Levemir (insulin detemir [rDNA origin] injection)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
WARNINGS AND PRECAUTIONS
- When a GLP-1 receptor agonist is used in combination with LEVEMIR, the LEVEMIR dose may need to be lowered or more conservatively titrated to minimize the risk of hypoglycemia.
- All patients…
Clinical trial experience
- In the LEVEMIR add-on to liraglutide+metformin trial, all patients received liraglutide 1.8 mg +metformin during a 12-week run-in period. During the run-in period, 167 patients (17% of enrolled total) withdrew from the trial: 76 (46% of withdrawals) of these patients doing so because of gastrointestinal adverse reactions and 15 (9% of withdrawals) doing so due to other adverse events…
How should I use Levemir?
- Give yourself separate injections. You may give the separate injections in the same body area (for example, your stomach area), but you should not give the injections right next to each other.
What are the possible side effects of Levemir?
- In some people their blood sugar may get so low that they need another person to help them.
- If you are using LEVEMIR with another diabetes medicine, your LEVEMIR dose may need to be changed to reduce your chance of getting low blood sugar.
6 ADVERSE REACTIONS
6.1 Clinical Trial Experience
- added..."A 52-week, multinational, multicentre, open-label, randomized, parallel, efficacy and safety comparison of insulin detemir and NPH insulin in children and adolescents 2-16 years with type 1 diabetes on a basal-bolus regimen with insulin aspart as bolus insulin”
8 USE IN SPECIAL POPULATIONS
8.4 Pediatric Use
- The pharmacokinetics, safety and effectiveness of subcutaneous injections of LEVEMIR have been established in pediatric patients (age 2 to 17 years) with type 1 diabetes
PATIENT PACKAGE INSERT (revised)