Apidra (insulin glulisine) - Sanofi Canada

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Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Table 3 - Common (≥1%) Adverse Drug Reactions in pooled adult Type 1 and 2 studies Adverse Event System Organ Class/ Preferred Term General Disorders and Administration Site Condition Injection site hypertrophy Metabolism and Nutrition Disorders Hypoglycemia NOS* Hypoglycemic seizure Hypoglycemic unawareness Nervous System Disorders Hypoglycemic coma *Not otherwise specified Insulin Glulisine (All studies) n=1833 (% of subjects) 9 (0.5) 83 (4.5) 16 (0.9) 1 (0.1) 49 (2.7) Lispro n= 333 (% of subjects) 7 (2.1) 22 (6.6) 7 (2.1) 4 (1.2) 13 (3.9) Regular Insulin n=1161 (% of subjects) - (-) 33 (2.8) 9 (0.8) - (-) 19 (1.6) Aspart n= 30 (% of subjects) - (-) 2 (6.7) - (-) 2 (6.7) Table 4 summarizes the adverse reactions occurring with frequency higher than 1% in a clinical study in children and adolescents with type 1 diabetes treated with insulin glulisine (n=277) or insulin lispro. - (-) Page 14 of 61
Table 4 - Common (≥1%) Adverse Drug Reactions in children and adolescents with Type 1 diabetes Adverse Event System Organ Class/ Preferred Term General Disorders and Administration Site Condition Injection site hypertrophy Metabolism and Nutrition Disorders Hypoglycemia NOS* Hypoglycemic seizure Nervous System Disorders Hypoglycemic coma *Not otherwise specified Insulin Glulisine n=277 (% of subjects) 3 (1.1) 6 (2.2) 17 (6.1) 1 (0.4) Lispro n= 295 (% of subjects) 1 (0.3) 7 (2.4) 14 (4.7) 3 (1.0) During clinical studies, there were no clinically noteworthy differences between insulin glulisine and comparator short-acting insulins in the overall incidences of adverse events. The adverse events observed were those known in this pharmacological class and consequently common to insulins. Less Common Clinical Trial Adverse Drug Reactions (
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: Table 2 - Number (percentage) of pe
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 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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