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

eli lilly and company - insulin glargine (unii: 2zm8cx04rz) (insulin glargine - unii:2zm8cx04rz) - insulin glargine 100 [iu] in 1 ml - basaglar® is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. limitations of use basaglar is not recommended for the treatment of diabetic ketoacidosis. basaglar is contraindicated: - during episodes of hypoglycemia [see warnings and precautions (5.3)] . - in patients with hypersensitivity to insulin glargine or any of the excipients in basaglar [see warnings and precautions (5.5)] . risk summary published studies with use of insulin glargine products during pregnancy have not reported a clear association with insulin glargine products and adverse developmental outcomes (see data). there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations). in animal reproduction studies, another insulin glargine product was administered to rats before, during and throughout pregnancy at doses up to 7 times the clinical dose of 10 units/day and to rabbits during organogenesis at doses approximately 2 times the clinical dose of 10 units/day. the effects of this other insulin glargine product did not generally differ from those observed with regular human insulin in rats or rabbits (see data). the estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with a hba1c >7 and has been reported to be as high as 20-25% in women with a hba1c >10. the estimated background risk of miscarriage for the indicated population is unknown. in the us 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 human data published data do not report a clear association with insulin glargine products and major birth defects, miscarriage, or adverse maternal or fetal outcomes when insulin glargine products are used during pregnancy. however, these studies cannot definitely establish the absence of any risk because of methodological limitations including small sample size and some with no comparative group. animal data subcutaneous reproduction and teratology studies have been performed with another insulin glargine product and with regular human insulin in rats and himalayan rabbits. this other insulin glargine product was given to female rats before mating, during mating, and throughout pregnancy at dose up to 0.36 mg/kg/day, which is approximately 7 times the recommended human subcutaneous starting dose of 10 units/day (0.008 mg/kg/day) based on mg/m2 . in rabbits, doses of 0.072 mg/kg/day, which is approximately 2 times the recommended human subcutaneous starting dose of 10 units/day (0.008 mg/kg/day), based on mg/m2 , were administered during organogenesis. the effects of this other insulin glargine product did not generally differ from those observed with regular human insulin in rats and rabbits. however, in rabbits, five fetuses from two litters of the high-dose group exhibited dilation of the cerebral ventricles. fertility and early embryonic development appeared normal. risk summary there are no data on the presence of insulin glargine in human milk, the effects on the breastfed infant, or the effects on milk production. endogenous insulin is present in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for basaglar and any potential adverse effects on the breastfed child from basaglar or from the underlying maternal condition. the safety and effectiveness of basaglar have been established in pediatric patients (age 6 to 15 years) with type 1 diabetes based on an adequate and well-controlled trial of another insulin glargine product, 100 units/ml, in pediatric patients (age 6 to 15 years) with type 1 diabetes and additional data in adults with type 1 diabetes [see clinical studies (14.2)] . the safety and effectiveness of basaglar in pediatric patients younger than 6 years of age with type 1 diabetes and pediatric patients with type 2 diabetes has not been established. in the pediatric clinical trial, pediatric patients (age 6 to 15 years) with type 1 diabetes had a higher incidence of severe symptomatic hypoglycemia compared to the adults in trials with type 1 diabetes [see adverse reactions (6.1)] . of the total number of subjects in clinical studies of patients with type 2 diabetes who were treated with basaglar or another insulin glargine product, 100 units/ml, each in combination with oral agents in a controlled clinical trial environment, 28.3% were 65 and over, while 4.5% were 75 and over. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. nevertheless, caution should be exercised when basaglar is administered to geriatric patients. in elderly patients with diabetes, the initial dosing, dose increments, and maintenance dosage should be conservative to avoid hypoglycemic reactions. hypoglycemia may be difficult to recognize in the elderly. the effect of renal impairment on the pharmacokinetics of basaglar has not been studied. some studies with human insulin have shown increased circulating levels of insulin in patients with renal failure. frequent glucose monitoring and dose adjustment may be necessary for basaglar in patients with renal impairment [see warnings and precautions (5.3)] . the effect of hepatic impairment on the pharmacokinetics of basaglar has not been studied. however, as with all insulin products, more frequent glucose monitoring and dose adjustment may be necessary for basaglar in patients with hepatic impairment [see warnings and precautions (5.3)] . instructions for use basaglar® kwikpen® (insulin glargine) injection, for subcutaneous use 100 units/ml, 3 ml single-patient-use pen read the instructions for use before you start using basaglar and each time you get another basaglar® kwikpen® . there may be new information. this information does not take the place of talking to your healthcare provider about your medical condition or your treatment. do not share your basaglar kwikpen with other people, even if the needle has been changed. you may give other people a serious infection or get a serious infection from them. basaglar kwikpen (“pen”) is a disposable single-patient-use prefilled pen containing 300 units (3ml) of basaglar. one pen contains multiple doses of medicine. - your