Apidra (insulin glulisine) - Sanofi Canada

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Pediatrics: The safety and effectiveness of APIDRA have been investigated in pediatric patients (age 4 to 17 years) with Type 1 diabetes [9(1.6%) < 6 years, 32 (5.6%) between 6 and 8 years, 149 (26%) between 8 and 12 years, and 382 (67%) above 12 years old]. APIDRA has not been studied in pediatric patients younger than 4 years of age. There is insufficient clinical data on the use of APIDRA in children below the age of 6 years. As in adults, the dosage of APIDRA must be individualized in pediatric patients based on metabolic needs and frequent monitoring of blood glucose. Geriatrics (≥ 65 years of age): Hypoglycemia may be difficult to recognize in the elderly (see WARNINGS AND PRECAUTIONS, Endocrine and Metabolism, Hypoglycemia). In the elderly, progressive deterioration of renal function may lead to steady decrease in insulin requirements. Careful glucose monitoring and dose adjustments of insulin or insulin analogues including APIDRA may be necessary (see WARNINGS AND PRECAUTIONS, Renal/ Hepatic/ Biliary/ Pancreatic impairment). In Phase III clinical trials (n=2408), APIDRA was administered to 147 patients ≥65 years of age and 27 patients ≥75 years of age. The majority of these were patients with Type 2 diabetes. The change in glycated hemoglobin (A1c) values and hypoglycemia frequencies did not differ by age, but greater sensitivity of some older individuals cannot be ruled out. Other: The presence of diseases such as Acromegaly, Cushing's Syndrome, Hyperthyroidism, and Pheochromocytoma can complicate the control of Diabetes Mellitus. Pens to be used with APIDRA cartridges The APIDRA cartridges should only be used with the following pens: ClikSTAR ® and Autopen ® 24 * and should not be used with any other reusable pen as the dosing accuracy has only been established with the listed pens. * Registered trade-mark of Owen Mumford Limited, used under license. Page 10 of 61
Occupational Hazards The patient’s ability to concentrate and react may be impaired as a result of hypoglycemia or hyperglycemia or, for example, as a result of visual impairment. This may constitute a risk in situations where these abilities are of special importance (e.g. driving a car or operating machinery). Patients should be advised to take precautions to avoid hypoglycemia whilst driving. This is particularly important in those who have reduced or absent awareness of the warning symptoms of hypoglycemia or have frequent episodes of hypoglycemia. It should be considered whether it is advisable to drive or operate machinery in these circumstances. ADVERSE REACTIONS Adverse Drug Reaction Overview Overall, clinical studies comparing APIDRA with short-acting insulins did not demonstrate a difference in frequency of adverse events. The adverse events observed were those known in this pharmacological class and consequently common to insulins. Body as a whole: Local Allergy As with other insulin therapy, local allergy in patient may occur as redness, itching, swelling, or hemorrhage. These minor reactions usually resolve in a few days to a few weeks. In some instances, these reactions may be related to factors other than insulin, such as irritants in a skin cleansing agent or poor injection technique. Systemic Allergy Less common, but potentially more serious, is generalized allergy to insulin (including insulin glulisine), which may cause rash (including pruritus) over the whole body, shortness of breath, wheezing, reduction in blood pressure, rapid pulse, or sweating. Severe cases of generalized allergy, including anaphylactic reactions, may be life threatening. Localized reactions and generalized myalgias have been reported with the use of m-cresol as an injectable excipient. Page 11 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 reduced insulin metabolism, sim
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 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
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Apidra (insulin glulisine) - Sanofi Canada

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