Product Monograph - Bydureon Bcise
RECENT MAJOR LABEL CHANGES
| 7 WARNINGS AND PRECAUTIONS, Hematologic | 03/2022 |
TABLE OF CONTENTS
Sections or subsections that are not applicable at the time of authorization are not listed.
RECENT MAJOR LABEL CHANGES ..................................................................................... 2
TABLE OF CONTENTS .......................................................................................................... 2
PART I: HEALTH PROFESSIONAL INFORMATION............................................................... 4
1 INDICATIONS.............................................................................................................. 4
1.1 Pediatrics ........................................................................................................... 4
1.2 Geriatrics............................................................................................................ 4
2 CONTRAINDICATIONS ............................................................................................... 4
3 SERIOUS WARNINGS AND PRECAUTIONS BOX...................................................... 5
4 DOSAGE AND ADMINISTRATION .............................................................................. 5
4.1 Dosing Considerations ........................................................................................ 5
4.2 Recommended Dose and Dosage Adjustment .................................................... 5
4.4 Administration..................................................................................................... 6
4.5 Missed Dose....................................................................................................... 6
5 OVERDOSAGE ........................................................................................................... 7
6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ........................ 7
7 WARNINGS AND PRECAUTIONS .............................................................................. 7
7.1 Special Populations .......................................................................................... 11
7.1.1 Pregnant Women ........................................................................................ 11
7.1.2 Breast-feeding............................................................................................. 11
7.1.3 Pediatrics .................................................................................................... 11
7.1.4 Geriatrics .................................................................................................... 12
8 ADVERSE REACTIONS ............................................................................................ 12
8.1 Adverse Reaction Overview .............................................................................. 12
8.2 Clinical Trial Adverse Reactions ........................................................................ 12
8.3 Less Common Clinical Trial Adverse Reactions................................................. 15
8.5 Post-Market Adverse Reactions ........................................................................ 15
9 DRUG INTERACTIONS ............................................................................................. 16
9.2 Drug Interactions Overview ............................................................................... 16
9.4 Drug-Drug Interactions...................................................................................... 16
9.5 Drug-Food Interactions ..................................................................................... 19
9.6 Drug-Herb Interactions...................................................................................... 19
9.7 Drug-Laboratory Test Interactions ..................................................................... 19
10 CLINICAL PHARMACOLOGY ................................................................................... 19
10.1 Mechanism of Action ................................................................................... 20
10.2 Pharmacodynamics..................................................................................... 20
10.3 Pharmacokinetics........................................................................................ 22
11 STORAGE, STABILITY AND DISPOSAL .................................................................. 23
12 SPECIAL HANDLING INSTRUCTIONS ..................................................................... 24
PART II: SCIENTIFIC INFORMATION .................................................................................. 25
13 PHARMACEUTICAL INFORMATION ........................................................................ 25
14 CLINICAL TRIALS .................................................................................................... 26
14.1 Clinical Trials by Indication .......................................................................... 26
15 MICROBIOLOGY....................................................................................................... 29
16 NON-CLINICAL TOXICOLOGY ................................................................................. 29
PATIENT MEDICATION INFORMATION .............................................................................. 33
PART I: HEALTH PROFESSIONAL INFORMATION
1 INDICATIONS
Monotherapy:
BYDUREON BCise (exenatide prolonged-release injectable suspension) is indicated for use as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus (T2DM) for whom metformin is inappropriate due to contraindications or intolerance.
Add on combination:
BYDUREON BCise (exenatide prolonged-release injectable suspension) is indicated in adult patients with T2DM to improve glycemic control, in combination with:
- metformin
- sulfonylurea (alone or with metformin)
when the existing therapy (with or without metformin), along with diet and exercise, does not provide adequate glycemic control (see 14 CLINICAL TRIALS).
1.1 Pediatrics
Pediatrics (<18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.
1.2 Geriatrics
Geriatrics (≥ 65 years of age): Greater sensitivity of some older individuals cannot be ruled out. Clinical experience in patients 75 years of age and older is very limited. Therefore, use with caution in the elderly (see 4 DOSAGE AND ADMINISTRATION, 7 WARNINGS AND PRECAUTIONS and 10 CLINICAL PHARMACOLOGY).
