Apidra (insulin glulisine) - Sanofi Canada

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Antibody Production: Insulin administration may cause insulin antibodies to form. Insulin antibodies are frequently cross-reactive. Insulin administration may cause the insulin antibodies to form. Insulin antibodies are frequently cross-reactive. In clinical studies, cross-reactive antibodies were observed in both insulin glulisine and comparator (insulin lispro, regular human insulin) treatment groups with similar percents of increased and decreased titers. There was no correlation between crossreactive insulin antibody concentration and changes in A1c, insulin doses, or incidence of hypoglycemia and the clinical significance of these antibodies is not clear. In theory, the presence of such insulin antibodies may necessitate adjustment of the insulin dose in order to correct a tendency to hyperglycemia or hypoglycemia but has not been found on review of APIDRA clinical trials. Intercurrent conditions Insulin requirements may be altered during illness, emotional disturbances or stress. Insulin pumps When used in an external insulin pump for subcutaneous infusion, APIDRA should not be mixed with any other insulin or diluted with any other solution. Patients using external pump infusion therapy should be trained appropriately. Physicians and patients should carefully evaluate information on pump use in the APIDRA product monograph, package insert, and the pump manufacturer’s manual. APIDRA specific information should be followed for period of use, frequency of changing infusion sets, or other details specific to APIDRA usage, because APIDRA specific information may differ from general or other insulin’s pump manual instructions. Pump or infusion set malfunctions or insulin degradation can lead to hyperglycemia and ketosis in a short time. This is especially pertinent for rapid-acting insulin analogues that are more rapidly absorbed and have a shorter duration of action. Prompt identification and correction of the cause of hyperglycemia or ketosis is necessary. Interim therapy with subcutaneous injection may be required (see DOSAGE AND ADMINISTRATION, Continuous Subcutaneous Insulin Infusion Pump, CONSUMER INFORMATION, Vials, Continuous Subcutaneous Insulin Infusion Pump, STORAGE AND STABILITY). Renal / Hepatic / Biliary / Pancreatic impairment The pharmacokinetic properties of APIDRA were generally maintained in subjects with renal impairment. Studies have not been performed in patients with hepatic impairment. As with all insulins, APIDRA requirements may be diminished due to reduced capacity for gluconeogenesis Page 8 of 61
and reduced insulin metabolism, similar to observations found with other insulins (see ACTION AND CLINICAL PHARMACOLOGY, Special Populations and Conditions). Careful glucose monitoring and dose adjustments of insulin or insulin analogues including APIDRA may be necessary in patients with hepatic or renal dysfunction. Transferring Patients from Other Insulins Any change of insulin should be made cautiously and only under medical supervision. Changes in insulin strength, timing of administration, manufacturer, type (e.g., regular, NPH, or insulin analogs), species (animal, human), or method of manufacture (recombinant DNA versus animalsource insulin) may result in the need for a change in dosage. Concomitant oral antidiabetic treatment may need to be adjusted. Special Populations Pregnant Women: There are no well-controlled clinical studies of the use of APIDRA in pregnant women. Animal reproduction studies have not revealed any differences between APIDRA and human insulin regarding pregnancy, embryonal/foetal development, parturition or postnatal development (see Part II: TOXICOLOGY, Reproduction toxicity). It is essential for patients with pre-existing or gestational diabetes to maintain good metabolic control before conception and during pregnancy. Insulin requirements may decrease during the first trimester and generally increase during the second and third trimesters. Immediately after delivery, insulin requirements decline rapidly. Careful monitoring of glucose control is essential. Patients with diabetes must inform their doctor if they are pregnant or are contemplating pregnancy. Nursing Women: It is unknown whether APIDRA is excreted in human milk. Many drugs including human insulin, are excreted in human milk. There are no adequate and well-controlled studies in nursing women. For this reason, caution should be exercised when APIDRA is administered to a nursing woman. Lactating women may require adjustments in insulin dose and diet (see Part II: TOXICOLOGY, Reproduction toxicity). Page 9 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: Hyperglycemia: The use of too low i
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 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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