PrAPO-SEMAGLUTIDE INJECTION - Antihyperglycemic Agent (GLP-1 Receptor Agonist) - Product Monograph Including Patient Medication Information

Oct 12, 2026

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PrAPO-SEMAGLUTIDE INJECTION is an antihyperglycemic agent formulated as a solution for subcutaneous injection in pre-filled pens. It is produced by solid-phase synthetic chemistry and is presented in 2 mg and 4 mg strengths per pen, with specified concentrations and pre-filled dose options (0.25/0.5 mg and 1 mg). The monograph includes sections for indications by population, contraindications, serious warnings and precautions, dosing and administration, overdose, composition and packaging, warnings and precautions, adverse reactions, drug interactions, clinical pharmacology, and storage, stability, and disposal.

LanguageEnglish

CategoryGeneral

FormatPDF

Pages63

Reading Time22 min

AccessFree to download

Part 1: Healthcare Professional Information

1 Indications

1.1 Pediatrics

1.2 Geriatrics

2 Contraindications

3 Serious Warnings and Precautions Box

4 Dosage and Administration

4.1 Dosing Considerations

4.2 Recommended Dose and Dosage Adjustment

4.4 Administration

4.5 Missed Dose

5 Overdose

6 Dosage Forms, Strengths, Composition and Packaging

7 Warnings and Precautions

7.1 Special Populations

7.1.1 Pregnancy

7.1.2 Breastfeeding

7.1.3 Pediatrics

7.1.4 Geriatrics

7.1.5 Renal Insufficiency

7.1.6 Hepatic Insufficiency

8 Adverse Reactions

8.1 Adverse Reaction Overview

8.2 Clinical Trial Adverse Reactions

8.3 Less Common Clinical Trial Adverse Reactions

8.5 Post-Market Adverse Reactions

9 Drug Interactions

9.2 Drug Interactions Overview

9.3 Drug-Behaviour Interactions

9.4 Drug-Drug Interactions

9.5 Drug-Food Interactions

9.6 Drug-Herb Interactions

9.7 Drug-Laboratory Test Interactions

10 Clinical Pharmacology

10.1 Mechanism of Action

10.2 Pharmacodynamics

10.3 Pharmacokinetics

10.4 Immunogenicity

11 Storage, Stability and Disposal

12 Special Handling Instructions

Product Monograph Including Patient Medication Information PrAPO-SEMAGLUTIDE INJECTION Solution for Subcutaneous Injection in a pre-filled pen Produced by solid-phase synthetic chemistry 2 mg / pen (0 .68 mg / mL) 4 mg / pen (1 .34 mg / mL) Pre-filled pen delivering doses of 0.25 mg or 0.5 mg and Pre-filled pen delivering doses of 1 mg Antihyperglycemic Agent Glucagon-like Peptide-1 (GLP-1) Receptor Agonist APOTEX INC. 150 Signet Drive Toronto, Ontario M9L 1T9 Date of Authorization: 2026-05-01 Control Number: 290796 Recent Major Label Changes None at time of the most recent authorization Table of Contents Certain sections or subsections that are not applicable at the time of the preparation of the most recent authorized product monograph are not listed. Recent Major Label Changes .................................................................................................. 2 Table of Contents..................................................................................................................... 2 Part 1: Healthcare 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 Overdose ....................................................................................................................... 6 6 Dosage Forms, Strengths, Composition and Packaging........................................... 7 7 Warnings and Precautions .......................................................................................... 8 7.1 Special Populations .................................................................................................. 11 7.1.1 Pregnancy.................................................................................................12 7.1.2 Breastfeeding ...........................................................................................12 7.1.3 Pediatrics .................................................................................................12 7.1.4 Geriatrics .................................................................................................12 7.1.5 Renal Insufficiency ...................................................................................12 7.1.6 Hepatic Insufficiency ................................................................................12 8 Adverse Reactions ......................................................................................................13 8.1 Adverse Reaction Overview ..................................................................................... 13 8.2 Clinical Trial Adverse Reactions .....................................................................

FAQs

What is PrAPO-SEMAGLUTIDE INJECTION and how is it administered?

It is an antihyperglycemic agent formulated as a solution for subcutaneous injection in pre-filled pens. The monograph specifies dosing by pen-delivered dose options.

What populations are covered for indications and special warnings?

Indications and warnings include sections for pediatrics and geriatrics, and special populations include pregnancy, breastfeeding, pediatrics, geriatrics, renal insufficiency, and hepatic insufficiency.

What topics are included regarding safety, interactions, and pharmacology?

The monograph covers contraindications, serious warnings and precautions, adverse reactions (including clinical trial and post-market), drug interactions (overview and interaction types), and clinical pharmacology such as mechanism of action, pharmacodynamics, pharmacokinetics, and immunogenicity.

Oct 12, 2026

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