healthcare provider will tell you how many units to give as your dose and how to inject your prescribed dose of medicine. - you can give a dose of 1 to 80 units in a single injection. - if your prescribed dose is more than 80 units, you will need to give yourself more than 1 injection. - the plunger only moves a little with each injection, and you may not notice that it moves. when the plunger reaches the end of the cartridge, you have used all 300 units in the pen. people who are blind or have vision problems should not use the pen without help from a person trained to use the basaglar prefilled pen. how to recognize your basaglar kwikpen - pen color: light grey - dose knob: light grey with green ring on the end - labels: light grey with green color bars supplies needed to give your injection - basaglar kwikpen - kwikpen compatible needle (becton, dickinson and company pen needles recommended) - alcohol swab preparing your pen - wash your hands with soap and water. - check the pen to make sure you are taking the right type of insulin. this is especially important if you use more than 1 type of insulin. - do not use your pen past the expiration date printed on the label or for more than 28 days after you first start using the pen. - always use a new needle for each injection to help prevent infections and blocked needles. do not reuse or share your needles with other people. you may give other people a serious infection or get a serious infection from them. - pull the pen cap straight off. - do not remove the pen label. - wipe the rubber seal with an alcohol swab. - check the liquid in the pen. basaglar should look clear and colorless. do not use if it is cloudy, colored, or has particles or clumps in it. - select a new needle. - pull off the paper tab from the outer needle shield. - push the capped needle straight onto the pen and twist the needle on until it is tight. - pull off the outer needle shield. do not throw it away. - pull off the inner needle shield and throw it away. priming your pen prime before each injection. - priming means removing the air from the needle and cartridge that may collect during normal use. it is important to prime your pen before each injection so that it will work correctly. - if you do not prime before each injection, you may get too much or too little insulin. - to prime your pen, turn the dose knob to select 2 units . - hold your pen with the needle pointing up. tap the cartridge holder gently to collect air bubbles at the top. - continue holding your pen with needle pointing up. push the dose knob in until it stops, and “0” is seen in the dose window. hold the dose knob in and count to 5 slowly . you should see insulin at the tip of the needle. - if you do not see insulin, repeat the priming steps, but not more than 4 times. - if you still do not see insulin, change the needle and repeat the priming steps. small air bubbles are normal and will not affect your dose. selecting your dose - if your dose is more than 80 units, you will need to give more than 1 injection. - talk to your healthcare provider about how to give your dose. - use a new needle for each injection and repeat the priming step. - turn the dose knob to select the number of units you need to inject. the dose indicator should line up with your dose. - the pen dials 1 unit at a time. - the dose knob clicks as you turn it. - do not dial your dose by counting the clicks because you may dial the wrong dose. - the dose can be corrected by turning the dose knob in either direction until the correct dose lines up with the dose indicator. - the even numbers are printed on the dial. - the odd numbers, after the number 1, are shown as full lines. - always check the number in the dose window to make sure you have dialed the correct dose. the pen will not let you dial more than the number of units left in the pen. - if you need to inject more than the number of units left in the pen, you may either: - inject the amount left in your pen and then use a new pen to give the rest of your dose, or - get a new pen and inject the full dose. - it is normal to see a small amount of insulin left in the pen that you can not inject. giving your injection - inject your insulin as your healthcare provider has shown you. - change (rotate) your injection sites within the area you choose for each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites. do not inject where the skin has pits, is thickened, or has lumps. do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin. - do not try to change your dose while injecting. - basaglar is injected under the skin (subcutaneously) of your stomach area, buttocks, upper legs or upper arms. - wipe the skin with an alcohol swab, and let the injection site dry before you inject your dose. - insert the needle into your skin. - push the dose knob all the way in. - continue to hold the dose knob in and slowly count to 5 before removing the needle. note: do not try to inject your insulin by turning the dose knob. you will not receive your insulin by turning the dose knob. - pull the needle out of your skin. - a drop of insulin at the needle tip is normal. it will not affect your dose. - check the number in the dose window - if you see “0” in the dose window, you have received the full amount you dialed. - if you do not see “0” in the dose window you did not receive your full dose. do not redial. insert the needle into your skin and finish your injection. - if you still do not think you received the full amount you dialed for your injection, do not start over or repeat that injection. monitor your blood glucose and call your healthcare provider for further instructions. - if you normally need to give 2 injections for your full dose, be sure to give your second injection. the plunger only moves a little with each injection, and you may not notice that it moves. if you see blood after you take the needle out of your skin, press the injection site lightly with a piece of gauze or an alcohol swab. do not rub the area. after your injection - carefully replace the outer needle shield. - unscrew the capped needle and throw it away (see disposing of pens