Insulin Degludec (rDNA Origin) Injection

Insulin degludec is a long-acting insulin analog approved to improve blood sugar (glycemic) control across the following uses:

• Type 1 diabetes mellitus in adults and children 1 year of age and older — must be combined with a short-acting insulin
• Type 2 diabetes mellitus in adults and children 1 year of age and older
• Not recommended for diabetic ketoacidosis (a serious condition where the blood becomes dangerously acidic)

Insulin degludec mimics the baseline insulin your pancreas would normally produce. It lowers blood sugar by helping muscles and fat cells pull glucose out of the bloodstream and by telling the liver to release less glucose. After it is injected under the skin, it bundles into large clusters that slowly break apart and release insulin steadily into your bloodstream — giving it a very long, flat action profile that can last over 42 hours.

Because it binds tightly to a protein in the blood called albumin, insulin degludec is released gradually and consistently, which helps reduce day-to-day swings in blood sugar compared to some other long-acting insulins.

Insulin degludec is injected subcutaneously (just under the skin) once daily. Adults may take it at any time of day; children should take it at the same time every day. It can be taken with or without food. Doses are individualized based on your blood sugar readings, diabetes type, and treatment goals — always follow your prescriber's instructions.

• If you miss a dose as an adult, inject it as soon as you remember during waking hours, making sure at least 8 hours pass before your next dose
• If a child misses a dose, contact the healthcare provider and monitor blood sugar more closely until the next scheduled dose
• Never dilute, mix with another insulin, give it into a vein, or use it in an insulin pump

The most common side effect is low blood sugar (hypoglycemia); other reported side effects include:

• Injection site reactions: pain, redness, swelling, itching, or bruising
• Headache
• Upper respiratory tract infection or nasal congestion (nasopharyngitis)
• Weight gain
• Skin changes at injection sites — thickening or thinning of fat tissue (lipodystrophy)
• Swelling of the hands or feet (peripheral edema)
• Rash or generalized itching

Seek emergency help right away for severe hypoglycemia (seizures, unconsciousness), signs of a severe allergic reaction (trouble breathing, swelling of face/lips/tongue), or irregular heartbeat that could signal low potassium.

• Hypoglycemia (low blood sugar): The most common and most dangerous risk. Severe episodes can cause seizures, coma, or death. Risk rises with dose changes, missed meals, extra exercise, or interacting medications. Because insulin degludec acts so long, hypoglycemia may last longer than with shorter-acting insulins.
• Medication mix-up risk: Always check your insulin label before every injection. Never pull insulin degludec out of its FlexTouch pen with a syringe — this can cause a severe, dangerous overdose.
• Low potassium (hypokalemia): All insulins can shift potassium into cells, potentially causing life-threatening drops in blood potassium levels — especially if you take potassium-lowering medicines.
• Severe allergic reactions: Anaphylaxis (a life-threatening allergic reaction) can occur. Stop the injection and seek emergency help if you develop hives, difficulty breathing, or a sudden drop in blood pressure.
• Heart failure risk with TZD pills: If you also take a thiazolidinedione (such as pioglitazone), watch for sudden weight gain, leg swelling, or shortness of breath — these may signal worsening heart failure.
• Never share pens or needles: Sharing poses a serious risk of transmitting blood-borne infections such as HIV or hepatitis.

Several medications can affect how well insulin degludec works or raise your risk of side effects — always tell your prescriber and pharmacist about every medicine you take:

• Other diabetes drugs (GLP-1 agonists, SGLT-2 inhibitors, DPP-4 inhibitors, pramlintide): Can boost blood-sugar-lowering effect and increase hypoglycemia risk
• ACE inhibitors, salicylates (aspirin-type drugs), MAO inhibitors, fibrates, fluoxetine, sulfonamide antibiotics: May strengthen insulin's effect and raise low blood sugar risk
• Corticosteroids, diuretics, estrogens, oral contraceptives, atypical antipsychotics, thyroid hormones, niacin, growth hormone: Can blunt insulin's effect and push blood sugar higher
• Beta-blockers, clonidine, alcohol, lithium: Can unpredictably raise or lower blood sugar — and beta-blockers/clonidine can also mask the warning signs of low blood sugar (like a racing heart)
• Thiazolidinediones (TZD pills): May cause fluid build-up and worsen or trigger heart failure when combined with insulin
• Pentamidine: May first cause hypoglycemia and then rebound hyperglycemia

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

• Do not use insulin degludec during an episode of low blood sugar — treat the low first
• Do not use if you have had a serious allergic reaction to insulin degludec or any of its ingredients
• Tell your doctor if you have kidney disease — blood sugar monitoring should be increased and your dose may need adjustment
• Tell your doctor if you have liver disease — closer monitoring and possible dose changes are needed
• Older adults (65+) may be more sensitive to insulin and should start with conservative doses; low blood sugar may be harder to recognize in this group
• If you are pregnant or planning to become pregnant, tell your doctor — poor blood sugar control during pregnancy increases risks for both mother and baby; insulin degludec has been used in pregnancy but discuss the benefits and risks with your provider
• If you are breastfeeding, talk to your doctor — it is not known whether insulin degludec passes into human breast milk
• Children under 1 year of age: safety and effectiveness have not been established
• Patients with visual impairment should use the FlexTouch pen with caution, as it requires careful dose dialing

Taking too much insulin degludec can cause severe, prolonged, and potentially life-threatening low blood sugar (hypoglycemia) and a dangerous drop in blood potassium (hypokalemia). Mild low blood sugar can be treated with oral glucose (juice, glucose tablets); severe episodes with seizures or unconsciousness require glucagon or intravenous glucose and emergency medical care. After recovering, extra carbohydrate intake and ongoing monitoring are important to prevent blood sugar from dropping again.

Insulin degludec begins lowering blood sugar within about an hour of the first injection. After several days of once-daily dosing, its blood-sugar-lowering effect becomes steady and consistent, lasting at least 42 hours after the last dose. The peak glucose-lowering effect occurs around 12 hours after injection, and the overall effect across 24 hours scales proportionally with the dose. Day-to-day variability in its blood-sugar-lowering action is relatively low, which helps provide more predictable blood sugar control.

After a subcutaneous injection, insulin degludec is absorbed slowly from a depot that forms under the skin, with blood levels peaking at a median of about 9 hours after dosing. It binds very tightly to a blood protein called albumin (more than 99%), which is a key reason for its long, gradual release. The average half-life (time for half the drug to clear the body) at steady state is about 25 hours, regardless of dose, and steady-state blood levels are reached after 3–4 days of once-daily dosing. The drug is broken down similarly to natural human insulin, and all breakdown products are inactive.

Keep in a cold place until first use. store between 36 to 86 degrees F. Protect from light.