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TEVA-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: Rheumatoid Arthritis Teva-Tofacitinib (tofacitinib), in combination with methotrexate (MTX), is indicated for reducing the signs and symptoms of rheumatoid arthritis (RA) in adult patients with moderately to severely active RA who have had an inadequate response to MTX and to one or more disease-modifying anti-…
Verbatim from this product's HC label. Tap a section to expand.
and 10 CLINICAL PHARMACOLOGY) 2 CONTRAINDICATIONS Teva-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 Teva-Tofacitinib (tofacitinib citrate)-Product Monograph 5
). 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 Teva-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 Teva-Tofacitinib in patients at risk of thrombosis. Discontinue Teva-Tofacitinib and promptly evaluate patients with symptoms of thrombosis (see 7 WARNINGS AND PRECAUTIONS).
Teva-Tofacitinib (tofacitinib citrate)-Product Monograph 6 For patients with ulcerative colitis (UC), use Teva-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 Teva-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 Teva-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 and UC patients.
, 4 DOSAGE AND ADMINISTRATION and 10 CLINICAL PHARMACOLOGY) 2 CONTRAINDICATIONS Teva-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 Teva-Tofacitinib (tofacitinib citrate)-Product Monograph 5 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • In patients with severe hepatic impairment (see 7 WARNINGS AND PRECAUTIONS). 2 Breast-feeding).
2 Clinical Trial Adverse Reactions). Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt Teva-Tofacitinib until the infection is controlled.
Reported infections include: • Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients should be tested for latent tuberculosis before Teva-Tofacitinib use and during therapy. Treatment for latent infection should be initiated prior to Teva-Tofacitinib use.
• Invasive fungal infections, including cryptococcosis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized disease. • Bacterial, viral, and other infections due to opportunistic pathogens.
Treatment with Teva-Tofacitinib should not be initiated in patients with active infections including chronic or localized infection. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with Teva-Tofacitinib, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy (see
Teva-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 Teva-Tofacitinib (tofacitinib citrate)-Product Monograph 5 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.
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g. azathioprine, tacrolimus, cyclosporine). 5 x 109 cells/L (see 7 WARNINGS AND PRECAUTIONS). 2 Recommended Dose and Dosage Adjustment Rheumatoid Arthritis Teva-Tofacitinib is to be used in combination with methotrexate. Teva-Tofacitinib monotherapy may be considered in cases of intolerance to methotrexate and to one or more DMARDs.
The recommended dose of Teva-Tofacitinib is 5 mg administered twice daily (BID). A dosage of Teva-Tofacitinib 10 mg BID is not recommended for the treatment of rheumatoid arthritis (see 7 WARNINGS AND PRECAUTIONS). Psoriatic Arthritis The recommended dose of Teva-Tofacitinib is 5 mg administered BID in combination with MTX or another csDMARD.
A dosage of Teva-Tofacitinib 10 mg BID is not recommended for the treatment of psoriatic arthritis (see 7 WARNINGS and PRECAUTIONS, Thrombosis). Teva-Tofacitinib (tofacitinib citrate)-Product Monograph 7 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).
Teva-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 Teva-Tofacitinib, corticosteroids may be cautiously reduced and/or discontinued in accordance with standard of care.
Dose Interruption or Discontinuation due to Serious Infections and Cytopenias • Avoid use of Teva-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).
5-1 x 109 cells/L For persistent decreases in this range, interrupt or reduce administration with Teva-Tofacitinib until ANC is >1x 109 cells/L • For patients receiving Teva-Tofacitinib 5 mg BID, interrupt Teva-Tofacitinib dosing. When ANC is >1 x 109 cells/L, resume Teva-Tofacitinib 5 mg BID.
UC patients: • For patients receiving Teva-Tofacitinib 10 mg BID, reduce dose to Teva-Tofacitinib 5 mg BID. When ANC is >1 x 109 cells/L, increase to Teva-Tofacitinib 10 mg BID based on clinical response. 5 x 109cells/L […]