Tofacitinib Application Scope

Indicated for the treatment of moderate-to-severe active rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis in adult patients who have had an inadequate response or intolerance to one or more DMARDs (disease-modifying antirheumatic drugs).

Tofacitinib Characteristics

Ingredients: Tofacitinib
Properties: Janus kinase (JAK) inhibitor, small molecule, orally administered
Packaging Specification: 5 mg and 10 mg film-coated tablets; blister packs or bottles
Storage: Store below 25°C in a dry place, protected from light and moisture
Expiry Date: 24 months from the date of manufacture
Executive Standard: In accordance with pharmacopeia standards and regulatory approval requirements
Approval Number: NDA 203214 S-038
Date of Revision: August 23, 2024
Manufacturer: Pfizer Inc.

Guidelines for the Use of Xeljanz

Dosage and Administration:
- Administration: Take with or without food; swallow whole, do not crush or split tablets
- Missed Dose: If a dose is missed, take as soon as possible; resume regular schedule
Adverse Reactions:
- Common Adverse Reactions (≥5% and >3% higher than placebo):
  - - Upper respiratory tract infections
    - Nasopharyngitis
    - Diarrhea
    - Headache
    - Hypertension
- Serious Adverse Reactions:
  - - Serious infections (tuberculosis, invasive fungal infections, opportunistic infections)
    - Thrombosis (DVT, PE, arterial thrombosis)
    - Malignancies (lymphoma and other cancers)
Contraindications:
- Patients with known hypersensitivity to Xeljanz or any excipient
- Patients with active, serious infections
Precautions:
- - Infections: Monitor for signs of infection; interrupt therapy if serious infection develops
  - Blood Counts: Monitor lymphocyte counts, neutrophil counts, and hemoglobin before and during treatment
  - Liver Function: Monitor liver enzymes periodically
  - Pregnancy and Lactation: Use during pregnancy only if clearly needed; breastfeeding is not recommended during and for 18 hours after the last dose

Tofacitinib Interactions

Strong CYP3A4 inhibitors (e.g., ketoconazole): May increase Xeljanz exposure; reduce dose accordingly
Strong CYP3A4 inducers (e.g., rifampin): May decrease Xeljanz exposure; avoid co-administration
Immunosuppressants (e.g., cyclosporine, azathioprine): Increased risk of immunosuppression—avoid combination

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.