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APO-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: 01/2025 1 INDICATIONS, 1.1 Pediatrics 01/2025 4 DOSAGE AND ADMINSTRATION, 4.2 Recommended Dose and Dosage Adjustment 01/2025 7 WARNINGS AND PRECAUTIONS, Cardiovascular 12/2023 7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism 01/2025 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic 01/2025 7 WARNINGS AND…
Verbatim from this product's HC label. Tap a section to expand.
and 10 CLINICAL PHARMACOLOGY). 2 CONTRAINDICATIONS APO-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
). 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 APO-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 APO-TOFACITINIB in patients at risk of thrombosis. Discontinue APO- TOFACITINIB and promptly evaluate patients with symptoms of thrombosis (see 7 WARNINGS AND PRECAUTIONS).
For patients with ulcerative colitis (UC), use APO-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 APO- TOFACITINIB in geriatric patients, patients who are current or past smokers, and patients with other CV risk factors (see 7 WARNINGS AND PRECAUTIONS). 1 Dosing Considerations • Use of APO-TOFACITINIB with other potent systemic immunosuppressants should be avoided.
Combined use of APO-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 01/2025 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 ............................................................................................................. 1 Pediatrics........................................................................................................
2 Geriatrics ........................................................................................................ 6 2 CONTRAINDICATIONS ................................................................................................
6 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ........................................................... 6 4 DOSAGE AND ADMINISTRATION................................................................................ 1 Dosing Considerations.....................................................................................
2 Recommended Dose and Dosage Adjustment .................................................. 1 […]
APO-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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g. azathioprine, tacrolimus, cyclosporine). 5 x 109 cells/L (see 7 WARNINGS AND PRECAUTIONS). • APO-TOFACITINIB is contraindicated in patients with severe hepatic impairment. 2 Recommended Dose and Dosage Adjustment Rheumatoid Arthritis APO-TOFACITINIB is to be used in combination with methotrexate.
APO-TOFACITINIB, monotherapy may be considered in cases of intolerance to methotrexate and to one or more DMARDs. The recommended dose of APO-TOFACITINIB is 5 mg administered twice daily (BID). A dosage of APO-TOFACITINIB 10 mg BID is not recommended for the treatment of rheumatoid arthritis (see 7 WARNINGS AND PRECAUTIONS).
Psoriatic Arthritis The recommended dose of APO-TOFACITINIB is 5 mg administered BID in combination with MTX or another csDMARD. A dosage of APO-TOFACITINIB 10 mg BID is not recommended for the treatment of psoriatic arthritis (see 7 WARNINGS AND PRECAUTIONS, Thrombosis).
APO-TOFACITINIB (Tofacitinib Tablets) Page 9 of 113 Unclassified / Non classifié Ankylosing Spondylitis The recommended dose of APO-TOFACITINIB is 5 mg administered BID. A dosage of APO-TOFACITINIB 10 mg BID is not recommended for the treatment of ankylosing spondylitis (see 7 WARNINGS AND PRECAUTIONS, Thrombosis).
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). APO-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 APO-TOFACITINIB, corticosteroids may be cautiously reduced and/or discontinued in accordance with standard of care. Active Juvenile Idiopathic Arthritis (JIA) APO-TOFACITINIB may be used as monotherapy or in combination with MTX.
The recommended dose in children ≥40 kg is one APO-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 APO-TOFACITINIB 10 mg BID is 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 APO-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).
APO-TOFACITINIB (Tofacitinib Tablets) Page 10 of 113 Unclassified / Non classifié 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) […]