FIASP PENFILL

Pharmacokinetics of subcutaneous administration of NOVOLOG is presented below. Absorption and Bioavailability In studies in healthy volunteers (total n=107) and patients with type 1 diabetes (total n=40), the median time to maximum concentration of NOVOLOG in these trials was 40 to 50 minutes versus 80 to 120 minutes, for regular human insulin respectively. The relative bioavailability of NOVOLOG (0.15 units/kg) compared to regular human insulin indicates that the two insulins are absorbed to a ...

14.1 Overview of Clinical Studies The safety and effectiveness of subcutaneous NOVOLOG were compared to regular human insulin in 596 type 1 diabetes adult, 187 pediatric type 1 diabetes, and 91 adult type 2 diabetes patients using NPH as basal insulin (see Tables 3, 4, 5). The reduction in glycated hemoglobin (HbA 1c ) was similar to regular human insulin. The safety and effectiveness of NOVOLOG administered by continuous subcutaneous insulin infusion (CSII) by external pump were compared to buffered regular human insulin (administered by CSII), to lispro (administered by CSII) and compared to...

The following adverse reactions are also 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 observed with NOVOLOG include: hypoglycemia, allergic reactions, local injection site reactions, lipodystrophy, rash, and pruritus ( 6 ). To report SUSPECTED ADVERSE R...

NOVOLOG is contraindicated:

• During episodes of hypoglycemia [see Warnings and Precautions ( 5.3 )]
• In patients with hypersensitivity to NOVOLOG or one of its excipients, [see Warnings and Precautions ( 5.5 )]
• During episodes of hypoglycemia ( 4 ).
• Hypersensitivity to NOVOLOG or one of its excipients.

• Never share a NOVOLOG FlexPen or a NOVOLOG FlexTouch, PenFill cartridge or PenFill cartridge device 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...

7 DRUG INTERACTIONS The table below presents clinically significant drug interactions with NOVOLOG. 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, somatostatin analog (e.g., octreotide), and sulfonamide an...