Apidra (insulin glulisine) - Sanofi Canada

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Figure 2: Pharmacokinetic profile of insulin glulisine and regular human insulin in patients with Type 1 diabetes after a dose of 0.15 U/kg. INSULIN CONC - µU/mL When APIDRA was injected subcutaneously into different areas of the body, the timeconcentration profiles were similar with a slightly faster absorption when administered in the abdomen compared to the deltoid or thigh (see DOSAGE AND ADMINISTRATION.) The absolute bioavailability of insulin glulisine after subcutaneous administration is about 70%, regardless of injection area (abdomen 73%, deltoid 71%, thigh 68%). The Tmax for the abdomen was 44 min (range 27-69 min); 58 min for the deltoid (range 30-85 min), and 66 min for the thigh (range 35-108 min). Distribution and Elimination: The distribution and elimination of insulin glulisine and regular human insulin after intravenous administration are similar with volumes of distribution of 13 L and 21 L and half lives of 13 and 17 minutes, respectively. After subcutaneous administration, insulin glulisine is eliminated more rapidly than regular human insulin with an apparent half life of 42 minutes compared to 86 minutes. Special Populations and Conditions 80 60 40 20 0 APIDRA REGULAR 0 1 2 3 TIME - hour 4 5 6 Pediatrics: The pharmacokinetic and pharmacodynamic properties of insulin glulisine and regular human insulin were assessed in a study conducted in pediatric patients with Type 1 diabetes (children [7 – 11 years, n = 10] and adolescents [12 – 16 years, n = 10]). The relative differences in pharmacokinetics and pharmacodynamics between insulin glulisine and regular human insulin in pediatric patients with Type 1 diabetes were similar to those in healthy adult subjects and adults with Type 1 diabetes. Gender: Information on the effect of gender on the pharmacokinetics of insulin glulisine is not available. However, in Phase III clinical trials in adults (n=2408), subgroup analyses based on Page 24 of 61
gender did not show differences in safety and efficacy between insulin glulisine and other shortacting insulin formulations. Hepatic Insufficiency: The effect of hepatic impairment on the pharmacokinetics of insulin glulisine has not been studied. However, some studies with human insulin have shown increased circulating levels of insulin in patients with liver failure (see WARNINGS AND PRECAUTIONS). Race: Information on the effect of race on the pharmacokinetics of insulin glulisine is not available. Renal Insufficiency: Studies with human insulin have shown increased circulating levels of insulin in patients with renal failure. In a study performed in 24 non-diabetic subjects covering a wide range of renal function (CrCl>80mL/min; 30-50mL/min;
Page 1 and 2: PRODUCT MONOGRAPH APIDRA ® insulin
Page 3 and 4: PRODUCT MONOGRAPH APIDRA ® insulin
Page 5 and 6: PHARMACOLOGY). APIDRA given by subc
Page 7 and 8: Hyperglycemia: The use of too low i
Page 9 and 10: and reduced insulin metabolism, sim
Page 11 and 12: Occupational Hazards The patient’
Page 13 and 14: Table 2 - Number (percentage) of pe
Page 15 and 16: Table 4 - Common (≥1%) Adverse Dr
Page 17 and 18: Table 5- Established or Potential D
Page 19 and 20: APIDRA should be administered by su
Page 21 and 22: ACTION AND CLINICAL PHARMACOLOGY Ph
Page 23: Table 7. Pharmacokinetic and Pharma
Page 27 and 28: Opened APIDRA SoloSTAR should not b
Page 29 and 30: glargine followed by randomization.
Page 31 and 32: treatment regimens. No differences
Page 33 and 34: TOXICOLOGY Single and Repeated Dose
Page 35 and 36: Table 14: Reproductive & Developmen
Page 37 and 38: Table 15: Reproductive & Developmen
Page 39 and 40: PART III: CONSUMER INFORMATION APID
Page 41 and 42: INTERACTIONS WITH THIS MEDICATION O
Page 43 and 44: 12. Make sure the tip of the needle
Page 45 and 46: Hyperglycemia Hyperglycemia (too mu
Page 47 and 48: MORE INFORMATION Your physician, ph
Page 49 and 50: APIDRA should be given within 15 mi
Page 51 and 52: Do not take a double dose to make u
Page 53 and 54: history of diabetes, or in patients
Page 55 and 56: MORE INFORMATION Your physician, ph
Page 57 and 58: efore or within 20 minutes after st
Page 59 and 60: Preparing the Dose 1. To avoid medi
Page 61: • redness, itching, swelling, or

Apidra (insulin glulisine) - Sanofi Canada

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