconds. continue holding the clear base firmly against your skin until you hear a second click. this happens when the needle starts retracting in about 5-10 seconds. - remove the pen from your skin. - put your used pens in a fda-cleared sharps disposal container right away after use. do not throw away (dispose of) pens in your household trash. - if you do not have a fda-cleared sharps disposal container, you may use a household container that is: - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. - 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 information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal. - do not recycle your used sharps disposal container. - store your pen in the refrigerator between 36°f to 46°f (2°c to 8°c). - you may store your pen at room temperature below 86°f (30°c) for up to a total of 14 days. - do not freeze your pen. if the pen has been frozen, throw the pen away and use a new pen. - storage of your pen in the original carton is recommended. protect your pen from direct heat and light. - the pen has glass parts. handle it carefully. if you drop it on a hard surface, do not use it. use a new pen for your injection. - keep your trulicity pen and all medicines out of the reach of children. - if you have vision problems, do not use your pen without help from a person trained to use the trulicity pen. - if you have any questions or problems with your trulicity single-dose pen, contact lilly at 1-800-lilly-rx (1-800-545-5979) or call your healthcare provider. - for more information about trulicity single-dose pen, visit our website at: www.trulicity.com. - trulicity single-dose pen (pen) is a disposable, prefilled medicine delivery device. each pen contains 1 dose of trulicity (1.5 mg/0.5 ml). each pen should only be used 1 time. - trulicity is used 1 time each week. make sure the pen is locked . - pull the base cap straight off and throw it away in your household trash. do not put the base cap back on — this could damage the needle. do not touch the needle. - place the clear base flat and firmly against your skin at the injection site. unlock by turning the lock ring. unlock by turning the lock ring. - press and hold the green injection button. you will hear a loud click. continue holding the clear base firmly against your skin until you hear a second click. this happens when the needle starts retracting in about 5-10 seconds. continue holding the clear base firmly against your skin until you hear a second click. this happens when the needle starts retracting in about 5-10 seconds. - remove the pen from your skin. - put your used pens in a fda-cleared sharps disposal container right away after use. do not throw away (dispose of) pens in your household trash. - if you do not have a fda-cleared sharps disposal container, you may use a household container that is: - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. - 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 information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal. - do not recycle your used sharps disposal container. - store your pen in the refrigerator between 36°f to 46°f (2°c to 8°c). - you may store your pen at room temperature below 86°f (30°c) for up to a total of 14 days. - do not freeze your pen. if the pen has been frozen, throw the pen away and use a new pen. - storage of your pen in the original carton is recommended. protect your pen from direct heat and light. - the pen has glass parts. handle it carefully. if you drop it on a hard surface, do not use it. use a new pen for your injection. - keep your trulicity pen and all medicines out of the reach of children. - if you have vision problems, do not use your pen without help from a person trained to use the trulicity pen. - if you have any questions or problems with your trulicity single-dose pen, contact lilly at 1-800-lilly-rx (1-800-545-5979) or call your healthcare provider. - for more information about trulicity single-dose pen, visit our website at: www.trulicity.com. information about trulicity single-dose pen please read this instructions for use and the medication guide carefully and completely before using your trulicity single-dose pen. talk to your healthcare provider about how to inject trulicity the right way. - trulicity single-dose pen (pen) is a disposable, prefilled medicine delivery device. each pen contains 1 dose of trulicity (3 mg/0.5 ml). each pen should only be used 1 time. - trulicity is used 1 time each week. you may want to mark your calendar to remind you when to take your next dose. before you get started choose your injection site your healthcare provider can help you choose the injection site that is best for you. step 1 uncap the pen make sure the pen is locked . - pull the base cap straight off and throw it away in your household trash. do not put the base cap back on — this could damage the needle. do not touch the needle. - place the clear base flat and firmly against your skin at the injection site. unlock by turning the lock ring. - press and hold the green injection button. you will hear a loud click. continue holding the clear base firmly against your skin until you hear a second click. this happens when the needle starts retracting in about 5-10 seconds. press and hold the green injection button. you will hear a loud click. continue holding the clear base firmly against your skin until you hear a second click. this happens when the needle starts retracting in about 5-10 seconds. - remove the pen from your skin. important information disposal of pen storage and handling commonly asked questions other information where to learn more - put your used pens in a fda-cleared sharps disposal container right away after use. do not throw away (dispose of) pens in your household trash. - if you do not have a fda-cleared sharps disposal container, you may use a household container that is: - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. - 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 information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal. - do not recycle your used sharps disposal container. storage and handling - store your pen in the refrigerator between 36°f to 46°f (2°c to 8°c). - you may store your pen at room temperature below 86°f (30°c) for a total of 14 days. - do not freeze your pen. if the pen has been frozen, throw the pen away and use a new pen. - storage of your pen in the original carton is recommended. protect your pen from direct heat and light. - the pen has glass parts. handle it carefully. if you drop it on a hard surface, do not use it. use a new pen for your injection. - keep your trulicity pen and all medicines out of the reach of children. commonly asked questions what if i see air bubbles in my pen? air bubbles are normal. what if i unlock the pen and press the green injection button before pulling