Do you want the EU/EMA Summary of Product Characteristics (SPC) for tofacitinib, or the US FDA label? I can summarize the key points or point you to the official document.
Here’s a concise, region-agnostic overview of what the SPC typically covers for tofacitinib (Xeljanz):
- Indications (adults):
- Moderate to severe active rheumatoid arthritis (RA) after inadequate response or intolerance to DMARDs
- Moderate to severe active psoriatic arthritis (PsA)
- Moderate to severe active ulcerative colitis (UC) after inadequate response to conventional therapy
- Dosing (typical starting points; exact dosing and adjustments are in the SPC):
- RA/PsA: commonly 5 mg twice daily; may be increased to 10 mg twice daily if inadequate response after several months (not to exceed 10 mg twice daily)
- UC: induction dosing around 10 mg twice daily for a defined short period (e.g., up to 8 weeks), then maintenance dosing (often 5 mg twice daily)
- Dosing may be adjusted for hepatic or renal impairment; see SPC for specifics
- Contraindications:
- Active serious infections or latent TB not adequately treated
- Known serious hypersensitivity to tofacitinib
- Concurrent use with other Janus kinase (JAK) inhibitors or potent immunosuppressants or with live vaccines (per SPC)
- Warnings and precautions:
- Increased risk of serious infections, including TB and fungal infections
- Risk of herpes zoster and other opportunistic infections
- Malignancies and lymphomas reported; cardiovascular events
- Thromboembolic events (DVT/PE) risk, especially at higher doses
- Elevations in lipid levels; potential hepatotoxicity and liver enzyme elevations
- GI perforations risk
- TB/hepatitis screening recommended prior to and during treatment
- Vaccination: avoid live vaccines during treatment
- Adverse reactions (common and serious):
- Common: nasopharyngitis, headache, diarrhea, nausea, increased ALT/AST, anemia, neutropenia, lipid elevations
- Serious: serious infections, malignancies, DVT/PE, cardiovascular events, GI perforations
- Interactions:
- Strong CYP3A4 inhibitors (e.g., ketoconazole) raise tofacitinib exposure; dose adjustment may be required
- CYP3A4 inducers (e.g., rifampin) decrease exposure
- Concurrent use with other JAK inhibitors or biologics not recommended
- Live vaccines not recommended during therapy
- Special populations:
- Pregnancy: generally contraindicated; effective contraception advised during and after treatment per SPC
- Lactation: not recommended; excretion in human milk not well studied
- Elderly and patients with hepatic/renal impairment require dose considerations per SPC
- Pharmacology (brief):
- Mechanism: oral JAK inhibitor (primarily JAK1/JAK3; some JAK2 activity)
- Pharmacokinetics: absorbed orally; metabolism via CYP enzymes (notably CYP3A4 and CYP2C19); elimination via urine/feces
If you want, I can:
- Provide a more detailed, section-by-section summary tailored to RA, PsA, or UC, or
- Give you direct links to the official SPC documents for the EU (EMA) or US (FDA), or
- Pull the exact current wording from the official SPC if you specify the country/region and I can guide you to the right page.