Insulin detemir

FDA label

Read the full label on DailyMed ↗

Renal PK no different from healthy volunteers, but human insulin studies show higher circulating insulin in kidney impairment - careful glucose monitoring and dose adjustment may be necessary.

Hepatic Systemic exposure was lower in severe hepatic impairment, but human insulin studies show higher circulating insulin in liver impairment - careful glucose monitoring and dosage adjustment may be necessary.

On a twice-daily regimen the evening dose is given with the evening meal, at bedtime, or 12 hours after the morning dose. Limitation of Use: not recommended to treat 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.
• Once-daily dosing: give with the evening meal or at bedtime.
• Twice-daily dosing: give the evening dose with the evening meal, at bedtime, or 12 hours after the morning dose.
• In type 1 diabetes it must be used in a regimen with a rapid- or short-acting insulin.
• Do NOT give intravenously or in an insulin infusion pump; do NOT dilute or mix with any other insulin or solution.
• Always check the insulin label before administration; use only if clear and colorless.
• The FlexPen dials in 1-unit increments - use with caution in visual impairment where the patient relies on audible clicks.
• Monitor blood glucose more frequently during any insulin-regimen change.

Available strengths

• inj 100 [iu]/ml

Contraindications

• During episodes of hypoglycemia

Cautions

• Never share a FlexPen, 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 - accidental mix-ups between insulin products; check labels before every injection.
• 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 heart failure with concomitant PPAR-gamma agonists (thiazolidinediones).

Adverse reactions

• Hypoglycemia (most common)
• Allergic reactions, including anaphylaxis
• Injection site reactions
• Lipodystrophy and localized cutaneous amyloidosis
• Rash, pruritus
• Hypokalemia

Pregnancy Published studies and postmarketing reports 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 Exogenous human insulin products including insulin detemir are transferred into human milk with no reported adverse reactions in breastfed infants; no data on milk production.