and needles section below). - do not store the pen with the needle attached to prevent leaking, blocking the needle, and air from entering the pen. - replace the pen cap by lining up the cap clip with the dose indicator and pushing straight on. disposing of pens and needles - put your used needles in a fda-cleared sharps disposal container right away after use. do not throw away (dispose of) loose needles 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 dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. - the used pen may be discarded in your household trash after you have removed the needle. storing your basaglar kwikpen unused pens - store unused pens in the refrigerator at 36°f to 46°f (2°c to 8°c). - do not freeze basaglar. do not use if it has been frozen. - unused pens may be used until the expiration date printed on the label, if the pen has been kept in the refrigerator. in-use pen - store the pen you are currently using at room temperature [up to 86°f (30°c)] and away from heat and light. - throw away the pen you are using after 28 days, even if it still has insulin left in it. general information about the safe and effective use of your pen - keep your pen and needles out of the sight and reach of children. - always use a new needle for each injection. - do not share your pen or needles with other people. you may give other people a serious infection or get a serious infection from them. - do not use your pen if any part looks broken or damaged. - always carry an extra pen in case yours is lost or damaged. troubleshooting - if you can not remove the pen cap, gently twist the cap back and forth, and then pull the cap straight off. - if the dose knob is hard to push: - pushing the dose knob more slowly will make it easier to inject. - your needle may be blocked. put on a new needle and prime the pen. - you may have dust, food, or liquid inside the pen. throw the pen away and get a new pen. if you have any questions or problems with your basaglar kwikpen, contact lilly at 1-800-lillyrx (1-800- 545-5979) or call your healthcare provider for help. for more information on basaglar kwikpen and insulin, go to www.basaglar.com. scan this code to launch www.basaglar.com this instructions for use have been approved by the u.s. food and drug administration. basaglar® and basaglar® kwikpen® are trademarks of eli lilly and company. instructions for use revised: november 2022 manufactured by: eli lilly and company indianapolis, in 46285, usa us license number 1891 copyright © 2015, 2022, eli lilly and company. all rights reserved. baskp-0009-ifu-20221115 instructions for use basaglar® tempo pen™ (insulin glargine) injection, for subcutaneous use 100 units/ml, 3 ml pen, single-patient-use read the instructions for use before you start using basaglar and each time you get another basaglar tempo pen. there may be new information. this information does not take the place of talking to your healthcare provider about your medical condition or your treatment. do not share your basaglar tempo pen with other people, even if the needle has been changed. you may give other people a serious infection or get a serious infection from them. basaglar tempo pen (“pen”) is a disposable single-patient-use prefilled pen containing 300 units (3ml) of basaglar. one pen contains multiple doses of medicine. - your healthcare provider will tell you how many units to give as your dose and how to inject your prescribed dose of medicine. - you can give a dose of 1 to 80 units in a single injection. - if your prescribed dose is more than 80 units, you will need to give yourself more than 1 injection. - the plunger only moves a little with each injection, and you may not notice that it moves. when the plunger reaches the end of the cartridge, you have used all 300 units in the pen. people who are blind or have vision problems should not use the pen without help from a person trained to use the basaglar prefilled pen. this basaglar tempo pen contains a component that allows for data connectivity when used with a compatible transmitter. how to recognize your basaglar tempo pen - pen color: light grey - dose knob: light grey - labels: light grey with green color bars supplies needed to give your injection - basaglar tempo pen - tempo pen compatible needle (becton, dickinson and company pen needles recommended) - alcohol swab preparing your pen - wash your hands with soap and water. - check the pen to make sure you are taking the right type of insulin. this is especially important if you use more than 1 type of insulin. - do not use your pen past the expiration date printed on the label or for more than 28 days after you first start using the pen. - always use a new needle for each injection to help prevent infections and blocked needles. do not reuse or share your needles with other people. you may give other people a serious infection or get a serious infection from them. - pull the pen cap straight off. - do not remove the pen label. - wipe the rubber seal with an alcohol swab. - check the liquid in the pen. basaglar should look clear and colorless. do not use if it is cloudy, colored, or has particles or clumps in it. - select a new needle. - pull off the paper tab from the outer needle shield. - push the capped needle straight onto the pen and twist the needle on until it is tight. - pull off the outer needle shield. do not throw it away. - pull off the inner needle shield and throw it away. priming your pen prime before each injection. - priming means removing the air from the needle and cartridge that may collect during normal use. it is important to prime your pen before each injection so that it will work correctly. - if you do not prime before each injection, you may get too much or too little insulin. - to prime your pen, turn the dose knob to select 2 units . - hold your pen with the needle pointing up. tap the cartridge holder gently to collect air bubbles at the top. - continue holding your pen with the needle pointing up. push the dose knob in until it stops, and “0 ” is seen in the dose window. hold the dose knob in and count to 5 slowly . you should see insulin at the tip of the