2 CONTRAINDICATIONS
BYDUREON BCise is contraindicated in patients with:
- known hypersensitivity to this product or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
- a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) (see 7 WARNINGS AND PRECAUTIONS).
- end-stage renal disease (ESRD) or severe renal impairment (creatinine clearance <30 mL/min), including patients on dialysis (see 7 WARNINGS AND PRECAUTIONS and Special Populations and Conditions).
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
Serious Warnings and Precautions
Thyroid C-cell tumours
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4 DOSAGE AND ADMINISTRATION
4.1 Dosing Considerations
- Switching from BYETTA (exenatide twice daily) to BYDUREON BCise (exenatide prolonged-release injectable suspension): Patients switching from BYETTA to BYDUREON BCise may experience transient elevations in blood glucose concentrations, which generally improve within two to four weeks after initiation of therapy.
- Switching between BYDUREON (exenatide for extended-release injectable suspension) and BYDUREON BCise (exenatide prolonged-release injectable suspension): Patients switching between BYDUREON and BYDUREON BCise may do so, with minimal expected effect on blood glucose concentrations.
- Discontinuation of BYDUREON BCise: After discontinuation of BYDUREON BCise, plasma levels of exenatide decline over 10 weeks (see General and 10 CLINICAL PHARMACOLOGY). Choice of other medicinal products and dose selection should be considered accordingly, as adverse reactions may continue and the anti-hyperglycemic effect may persist until exenatide levels decline.
The concurrent use of BYDUREON BCise with insulin has not been studied and is not recommended.
4.2 Recommended Dose and Dosage Adjustment
- BYDUREON BCise should be administered once every seven days (weekly). The dose can be administered at any time of day, with or without meals.
- When BYDUREON BCise is added to sulfonylurea therapy, a decrease in the dose of the sulfonylurea may be considered to reduce the risk of hypoglycemia (see Endocrine and Metabolism).
Special Populations:
Geriatrics (≥65 years of age)
A greater sensitivity of some older individuals cannot be ruled out. Use caution when initiating BYDUREON BCise in patients 65 years of age or older (see Special Populations and Conditions).
Pediatrics
Health Canada has not authorized an indication for pediatric use.
Hepatic Impairment
No dosage adjustment is required in patients with hepatic impairment (see Special Populations and Conditions).
Renal Impairment
BYDUREON BCise is contraindicated in patients with end-stage renal disease (ESRD) or severe renal impairment (creatinine clearance <30 mL/min), including patients on dialysis (see 2 CONTRAINDICATIONS).
No dosage adjustment of BYDUREON BCise is required in patients with mild renal impairment (creatinine clearance 50 to 80 mL/min). BYDUREON BCise should be used with caution in patients with moderate renal impairment (creatinine clearance 30 to 50 mL/min) and renal transplant patients (see Renal and Special Populations and Conditions).
4.4 Administration
Appropriate training is recommended for non-healthcare professionals administering BYDUREON BCise. The “Instructions for Use”, which are attached to the PATIENT MEDICATION INFORMATION and also provided in the carton, must be followed carefully by the patient.
BYDUREON BCise is intended for subcutaneous (SC) self-administration by the patient, and must not be administered intravenously or intramuscularly. BYDUREON BCise is administered as a SC injection in the abdomen, thigh or upper arm region. Advise patients to use a different injection site each week when injecting in the same region.
BYDUREON BCise is supplied as an autoinjector, containing a suspension of exenatide packaged in a 2-mL glass cartridge. The autoinjector contains an integrated needle.
BYDUREON BCise must be removed from the refrigerator 15 minutes before use. The suspension must be mixed by shaking hard for at least 15 seconds, and visually inspected prior to use. The suspension should only be used if it is evenly mixed and cloudy with no white medicine seen along the side, bottom or top of the autoinjector window. BYDUREON BCise must be injected immediately after the autoinjector is prepared.
4.5 Missed Dose
If a dose of BYDUREON BCise is missed, the patient should take it as soon as they remember within 3 days after the missed dose. The patient can take the next dose at the usual weekly time.