DailyMed Label: Insulin Glargine

DailyMed Label: Insulin Glargine

2024

DailyMed Prescription

Insulin Glargine

insulin glargine

Winthrop U.S.

NDC: 0955-1728

NDC: 0955-1729

NDC: 0955-1728

NDC: 0955-1729

NDC: 0955-1728

NDC: 0955-1729

NDC: 0955-1728

NDC: 0955-1729

NDC: 0955-1728

NDC: 0955-1729

NDC: 0955-1729

NDC: 0955-1729

NDC: 0955-1729

NDC: 0955-1729

NDC: 0955-1729

NDC: 0955-1729

NDC: 0955-1728

NDC: 0955-1728

Insulin glargine is a long-acting human insulin analog produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli (K12). Insulin glargine differs from human insulin in that the amino acid asparagine at position A21 is replaced by glycine and two arginines are added to the C-terminus of the B-chain. Insulin glargine has a molecular weight of 6063 Da. Insulin Glargine injection is a sterile, clear and colorless solution for subcutaneous use in a 10 mL multiple-dose vial or a 3 mL single-patient use prefilled pen (Insulin Glargine Solostar). Prefilled Pen (Insulin Glargine Solostar) and Vial: Each mL contains 100 units of insulin glargine and the inactive ingredients: glycerol 85% (20 mg), m-cresol (2.7 mg), zinc (30 mcg), and Water for Injection, USP. The vial also contains polysorbate 20 (20 mcg). The pH is adjusted by addition of aqueous solutions of hydrochloric acid and sodium hydroxide. Insulin Glargine has a pH of approximately 4.

Insulin Glargine is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.

Individualize dosage based on metabolic needs, blood glucose monitoring, glycemic control, type of diabetes, and prior insulin use. ( 2.2 ) Administer subcutaneously into the abdominal area, thigh, or deltoid once daily at any time of day, but at the same time every day. ( 2.1 ) Do not dilute or mix with any other insulin or solution. ( 2.1 ) Rotate injection sites to reduce risk of lipodystrophy and localized cutaneous amyloidosis. ( 2.1 ) See Full Prescribing Information for the recommended starting dosage in patients with type 2 diabetes ( 2.3 ) and how to change to Insulin Glargine from other insulins ( 2.4 ) Closely monitor glucose when switching to Insulin Glargine and during initial weeks thereafter. ( 2.4 )

Injection: 100 units/mL (U-100) a clear and colorless solution available as: 10 mL multiple-dose vial 3 mL single-patient-use Insulin Glargine SoloStar prefilled pen

Insulin Glargine 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 Insulin Glargine [see Warnings and Precautions (5.5) ]

Never share an Insulin Glargine SoloStar prefilled pen, insulin syringe, or needle between patients, even if the needle is changed. ( 5.1 ) Hyperglycemia or hypoglycemia with changes in insulin regimen : Make changes to a patient's insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) under close medical supervision with increased frequency of blood glucose monitoring. ( 5.2 ) Hypoglycemia : May be life-threatening. Increase frequency of glucose monitoring with changes to: insulin dosage, concomitant drugs, meal pattern, physical activity; and in patients with renal or hepatic impairment and hypoglycemia unawareness. ( 5.3 ) Hypoglycemia due to medication errors : Accidental mix-ups between insulin products can occur. Instruct patients to check insulin labels before injection. ( 5.4 ) Hypersensitivity reactions : Severe, life-threatening, generalized allergy, including anaphylaxis, can occur. Discontinue Insulin Glargine. Monitor and treat if indicated. ( 5.5 ) Hypokalemia : May be life-threatening. Monitor potassium levels in patients at risk of hypokalemia and treat if indicated. ( 5.6 ) Fluid retention and heart failure with concomitant use of thiazolidinediones (TZDs) : Observe for signs and symptoms of heart failure; consider dosage reduction or discontinuation of TZD if heart failure occurs. ( 5.7 )

The following adverse reactions are discussed elsewhere:

Table 8 includes clinically significant drug interactions with Insulin Glargine. Table 8: Clinically Significant Drug Interactions with Insulin Glargine Drugs that May Increase the Risk of Hypoglycemia Drugs : Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analogs (e.g., octreotide), sulfonamide antibiotics. GLP-1 receptor agonists, DPP-4 inhibitors, and SGLT-2 inhibitors. Intervention : Dosage reductions and increased frequency of glucose monitoring may be required when Insulin Glargine is coadministered with these drugs. Drugs that May Decrease the Blood Glucose Lowering Effect of Insulin Glargine Drugs : Atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones. Intervention : Dosage increases and increased frequency of glucose monitoring may be required when Insulin Glargine is coadministered with these drugs. Drugs that May Increase or Decrease the Blood Glucose Lowering Effect of Insulin Glargine Drugs : Alcohol, beta-blockers, clonidine, and lithium salts. Pentamidine may cause hypoglycemia, which may sometimes be followed by hyperglycemia. Intervention : Dosage adjustment and increased frequency of glucose monitoring may be required when Insulin Glargine is coadministered with these drugs. Drugs that May Blunt Signs and Symptoms of Hypoglycemia Drugs : Beta-blockers, clonidine, guanethidine, and reserpine. Intervention : Increased frequency of glucose monitoring may be required when Insulin Glargine is coadministered with these drugs.