needle. - if you do not see insulin, repeat the priming steps 6 to 8, but not more than 4 times. - if you still do not see insulin, change the needle and repeat the priming steps 6 to 8. small air bubbles are normal and will not affect your dose. selecting your dose - you can give a dose of 1 to 80 units in a single injection. - if your dose is more than 80 units, you will need to give more than 1 injection. - talk to your healthcare provider about how to give your dose. - use a new needle for each injection and repeat the priming step. - turn the dose knob to select the number of units you need to inject. the dose indicator should line up with your dose. - the pen dials 1 unit at a time. - the dose knob clicks as you turn it. - do not dial your dose by counting the clicks because you may dial the wrong dose. - the dose can be corrected by turning the dose knob in either direction until the correct dose lines up with the dose indicator. - the even numbers are printed on the dial. - the odd numbers, after the number 1, are shown as full lines. - always check the number in the dose window to make sure you have dialed the correct dose. - the pen will not let you dial more than the number of units left in the pen. - if you need to inject more than the number of units left in the pen, you may either: - inject the amount left in your pen and then use a new pen to give the rest of your dose, or - get a new pen and inject the full dose. - it is normal to see a small amount of insulin left in the pen that you cannot inject. giving your injection - inject your insulin as your healthcare provider has shown you. - change (rotate) your injection sites within the area you choose for each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites. do not inject where skin has pits, is thickened, or has lumps. do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin. - do not try to change your dose while injecting. - basaglar is injected under the skin (subcutaneously) of your stomach area, buttocks, upper legs or upper arms. - wipe the skin with an alcohol swab, and let the injection site dry before you inject your dose. - insert the needle into your skin. - push the dose knob all the way in. - continue to hold the dose knob in and slowly count to 5 before removing the needle. note: do not try to inject your insulin by turning the dose knob. you will not receive your insulin by turning the dose knob. - pull the needle out of your skin. - a drop of insulin at the needle tip is normal. it will not affect your dose. - check the number in the dose window - if you see “0” in the dose window, you have received the full amount you dialed. - if you do not see “0” in the dose window you did not receive your full dose. do not redial . insert the needle into your skin and finish your injection. - if you still do not think you received the full amount you dialed for your injection, do not start over or repeat that injection. monitor your blood sugar (glucose) and call your healthcare provider for further instructions. - if you normally need to give 2 injections for your full dose, be sure to give your second injection. the plunger only moves a little with each injection, and you may not notice that it moves. if you see blood after you take the needle out of your skin, press the injection site lightly with a piece of gauze or an alcohol swab. do not rub the area. after your injection - carefully replace the outer needle shield. - unscrew the capped needle and throw it away (see disposing of pens and needles section below). - do not store the pen with the needle attached to prevent leaking, blocking the needle, and air from entering the pen. - replace the pen cap by lining up the cap clip with the dose indicator and pushing straight on. disposing of pens and needles - put your used needles in a fda-cleared sharps disposal container right away after use. do not throw away (dispose of) loose needles 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 dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. - the used pen may be thrown away (discarded) in your household trash after you have removed the needle. storing your basaglar tempo pen unopened pens - store unopened pens in the refrigerator at 36°f to 46°f (2°c to 8°c). - do not freeze basaglar. do not use if it has been frozen. - unopened pens may be used until the expiration date printed on the label, if the pen has been kept in the refrigerator. in-use pen - store the pen you are currently using at room temperature [up to 86°f (30°c)] and away from heat and light. - throw away the pen you are using after 28 days, even if it still has insulin left in it. general information about the safe and effective use of your pen - keep your pen and needles out of the sight and reach of children. - always use a new needle for each injection. - do not share your pen or needles with other people. you may give other people a serious infection or get a serious infection from them. - do not use your pen if any part looks broken or damaged. - always carry an extra pen in case yours is lost or damaged. troubleshooting - if you cannot remove the pen cap, gently twist the cap back and forth, and then pull the cap straight off. - if the dose knob is hard to push: - pushing the dose knob more slowly will make it easier to inject. - your needle may be blocked. put on a new needle and prime the pen. - you may have dust, food, or liquid inside the pen. throw the pen away and get a new pen. if you have any questions or problems with your basaglar tempo pen, contact lilly at 1-800-lillyrx (1-800-545-5979) or call your healthcare provider for help. for more information on basaglar tempo pen and insulin, go to www.basaglar.com. scan this code to launch www.basaglar.com this instructions for use have been approved by the u.s. food and drug administration. basaglar® is a registered trademark and tempo pentm is a trademark of eli lilly and company. instructions for use revised: november 2022 manufactured by: eli lilly and company indianapolis, in 46285, usa us license number 1891 copyright © 2021, 2022, eli lilly and company. all rights reserved. bastp-0004-ifu-20221115

