Semglee

— THERAPEUTIC CATEGORIES —
  • Diabetes
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Semglee Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Insulin glargine-yfgn (rDNA origin) 100 Units/mL; for SC inj; contains m-cresol.

    How Supplied

    Vials (10mL)—1; prefilled pens (3mL)—5

    How Supplied

    Semglee (insulin glargine-yfgn) injection is supplied as a clear and colorless solution containing 100 units/mL (U-100) available as follows: 

    • 10 mL multiple-dose vial: 1 vial.

    • 3 mL single-patient-use prefilled pen: 1 pen; 3 pens; 5 pens.

    Storage

    Store unused Semglee in a refrigerator between 2° to 8°C (36° to 46°F). Do not freeze.

    Discard Semglee if it has been frozen. Protect Semglee from direct heat and light.

    For both multiple-dose vial and single-patient-use prefilled pen:

    • Not-in-use (unopened) at room temperature (up to 30°C [86°F]): 28 days

    • In-use (opened): 28 days refrigerated or room temperature for vials; 28 days at room temperature only (do not refrigerate) for pens.

    Manufacturer

    Mylan Inc.

    Generic Availability

    NO

    Mechanism of Action

    Insulin glargine lowers blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. It inhibits lipolysis and proteolysis and enhances protein synthesis.

    Semglee Indications

    Indications

    Diabetes mellitus (type 1 & 2).

    Limitations of Use

    Not for treating diabetic ketoacidosis.

    Semglee Dosage and Administration

    Adults and Children

    Give by SC inj once daily at same time each day into abdominal area, thigh, buttocks or deltoids; rotate inj sites. No pronounced peak, duration over 24hrs. <6yrs: not established. ≥6yrs: individualize; monitor and adjust as needed. Type 1 diabetes: initially ⅓ of total daily insulin dose. Give remainder of the total dose as short-acting, premeal insulin. Type 2 diabetes: initially 0.2 Units/kg or up to 10 Units once daily. May need to adjust amount, timing of short- or rapid-acting insulins and doses of any oral antidiabetics. Switching from once-daily insulin glargine 300 Units/mL: initially 80% of the previous insulin glargine 300 Units/mL dose. Switching from once-daily NPH: initial Semglee dose should be the same as previous NPH dose. Switching from twice-daily NPH: initially 80% of the previous total NPH dose.

    Semglee Contraindications

    Contraindications

    During episodes of hypoglycemia.

    Semglee Boxed Warnings

    Not Applicable

    Semglee Warnings/Precautions

    Warnings/Precautions

    Instruct patients on proper administration of insulin, type of insulin, and management of hypoglycemia. Do not reuse or share pens, needles, or syringes between patients, even if the needle is changed. Visual impairment: will need assistance with prefilled pens. Do not inject into areas of lipodystrophy or localized cutaneous amyloidosis. Increased risk of hyper- or hypoglycemia if changes in physical activity, meal patterns, renal or hepatic function, insulin regimen, administration site, and if acute illness occurs: monitor glucose more frequently and may need to adjust dose. Discontinue if hypersensitivity reactions occur. Monitor potassium levels in patients at risk for hypokalemia (eg, concomitant K+-lowering or K+-sensitive drugs). Renal or hepatic impairment: monitor more frequently and adjust dose if needed. Elderly. Pregnancy. Nursing mothers.

    Warnings/Precautions

    Never Share a Semglee Prefilled Pen, Insulin Syringe, or Needle Between Patients 

    • Do not reuse or share pens, needles, or syringes between patients, even if the needle is changed. Sharing poses a risk for transmission of blood-borne pathogens.

    Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen

    • Changes in an insulin regimen may affect glycemic control and predispose to hypoglycemia or hyperglycemia. Any changes to the insulin regimen should be made under close medical supervision with increased blood glucose monitoring.

    • Hyperglycemia has been reported when repeated insulin injections were administered into areas of lipodystrophy or localized cutaneous amyloidosis. Hypoglycemia has been reported when a sudden change in the injection site (to the affected area) was administered. 

    • For patients with type 2 diabetes, may need to adjust the dose of concomitant oral and antidiabetic products.

    Hypoglycemia

    • Increase frequency of glucose monitoring with changes to: insulin dose, concomitant drugs, meal pattern, physical activity, and in patients with renal or hepatic impairment and hypoglycemia unawareness.

    • Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes, in patients with diabetic neuropathy, using drugs that block the sympathetic nervous system (eg, beta-blockers), or who experience recurrent hypoglycemia. The long-acting effect of insulin glargine products may delay recovery from hypoglycemia.

    Hypoglycemia Due to Medication Errors

    • Advise patients to always check the insulin label prior to each injection to avoid medication errors.

    Hypersensitivity Reactions

    • Discontinue if hypersensitivity reactions occur; treat per standard of care and monitor until signs/symptoms resolve.

    Hypokalemia

    • Monitor potassium levels in patients at risk for hypokalemia (eg, concomitant K+-lowering or K+-sensitive drugs). Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death.

    Fluid Retention and Heart Failure with Concomitant Use of PPAR-gamma Agonists

    • Concomitant use with thiazolidinediones, which are PPAR-gamma agonists, may cause dose-related fluid retention, which can lead to or worsen heart failure. If Semglee is used with a PPAR-gamma agonist, observe patient for signs and symptoms of heart failure.

