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[Product Monograph Template PRODUCT MONOGRAPH PrXELJANZ® tofacitinib, tablets, oral 5 mg tofacitinib (as tofacitinib citrate) 10 mg tofacitinib (as tofacitinib citrate) PrXELJANZ® XR tofacitinib extended-release, tablets, oral 11 mg tofacitinib (as tofacitinib citrate) ATC Code: L04AA29 Selective Immunosuppressant Pfizer Canada ULC Date of Preparation: 17,300 Trans-Canada Highway October 24, 2019 Kirkland, Quebec H9J 2M5 TMPF PRISM C.V. c/o Pfizer Manufacturing Holdings LLC Pfizer Canada ULC, Licensee © Pfizer Canada ULC 2019 Submission Control No: 230976 XELJANZ/XELJANZ XR Page 1 of 80 Table of Contents PART I: HEALTH PROFESSIONAL INFORMATION.........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 ADVERSE REACTIONS..................................................................................................15 DRUG INTERACTIONS ..................................................................................................29 DOSAGE AND ADMINISTRATION..............................................................................34 OVERDOSAGE ................................................................................................................38 ACTION AND CLINICAL PHARMACOLOGY ............................................................38 STORAGE AND STABILITY..........................................................................................45 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................45 PART II: SCIENTIFIC INFORMATION ...............................................................................46 PHARMACEUTICAL INFORMATION..........................................................................46 CLINICAL TRIALS..........................................................................................................47 TOXICOLOGY .................................................................................................................65 REFERENCES ..................................................................................................................75 PART III: CONSUMER INFORMATION..............................................................................76 XELJANZ/XELJANZ XR Page 2 of 80 PrXELJANZ® PrXELJANZ® XR Tofacitinib tablets PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION Route of Dosage Form / Strength Clinically Relevant Nonmedicinal Administration Ingredients Oral Tofacitinib tablets / 5 mg For a complete listing see Dosage Forms, tofacitinib and 10 mg (as Composition and Packaging section. tofacitinib citrate) Tofacitinib extended- release tablets / 11 mg tofacitinib (as tofacitinib citrate) INDICATIONS AND CLINICAL USE Rheumatoid Arthritis XELJANZ/XELJANZ XR (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. In cases of intolerance to MTX, physicians may consider the use of XELJANZ/XELJANZ XR (tofacitinib) as monotherapy. Limitations of Use: Use of XELJANZ/XELJANZ XR in combination with biological disease- modifying anti-rheumatic drugs (bDMARDs) or potent immunosuppressants such as azathioprine and cyclosporine is not recommended. Psoriatic Arthritis XELJANZ (tofacitinib), in combination with methotrexate (MTX) or another conventional synthetic disease-modifying antirheumatic drug (DMARD), is indicated for reducing the signs and symptoms of psoriatic arthritis (PsA) in adult patients with active PsA when the response to previous DMARD therapy has been inadequate. Limitations of Use: Use of XELJANZ in combination with biological disease-modifying anti- rheumatic drugs (bDMARDs) or potent immunosuppressants such as azathioprine and cyclosporine is not recommended. XELJANZ/XELJANZ XR Page 3 of 80 Ulcerative Colitis XELJANZ (tofacitinib) is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) with an inadequate response, loss of response or intolerance to either conventional UC therapy or a TNF inhibitor. Limitations of Use: Use of XELJANZ in combination with biological UC therapies or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended. Pediatrics (<18 years of age) The safety and effectiveness of XELJANZ/XELJANZ XR in pediatric patients have not been established. Therefore, XELJANZ/XELJANZ XR should not be used in this patient population (see DOSAGE AND ADMINISTRATION and ACTION AND CLINICAL PHARMACOLOGY). Geriatrics (>65 years of age) The frequency of serious infection among XELJANZ treated subjects 65 years of age and older was higher than among those under the age of 65. Therefore, caution should be used when treating the elderly with XELJANZ/XELJANZ XR (see WARNINGS AND PRECAUTIONS, DOSAGE AND ADMINISTRATION and ACTION AND CLINICAL PHARMACOLOGY). CONTRAINDICATIONS XELJANZ/XELJANZ XR (tofacitinib) is contraindicated: In patients with known hypersensitivity to tofacitinib or any of its components. For a complete listing, see DOSAGE FORMS, COMPOSITION AND PACKAGING section of the product monograph. In patients with severe hepatic impairment. During pregnancy and breastfeeding. XELJANZ/XELJANZ XR Page 4 of 80 WARNINGS AND PRECAUTIONS WARNING: RISK OF SERIOUS INFECTIONS Patients treated with XELJANZ/XELJANZ XR (tofacitinib) are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt XELJANZ/XELJANZ XR 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 XELJANZ/XELJANZ XR use and during therapy. Treatment for latent infection should be initiated prior to XELJANZ/XELJANZ XR 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 XELJANZ/XELJANZ XR 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 XELJANZ/XELJANZ XR, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy (see ADVERSE REACTIONS). MALIGNANCIES Lymphoma and other malignancies have been observed in patients treated with XELJANZ. Epstein Barr Virus-associated post-transplant lymphoproliferative disorder has been observed at an increased rate in renal transplant patients treated with XELJANZ and concomitant immunosuppressive medications (see WARNINGS AND PRECAUTIONS). THROMBOSIS Rheumatoid arthritis patients with at least one cardiovascular (CV) risk factor had a higher rate of all-cause mortality and thrombosis, including pulmonary embolism, deep venous thrombosis, and arterial thrombosis, with XELJANZ 10 mg twice daily compared to those treated with 5 mg twice daily or TNF blockers. Many of these adverse events were serious and some resulted in death. Avoid XELJANZ/XELJANZ XR in patients at risk of thrombosis. Discontinue XELJANZ/XELJANZ XR and promptly evaluate patients with symptoms of thrombosis (see WARNINGS AND PRECAUTIONS, Cardiovascular). XELJANZ/XELJANZ XR Page 5 of 80 For patients with ulcerative colitis (UC), use XELJANZ at the lowest effective dose and for the shortest duration needed to achieve/maintain therapeutic response (see DOSAGE AND ADMINISTRATION). General Specific to XELJANZ XR: As with any other non-deformable material, caution should be used when administering XELJANZ XR to patients with pre-existing severe gastrointestinal narrowing (pathologic or iatrogenic). There have been rare reports of obstructive symptoms in patients with known strictures in association with the ingestion of other drugs utilizing a non- deformable extended release formulation. Cardiovascular Heart Rate Decrease and PR Interval Prolongation: XELJANZ caused a decrease in heart rate and a prolongation of the PR interval (see WARNINGS AND PRECAUTIONS – Monitoring and Laboratory Tests and ADVERSE REACTIONS). Caution should be observed in patients with a low heart rate at baseline (<60 beats per minute), a history of syncope or arrhythmia, sick sinus syndrome, sinoatrial block, atrioventricular (AV) block, ischemic heart disease, or congestive heart failure. Concomitant medications that result in a decrease in heart rate and/or PR interval prolongation should be avoided to the extent possible during treatment with XELJANZ/XELJANZ XR (see DRUG INTERACTIONS). Thrombosis Thrombosis, including pulmonary embolism, deep venous thrombosis, and arterial thrombosis, was observed at an increased incidence in patients treated with XELJANZ in a large, ongoing post-marketing study. Rheumatoid arthritis (RA) patients 50 years of age and older with at least one cardiovascular
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