Levemir®—a basal insulin containing insulin detemir indicated to improve glycemic control in adults and children with diabetes mellitus
Same Insulin, Different Pen.
Starting early February, Levemir® FlexTouch® (NDC: 0169-6438-10) is being phased out and replaced with Levemir® FlexPen® (NDC: 0169-6432-10).
In order to minimize disruption, please make sure your patients have an updated prescription for Levemir® FlexPen® (NDC: 0169-6432-10).
What patients need to know about Levemir® FlexPen®
- Prefilled with the same insulin patients using Levemir® FlexTouch® are taking now, and they would continue taking it as prescribed
- Delivers up to 60 units of insulin with a single injection
- Same co-pay as FlexTouch® on most managed care plans
- All affordability offerings for Levemir® will continue to be honored
- Patients new to FlexPen® will need some initial instruction on the pen. Please review the Instructions For Use with them
Resources to assist with the transition
Commonly asked questions
Why is Novo Nordisk transitioning Levemir® from FlexTouch® to FlexPen®?
As some Novo Nordisk products have experienced supply challenges due to extraordinary patient demand, we are taking immediate steps and making long-term investments to increase manufacturing capacity for the patients we serve. To help address current supply anomalies, Novo Nordisk will be transitioning Levemir® from FlexTouch® to its original FlexPen® device, with the intent to alleviate strain on the manufacturing lines.
This modification is being made as a result of the rising patient demand across the Novo Nordisk portfolio of products. As Levemir® FlexPen® was previously approved by the FDA, this update allows Levemir® patients to remain on therapy and enables Novo Nordisk to more broadly meet the needs of the patients we support.
When will Levemir® FlexPen® be available to patients in pharmacies?
Levemir® FlexPen® will be available starting in early February 2023. Levemir® FlexTouch® will remain available until stock is depleted, which will vary by location throughout the U.S.
Will the switch from FlexTouch® to FlexPen® affect patient dosing?
FlexTouch® and FlexPen® have different features and functions, and will require patients to adopt new Instructions For Use (IFU). However, the active medicine will not change with the conversion from FlexTouch® to FlexPen®, and it will not affect the efficacy and safety profile of Levemir®.
Patients who are currently using Levemir® FlexTouch® to manage their diabetes who require more than the maximum 60 units per injection that the Levemir® FlexPen® provides should discuss how to manage dosing options with their HCPs.
Will patients need a new prescription, or can pharmacists use existing scripts?
While supplies last, patients with existing refills can continue to receive their Levemir® FlexTouch®. Once the FlexTouch® supply is depleted, some pharmacists may be required to, or feel the need to, inform your practice about the switch to confirm that the Levemir® FlexPen® is authorized. In order to minimize disruption, please proactively make sure your Levemir® patients also have an updated prescription for Levemir® FlexPen®.
Are wholesalers/pharmacies/patients expected to return any Levemir® FlexTouch® stock they have on hand?
This change is not the result of any safety or performance issue related to Levemir® FlexTouch®, and therefore patients/pharmacies/wholesalers do not need to return this product if they have it on hand. Levemir® FlexTouch® will remain available through pharmacies and wholesalers while supplies last. Once FlexTouch® inventory is exhausted, no additional product will be available.
How much will Levemir® FlexPen® cost, and does this differ from the current FlexTouch® option?
There will be no change in cost—Levemir® FlexPen® and Levemir® FlexTouch® are priced the same. Levemir® will continue to be available as an option through numerous Novo Nordisk affordability offerings, depending on a person's situation. We encourage anyone in need to go to NovoCare.com to learn more about our affordability options.
Will insurance continue to cover cost to patients?
There will be no change in patients' eligibility for insurance coverage for the FlexPen® vs the FlexTouch®.
I do not see Levemir® FlexPen® in my EHR yet, what should I do?
It may take a while for new products to appear in local EHR systems. Levemir® FlexPen® will appear once your local EHR system has been updated. Please check with your local IT team or EHR support service for any software updates. In the interim, a paper prescription or a manual entry into the EHR may be required.
What needles can be used with FlexPen®?
Both FlexTouch® and FlexPen® are compatible with all universal needles, so patients can continue to use the same needles. Needles are sold separately and require a prescription in some states. Novo Nordisk recommends NovoFine® 32G 6 mm needles, which are available in pharmacies in packs of 100. For more information on needles, visit NovoNeedles.com.
Unit-to-unit dose conversion from Levemir® to Tresiba®
With a 1:1 dose conversion from other basal insulins, your adult patients can switch to Tresiba® at the same dose they are currently taking.1
Indications and Usage for Levemir® (insulin detemir) injection 100 U/mL
- 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 insulin detemir or any of the excipients in Levemir®. Reactions have included anaphylaxis.
