LEVEMIR

AbsorptionAfter subcutaneous injection of LEVEMIR in healthy subjects and in patients with diabetes, insulin detemir serum concentrations had a relatively constant concentration/time profile over 24 hours with the maximum serum concentration (Cmax) reached between 6-8 hours post-dose. Insulin detemir was more slowly absorbed after subcutaneous administration to the thigh where AUC 0-5h was 30-40% lower and AUC 0-inf was 10% lower than the corresponding AUCs with subcutaneous injections to the d...

The efficacy and safety of LEVEMIR given once-daily at bedtime or twice-daily (before breakfast and at bedtime, before breakfast and with the evening meal, or at 12-hour intervals) was compared to that of once-daily or twice-daily NPH insulin in open-label, randomized, parallel trials of 1155 adults with type 1 diabetes mellitus, 347 pediatric patients with type 1 diabetes mellitus, and 869 adults with type 2 diabetes mellitus. The efficacy and safety of LEVEMIR given twice-daily was compared to once-daily insulin glargine in an open-label, randomized, parallel trial of 320 patients with type ...

The following adverse reactions are discussed elsewhere:

• Hypoglycemia [see Warnings and Precautions ( 5.3 )]
• Hypoglycemia Due to Medication errors [see Warnings and Precautions ( 5.4 )]
• Hypersensitivity Reactions [see Warnings and Precautions ( 5.5 )]
• Hypokalemia [see Warnings and Precautions ( 5.6 )] Adverse reactions associated with LEVEMIR include hypoglycemia, allergic reactions, injection site reactions, lipodystrophy, rash and pruritus ( 6 ). To report SUSPECTED ADVERSE REACTIONS, ...

LEVEMIR is contraindicated:

• During episodes of hypoglycemia [see Warnings and Precautions (5.3)]
• In patients with hypersensitivity to insulin detemir or any of the excipients in LEVEMIR. Reactions have included anaphylaxis [see Warnings and Precautions (5.5) and Adverse Reactions (6.1) ] .
• During episodes of hypoglycemia ( 4 )
• Hypersensitivity to insulin detemir or any of the excipients i...

• Never Share a LEVEMIR FlexPen, insulin syringe, or needle between patients, even if the needle is changed ( 5.1 ).
• Hyperglycemia or hypoglycemia with changes in insulin regimen: Make changes to a patient’s insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) under close medical supervision with increased frequency of blood glucose monitoring ( 5.2 ).
• Hypoglycemia: May be life-threatening. Increase frequency of glucose monitoring with chan...

7 DRUG INTERACTIONS Table 6 includes clinically significant drug interactions with LEVEMIR.

Table 6Clinically Significant Drug Interactions with LEVEMIR Drugs That May Increase the Risk of Hypoglycemia Drugs: Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, som...