insulin degludec (Rx)

Brand and Other Names:Tresiba
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 100 units/mL (prefilled pen, FlexTouch)
  • 200 units/mL (prefilled pen, FlexTouch)

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

  • 100 units/mL (prefilled pen, FlexTouch)
  • 200 units/mL (prefilled pen, FlexTouch)

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
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Interactions

Interaction Checker

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            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

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            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

            Hypoglycemia

            • 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

            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
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            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.

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            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

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            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
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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.