Warnings and Precautions
- Never Share a Levemir® FlexPen® prefilled pen, Needle, or Syringe Between Patients: Levemir® FlexPen® 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®. Severe hypoglycemia can cause seizures, may be life-threatening or cause death. Hypoglycemia can impair concentration ability and reaction time; this may place the patient and others at risk in situations where these abilities are important (e.g., driving or operating other machinery). Hypoglycemia can happen suddenly and symptoms may differ in each patient and change over time in the same patient. 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 (e.g., beta-blockers), or who experience recurrent hypoglycemia.
Risk Factors for Hypoglycemia: The risk of hypoglycemia generally increases with intensity of glycemic control. The risk of hypoglycemia after an injection is related to the duration of action of the insulin and, in general, is highest when the glucose lowering effect of the insulin is maximal. As with all insulins, the glucose lowering effect time course of Levemir® may vary among different patients or at different times in the same patient and depends on many conditions, including the area of injection as well as the injection site blood supply and temperature. Other factors which may increase the risk of hypoglycemia include changes in meal pattern, changes in level of physical activity, or changes to concomitant drugs. When a GLP-1 receptor agonist is used in combination with Levemir®, the Levemir® dose may need to be lowered or more conservatively titrated to minimize the risk of hypoglycemia. Patients with renal or hepatic impairment may be at higher risk of hypoglycemia. Patients and caregivers must be educated to recognize and manage hypoglycemia. In patients at higher risk for hypoglycemia and patients who have reduced symptomatic awareness of hypoglycemia, increased frequency of blood glucose monitoring is recommended. - Hypoglycemia Due to Medication Errors: Accidental mix-ups between insulin products 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: Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulin, including Levemir®. If hypersensitivity reactions occur, discontinue Levemir®; treat per standard of care and monitor until symptoms and signs resolve.
- Hypokalemia: All insulins, 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, and pruritus.
Drug Interactions
- There are certain drugs that may cause clinically significant drug interactions with Levemir®.
- 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
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.
- 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.
Indications and Usage for Tresiba® (insulin degludec) injection 100 U/mL, 200 U/mL
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 insulin degludec or any of the excipients in Tresiba®
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: Hypoglycemia is the most common adverse reaction of insulin, including Tresiba®. Severe hypoglycemia can cause seizures, may be life-threatening or cause death. Hypoglycemia can impair concentration ability and reaction time; this may place the patient and others at risk in situations where these abilities are important (e.g., driving or operating other machinery). Hypoglycemia can happen suddenly and symptoms may differ in each patient and change over time in the same patient. 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 (e.g., beta-blockers) or who experience recurrent hypoglycemia. The long-acting effect of Tresiba® may delay recovery from hypoglycemia compared to shorter-acting insulins.
Risk Factors for Hypoglycemia: The risk of hypoglycemia generally increases with intensity of glycemic control. The risk of hypoglycemia after an injection is related to the duration of action of the insulin and, in general, is highest when the glucose lowering effect of the insulin is maximal. As with all insulins, the glucose lowering effect time course of Tresiba® may vary among different patients or at different times in the same patients and depends on many conditions, including the area of injection as well as the injection site blood supply and temperature. Other factors which may increase the risk of hypoglycemia include changes in meal pattern, changes in level of physical activity, or changes to concomitant drugs. Patients with renal or hepatic impairment may be at higher risk of hypoglycemia. Patients and caregivers must be educated to recognize and manage hypoglycemia. In patients at higher risk for hypoglycemia and patients who have reduced symptomatic awareness of hypoglycemia, increased frequency of blood glucose monitoring is recommended. - Hypoglycemia Due to Medication Errors: Accidental mix-ups between insulin products have been reported. To avoid medication errors between Tresiba® and other insulins, always instruct patients to always check the insulin label before each injection. To avoid dosing errors and potential overdose, never use a syringe to remove Tresiba® from the Tresiba® FlexTouch® disposable insulin prefilled pen.
- Hypersensitivity Reactions: Severe, life-threatening, generalized allergy, including anaphylaxis, can occur with insulins, including Tresiba®. If hypersensitivity reactions occur, discontinue Tresiba®; treat per standard of care and monitor until symptoms and signs resolve.
- Hypokalemia: All insulins, including Tresiba®, 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 and treat if indicated.
- Fluid Retention and Heart Failure with Concomitant Use of PPAR-gamma Agonists: 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.
Reference:
- Tresiba [package insert]. Plainsboro, NJ: Novo Nordisk Inc; July 2022.