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REMSIMA SC is a brand name for Infliximab, supplied as a kit. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: [02/2024] 4 DOSAGE AND ADMINITRATION, 4.2 Recommended Dose and Dosage Adjustment, 4.4 Administration [02/2024] 7 WARNINGS AND PRECAUTIONS [02/2024] 8 ADVERSE REACTIONS, 8.2 Clinical Trial Adverse Reactions, 8.3 Less Common Clinical Trial Adverse Drug Reactions, 8.5 Post-Market Adverse Reactions [02/2024] 10 CLINICAL…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations It is important to check the product labels to ensure that the correct formulation of infliximab (intravenous or subcutaneous) is being administered to the patient, as prescribed. 4 Administration. 2 Recommended Dose and Dosage Adjustment Rheumatoid Arthritis For patients initiating treatment with infliximab: Treatment with Remsima SC administered subcutaneously in adult patients with moderately to severely active rheumatoid arthritis should be initiated with loading doses of infliximab which may be intravenous or subcutaneous.
When subcutaneous loading is used, Remsima 120 mg RemsimaTM SC Product Monograph Page 6 of 81 should be given as a subcutaneous injection followed by additional subcutaneous injections at 1, 2, 3 and 4 weeks after the first injection, then every 2 weeks thereafter.
If intravenous loading doses of infliximab are given to initiate treatment, 2 intravenous infusions of infliximab 3 mg/kg should be given 2 weeks apart. 4 Administration. The recommended maintenance dose for Remsima SC is 120 mg once every 2 weeks.
Remsima SC should be given in combination with methotrexate. Crohn’s Disease and Ulcerative Colitis For patients who have completed an induction regimen with intravenously administered infliximab: The recommended maintenance dosing regimen of Remsima SC is 120 mg (given as one subcutaneous injection) once every 2 weeks, starting 4 weeks following completion of an induction regimen.
For patients already receiving intravenous infliximab maintenance therapy For patients who have been on maintenance therapy with intravenous infliximab and who are switching to Remsima SC maintenance therapy, the first dose of Remsima SC may be administered 8 weeks after the last infliximab intravenous infusion.
There is insufficient information regarding the switching of patients who received the intravenous infusions of infliximab higher than 3 mg/kg for rheumatoid arthritis or 5 mg/kg for Crohn’s disease or ulcerative colitis every 8 weeks to Remsima SC.
Information regarding switching patients from the subcutaneous formulation to intravenous infliximab is not available. Pediatrics Health Canada has not authorized an indication for pediatric use (see INDICATIONS). 4 Administration Remsima SC 120 mg solution for subcutaneous injection is provided with a pre-filled syringe (with or without needle guard) or in a pre-filled pen, and administered by subcutaneous (under the skin) injection only.
4 Immunogenicity, [02/2024] TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .................................................................. 4 1 INDICATIONS ...................................................................................................................
1 Pediatrics ................................................................................................................. 2 Geriatrics .................................................................................................................
4 2 CONTRAINDICATIONS .................................................................................................... 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ......................................................... 5 4 DOSAGE AND ADMINISTRATION ..................................................................................
1 Dosing Considerations............................................................................................. 2 Recommended Dose and Dosage Adjustment ........................................................ 4 Administration ..........................................................................................................
5 Missed Dose ............................................................................................................ 7 5 OVERDOSAGE .................................................................................................................
8 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .......................... 8 7 WARNINGS AND PRECAUTIONS ................................................................................... 1 Special Populations ...............................................................................................
1 Pregnant Women .............................................................................................. 2 Breast-feeding ................................................................................................... 3 Pediatrics ..........................................................................................................
[02/2024]
Remsima SC is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see Dosage Forms, Strengths, Composition and Packaging.
• Patients with severe infections such as sepsis, abscesses, tuberculosis and opportunistic infections (see WARNINGS AND PRECAUTIONS, Risk of Infections). • Patients with moderate or severe (NYHA Class III/IV) congestive heart failure (see WARNINGS AND PRECAUTIONS, Cardiovascular and ADVERSE REACTIONS, Congestive Heart Failure).
• Patients with history of hypersensitivity to infliximab, to other murine proteins, or to any excipients. For a complete listing, see DOSAGE FORMS, STRENGTHS, COMPOSITION RemsimaTM SC Product Monograph Page 5 of 81 AND PACKAGING section of the product monograph.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Infliximab in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Full instructions for use are provided in the PATIENT MEDICATION INFORMATION.
