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Levemir® dosing and administration

Tresiba® (insulin degludec injection) 100 U/mL, 200 U/mL

Another long-acting insulin from Novo Nordisk

With a 1:1 dose conversion, adult patients taking Levemir® can switch to Tresiba® at the same dose they are currently taking.1

Starting adult patients on Levemir®

Starting dose: When initiating Levemir®, start insulin-naïve patients with type 2 diabetes on 10 units once-dailya dosage or 0.1 to 0.2 units/kg daily dosage with the evening meal or at bedtime and titrate accordingly.2

Starting adult patients on Levemir®

Starting dose: When initiating Levemir®, start insulin-naïve patients with type 2 diabetes on 10 units once-dailya dosage or 0.1 to 0.2 units/kg daily dosage with the evening meal or at bedtime and titrate accordingly.2

Physician-directed patient self-titrationb: For patients taking Levemir® once daily,a the dose can be adjusted to reach FPG goals: 70-90 mg/dL or 80-110 mg/dL, as seen in the TITRATE study.3

Dose adjustments: Can be made every third day based on an average of 3 consecutive FPG values.3

Titrate Levemir® every 3 days based on FPG3

Titrate Levemir® based on FPG target
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aLevemir® can be dosed once or twice daily.2

bClinical judgment should be used for dose adjustments and to account for hypoglycemia. The dose of Levemir® should be adjusted to achieve glycemic targets.

Levemir® is available in the FlexTouch® Pen

Levemir® FlexTouch Pen
No push-button extension

No push-button extension

No matter what dose is dialed, the Levemir® FlexTouch® push button doesn’t extend

Accurate dosing

Accurate dosing from 1‑80 units4,5

Patients may hear or feel a click when the dose is deliveredc

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cAfter the dose display has returned to zero, the needle should be kept under the skin for at least 6 seconds to ensure the full dose is delivered.

Levemir® Vial

Also available in a 10-mL vial

For patients who use conventional insulin injection techniques.

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Selected Important Safety Information for Levemir® (insulin detemir injection) 100 U/mL

Contraindications

  • Levemir® is contraindicated during episodes of hypoglycemia and in patients hypersensitive to Levemir® or any of its excipients. Reactions have included anaphylaxis.

Warnings and Precautions

  • Never Share a Levemir® FlexTouch® Pen, Needle, or Syringe Between Patients: Levemir® FlexTouch® prefilled pens must never be shared between patients, even if the needle is changed. Patients using Levemir® vials should never share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens.
  • Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen: Changes in an insulin regimen (e.g., insulin strength, manufacturer, type, or injection site or method of administration) may affect glycemic control and predispose to hypoglycemia or hyperglycemia. Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis have been reported to result in hyperglycemia; and a sudden change in the injection site (to an unaffected area) has been reported to result in hypoglycemia. Make any changes to a patient’s insulin regimen under close medical supervision with increased frequency of blood glucose monitoring. Advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change the injection site to unaffected areas and closely monitor for hypoglycemia. Adjustments in concomitant anti-diabetic treatment may be needed.
  • Hypoglycemia: Hypoglycemia is the most common adverse reaction of insulin, including Levemir®, and may be life-threatening. Increase monitoring with changes to: insulin dose, co-administered glucose lowering medications, meal pattern, physical activity; and in patients with hypoglycemia unawareness or renal or hepatic impairment.

Levemir® (insulin detemir injection) 100 U/mL Indications and Usage

  • Levemir® (insulin detemir injection) 100 U/mL 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.

Important Safety Information

Contraindications

  • Levemir® is contraindicated during episodes of hypoglycemia and in patients hypersensitive to Levemir® or any of its excipients. Reactions have included anaphylaxis.

Warnings and Precautions

  • Never Share a Levemir® FlexTouch® Pen, Needle, or Syringe Between Patients: Levemir® FlexTouch® prefilled pens must never be shared between patients, even if the needle is changed. Patients using Levemir® vials should never share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens.
  • Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen: Changes in an insulin regimen (e.g., insulin strength, manufacturer, type, or injection site or method of administration) may affect glycemic control and predispose to hypoglycemia or hyperglycemia. Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis have been reported to result in hyperglycemia; and a sudden change in the injection site (to an unaffected area) has been reported to result in hypoglycemia. Make any changes to a patient’s insulin regimen under close medical supervision with increased frequency of blood glucose monitoring. Advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change the injection site to unaffected areas and closely monitor for hypoglycemia. Adjustments in concomitant anti-diabetic treatment may be needed.
  • Hypoglycemia: Hypoglycemia is the most common adverse reaction of insulin, including Levemir®, and may be life-threatening. Increase monitoring with changes to: insulin dose, co-administered glucose lowering medications, meal pattern, physical activity; and in patients with hypoglycemia unawareness or renal or hepatic impairment
  • Hypoglycemia Due to Medication Errors: Accidental mix-ups between basal insulin products and other insulins, particularly rapid-acting insulins, have been reported. To avoid medication errors between Levemir® and other insulins, instruct patients to always check the insulin label before each injection.
  • Hypersensitivity and Allergic Reactions: If hypersensitivity reactions occur, discontinue Levemir®; treat per standard of care and monitor until symptoms and signs resolve. Levemir® is contraindicated in patients who have had hypersensitivity reactions to insulin detemir or any of the excipients.
  • Hypokalemia: All insulin products, including Levemir®, cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia. Untreated hypokalemia may cause respiratory paralysis, ventricular arrhythmia, and death. Monitor potassium levels in patients at risk for hypokalemia if indicated (e.g., patients using potassium-lowering medications, patients taking medications sensitive to serum potassium concentrations).
  • Fluid Retention and Heart Failure with Concomitant Use of PPAR-gamma Agonists: Thiazolidinediones (TZDs), which are peroxisome proliferator-activated receptor (PPAR)-gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin. Fluid retention may lead to or exacerbate heart failure. Patients treated with insulin, including Levemir®, and a PPAR-gamma agonist should be observed for signs and symptoms of heart failure. If heart failure develops, it should be managed according to current standards of care, and discontinuation or dose reduction of the PPAR-gamma agonist must be considered.

