| Approved Uses |
• Rheumatoid arthritis (RA) in adults who have had an inadequate response to one or more disease‑modifying antirheumatic drugs (DMARDs).
• Active psoriatic arthritis (PsA) in adults who have had an inadequate response to methotrexate or another biologic.
• Active ulcerative colitis (UC) in adults who have had an inadequate response to or intolerance of conventional therapies or biologics. |
| Mechanism of Action |
Tofacitinib blocks the JAK1 and JAK3 enzymes that transmit inflammatory signals inside cells. This reduces the production of inflammatory cytokines, slowing the autoimmune attack on joints, skin, or gut. |
| Typical Dosing |
• Rheumatoid arthritis & psoriatic arthritis: 5 mg twice daily (BID).
• Ulcerative colitis: 10 mg BID for induction, then 5 mg BID for maintenance.
Dose adjustments may be needed for renal impairment or other conditions. |
| How It’s Taken |
Oral tablets, taken with or without food. Take at the same time each day to keep blood levels steady. |
| Common Side Effects |
• Upper respiratory infections (cold, flu)
• Headache
• Diarrhea
• Elevated cholesterol or triglycerides
• Mild nausea or stomach upset |
| Serious (but rare) Risks |
• Serious infections (e.g., tuberculosis, fungal infections)
• Blood clots (deep vein thrombosis, pulmonary embolism)
• Hepatotoxicity (liver damage)
• Increased cancer risk (certain lymphomas, skin cancers)
• Blood disorders (low platelets, low white cells) |
| What to Watch For |
• Persistent fever, chills, or flu‑like symptoms → could indicate infection.
• Unusual pain or swelling in a leg, shortness of breath, chest pain → possible clot.
• Unexplained bruising or bleeding → blood disorder.
• Sudden weight loss, night sweats, or enlarged lymph nodes → possible lymphoma. |
| Lab Monitoring |
• CBC (blood count) at baseline, 1‑2 weeks after starting, then periodically.
• Liver tests (ALT, AST) at baseline and as directed.
• Lipid profile at baseline and after 6 months.
• Screening for latent TB before starting therapy. |
| Drug Interactions |
• CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) → increase tofacitinib levels → risk of toxicity.
• CYP3A4 inducers (e.g., rifampin, carbamazepine) → lower tofacitinib levels → reduced efficacy.
• Other immunosuppressants (e.g., methotrexate, biologics) → additive infection risk.
• Vaccines (live or live‑attenuated) → avoid while on treatment. |
| Contraindications |
• Active infections (especially tuberculosis)
• Severe liver disease
• Known hypersensitivity to tofacitinib or any component of the formulation
• Current use of strong CYP3A4 inhibitors (unless dose reduced). |
| Pregnancy & Breastfeeding |
• Animal studies show fetal harm; no data confirm safety in humans. Avoid use if pregnant.
• Tofacitinib is excreted into breast milk; breastfeeding is not recommended while taking the drug. |
| Vaccinations |
• Ensure all routine vaccinations (e.g., influenza, COVID‑19, pneumococcal, shingles) are up to date before starting.
• Live vaccines (MMR, varicella, HPV) should be avoided during therapy. |
| Lifestyle & Self‑Care |
• Maintain a healthy diet and exercise routine to manage weight and cholesterol.
• Monitor for flu‑like symptoms and seek prompt medical care if they occur.
• Keep regular appointments for blood work and follow‑up. |
| When to Call Your Doctor |
• Fever ≥101 °F (38 °C) that persists >48 hrs.
• New or worsening pain/swelling in a limb.
• Signs of infection (redness, warmth, pus).
• Unusual fatigue, shortness of breath, chest discomfort. |