Insulin Degludec

Insulin Degludec is a prescription medication used to treat Type 1 and Type 2 Diabetes Mellitus.  

• Insulin Degludec is available under the following different brand names: Tresiba

Adult and pediatric dosage

Injectable solution (prefilled pen, FlexTouch)

• 100 units/mL
• 200 units/mL

Type 1 Diabetes Mellitus

Adult dosage

Initial dose

• 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

Pediatric dosage

• Children younger than 1 years of age: Safety and efficacy not established
• Children 1-17 years of age: 
• Starting dose: 
  • 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

Type 2 Diabetes Mellitus

Adult dosage

Initial dose

• Start 10 units SC once daily

Pediatric dosage

• Children younger than 1 years of age: Safety and efficacy not established
• Children 1-17 years of age: 
• Starting dose: 
  • 10 units SC once daily

Dosage Considerations – Should be Given as Follows: 

• See "Dosages."

Common side effects of Insulin Degludec include:

• low blood sugar, 
• swelling, 
• weight gain, 
• itching, 
• rash, and
• thickening or hallowing of the skin at the injection site

Serious side effects of Insulin Degludec include:

• hives, 
• itching, 
• skin rash, 
• wheezing, 
• tiredness, 
• trouble breathing, 
• lightheadedness, 
• nausea, 
• diarrhea, 
• swelling of the face, lips, tongue, or throat, 
• weight gain, 
• swelling in the hands or feet, 
• shortness of breath, 
• leg cramps, 
• constipation, 
• irregular heartbeats, 
• fluttering in the chest, 
• increased thirst or urination, 
• numbness or tingling, 
• muscle weakness, and
• limp feeling

Rare side effects of Insulin Degludec include:

• none 

This is not a complete list of side effects and other serious side effects or health problems may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

• Insulin Degludec has severe interactions with no other drugs.
• Insulin Degludec has serious interactions with the following drugs:
  • ethanol
  • macimorelin
• Insulin Degludec has moderate interactions with at least 175 drugs.
• Insulin Degludec has minor interactions with the following drug: 
  • stevia 

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this drug, tell your doctor or pharmacist of all the drugs you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

Contraindications

• During episodes of hypoglycemia
• Documented hypersensitivity

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Insulin Degludec?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Insulin Degludec?”

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 (e.g., 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 (e.g., 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 (e.g., atypical antipsychotics [e.g., olanzapine and clozapine], corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens [e.g., 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 and Lactation

• 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.
• 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.