off the base cap? do not remove the base cap. throw away the pen and get a new pen. what if there is a drop of liquid on the tip of the needle when i remove the base cap? a drop of liquid on the tip of the needle is normal. do i need to hold the injection button down until the injection is complete? this is not necessary, but it may help you keep the pen steady and firm against your skin. i heard more than 2 clicks during my injection—2 louder clicks and 1 soft one. did i get my complete injection? some people may hear a soft click right before the second loud click. that is the normal operation of the pen. do not remove the pen from your skin until you hear the second louder click. what if there is a drop of liquid or blood on my skin after my injection? this is normal. i am not sure if my pen worked the right way. check to see if you have received your dose. your dose was delivered the right way if the gray plunger is visible (see step 3) . also contact lilly at 1-800-lilly-rx (1-800-545-5979) for further instructions. until then, store your pen safely to avoid an accidental needle stick. other information - if you have vision problems, do not use your pen without help from a person trained to use the trulicity pen. where to learn more - if you have any questions or problems with your trulicity single-dose pen, contact lilly at 1-800-lilly-rx (1-800-545-5979) or call your healthcare provider. - for more information about trulicity single-dose pen, visit our website at: www.trulicity.com. this instructions for use has been approved by the u.s. food and drug administration. eli lilly and company indianapolis, in 46285, usa us license number 1891 trulicity is a registered trademark of eli lilly and company. copyright © 2020, 2023, eli lilly and company. all rights reserved. the trulicity pen meets the current dose accuracy and functional requirements of iso 11608-1:2012 and 11608-5:2012. implemented: 04/2023 tru3mg-0002-ifu-20230407 information about trulicity single-dose pen please read this instructions for use and the medication guide carefully and completely before using your trulicity single-dose pen. talk to your healthcare provider about how to inject trulicity the right way. - trulicity single-dose pen (pen) is a disposable, prefilled medicine delivery device. each pen contains 1 dose of trulicity (4.5 mg/0.5 ml). each pen should only be used 1 time. - trulicity is used 1 time each week. you may want to mark your calendar to remind you when to take your next dose. before you get started choose your injection site your healthcare provider can help you choose the injection site that is best for you. step 1 uncap the pen make sure the pen is locked . - pull the base cap straight off and throw it away in your household trash. do not put the base cap back on — this could damage the needle. do not touch the needle. - place the clear base flat and firmly against your skin at the injection site . place the clear base flat and firmly against your skin at the injection site . unlock by turning the lock ring. - press and hold the green injection button. you will hear a loud click. continue holding the clear base firmly against your skin until you hear a second click. this happens when the needle starts retracting in about 5-10 seconds. press and hold the green injection button. you will hear a loud click. continue holding the clear base firmly against your skin until you hear a second click. this happens when the needle starts retracting in about 5-10 seconds. - remove the pen from your skin. important information disposal of pen storage and handling commonly asked questions other information where to learn more - put your used pens in a fda-cleared sharps disposal container right away after use. do not throw away (dispose of) pens in your household trash. - if you do not have a fda-cleared sharps disposal container, you may use a household container that is: - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. - 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 information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal. - do not recycle your used sharps disposal container. storage and handling - store your pen in the refrigerator between 36°f to 46°f (2°c to 8°c). - you may store your pen at room temperature below 86°f (30°c) for a total of 14 days. - do not freeze your pen. if the pen has been frozen, throw the pen away and use a new pen. - storage of your pen in the original carton is recommended. protect your pen from direct heat and light. - the pen has glass parts. handle it carefully. if you drop it on a hard surface, do not use it. use a new pen for your injection. - keep your trulicity pen and all medicines out of the reach of children. commonly asked questions what if i see air bubbles in my pen? air bubbles are normal. what if i unlock the pen and press the green injection button before pulling off the base cap? do not remove the base cap. throw away the pen and get a new pen. what if there is a drop of liquid on the tip of the needle when i remove the base cap? a drop of liquid on the tip of the needle is normal. do i need to hold the injection button down until the injection is complete? this is not necessary, but it may help you keep the pen steady and firm against your skin. i heard more than 2 clicks during my injection—2 louder clicks and 1 soft one. did i get my complete injection? some people may hear a soft click right before the second loud click. that is the normal operation of the pen. do not remove the pen from your skin until you hear the second louder click. what if there is a drop of liquid or blood on my skin after my injection? this is normal. i am not sure if my pen worked the right way. check to see if you have received your dose. your dose was delivered the right way if the gray plunger is visible (see step 3) . also contact lilly at 1-800-lilly-rx (1-800-545-5979) for further instructions. until then, store your pen safely to avoid an accidental needle stick. other information - if you have vision problems, do not use your pen without help from a person trained to use the trulicity pen. where to learn more - if you have any questions or problems with your trulicity single-dose pen, contact lilly at 1-800-lilly-rx (1-800-545-5979) or call your healthcare provider. - for more information about trulicity single-dose pen, visit our website at: www.trulicity.com. this instructions for use has been approved by the u.s. food and drug administration. eli lilly and company indianapolis, in 46285, usa us license number 1891 trulicity is a registered trademark of eli lilly and company. copyright © 2020, 2023, eli lilly and company. all rights reserved. the trulicity pen meets the current dose accuracy and functional requirements of iso 11608-1:2012 and 11608-5:2012. implemented: 04/2023 tru4.5mg-0002-ifu-20230407