    • If heart failure develops, manage as per standard of care and consider discontinuing or reducing the dose of the PPAR-gamma agonist

    Pregnancy Considerations

    Risk Summary

    • Published studies have not reported a clear association between insulin glargine products and adverse developmental outcomes during pregnancy.

    Clinical Considerations 

    • Disease-Associated Maternal and/or Embryo-Fetal Risk: Hypoglycemia and hyperglycemia occur more frequently during pregnancy in patients with pregestational diabetes. Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia-related morbidity. 

    Nursing Mother Considerations

    Risk Summary 

    • Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for Semglee, and any potential adverse effects on the breastfed child from Semglee or from the underlying maternal condition.

    Pediatric Considerations

    The safety and effectiveness of insulin glargine products to improve glycemic control in pediatric patients with diabetes mellitus have been established.

    Geriatric Considerations

    Exercise caution when Semglee is administered to geriatric patients. In geriatric patients with diabetes, the initial dosing, dosage increments, and maintenance dosage should be conservative to avoid hypoglycemic reactions.

    Renal Impairment Considerations

    May need to monitor blood glucose more frequently and adjust the dose for Semglee in patients with renal impairment.

    Hepatic Impairment Considerations

    May need to monitor blood glucose more frequently and adjust the dose for Semglee in patients with hepatic impairment.

    Semglee Pharmacokinetics

    Absorption

    The insulin serum concentrations indicated a slower, more prolonged absorption and a relatively constant concentration/time profile over 24 hours with no pronounced peak compared with NPH insulin.

    Metabolism

    A metabolism study in humans indicates that insulin glargine is partly metabolized at the carboxyl terminus of the B chain in the subcutaneous depot to form two active metabolites with in vitro activity similar to that of human insulin, M1 (21A-Gly-insulin) and M2 (21A-Gly-des30B-Thr-insulin).

    Semglee Interactions

    Interactions

    Do not mix or dilute with other insulins. Concomitant thiazolidinediones (TZDs) may cause fluid retention and heart failure; consider dose reduction or discontinue TZDs. Potentiated by antidiabetic agents, ACEIs, ARBs, disopyramide, fibrates, fluoxetine, MAOIs, pentoxifylline, pramlintide, salicylates, somatostatin analogs (eg, octreotide), sulfonamide antibiotics. Antagonized by atypical antipsychotics (eg, olanzapine, clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, phenothiazines, progestogens (eg, in oral contraceptives), protease inhibitors, somatropin, sympathomimetics (eg, albuterol, epinephrine, terbutaline), thyroid hormones. Variable effects with alcohol, β-blockers, clonidine, lithium salts, pentamidine. Concomitant β-blockers, clonidine, guanethidine, or reserpine may blunt signs of hypoglycemia.

    Semglee Adverse Reactions

    Adverse Reactions

    Hypoglycemia, allergic reactions, inj site reactions, lipodystrophy, pruritus, rash, edema, weight gain; hypokalemia.

    Semglee Clinical Trials

    Clinical Trials

    The approval was based on data from the INSTRIDE 1 (ClinicalTrials.gov Identifier: NCT02227862) and 2 (ClinicalTrials.gov Identifier: NCT02227875) confirmatory studies that evaluated the efficacy and safety of Semglee compared with Lantus in patients with type 1 and type 2 diabetes, respectively. INSTRIDE 1 was a 52-week noninferiority study in 558 patients with type 1 diabetes, while INSTRIDE 2 was a 24-week study in 560 patients with type 2 diabetes (including insulin-naïve patients).

    Results from INSTRIDE 1 showed that treatment with Semglee was found to be noninferior to that achieved with Lantus with regard to the mean change in HbA1c over 24 weeks of treatment in adult patients with type 1 diabetes (difference from comparator, 0.03 [95% CI, -0.06-0.12]). 

    Similarly, noninferiority with regard to the reduction in HbA1c over 24 weeks of treatment was established in the INSTRIDE 2 study among adult patients with type 2 diabetes administered Semglee in combination with oral antidiabetic drugs (difference from Lantus + oral antidiabetic medication, 0.05 [95% CI, -0.11-0.21)].

    Semglee Note

    Not Applicable

    Semglee Patient Counseling

    Patient Counseling

    Never Share a Semglee Prefilled Pen, Insulin Syringe, or Needle Between Patients 

    • Do not reuse or share pens, needles, or syringes between patients, even if the needle is changed. Sharing poses a risk for transmission of blood-borne pathogens.

    Hyperglycemia or Hypoglycemia 

    • Advise patients who frequently experience hypoglycemia or reduced or absent warning signs of hypoglycemia to use caution when driving or operating machinery.

    • Changes in an insulin regimen may affect glycemic control and predispose to hypoglycemia or hyperglycemia. Any changes to the insulin regimen should be made under close medical supervision with increased blood glucose monitoring.

    Hypoglycemia Due to Medication Errors

    • Advise patients to always check the insulin label prior to each injection to avoid medication errors.

    Cost Savings Program

    Semglee Savings & Support

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