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

novo nordisk - insulin detemir (unii: 4ft78t86xv) (insulin detemir - unii:4ft78t86xv) - insulin detemir 100 [iu] in 1 ml - levemir is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. limitations of use levemir is not recommended for the treatment of diabetic ketoacidosis. levemir is contraindicated: risk summary available data from published studies and postmarketing case reports with levemir use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in a randomized, parallel-group, open-label clinical trial that included 152 pregnant women with type 1 diabetes who were administered levemir once or twice daily, beginning in gestational weeks 8 to 12 or prior to conception, no clear evidence of maternal or fetal risk associated with levemir was observed (see data). there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations). animal reproduction studies were conducted in non-diabetic pregnant rats and rabbits with insulin detemir administrat

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

sanofi-aventis u.s. llc - insulin lispro (unii: gfx7qis1ii) (insulin lispro - unii:gfx7qis1ii) - insulin lispro 100 u in 1 ml - admelog is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. admelog is contraindicated: - during episodes of hypoglycemia [see warnings and precautions (5.3)] . - in patients who are hypersensitive to insulin lispro or to any of the excipients in admelog [see warnings and precautions (5.5)]. risk summary published studies with another insulin lispro product used during pregnancy have not reported an association between insulin lispro and the induction of major birth defects, miscarriage, or adverse maternal or fetal outcomes [see data] . there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see clinical considerations] . pregnant rats and rabbits were exposed to another insulin lispro product in animal reproduction studies during organogenesis. fetal growth retardation was observed in offspring of rats exposed to insulin lispro at a dose approximately 3 times the human subcutaneous dose of 1.0 unit/kg/day. no adverse effe

New Zealand - English - Ministry for Primary Industries

schering-plough animal health limited - insulin - insulin 0.04 thou iu/ml - endocrine agent (hormone)

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

intervet international b.v. - insulin porcine 40 iu/ml - suspension for injection - 40 iu/ml - insulin zinc suspension, crystalline 28 iu/ml; insulin zinc suspension, amorphous 12 iu/ml - insulin (pork) - dog; cat