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

a-s medication solutions - dulaglutide (unii: wtt295hsy5) (dulaglutide - unii:wtt295hsy5) - trulicity® is indicated: - as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. - 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 who have established cardiovascular disease or multiple cardiovascular risk factors. limitations of use trulicity: - has not been studied in patients with a history of pancreatitis [see warnings and precautions (5.2)] . consider other antidiabetic therapies in patients with a history of pancreatitis. - should not be used in patients with type 1 diabetes mellitus. - has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis and is therefore not recommended in these patients [see warnings and precautions (5.6)] . trulicity is contraindicated in patients with: - personal or family history of medullary thyroid carcino

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

a-s medication solutions - dulaglutide (unii: wtt295hsy5) (dulaglutide - unii:wtt295hsy5) - trulicity® is indicated: - as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. - 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 who have established cardiovascular disease or multiple cardiovascular risk factors. limitations of use trulicity: - has not been studied in patients with a history of pancreatitis [see warnings and precautions (5.2)] . consider other antidiabetic therapies in patients with a history of pancreatitis. - should not be used in patients with type 1 diabetes mellitus. - has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis and is therefore not recommended in these patients [see warnings and precautions (5.6)] . trulicity is contraindicated in patients with: - personal or family history of medullary thyroid carcino

Israel - English - Ministry of Health

eli lilly israel ltd, israel - dulaglutide - solution for injection - dulaglutide 0.75 mg / 0.5 ml - dulaglutide - type 2 diabetes mellitustrulicity 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.

Israel - English - Ministry of Health

eli lilly israel ltd, israel - dulaglutide - solution for injection - dulaglutide 1.5 mg / 0.5 ml - dulaglutide - type 2 diabetes mellitustrulicity 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.

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

eli lilly and company - dulaglutide - solution for injection - 0,75mg/0.5ml