Tofacitinib 5 mg tablets are oral prescription medicines containing 5 mg of tofacitinib, a Janus kinase (JAK) inhibitor. Tofacitinib is used in the management of certain chronic inflammatory and immune-mediated conditions. Product indications and approved uses can vary by country.
Product Overview
| Product | Tofacitinib 5 mg Tablets |
|---|---|
| Active ingredient | Tofacitinib |
| Strength | 5 mg |
| Dosage form | Film-coated tablet |
| Route | Oral |
| Drug class | Janus kinase (JAK) inhibitor |
| Common reference brand | XELJANZ® |
| Prescription status | Prescription medicine |
The Pfizer India product information describes the 5 mg tablet as containing tofacitinib citrate equivalent to 5 mg of tofacitinib free base.
Therapeutic Uses
Depending on the applicable regulatory label, tofacitinib may be prescribed for conditions including:
- Rheumatoid arthritis (RA)
- Psoriatic arthritis (PsA)
- Ulcerative colitis (UC)
- Ankylosing spondylitis (AS)
- Certain pediatric indications in applicable jurisdictions
The current U.S. prescribing information specifies particular treatment-history requirements for several adult indications, so the indication should always be checked against the regulatory labeling applicable to the patient's country.
How Tofacitinib Works
Tofacitinib inhibits Janus kinase pathways involved in immune-system signaling. By reducing signaling through these pathways, it can decrease inflammatory activity associated with certain immune-mediated diseases.
Dosage and Administration
The appropriate dose depends on the indication, patient age, kidney and liver function, concomitant medicines, and applicable regulatory labeling. Tofacitinib 5 mg is commonly used as a twice-daily immediate-release tablet for certain adult indications, but dosing should be determined by the treating healthcare professional. Dose modifications may be required in patients with renal or hepatic impairment and with certain drug interactions.
Patients should not change the dose or frequency without medical advice.
Important Safety Information
Tofacitinib carries significant safety warnings. Treatment can increase the risk of serious infections, including tuberculosis and opportunistic infections. The U.S. label also contains boxed warnings concerning mortality, malignancies, major adverse cardiovascular events (MACE), and thrombosis.
Before and during treatment, healthcare professionals may recommend appropriate screening and monitoring, including:
- Tuberculosis screening
- Blood-cell counts
- Liver enzyme monitoring
- Lipid monitoring
- Assessment for infections
- Appropriate vaccination review
Live vaccines should generally be avoided during treatment according to the applicable prescribing information.
Commonly Reported Adverse Effects
Reported adverse reactions can include:
- Upper respiratory tract infections
- Nasopharyngitis
- Headache
- Diarrhea
The complete adverse-effect profile is broader and depends on the indication and patient population.
Storage
Storage requirements should follow the specific manufacturer's product label and local regulatory requirements. Patients should keep the tablets in their original packaging and away from conditions that could compromise product quality.
Important Note
Tofacitinib is an immunomodulatory prescription medicine and should be used only under appropriate medical supervision. This product information is intended for general educational and pharmaceutical reference purposes and does not replace the approved prescribing information or advice from a qualified healthcare professional.
For export or commercial product pages, the country-specific regulatory status, approved indication, packaging, manufacturer information, and import requirements should be verified before making purchasing or availability claims.