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

intervet international b.v. - insulin porcine 40 iu/ml - suspension for injection - 40 iu/ml - insulin zinc suspension, amorphous 12 iu/ml; insulin zinc suspension, crystalline 28 iu/ml - insulin (pork) - dog; cat

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

mannkind corporation - insulin human (unii: 1y17cti5sr) (insulin human - unii:1y17cti5sr) - insulin human 4 - afrezza® is a rapid acting inhaled human insulin indicated to improve glycemic control in adult patients with diabetes mellitus. limitations of use: - afrezza is not recommended for the treatment of diabetic ketoacidosis [see warning and precautions (5.6)] . - the safety and effectiveness of afrezza in patients who smoke have not been established. the use of afrezza is not recommended in patients who smoke or who have recently stopped smoking. afrezza is contraindicated: - during episodes of hypoglycemia [see warning and precautions (5.3)]. - chronic lung disease, such as asthma or chronic obstructive pulmonary disease (copd), because of the risk of acute bronchospasm [see warnings and precautions (5.1)] - hypersensitivity to regular human insulin or any of the excipients in afrezza [see warnings and precautions (5.7)] risk summary limited available data with afrezza use in pregnant women are insufficient to determine drug-associated risks for adverse developmental outcomes. available information from published studies with human insulin use during pregnancy has not reported a clear association with human insulin and adverse developmental outcomes (see data ). there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations ). in animal reproduction studies, there were no adverse developmental outcomes with subcutaneous administration of carrier particles (vehicle without insulin) to pregnant rats during organogenesis at doses 21 times the human daily dose of 99 mg afrezza, based on auc (see data) . the estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with hba1c >7 and has been reported to be as high as 20-25% in women with 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, stillbirth, and delivery complications. poorly controlled diabetes increases the fetal risk for major birth defects, still birth, and macrosomia- related morbidity. data human data there are limited data with afrezza use in pregnant women. published data do not report a clear association with human insulin and major birth defects, miscarriage, or adverse maternal or fetal outcomes when human insulin is used during pregnancy. however, these studies cannot definitely establish the absence of any risk because of methodological limitations including small sample size and lack of blinding. animal data in pregnant rats given subcutaneous doses of 10, 30, and 100 mg/kg/day of carrier particles (vehicle without insulin) from gestation day 6 through 17 (organogenesis), no major malformations were observed at doses up to 100 mg/kg/day (21 times the human systemic exposure at a daily dose of 99 mg afrezza, based on auc). in pregnant rabbits given subcutaneous doses of 2, 10, and 100 mg/kg/day of carrier particles (vehicle without insulin) from gestation day 7 through 19 (organogenesis), adverse maternal effects were observed in all dose groups (at human systemic exposure following a daily dose of 99 mg afrezza, based on auc). in pregnant rats given subcutaneous doses of 10, 30, and 100 mg/kg/day of carrier particles (vehicle without insulin) from gestation day 7 through lactation day 20 (weaning), decreased epididymis and testes weights were observed in f1 male offspring, however, no decrease in fertility was noted, and impaired learning were observed in f1 pups at ³ 30 mg/kg/day (6 times the human systemic exposure at a daily dose of 99 mg afrezza, based on auc). risk summary there are no data on the presence of afrezza in human milk, the effects on the breastfed infant, or the effects on milk production. one small published study reported that exogenous subcutaneous insulin was present in human milk. no adverse effects in infants were noted. the carrier particles are present in rat milk (see data ). potential adverse reactions that are related to inhalational administration of afrezza are unlikely to be associated with potential exposure of afrezza through breast milk. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for afrezza and any potential adverse effects on the breastfed infant from afrezza or from the underlying maternal condition. data subcutaneous administration of the carrier particle in lactating rats resulted in excretion of the carrier particle in rat milk at levels that were approximately 10% of the maternal exposure. given the results of the rat study, it is highly likely that the insulin and carrier in afrezza are excreted in human milk. the safety and effectiveness of afrezza to improve glycemic control in pediatric patients with diabetes mellitus has not been established. afrezza has not been studied in pediatric patients. in the afrezza clinical studies, 671 (12%) patients were 65 years of age or older, of which 42 (0.8%) were 75 years of age or older. in these studies, 381 (13%) of afrezza-treated patients were 65 years of age or older, of which 20 (0.7%) were 75 years of age or older. no overall differences in effectiveness of afrezza have been observed between patients 65 years of age and older and younger adult patients [see clinical studies (14)] . clinical studies of afrezza did not include sufficient numbers of patients 65 years of age and older to determine whether there were differences in safety between these patients and younger adult patients. pharmacokinetic and pharmacodynamic studies to assess the effect of age on pharmacokinetics or pharmacodynamics on insulin human, respectively, have not been conducted. the effect of hepatic impairment on the pharmacokinetics of afrezza has not been studied. frequent glucose monitoring and a lower dosage may be necessary in afrezza-treated patients with hepatic impairment [see warnings and precautions (5.3)] . the effect of renal impairment on the pharmacokinetics of afrezza has not been studied. some studies with human insulin have shown increased circulating levels of insulin in patients with renal failure. frequent glucose monitoring and a lower dosage may be necessary in afrezza-treated patients with renal impairment [see warnings and precautions (5.3)] . instructions for use afrezza® (uh-frezz-uh) (insulin human) inhalation powder, for oral inhalation use this “instructions for use” contains information on how to use afrezza® (insulin human) inhalation powder. read this instructions for use before you start using afrezza and each time you get a new afrezza inhaler. there may be new information. this information does not take the place of talking to your healthcare provider about your medical condition or your treatment. your healthcare provider should show you how to use your afrezza inhaler the right way before you use it for the first time. important information about afrezza: - afrezza comes in 3 strengths (see figure a): 4 units (blue cartridge) 8 units (green cartridge) 12 units (yellow cartridge) - 4 units (blue cartridge) - 8 units (green cartridge) - 12 units (yellow cartridge) - if your prescribed afrezza dose is higher than 12 units, you will need to use more than 1 cartridge. - if you need to use more than 1 cartridge for your dose, throw away the used cartridge before getting a new one. you can tell when a cartridge has been used, because the cup has moved to the center. - do not try to open the afrezza cartridges. the afrezza inhaler opens the cartridge automatically during use. - afrezza cartridges should only be used with the afrezza inhaler. do not try to breathe in the afrezza insulin powder in any other way. do not put cartridges in your mouth and do not swallow cartridges. - use only 1 afrezza inhaler at a time. the same inhaler should be used for the 4 unit, 8 unit or 12 unit cartridges. - store the inhaler in a clean, dry place with the mouthpiece cover on until your next dose. - throw away your afrezza inhaler after 15 days and get a new one. if you are having problems with your afrezza inhaler or if it breaks and you need a new one, call 1-877-323-8505. know your afrezza inhaler: know your afrezza cartridges: manufactured by: mannkind corporation danbury, ct 06810 us license no. #2190 © 2016 – 2023 mannkind corporation this instructions for use has been approved by the u.s. food and drug administration. revised: 02/2023 afrezza is a registered trademark of mannkind corporation patent: www.mannkindcorp.com/patent-notices