Dose-induction for initiation of infliximab therapy:
Rheumatoid Arthritis For patients beginning infliximab therapy, initial induction doses may be given intravenously or subcutaneously. When subcutaneous loading is used, Remsima SC 120 mg should be given as a subcutaneous injection followed by additional subcutaneous injections at 1, 2, 3 and 4 weeks after the first injection.
If intravenous loading doses of infliximab are given to initiate treatment, 2 intravenous infusions of infliximab 3 mg/kg should be given 2 weeks apart. See detailed instructions in the appropriate labelling for the selected intravenous infliximab preparation.
RemsimaTM SC Product Monograph Page 7 of 81 Ulcerative Colitis and Crohn’s Disease For patients beginning infliximab therapy, induction doses should be given intravenously. See detailed instructions in the appropriate labelling for the selected intravenous infliximab preparation.
e. at Week 6 following two IV infusion doses at Weeks 0 & 2 for rheumatoid arthritis; at Week 10 following three IV infusion doses at Weeks 0, 2 & 6 for ulcerative colitis or Crohn’s disease) or 2 weeks after five SC injection doses at Weeks 0, 1, 2, 3 & 4 for rheumatoid arthritis.
• The first maintenance dose of Remsima SC may also be administered under the supervision of a health professional 8 weeks after the most recent IV infusion for patients already receiving infliximab maintenance therapy. • The health professional should ensure appropriate follow-up of patients for any systemic injection reaction(s) and localized injection site reaction(s).
• For subsequent Remsima SC injections and after proper training in subcutaneous injection technique, patients may self-inject with Remsima SC if their physician determines that it is appropriate. Adequate medical follow-up should be provided by the physician as necessary.
Suitability of the patient for subcutaneous home use should be assessed and patients should be advised to inform their healthcare professional if they experience symptoms of an allergic reaction before administering the next dose. Patients should seek immediate medical attention if developing symptoms of serious allergic reactions.
Remsima SC should be discontinued in patients who have experienced a serious systemic allergic or hypersensitivity reaction. • Remsima SC should be refrigerated at 2 to 8oC. Do not freeze. Remsima SC may be stored at temperatures up to a maximum of 25°C for a period of up to 28 days.
Remsima SC must be discarded if not used within the 28-day period (See STORAGE, STABILITY AND DISPOSAL). 5 Missed Dose Missed dose for up to 7 days If the patient misses a dose of Remsima SC for up to 7 days after the original scheduled dose, the missed dose should be taken immediately.
The next dose should be administered as per the originally planned date and thereafter on the original bi-weekly schedule. Missed dose for 8 days or more If the patient misses […]
4 Geriatrics ........................................................................................................... 15 8 ADVERSE REACTIONS .................................................................................................
1 Adverse Reaction Overview .................................................................................. 2 Clinical Trial Adverse Reactions ............................................................................ 3 Less Common Clinical Trial Adverse Drug Reactions ...........................................
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data ............................................................................................................. 5 Post-Market Adverse Reactions ............................................................................
27 9 DRUG INTERACTIONS .................................................................................................. 2 Drug Interactions Overview ...................................................................................
4 Drug-Drug Interactions .......................................................................................... 5 Drug-Food Interactions .......................................................................................... 6 Drug-Herb Interactions ..........................................................................................
7 Drug-Laboratory Test Interactions ......................................................................... 30 10 CLINICAL PHARMACOLOGY ....................................................................................... 1 Mechanism of Action ..........................................................................................
2 Pharmacodynamics ............................................................................................ 3 Pharmacokinetics ............................................................................................... 30 11 STORAGE, STABILITY AND DISPOSAL ......................................................................
32 12 SPECIAL HANDLING INSTRUCTIONS ......................................................................... 32 PART II: SCIENTIFIC INFORMATION .......................................................................................
33 13 PHARMACEUTICAL INFORMATION ............................................................................ 33 14 CLINICAL TRIALS ..........................................................................................................
1 Clinical Trials by Indication ................................................................................ 4 Immunogenicity .................................................................................................. 40 15 MICROBIOLOGY ............................................................................................................
40 16 NON-CLINICAL TOXICOLOGY ...................................................................................... 41 PATIENT MEDICATION INFORMATION ...................................................................................
42 RemsimaTM SC Product Monograph Page 4 of 81 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS REMSIMA SC (infliximab injection) is indicated for: • use in combination with methotrexate for the reduction in signs and symptoms, […]