Apidra (insulin glulisine) - Sanofi Canada

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Cartridges or SoloSTAR APIDRA cartridges or APIDRA SoloSTAR are not designed to allow any other insulin to be mixed in the cartridge. If the injection pen malfunctions, the solution may be drawn from the cartridge into a syringe (suitable for an insulin with U-100) and injected. Continuous Subcutaneous Insulin Infusion pump APIDRA may be used for Continuous Subcutaneous Insulin Infusion (CSII) in pump systems suitable for insulin infusion. When used with an insulin infusion pump, APIDRA should not be mixed with any other insulin or diluted with any other solution. Patients using CSII should be comprehensively instructed on the use of the system pump. The infusion set and reservoir should be changed every 48 hours using aseptic technique. Patients administering APIDRA by CSII must have an alternative insulin delivery system available in case of pump system failure. OVERDOSAGE Hypoglycemia may occur as a result of an excess of insulin relative to food intake, energy exposure or both. Mild/moderate episodes of hypoglycemia can usually be treated with oral carbohydrates. Adjustments in dosage of the medicinal product, meal patterns, or physical activity may be needed. Severe episodes with coma, seizure, or neurologic impairment may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose. Sustained carbohydrate intake and observation may be necessary because hypoglycemia may recur after apparent clinical recovery. For management of a suspected drug overdose, contact your regional Poison Control Centre. Page 20 of 61
ACTION AND CLINICAL PHARMACOLOGY Pharmacodynamics The primary activity of insulins and insulin analogues, including insulin glulisine, is regulation of glucose metabolism. Insulins lower blood glucose levels by stimulating peripheral glucose uptake by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulins inhibit lipolysis in the adipocyte, inhibit proteolysis, and enhance protein synthesis. The glucose lowering activities of APIDRA and of regular human insulin are equipotent when administered by the intravenous route. After subcutaneous administration the effect of APIDRA is more rapid in onset and of shorter duration compared to regular human insulin. This has been demonstrated in studies in healthy volunteers and patients with diabetes. In a study in patients with Type 1 diabetes (n= 20), the glucose-lowering profiles of APIDRA and regular human insulin were assessed at various times in relation to a standard meal at a dose of 0.15 U/kg (see Figure 1). Figure 1: Glucose-lowering effect over 6 hours. APIDRA given 2 minutes (glulisine-pre) before the start of a meal compared to regular human insulin given 30 minutes (Regular - 30 min) before start of the meal (Figure 1A) and compared to regular human insulin (Regular - pre) given 2 minutes before a meal (Figure 1B). APIDRA given 15 minutes (glulisine-post) after start of a meal compared to regular human insulin (Regular - pre) given 2 minutes before a meal (Figure 1C). On the x-axis zero (0) is the start of a 15-minute meal. Figure 1A Figure 1B Figure 1C BLOOD GLUCOSE - mg/dL 200 180 160 140 120 100 80 MEAL APIDRA - before REGULAR - 30 min -1 0 1 2 3 4 5 6 TIME - hour Legend: ↑ = Injection time Regular Human Insulin ↑ = Injection time Apidra BLOOD GLUCOSE - mg/dL 200 180 160 140 120 100 80 MEAL -1 0 1 2 3 4 5 6 TIME - hour APIDRA - before REGULAR - before BLOOD GLUCOSE - mg/dL 200 180 160 140 120 100 80 MEAL -1 0 1 2 3 4 5 6 TIME - hour APIDRA - after REGULAR - before Page 21 of 61
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: APIDRA should be administered by su
Page 23 and 24: Table 7. Pharmacokinetic and Pharma
Page 25 and 26: gender did not show differences in
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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