Dosing & Uses
Dosage Forms & Strengths
injectable solution (prefilled pen, FlexTouch)
- 100 units/mL
- 200 units/mL
Type 1 Diabetes Mellitus
Long-acting basal insulin indicated to improve glycemic control in patients with diabetes mellitus
Initial dose
For insulin-naïve patients
- Start ~1/3 to 1/2 of the total daily insulin dose; use remaining of total daily insulin dose on short-acting insulin and divided between each daily meal
- Usual initial dose range: 0.2-0.4 units/kg
- See Dosing Consideration and Administration
Type 2 Diabetes Mellitus
Long-acting basal insulin indicated to improve glycemic control in adults with type 2 diabetes mellitus
Initial dose
For insulin-naïve patients
- Start 10 units SC qDay
- See Dosing Consideration and Administration
Dosage Modifications
Hepatic impairment
- No difference in the pharmacokinetics of insulin degludec was identified in a study comparing healthy subjects and subjects with hepatic impairment (mild, moderate, and severe hepatic impairment)
Renal impairment
- No clinically relevant difference in the pharmacokinetics of insulin degludec was identified in a study comparing healthy subjects and subjects with renal impairment including subjects with end stage renal disease
Dosing Considerations
Use insulin degludec with caution in patients with visual impairment that may rely on audible clicks to dial their dose
Starting dose in patients already on insulin therapy
- Type 1 or 2 diabetes mellitus: Start insulin degludec at the same unit dose as the total daily long or intermediate-acting insulin unit dose
Limitation of use
- Not indicated for diabetic ketoacidosis
Dosage Forms & Strengths
injectable solution (prefilled pen, FlexTouch)
- 100 units/mL
- 200 units/mL
Type 1 Diabetes Mellitus
Long-acting basal insulin indicated to improve glycemic control in children and adolescents aged 1-17 yr with type 1 diabetes mellitus
<1 year: Safety and efficacy not established
Children and adolescents aged 1-17 years
Starting dose in insulin naïve patients
- Start ~1/3 to 1/2 of the total daily insulin dose; use remaining of total daily insulin dose on short-acting insulin and divided between each daily meal
- Usual initial dose range: 0.2-0.4 units/kg
- See Dosing Consideration and Administration
Type 2 Diabetes Mellitus
Long-acting basal insulin indicated to improve glycemic control in children and adolescents aged 1-17 yr with type 2 diabetes mellitus
<1 year: Safety and efficacy not established
Children and adolescents aged 1-17 years
Starting dose in insulin naïve patients
- 10 units SC qDay
- See Dosing Consideration and Administration
Dosing Considerations
Limitations of use
- Not indicated for diabetic ketoacidosis
- Not recommended for pediatric patients requiring <5 units of insulin degludec
Interactions
Interaction Checker
No Results

Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor

Adverse Effects
>10%
Nasopharyngitis (12.9-23.9%)
Severe hypoglycemic episode (0.3-12.3%)
Upper respiratory tract infection (8.4-11.9%)
Headache (8.8-11.8%)
1-10%
Diarrhea (6.3%)
Sinusitis (5.1%)
Gastroenteritis (5.1%)
Injection site reactions (3.8%)
Peripheral edema (0.9-3%)
<1%
Lipodystrophy
Postmarketing Reports
Localized cutaneous amyloidosis at the injection
Warnings
Contraindications
During episodes of hypoglycemia
Documented hypersensitivity
Cautions
Do not share, even if the needle is changed; sharing poses a risk for transmission of blood-borne pathogens
Changes in insulin, manufacturer, type, or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia; these changes should be made cautiously and only under medical supervision, and the frequency of blood glucose monitoring should be increased
Severe, life-threatening, generalized allergy, including anaphylaxis, can occur
All insulin products cause a shift in potassium from the extracellular to intracellular space, possibly leading to hypokalemia; monitor potassium levels in patients at risk for hypokalemia including patients using potassium-lowering medications or those taking medications sensitive to serum potassium concentrations; treat if indicated
To avoid dosing errors and potential overdose, never use a syringe to remove drug from pen injector into a syringe
Thiazolidinediones, which are peroxisome proliferator-activated receptor (PPAR)-gamma agonists can cause dose-related fluid retention, particularly when used in combination with insulin; this may lead to or exacerbate heart failure
Hyperglycemia or hypoglycemia with changes in insulin regimen
- Hypoglycemia is the most common adverse effect and can happen suddenly; severe hypoglycemia can cause seizures, may be life-threatening, or cause death
- Hypoglycemia can impair concentration ability and reaction time and place an individual and others at risk in situations where these abilities are important (eg, driving or operating other machinery)
- Risk increases with intensity of glycemic control and is related to the duration of action of the insulin
- Other factors that may increase the risk of hypoglycemia include changes in meal pattern (eg, macronutrient content or timing of meals), changes in level of physical activity, or changes to coadministered medication
- Renal or hepatic impairment may increase hypoglycemia risk
- In patients at higher risk for hypoglycemia and patients who have reduced symptomatic awareness of hypoglycemia, increased frequency of blood glucose monitoring is recommended
- Accidental mix-ups between basal insulin products and other insulins, particularly rapid-insulins, have been reported
