Insulin degludec

FDA label

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Titration Wait 3 to 4 days between dose increases.

Renal PK unchanged across kidney impairment including end-stage kidney disease and no safety/efficacy differences by eGFR; still intensify glucose monitoring and adjust dosage individually.

Hepatic PK unchanged in mild, moderate and severe hepatic impairment; still intensify glucose monitoring and adjust dosage individually.

At least 8 hours must elapse between consecutive doses. Limitations of Use: not recommended for the treatment of diabetic ketoacidosis.

Instructions

• Inject SC into the thigh, upper arm or abdomen; rotate sites within the same region and do not inject into areas of lipodystrophy or localized cutaneous amyloidosis.
• Adults: inject once daily at any time of day. Pediatric patients: inject once daily at the same time every day.
• In type 1 diabetes it must be used together with a short-acting insulin.
• Do NOT give intravenously or in an insulin infusion pump; do NOT dilute or mix with any other insulin or solution.
• Do NOT transfer from the FlexTouch pen into a syringe - overdose and severe hypoglycemia can result.
• For pediatric patients needing less than 5 units per day, use the U-100 vial.
• Do not dose-convert between U-100 and U-200 pens - the dose window shows units to be delivered (U-100 pen dials in 1-unit steps, U-200 pen in 2-unit steps).
• Missed dose, adults: inject the daily dose during waking hours when discovered, keeping at least 8 hours between consecutive injections. Missed dose, pediatrics: contact the prescriber and monitor glucose more frequently until the next scheduled dose.
• Always check the insulin label before administration; use only if clear and colorless.
• Use FlexTouch pens with caution in visual impairment where the patient relies on audible clicks.

Contraindications

• During episodes of hypoglycemia

Cautions

• Never share a FlexTouch pen, insulin syringe or needle between patients, even if the needle is changed.
• Hyperglycemia or hypoglycemia with changes in insulin regimen (strength, manufacturer, type, injection site or route) - change only under close supervision with more frequent glucose monitoring.
• Hypoglycemia may be life-threatening; risk rises with dosage changes, concomitant drugs, meal or activity changes, renal or hepatic impairment, and hypoglycemia unawareness.
• Hypoglycemia due to medication errors - insulin mix-ups; never transfer drug from the pen into a syringe.
• Severe, life-threatening generalized allergy including anaphylaxis - discontinue, monitor and treat.
• Hypokalemia - insulin shifts potassium intracellularly; monitor and treat in patients at risk.
• Fluid retention and congestive heart failure with concomitant PPAR-gamma agonists (thiazolidinediones).

Adverse reactions

• Hypoglycemia (most common)
• Allergic reactions
• Injection site reactions
• Lipodystrophy and localized cutaneous amyloidosis
• Pruritus, rash
• Peripheral edema
• Weight gain
• Hypokalemia

Pregnancy Trial and published data have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal/fetal outcomes; poorly controlled diabetes in pregnancy itself carries substantial maternal and fetal risk.

Lactation No human milk data (present in rat milk); weigh the developmental and health benefits of breastfeeding against the mother's clinical need.