FIASP

AbsorptionPharmacokinetic results from a euglycemic clamp study in adult patients with type 1 diabetes mellitus (N=51) showed that insulin aspart appeared in the circulation ~2.5 minutes after administration of FIASP (Figure 3). Time to maximum insulin concentrations was achieved ~63 minutes after administration of FIASP. Figure 3. Mean Insulin Aspart Serum Concentration Profile in Adult Subjects with Type 1 Diabetes Mellitus (N=51) following a single 0.2 unit/kg dose (subcutaneous) of FIASP To...

14.1 Overview of Clinical Studies The efficacy of FIASP was evaluated in 3 randomized, active-controlled trials of 18 to 26 weeks duration in adults and one randomized, active-controlled, treat-to-target trial of 26 weeks duration in pediatric patients. In total 1,224 adult subjects (N=763 with type 1 diabetes mellitus; N=461 with type 2 diabetes mellitus) and 519 pediatric subjects with type 1 diabetes mellitus were randomized to FIASP. In adult and pediatric patients with type 1 diabetes mellitus, mealtime FIASP and postmeal FIASP led to non-inferior glycemic control compared to mealtime Nov...

The following clinically significant adverse reactions are described elsewhere in labeling:

• Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen [see Warnings and Precautions ( 5.2 )]
• Hypoglycemia [see Warnings and Precautions ( 5.3 )]
• Hypokalemia [see Warnings and Precautions ( 5.5 )]
• Hypersensitivity and allergic reactions [see Warnings and Precautions ( 5.6 )] Adverse reactions observed with FIASP include: hypoglycemia, allergic reactions, hypersensitivity, injection/infusion...

FIASP is contraindicated:

• During episodes of hypoglycemia [see Warnings and Precautions ( 5.3 )] .
• In patients with known hypersensitivity to insulin aspart or any of the excipients in FIASP [see Warnings and Precautions ( 5.6 )] .
• During episodes of hypoglycemia ( 4 ).
• Hypersensitivity to insulin aspart or any of the excipients in FIASP ( 4 ).

• Never share a FIASP FlexTouch pen, 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 frequency of gluc...

7 DRUG INTERACTIONS Table 5 includes clinically significant drug interactions with FIASP. Table 5. Clinically Significant Drug Interactions with FIASP 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, somatos...