General

Pronunciation:
in-soo-lin deg-lu-dek

Trade Name(s)

• Tresiba

Ther. Class.
antidiabetics
hormones

Pharm. Class.
pancreatics

Indications

Improvement of glycemic control in adults with diabetes mellitus.

Action

• Lowers blood glucose by:
  • stimulating glucose uptake in skeletal muscle and fat,
  • inhibiting hepatic glucose production.
• Other actions:
  • inhibition of lipolysis and proteolysis,
  • enhanced protein synthesis.

Therapeutic Effect(s):

Control of hyperglycemia in diabetic patients.

Pharmacokinetics

Absorption: Absorption is slow and delayed.

Distribution: Widely distributed.

Protein Binding: >99%.

Metabolism and Excretion: Metabolized by liver, spleen, kidney, and muscle.

Half-life: 25 hr (as a result of rate of absorption).

TIME/ACTION PROFILE (effect on blood sugar)

Contraindication/Precautions

Contraindicated in:

• Hypersensitivity to insulin degludec;
• Hypoglycemia.

Use Cautiously in:

• Stress and infection (may temporarily ↑ insulin requirements);
• Renal/hepatic impairment (may ↓ insulin requirements);
• Concomitant use with pioglitazone or rosiglitazone (↑ risk of fluid retention and worsening HF);
• Effects may be ↓ in obese patients;
• Patients with visual impairment who may rely on audible clicks to dial their dose;
• Geri:  Elderly may be ↑ sensitive to drug effects;
• OB:  Pregnancy may temporarily ↑ insulin requirements;
• Lactation: Consider possible effects on infant (lactating females may require adjustments in insulin dose and/or meal plan);
• Pedi:  Children <1 yr (safety and effectiveness not established).

Adverse Reactions/Side Effects

Endo: HYPOGLYCEMIA

F and E: hypokalemia

Local: lipodystrophy, pruritus, erythema, swelling

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS)

* CAPITALS indicate life-threatening.
Underline indicate most frequent.

Interactions

Drug-Drug

•  Beta blockers  and  clonidine  may mask some of the signs and symptoms of hypoglycemia.
• Corticosteroids, thyroid supplements, estrogens, isoniazid, niacin, phenothiazines, and  rifampin  may ↑ insulin requirements.
• Alcohol, ACE inhibitors, MAO inhibitors, octreotide, oral hypoglycemic agents, and  salicylates  may ↓ insulin requirements.
• Concurrent use with  pioglitazone  or  rosiglitazone  may ↑ risk of fluid retention and worsening HF.

Drug-Natural Products:

•  Glucosamine  may worsen blood glucose control.
•  Fenugreek,  chromium, and  coenzyme Q-10  may produce additive hypoglycemic effects.

Route/Dosage

SC (Adults):  Type 1 diabetes (insulin naïve)– ࡩ–½ of the total daily insulin dose given once daily, then adjust on the basis of patient's needs (remainder of insulin dose should be given as a short-acting insulin and divided between each daily meal) (usual starting total daily insulin dose = 0.2–0.4 units/kg);  Type 2 diabetes (insulin naïve)– 10 units once daily, then adjust on the basis of patient's needs;  Type 1 or 2 diabetes (and already on insulin)– Give the same dose as the total daily dose of the long-acting or intermediate-acting insulin once daily, then adjust on the basis of patient's needs.

SC (Children ≥1 yr):  Type 1 or 2 diabetes (and already on insulin)– Give 80% of the total daily dose of the long-acting or intermediate-acting insulin once daily, then adjust on the basis of patient's needs.

Availability

Solution for injection: 100 units/mL (prefilled pens and vials), 200 units/mL (prefilled pens)

In Combination with: insulin aspart (Rysodeg 70/30); liraglutide (Xultophy). See combination drugs

Assessment

• Assess patient for signs and symptoms of hypoglycemia (anxiety; restlessness; tingling in hands, feet, lips, or tongue; chills; cold sweats; confusion; cool, pale skin; difficulty in concentration; drowsiness; nightmares or trouble sleeping; excessive hunger; headache; irritability; nausea; nervousness; tachycardia; tremor; weakness; unsteady gait) and hyperglycemia (confusion, drowsiness; flushed, dry skin; fruit-like breath odor; rapid, deep breathing, polyuria; loss of appetite; nausea; vomiting; unusual thirst) periodically during therapy.
• Monitor body weight periodically. Changes in weight may necessitate changes in insulin dose.
• Monitor for signs and symptoms of hypersensitivity reactions (swelling of tongue and lips, diarrhea, nausea, tiredness, itching, urticaria). Discontinue insulin degludec and treat symptomatically.

Lab Test Considerations:

Monitor blood glucose during therapy, more frequently in ketoacidosis and times of stress. Hemoglobin A_1C  may be monitored every 3–6 mo to determine effectiveness.