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)

imclone llc - insulin lispro (unii: gfx7qis1ii) (insulin lispro - unii:gfx7qis1ii) - insulin lispro injection is a rapid acting human insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus. insulin lispro injection is contraindicated: - during episodes of hypoglycemia - in patients who are hypersensitive to insulin lispro injection or to any of its excipients. risk summary the limited available data with insulin lispro injection in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. published studies with insulin lispro used during pregnancy have not reported an association between insulin lispro and the induction of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data) . there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations) . pregnant rats and rabbits were exposed to insulin lispro in animal reproduction studies during organogenesis. no adverse effects on embryo/fetal viability or morphology were obser

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

novo nordisk pharma, inc. - insulin aspart (unii: d933668qvx) (insulin aspart - unii:d933668qvx) - insulin aspart is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. insulin aspart is contraindicated: risk summary available information from published randomized controlled trials with insulin aspart use during the second trimester of pregnancy have not reported an association with insulin aspart and major birth defects or adverse maternal or fetal outcomes [see data] . there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see clinical considerations] . in animal reproduction studies, administration of subcutaneous insulin aspart to pregnant rats and rabbits during the period of organogenesis did not cause adverse developmental effects at exposures 8-times and equal to the human subcutaneous dose of 1 unit/kg/day, respectively. pre- and post-implantation losses and visceral/skeletal abnormalities were seen at higher exposures, which are considered secondary to maternal hypoglycemia. these effects were similar to those o