Risk Summary Published studies with use of insulin glargine during pregnancy have not reported a clear association with insulin glargine and adverse developmental outcomes (see Data ) . There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see Clinical Considerations ) . Rats and rabbits were exposed to insulin glargine in animal reproduction studies during organogenesis, respectively 50 times and 10 times the human subcutaneous dosage of 0.2 units/kg/day. Overall, the effects of insulin glargine did not generally differ from those observed with regular human insulin (see Data ) . In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The estimated background risk of major birth defects is 6% to 10% in women with pregestational diabetes with a peri-conceptional HbA1c >7 and has been reported to be as high as 20% to 25% in women with a peri-conceptional HbA1c >10. The estimated background risk of miscarriage for the indicated population is unknown.

Insulin Glargine injection is supplied as a clear and colorless solution containing 100 units/mL (U-100) available as follows: Insulin Glargine NDC number Package size 10 mL Multiple-dose vial 0955-1729-01 1 vial per carton 3 mL SoloStar single-patient-use prefilled pen 0955-1728-05 5 pens per carton Additional Information about Insulin Glargine Solostar: The Insulin Glargine SoloStar prefilled pen dials in 1-unit increments. Needles are not included in the packs. Use BD Ultra-Fine ® needles Other brands listed are the trademarks of their respective owners and are not trademarks of sanofi-aventis U.S. LLC with the SoloStar prefilled pens (these BD manufactured needles are sold separately).

The primary activity of insulin, including insulin glargine, is regulation of glucose metabolism. Insulin and its analogs lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis and proteolysis, and enhances protein synthesis.

In mice and rats, standard two-year carcinogenicity studies with insulin glargine were performed at doses up to 0.455 mg/kg, which was for the rat approximately 65 times the recommended human subcutaneous starting dosage of 0.2 units/kg/day (0.007 mg/kg/day) on a mg/kg basis. Histiocytomas were found at injection sites in male rats and mice in acid vehicle containing groups and are considered a response to chronic tissue irritation and inflammation in rodents. These tumors were not found in female animals, in saline control, or insulin comparator groups using a different vehicle. Insulin glargine was not mutagenic in tests for detection of gene mutations in bacteria and mammalian cells (Ames and HGPRT-test) and in tests for detection of chromosomal aberrations (cytogenetics in vitro in V79 cells and in vivo in Chinese hamsters). In a combined fertility and prenatal and postnatal study in male and female rats at subcutaneous doses up to 0.36 mg/kg/day, which was approximately 50 times the recommended human subcutaneous starting dosage of 0.2 units/kg/day (0.007 mg/kg/day) maternal toxicity due to dose-dependent hypoglycemia, including some deaths, was observed. Consequently, a reduction of the rearing rate occurred in the high-dose group only. Similar effects were observed with NPH insulin.

The safety and effectiveness of Insulin Glargine given once-daily at bedtime was compared to that of once-daily and twice-daily NPH insulin in open-label, randomized, active-controlled, parallel studies of 2,327 adult patients and 349 pediatric patients with type 1 diabetes mellitus and 1,563 adult patients with type 2 diabetes mellitus (see Tables 9–11). In general, the reduction in glycated hemoglobin (HbA1c) with Insulin Glargine was similar to that with NPH insulin.