• Monitor serum potassium periodically during therapy, especially in patients at risk (patients using potassium-lowering medications, patients taking medications sensitive to serum potassium concentrations). May cause hypokalemia.

Toxicity Overdose:

Overdose is manifested by symptoms of hypoglycemia. Mild hypoglycemia may be treated by ingestion of oral glucose. Severe hypoglycemia is a life-threatening emergency; treatment consists of IV glucose, glucagon, or epinephrine.

Potential Diagnoses

• Deficient knowledge, related to diet and medication regimen (Patient/Family/Teaching) 

Implementation

• High Alert: Insulin-related medication errors have resulted in patient harm and death. Clarify ambiguous orders; do not accept orders using the abbreviation "u" for units (can be misread as a zero or the numeral 4; has resulted in tenfold overdoses). Insulins are available in different types, strengths. Check type, dose, and expiration date. Do not interchange insulins without consulting health care professional. Do not confuse Tresiba (insulin degludec) with Tarceva (erlotinib), Toujeo (insulin glargine), Tradjenta (linagliptin), or Trulicity (dulaglutide).
  • Use U-100 vial for pediatric patients requiring <5 units of insulin degludec each day.
• SC Inject once daily at the same time each day. Administer into thigh, upper arm, or abdomen. Press and hold down the dose button until dose counter shows 0 and then keep needle in the skin and count slowly to 6. When dose counter returns to 0, prescribed dose is not completely delivered until 6 sec later. If the needle is removed earlier, a stream of insulin may be seen coming from the needle tip. If so, full dose will not be delivered; frequently check blood glucose levels, may need additional insulin. Use a new needle for each dose; do not reuse needles. Rotate injection sites to reduce risk of lipodystrophy. Do not administer IV, IM, or in an insulin infusion pump. Solution is clear and colorless; do not administer solutions that are discolored or contain a precipitate. Store unopened prefilled pens in refrigerator; do not freeze. Do not store opened (in-use) prefilled pens in refrigerator; stable at controlled room temperature, protected from light for 56 days (8 wk).
  • Do not mix with other insulins or solutions.
  • Do not transfer from pen into a syringe for administration.
  • Dose increases should be made every 3–4 days as needed.
  • Do not perform dose conversion when using the  Tresiba  U-100 or U-200  FlexTouch  pens. Dose window for both the  Tresiba  U-100 and U-200  FlexTouch  pens shows number of insulin units to be delivered and no conversion is needed.
• Starting Dose in Insulin Naïve Patients :  Type 1 Diabetes Mellitus:  Starting dose is one-third to one-half total daily insulin dose. Administer remainder of total daily insulin dose as short-acting insulin divided between daily meals. Generally, 0.2 to 0.4 units of insulin/kg can be used to calculate initial total daily insulin dose in insulin naïve patients with type 1 diabetes.  Type 2 Diabetes Mellitus:  10 units once daily.
• Starting Dose in Patients Already on Insulin Therapy :  Type 1 and Type 2 Diabetes Mellitus:  Start insulin degludec at same unit dose as total daily long or intermediate-acting insulin unit dose.

Patient/Family Teaching

• Instruct patient on proper technique for administration. Include type of insulin, equipment (syringe, cartridge pens, alcohol swabs), storage, and place to discard syringes. If a dose is missed, inject daily dose during waking hrs upon discovering missed dose. Ensure that at least 8 hrs have elapsed between consecutive injections. Discuss importance of not changing brands of insulin or syringes, selection and rotation of injection sites, and compliance with therapeutic regimen. Advise patient to read  Patient Information  before starting therapy and with each Rx refill in case of changes.
• Caution patient not to share pen device with another person, even if needle is changed; may risk transmission of bloodborne pathogens.
• Explain to patient that this medication controls hyperglycemia but does not cure diabetes. Therapy is long term.
• Instruct patient in proper testing of serum glucose and ketones. These tests should be closely monitored during periods of stress or illness, and health care professional notified of significant changes.
• Emphasize the importance of compliance with nutritional guidelines and regular exercise as directed by health care professional.
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other Rx, OTC, herbal products, or alcohol.
• Advise patient to notify health care professional of medication regimen prior to treatment or surgery.
• Advise patient to notify health care professional if nausea, vomiting, or fever develops, if unable to eat regular diet, or if blood glucose levels are not controlled.
• Instruct patient and caregiver on signs and symptoms of hypoglycemia and hyperglycemia and what to do if they occur.
• Patients with diabetes mellitus should carry a source of sugar (candy, glucose gel) and identification describing their disease and treatment regimen at all times.
• Advise patient to notify health care professional if pregnancy is planned or suspected or if breast feeding.
• Emphasize the importance of regular follow-up, especially during first few wk of therapy.

Evaluation/Desired Outcomes

Control of blood glucose levels in diabetic patients without the appearance of hypoglycemic or hyperglycemic episodes.