Adverse Reactions

  • Adverse reactions associated with Levemir® include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, rash, pruritus.

Drug Interactions

  • Drugs that increase hypoglycemia risk or increase or decrease blood glucose lowering effect: adjustment of dosage may be needed; closely monitor blood glucose.
  • Drugs that blunt hypoglycemia signs and symptoms (e.g., beta-blockers, clonidine, guanethidine, and reserpine): Increased frequency of glucose monitoring may be required.

Use in Specific Populations

  • Pregnancy: 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.
    • Clinical Considerations - Disease-Associated Maternal and/or Embryo/Fetal Risk: 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.

Please click here for Levemir® Prescribing Information.

 

 

Tresiba® (insulin degludec injection) is indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus.

Limitations of Use

Tresiba® is not recommended for treating diabetic ketoacidosis.

Important Safety Information

Contraindications

  • Tresiba® is contraindicated during episodes of hypoglycemia and in patients with hypersensitivity to Tresiba® or one of its excipients

Warnings and Precautions

  • Never Share a Tresiba® FlexTouch® Pen, Needle, or Syringe Between Patients, even if the needle is changed. Patients using Tresiba® vials should never share needles or syringes with another person. Sharing poses a risk for transmission of blood-borne pathogens
  • Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen: Changes in an insulin regimen (e.g., insulin strength, manufacturer, type, or injection site or method of administration) may affect glycemic control and predispose to hypoglycemia or hyperglycemia. Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis have been reported to result in hyperglycemia; and a sudden change in the injection site (to an unaffected area) has been reported to result in hypoglycemia. Make any changes to a patient’s insulin regimen under close medical supervision with increased frequency of blood glucose monitoring. Advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change the injection site to unaffected areas and closely monitor for hypoglycemia. Adjustments in concomitant anti-diabetic treatment may be needed.
  • Hypoglycemia is the most common adverse reaction of insulin, including Tresiba®, and may be life-threatening. Increase monitoring with changes to: insulin dose, co-administered glucose lowering medications, meal pattern, physical activity; and in patients with hypoglycemia unawareness or renal or hepatic impairment
  • Accidental mix-ups between basal insulin products and other insulins, particularly rapid-acting insulins, have been reported. To avoid medication errors, always instruct patients to check the insulin label before each injection
  • Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin products, including Tresiba®
  • As with all insulins, Tresiba® use can lead to life-threatening hypokalemia, which then may cause respiratory paralysis, ventricular arrhythmia, and death. Closely monitor potassium levels in patients at risk of hypokalemia and treat if indicated
  • Fluid retention and heart failure can occur with concomitant use of thiazolidinediones (TZDs), which are PPAR-gamma agonists, and insulin, including Tresiba®. Patients should be observed for signs and symptoms of heart failure. If heart failure occurs, dosage reduction or discontinuation of the TZD must be considered

Adverse Reactions

  • Adverse reactions commonly associated with Tresiba® are hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, pruritus, rash, edema, and weight gain

Drug Interactions

  • There are certain drugs that may cause clinically significant drug interactions with Tresiba®.
    • Drugs that may increase the risk of hypoglycemia: antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, somatostatin analog (e.g., octreotide), sulfonamide antibiotics, GLP-1 receptor agonists, DPP-4 inhibitors, and SGLT-2 inhibitors
    • Drugs that may decrease the blood glucose lowering effect: 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
    • Drugs that may increase or decrease the blood glucose lowering effect: alcohol, beta-blockers, clonidine, lithium salts, and pentamidine
    • Drugs that may blunt the signs and symptoms of hypoglycemia: beta-blockers, clonidine, guanethidine, and reserpine

Please click here for Tresiba® Prescribing Information.

References:

  1. Tresiba [package insert]. Plainsboro, NJ: Novo Nordisk Inc; November 2019.
  2. Levemir [package insert]. Plainsboro, NJ: Novo Nordisk Inc; December 2019.
  3. Blonde L, Merilainen M, Karwe V, Raskin P; TITRATE™ Study Group. Patient-directed titration for achieving glycaemic goals using a once-daily basal insulin analogue: an assessment of two different fasting plasma glucose targets—the TITRATE™ study. Diabetes Obes Metab. 2009;11(6):623-631.
  4. Wielandt JO, Niemeyer M, Hansen MR, et al. FlexTouch: a prefilled insulin pen with a novel injection mechanism with consistent high accuracy at low- (1 U), medium- (40 U), and high- (80 U) dose settings. J Diabetes Sci Technol. 2011;5:1195–1199.
  5. Wielandt JO, Niemeyer M, Hansen MR, Bucher D, Thomsen NB. An assessment of dose accuracy and injection force of a novel prefilled insulin pen: comparison with a widely used prefilled insulin pen. Expert Opin Drug Deliv. 2011;8(10):1271-1276.