TARO-TOFACITINIB

and 10 CLINICAL PHARMACOLOGY) 2 CONTRAINDICATIONS TARO-TOFACITINIB/TARO-TOFACITINIB XR 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 TARO-TOFACITINIB/TARO-TOFACITINIB XR 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 TARO-TOFACITINIB/TARO-TOFACITINIB XR in patients at risk of thrombosis. Discontinue TARO-TOFACITINIB/TARO-TOFACITINIB XR and promptly evaluate patients with symptoms of thrombosis (see 7 WARNINGS AND PRECAUTIONS).

For patients with ulcerative colitis (UC), use TARO-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 TARO- TOFACITINIB/TARO-TOFACITINIB XR 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 TARO-TOFACITINIB/TARO-TOFACITINIB XR with other potent systemic immunosuppressants should be avoided.

Combined use of TARO-TOFACITINIB/TARO- TOFACITINIB XR 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. 2 TABLE OF CONTENTS.............................................................................................................

2 PART I: HEALTH PROFESSIONAL INFORMATION .................................................................... 5 1 INDICATIONS .....................................................................................................................

1 Pediatrics ........................................................................................................................ 2 Geriatrics.........................................................................................................................

5 2 CONTRAINDICATIONS ........................................................................................................ 6 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ...................................................................

6 4 DOSAGE AND ADMINISTRATION ........................................................................................ 1 Dosing Considerations .....................................................................................................

2 Recommended Dose and Dosage Adjustment .................................................................. 49 11 STORAGE, STABILITY AND DISPOSAL […]

TARO-TOFACITINIB/TARO-TOFACITINIB XR 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).