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SANDOZ TOFACITINIB is a brand name for Tofacitinib, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 02/2025 1.1 INDICATIONS, Pediatrics 02/2025 4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations 02/2025 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage Adjustment 02/2025 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage Adjustment, Special populations, Pediatrics (<18 years of age 02/2025 7…
Verbatim from this product's HC label. Tap a section to expand.
3 Pediatrics 02/2025 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 ......................................................................
5 1 INDICATIONS ............................................................................................................... 6 2 CONTRAINDICATIONS .................................................................................................
6 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 6 4 DOSAGE AND ADMINISTRATION ................................................................................. 12 5 OVERDOSAGE............................................................................................................
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). MALIGNANCIES Lymphoma and other malignancies have been observed in patients treated with tofacitinib. Epstein Barr Virus-associated post-transplant lymphoproliferative disorder has been observed at an increased rate in renal transplant patients treated with tofacitinib and concomitant immunosuppressive medications.
2 Clinical Trial Adverse Reactions). Caution should be applied when using Sandoz Tofacitinib in geriatric patients, patients who are current or past smokers, and patients with other malignancy risk factors (see 7 WARNINGS AND PRECAUTIONS).
THROMBOSIS Rheumatoid arthritis patients with at least one CV risk factor had a higher rate of all-cause mortality and thrombosis, including pulmonary embolism, deep venous thrombosis, and arterial thrombosis, with tofacitinib 10 mg twice daily (BID) compared to those treated with 5 mg BID or TNF blockers.
Many of these adverse events were serious and some resulted in death. Avoid Sandoz Tofacitinib in patients at risk of thrombosis. Discontinue Sandoz Tofacitinib and promptly evaluate patients with symptoms of thrombosis (see 7 WARNINGS AND PRECAUTIONS).
For patients with ulcerative colitis (UC), use Sandoz Tofacitinib at the lowest effective dose and for the shortest duration needed to achieve/maintain therapeutic response (see 4 DOSAGE AND ADMINISTRATION). 2 Clinical Trial Adverse Reactions).
Caution should be applied when using Sandoz Tofacitinib in geriatric patients, patients who are current or past smokers, and patients with other CV risk factors (see 7 WARNINGS AND Sandoz Tofacitinib Page 8 of 102 Protected B / Protégé B PRECAUTIONS).
1 Dosing Considerations • Use of Sandoz Tofacitinib with other potent systemic immunosuppressants should be avoided. Combined use of tofacitinib with potent immunosuppressants or biologic DMARDS (tumor necrosis factor (TNF) antagonists, interleukin 1 receptor (IL-1R) antagonists, IL-6R antagonists, anti-CD20 monoclonal antibodies, IL-17 antagonists, IL- 12/IL-23 antagonists and selective co-stimulation modulators) has not been studied in RA, PsA, JIA, and UC patients.
3 Pediatrics 02/2025 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 ......................................................................
5 1 INDICATIONS ............................................................................................................... 6 2 CONTRAINDICATIONS .................................................................................................
6 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 6 4 DOSAGE AND ADMINISTRATION ................................................................................. 12 5 OVERDOSAGE............................................................................................................
12 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ............................... 12 7 WARNINGS AND PRECAUTIONS ................................................................................ 23 8 ADVERSE REACTIONS ................................................................................................
43 9 DRUG INTERACTIONS ................................................................................................ 48 10 CLINICAL PHARMACOLOGY .......................................................................................
49 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 54 12 SPECIAL HANDLING INSTRUCTIONS ........................................................................... 54 PART II: SCIENTIFIC INFORMATION .......................................................................................
Sandoz Tofacitinib (tofacitinib) is contraindicated: • In patients with known hypersensitivity to tofacitinib or 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.
• In patients with severe hepatic impairment (see 7 WARNINGS AND PRECAUTIONS). 2 Breast-feeding).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Tofacitinib 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.
g. azathioprine, tacrolimus, cyclosporine). 5 x 109 cells/L (see 7 WARNINGS AND PRECAUTIONS). • Sandoz Tofacitinib is contraindicated in patients with severe hepatic impairment. 2 Recommended Dose and Dosage Adjustment Rheumatoid Arthritis Sandoz Tofacitinib is to be used in combination with methotrexate.
Sandoz Tofacitinib monotherapy may be considered in cases of intolerance to methotrexate and to one or more DMARDs. The recommended dose of Sandoz Tofacitinib is 5 mg administered twice daily (BID). A dosage of Sandoz Tofacitinib 10 mg BID is not recommended for the treatment of rheumatoid arthritis (see 7 WARNINGS AND PRECAUTIONS).
Psoriatic Arthritis The recommended dose of Sandoz Tofacitinib is 5 mg administered BID in combination with MTX or another csDMARD. A dosage of Sandoz Tofacitinib 10 mg BID is not recommended for the treatment of psoriatic arthritis (see 7 WARNINGS AND PRECAUTIONS, Thrombosis).
Ankylosing Spondylitis The recommended dose of Sandoz Tofacitinib is 5 mg administered BID. A dosage of Sandoz Tofacitinib 10 mg BID is not recommended for the treatment of ankylosing spondylitis (see 7 WARNINGS and PRECAUTIONS, Thrombosis).
Sandoz Tofacitinib Page 9 of 102 Protected B / Protégé B Ulcerative Colitis The recommended dose is 10 mg given orally BID for induction for at least 8 weeks and 5 mg given BID for maintenance. Depending on therapeutic response; 10 mg BID may also be used for maintenance in some patients.
However, the lowest effective dose possible should be used for maintenance therapy to minimize adverse effects (see 7 WARNINGS AND PRECAUTIONS). Sandoz Tofacitinib induction therapy should be discontinued in patients who show no evidence of adequate therapeutic benefit by Week 16.
In patients who have responded to treatment with Sandoz Tofacitinib, corticosteroids may be cautiously reduced and/or discontinued in accordance with standard of care. Active Juvenile Idiopathic Arthritis (JIA) Sandoz Tofacitinib may be used as monotherapy or in combination with MTX.
The recommended dose in children ≥40 kg is one Sandoz Tofacitinib 5 mg tablet administered BID. An oral solution formulation that was used in the JIA clinical trials for patients weighing <40 kg is not marketed in Canada. Dosage of Sandoz Tofacitinib 10 mg BID are not recommended for the treatment of JIA (see 7 WARNINGS and PRECAUTIONS).
Dose Interruption or Discontinuation due to Serious Infections and Cytopenias • Avoid use of Sandoz Tofacitinib if a patient develops a serious infection until the infection is controlled. • Dose interruption is recommended for management of anemia, lymphopenia, and neutropenia as described in Table 1 (see 7 WARNINGS AND PRECAUTIONS and 8 ADVERSE REACTIONS).
Table 1:
Laboratory measures and dose adjustment recommendations Laboratory Measure Lab Value Recommendation Hemoglobin <20 g/L decrease and ≥90 g/L Maintain dose ≥20 g/L decrease or <80 g/L (Confirmed by repeat testing) Interrupt the administration of Sandoz Tofacitinib until hemoglobin […]
55 13 PHARMACEUTICAL INFORMATION ............................................................................ 55 Sandoz Tofacitinib Page 4 of 102 Protected B / Protégé B 14 CLINICAL TRIALS […]