PATIENT INFORMATION Insulin Glargine (IN-su-lin-GLAR-gine) injection, for subcutaneous use VIAL: 100 units/mL (U-100) This product is LANTUS ® (insulin glargine). Do not share your syringes 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. What is Insulin Glargine? Insulin Glargine is a long-acting man-made-insulin used to control high blood sugar in adults and children with diabetes mellitus. Insulin Glargine is not for use to treat diabetic ketoacidosis. Who should not use Insulin Glargine? Do not use Insulin Glargine if you: are having an episode of low blood sugar (hypoglycemia). have an allergy to insulin glargine or any of the ingredients in Insulin Glargine. See the end of this Patient Information leaflet for a complete list of ingredients in Insulin Glargine. What should I tell my healthcare provider before using Insulin Glargine? Before using Insulin Glargine, tell your healthcare provider about all your medical conditions including if you: have liver or kidney problems. take other medicines, especially ones called TZDs (thiazolidinediones). have heart failure or other heart problems. If you have heart failure, it may get worse while you take TZDs with Insulin Glargine. are pregnant, planning to become pregnant, or are breastfeeding. It is not known if Insulin Glargine may harm your unborn baby or breastfeeding baby. Tell your healthcare provider about all the medicines you take including prescription and over-the-counter medicines, vitamins, and herbal supplements. Before you start using Insulin Glargine, talk to your healthcare provider about low blood sugar and how to manage it. How should I use Insulin Glargine? Read the detailed Instructions for Use that come with your Insulin Glargine insulin. Use Insulin Glargine exactly as your healthcare provider tells you to. Your healthcare provider should tell you how much Insulin Glargine to use and when to use it. Know the amount of Insulin Glargine you use. Do not change the amount of Insulin Glargine you use unless your healthcare provider tells you to. Check your insulin label each time you give your injection to make sure you are using the correct insulin. Do not re-use needles. Always use a new needle for each injection. Re-use of needles increases your risk of having blocked needles, which may cause you to get the wrong dose of Insulin Glargine. Using a new needle for each injection lowers your risk of getting an infection. You may take Insulin Glargine at any time during the day but you must take it at the same time every day. Only use Insulin Glargine that is clear and colorless. If your Insulin Glargine is cloudy or slightly colored, return it to your pharmacy for a replacement. Insulin Glargine is injected under the skin (subcutaneously) of your upper legs (thighs), upper arms, or stomach area (abdomen). Do not use Insulin Glargine in an insulin pump or inject Insulin Glargine into your vein (intravenously). Change (rotate) injection sites within the area you chose with 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 use the exact same spot for each injection. 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 mix Insulin Glargine with any other type of insulin or liquid medicine. Check your blood sugar levels. Ask your healthcare provider what your blood sugar should be and when you should check your blood sugar levels. Keep Insulin Glargine and all medicines out of the reach of children. Your dose of Insulin Glargine may need to change because of: a change in level of physical activity or exercise, weight gain or loss, increased stress, illness, change in diet, or because of the medicines you take. What should I avoid while using Insulin Glargine? While using I nsulin Glargine do not: drive or operate heavy machinery, until you know how Insulin Glargine affects you. drink alcohol or use over-the-counter medicines that contain alcohol. What are the possible side effects of Insulin Glargine and other insulins? Insulin Glargine may cause serious side effects that can lead to death, including: low blood sugar (hypoglycemia). Signs and symptoms that may indicate low blood sugar include: dizziness or light-headedness, sweating, confusion, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability or mood change, hunger. severe allergic reaction (whole body reaction). Get medical help right away if you have any of these signs or symptoms of a severe allergic reaction: a rash over your whole body, trouble breathing, a fast heartbeat, or sweating. low potassium in your blood (hypokalemia). heart failure. Taking certain diabetes pills called TZDs (thiazolidinediones) with Insulin Glargine may cause heart failure in some people. This can happen even if you have never had heart failure or heart problems before. If you already have heart failure it may get worse while you take TZDs with Insulin Glargine. Your healthcare provider should monitor you closely while you are taking TZDs with Insulin Glargine. Tell your healthcare provider if you have any new or worse symptoms of heart failure including: shortness of breath, swelling of your ankles or feet, sudden weight gain. Treatment with TZDs and Insulin Glargine may need to be changed or stopped by your healthcare provider if you have new or worse heart failure. Get emergency medical help if you have: trouble breathing; shortness of breath; fast heartbeat; swelling of your face, tongue, or throat; sweating; extreme drowsiness; dizziness; confusion. The most common side effects of Insulin Glargine include: low blood sugar (hypoglycemia); weight gain; allergic reactions, including reactions at your injection site; skin thickening or pits at the injection site (lipodystrophy). These are not all the possible side effects of Insulin Glargine. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. General information about the safe and effective use of Insulin Glargine. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Insulin Glargine for a condition for which it was not prescribed. Do not give Insulin Glargine to other people, even if they have the same symptoms that you have. It may harm them. This Patient Information leaflet summarizes the most important information about Insulin Glargine. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Insulin Glargine that is written for healthcare professionals. For more information, go to www.winthropus.com or call 1-800-633-1610. What are the ingredients in Insulin Glargine? Active ingredient: insulin glargine 10 mL vial inactive ingredients: glycerol 85%, m-cresol, polysorbate 20, zinc, and Water for Injection, USP. Hydrochloric acid and sodium hydroxide may be added to adjust the pH. Manufactured by : sanofi-aventis U.S. LLC, Bridgewater, NJ 08807, U.S. License No. 1752. Manufactured for: Winthrop U.S., a business of sanofi-aventis U.S. LLC, Bridgewater, NJ 08807, A SANOFI COMPANY. This Patient Information has been approved by the U.S. Food and Drug Administration Revised: June 2023

NDC 0955-1729-01 Rx only Winthrop A SANOFI COMPANY Insulin glargine injection 100 units/mL (U-100) For subcutaneous injection only Do not mix with other insulins Use only if solution is clear and colorless with no particles visible Use with U-100 syringe only One 10 mL multiple-dose vial SANOFI