- Do not transfer insulin degludec from the prefilled pen to a syringe; the markings on the insulin syringe will not measure the dose correctly and can result in overdosage and severe hypoglycemia
- Changes in insulin, insulin strength, manufacturer, type, or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia
- Changes should be made cautiously and only under close medical supervision and frequency of blood glucose monitoring should be increased
- Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis reported to result in hyperglycemia; a sudden change in the injection site (to 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 injection site to unaffected areas and closely monitor for hypoglycemia
- For patients with type 2 diabetes, dosage adjustments in concomitant oral antidiabetic treatment may be needed
Drug interactions overview
- Thiazolidinediones are peroxisome proliferator-activated receptor (PPAR)-gamma agonists and can cause dose-related fluid retention, particularly when used in combination with insulin; fluid retention may lead to or exacerbate heart failure; monitor for signs and symptoms of heart failure, treat accordingly, and consider discontinuing thiazolidinediones
- Coadministration with these drugs (eg, antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, propoxyphene, salicylates, somatostatin analogs [eg, octreotide], sulfonamide antibiotics, GLP-1 receptor agonists, DPP-4 inhibitors, and SGLT-2 inhibitors) may increase the risk of hypoglycemia
- Coadministration with these drugs (eg, atypical antipsychotics [eg, olanzapine and clozapine], corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens [eg, oral contraceptives], protease inhibitors, somatropin, sympathomimetic agents [eg, albuterol, epinephrine, terbutaline], and thyroid hormones) may decrease the risk of hypoglycemia
- Concomitant use of alcohol, beta-blockers, clonidine, and lithium salts with insulin degludec may increase or decrease blood glucose lowering effect of insulin glargine
- Pentamidine may cause hypoglycemia, which may sometimes be followed with hyperglycemia
- Coadministration with beta-blockers, clonidine, guanethidine, or reserpine may blunt signs and symptoms of hypoglycemia
Pregnancy
Pregnancy
There are no available data with insulin degludec in pregnant women to inform a drug-associated risk for major birth defects and miscarriage
There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy
Animal studies
- The effect of insulin degludec was consistent with those observed with human insulin as both caused preimplantation and postimplantation losses and visceral/skeletal abnormalities in rats at an insulin degludec dose of 21 U/kg/day (~5 times the human exposure [AUC] at a human SC dose of 0.75 U/kg/day) and in rabbits at a dose of 3.3 U/kg/day (~10 times the AUC at a human SC dose of 0.75 U/kg/day)
- The effects are probably secondary to maternal hypoglycemia
Lactation
There are no data on the presence of insulin degludec in human milk, the effects on the breastfed infant, or the effects on milk production
Insulin degludec is present in rat milk
Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Once-daily basal insulin analogue
Insulin and its analogues 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; targets include skeletal muscle, liver, and adipose tissue
Absorption
Peak plasma time: 9 hr
Peak plasma concentration: 4472 pmol/L
Steady state: 3-4 days
Distribution
Protein bound: >99% to albumin
Metabolism
Metabolites: Inactive
Elimination
Half-life: ~25 hr
Clearance: 0.03 L/kg
Administration
Preparation
Inspect visually for particulate matter and discoloration; only use if the solution appears clear and colorless
Do not dilute or mix with any other insulin products or solutions
Do not transfer drug from the insulin degludec pen into a syringe for administration
SC Administration
Inject SC once daily at any time of day
Inject SC into the thigh, upper arm, or abdomen
Rotate injection sites within the same region from one injection to the next to reduce the risk of lipodystrophy
Do not administer IV, IM, or in an insulin infusion pump
Individualize and titrate the dose based on the patient’s metabolic needs, blood glucose monitoring results, and glycemic control goal
Recommended days between dose increases is 3-4 days
Dose adjustments may be needed with changes in physical activity, changes in meal patterns (ie, macronutrient content or timing of food intake), changes in renal or hepatic function, or during acute illness to minimize the risk of hypoglycemia or hyperglycemia
Instruct patients who miss a dose to inject their daily dose during waking hours upon discovering the missed dose
Instruct patients to ensure that at least 8 hr have elapsed between consecutive insulin degludec injections
DO NOT perform dose conversion when using the insulin degludec U-100 or U-200 FlexTouch pens; the dose window for both the U-100 and U-200 FlexTouch pens shows the number of insulin units to be delivered and NO conversion is needed
Storage
Unopened (not in-use) prefilled pen
- Refrigerate at 36-46°F (2-8°C)
- Do not store in the freezer or directly adjacent to the refrigerator cooling element
- Do not freeze
- Do not use if it has been frozen
Open (in-use) prefilled pen
- Refrigerate at 36-46°F (2-8°C) or store at room temperature (<86°F [30°C]) for up to 56 days (8 wk)
- Do not freeze
- Keep away from direct heat and light
Images
Patient Handout
Formulary
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