Insulin detemir

The retained label covers improvement of glycemic control in adults and pediatric patients with diabetes mellitus. Pediatric support includes ages 2–17 with type 1 diabetes. It is not recommended for diabetic ketoacidosis; in type 1 diabetes it must accompany rapid/short-acting insulin, not replace all insulin.

FDA’s June 2026 discontinued biologic list includes Levemir U-100 vial added December 31, 2024 and FlexPen added April 1, 2024. Other historical presentations have separate entries. The list can include still-licensed products discontinued from marketing; it does not establish a safety-based withdrawal or available local stock. Arrange replacement with the prescriber/pharmacist rather than stop basal insulin.

Inject subcutaneously in thigh, upper arm or abdomen; rotate within the region and avoid abnormal lipodystrophy/amyloid sites. Use only clear/colorless solution. Do not mix or dilute, administer IV or use an insulin pump. Adjust for glucose goals, meal/activity changes, illness, interacting drugs and renal/hepatic function under supervision; no universal daily maximum or missed-dose algorithm is supplied.

The retained label says conversion FROM glargine or NPH TO detemir can be unit-to-unit with recommended adjustments/monitoring; some type 2 patients need more detemir than NPH. That does not validate the reverse switch to every replacement insulin after discontinuation. Verify the exact new product/strength and clinician’s plan. FlexPen’s one-unit increments and device delivery limit are device features, not a clinical dose ceiling.

Do not use during an episode of hypoglycemia or with hypersensitivity to insulin detemir or an excipient, including prior anaphylaxis.

The retained selected label has no boxed warning. Severe hypoglycemia, potassium disturbances and product/device errors remain major risks.

Hypoglycemia is the most common insulin reaction. Other reported effects include injection-site reactions, allergy, rash/pruritus and lipodystrophy; localized cutaneous amyloidosis has been reported. Rates depend on regimen and trial definitions and are not directly comparable across insulin products.

Other antidiabetic agents, ACE inhibitors/ARBs and selected antimicrobials can increase hypoglycemia risk. Corticosteroids, some antipsychotics, thyroid hormones, sympathomimetics and hormonal medicines can reduce glucose-lowering effect. Review the actual full interaction list; adjustments and increased monitoring may be needed.

Alcohol, beta blockers, clonidine and lithium can increase or decrease glucose lowering; pentamidine may cause hypoglycemia then hyperglycemia. Beta blockers and other antiadrenergic medicines can blunt warning symptoms. TZDs add fluid-retention/failure risk; their reduction/discontinuation may be considered if failure develops.

Published pregnancy/postmarketing data have not identified a developmental-risk signal, and the randomized type 1 pregnancy study found no clear additional risk; this does not establish zero risk. Poor glucose control itself harms mother/fetus. Exogenous insulin products including detemir enter milk; no published infant adverse-reaction reports are identified, while milk-production effects are unknown. Consider maternal need, feeding benefits and changing insulin requirements.

Pediatric efficacy support includes type 1 ages 2–17; no infant regimen is supplied. Older adults require conservative starts/increments and careful monitoring because hypoglycemia may be difficult to recognize. Marketing discontinuation requires supervised alternatives for all ages.

Single-dose studies found similar detemir PK across renal function and lower exposure in severe hepatic impairment, but broader insulin physiology can still increase circulating insulin and hypoglycemia risk. Carefully monitor and adjust in either impairment; no fixed CrCl/Child-Pugh percentage or dialysis conversion is established.

Insulin promotes peripheral glucose uptake and inhibits hepatic glucose output, lipolysis and proteolysis. Detemir self-association at the site and albumin binding slow absorption/distribution. It has a relatively constant basal profile with action up to twenty-four hours; measured duration varies and twice-daily regimens can be needed.

Serum peaks are around six to eight hours; absolute bioavailability about 60%. More than 98% is albumin bound. Terminal half-life after subcutaneous dosing is about five to seven hours and is not the same as duration of glucose lowering. Injection region, age and organ function can alter exposure/effect.

Follow glucose measurements and the prescribed glycemic goal; increase checks during switching, illness or organ changes. Monitor potassium when at risk and signs of fluid retention with TZDs. Review meals/activity, injection sites, label/strength and device technique. Use a new needle, never share and remove a pen needle after use; obtain trained help with visual impairment. Arrange safe sharps disposal and a supervised replacement plan because U.S. presentations are discontinued.

Use the clinician-taught oral-glucose plan for mild episodes when safely able to swallow. Seizures, unconsciousness or severe impairment need emergency help and trained glucagon/IV glucose management; do not give oral intake to an unconscious person. Excess insulin can cause prolonged/recurrent hypoglycemia and hypokalemia even after apparent recovery; no safe excess dose or self-directed replacement conversion is supplied.

Product

Levemir insulin detemir U-100

Route

Subcutaneous injection only

Appearance

Clear, colorless solution

Retained repackaged vial

10 mL · NDC 50090-1276-0

U-100 is 100 units/mL: a 10 mL vial has 1,000 units; historical 3 mL pens contain 300 units. The retained full text names FlexPen, while the embedded patient instructions also include older FlexTouch. Their single-injection limits differ; follow the actual device’s instructions. These historical instructions do not establish current U.S. supply.

Retained vial instructions: unopened at 2–8°C until labeled expiry; room-temperature storage up to 30°C limits unopened use to forty-two days. Opened vials may be refrigerated or kept up to 30°C, but discard after forty-two days. In-use FlexPen/FlexTouch instructions require storage outside the refrigerator up to 30°C and disposal after forty-two days. Protect from heat/light, never freeze or use previously frozen insulin; follow actual expiry and do not use expired residual stock.