Formulary
Tofacitinib: Indications, Dosing, Side Effects and Interactions
Tofacitinib selectively inhibits the Janus-associated tyrosine kinases JAK1 and JAK3.
MedNext Academy | 4 min read
Tofacitinib: Indications, Dosing, Side Effects and Interactions
Tofacitinib selectively inhibits the Janus-associated tyrosine kinases JAK1 and JAK3.
Drug action
Tofacitinib selectively inhibits the Janus-associated tyrosine kinases JAK1 and JAK3.
Indications and dose
**Moderate to severe rheumatoid arthritis (specialist use only),Psoriatic arthritis (specialist use only)**
- **Adult** (By Mouth Using Film-Coated Tablets): Moderate to severe rheumatoid arthritis (specialist use only), Psoriatic arthritis (specialist use only) 5 mg twice daily, for dose interruption or treatment discontinuation due to side-effects-consult product literature.
- **Adult** (By Mouth Using Modified-Release Tablets): 11 mg once daily, for dose interruption or treatment discontinuation due to side-effects-consult product literature.
**Moderate to severe ulcerative colitis (specialist use only)**
- **Adult** (By Mouth Using Film-Coated Tablets): Initially 10 mg twice daily for 8 weeks, then maintenance 5 mg twice daily, if an adequate therapeutic response is not achieved after 8 weeks, the initial dose can be extended for an additional 8 weeks, discontinue treatment if no response after 16 weeks, for dose adjustments due to side-effects, decreased response during maintenance treatment, or following treatment interruption-consult product literature.
**Ankylosing spondylitis (specialist use only)**
- **Adult** (By Mouth Using Film-Coated Tablets): 5 mg twice daily, consider treatment discontinuation if no response 16 weeks after initial dose, for dose interruption or treatment discontinuation due to side-effects-consult product literature.
**Polyarticular juvenile idiopathic arthritis (specialist use only), Juvenile psoriatic arthritis (specialist use only) for tofacitinib**
- **Child 2-17 years (body-weight 20-39 kg)** (By mouth using oral solution): 4 mg twice daily, consider treatment discontinuation if no response 18 weeks after initial dose, for dose interruption or treatment discontinuation due to side-effects-consult product literature.
- **Child 2-17 years (body-weight 40 kg and above)** (By mouth using film-coated tablets, or by mouth using oral solution): 5 mg twice daily, consider treatment discontinuation if no response 18 weeks after initial dose, for dose interruption or treatment discontinuation due to side-effects-consult product literature.
Cautions
Elderly (65 years and older); history of atherosclerotic cardiovascular disease or other cardiovascular risk factors; known risk factors for fractures; patients at risk of gastro-intestinal perforation (new onset abdominal signs and symptoms should be evaluated promptly); predisposition to infection; raised serum transaminases (particularly in combination with potentially hepatotoxic drugs); recurrent infection or history of serious infection; risk factors for malignancy; risk factors for venous thromboembolism (VTE); risk of diverticulitis; risk of viral reactivation (consult product literature); tuberculosis exposure Cautions, further information Immunisation Patients should receive all recommended vaccinations before starting treatment (consider prophylactic varicella zoster vaccination); live vaccines should be given at least 2 weeks, but preferably 4 weeks, before treatment initiation-consult product literature. M Tuberculosis Anti-tuberculosis therapy should be initiated in patients with latent tuberculosis before starting tofacitinib. Consider anti-tuberculosis therapy prior to initiation of tofacitinib in patients with a history of previously untreated latent or active tuberculosis or in patients at risk of tuberculosis infection. Use tofacitinib with caution in patients who have travelled or resided in areas of endemic mycoses, or who have had previous exposure to tuberculosis. M VTE When used for Rheumatoid arthritis: In patients with known risk factors for VTE, consider measuring D-dimer levels after approximately 12 months of treatment. If D-dimer level is 2 times the upper limit of normal or more, consider treatment discontinuation unless potential benefit outweighs risk. M
Contraindications
Absolute lymphocyte count less than 750 cells/mm 3 (do not initiate); absolute neutrophil count less than 1000 cells/mm 3 (do not initiate); active infection including localised infection; active tuberculosis; haemoglobin less than 9 g/dL (do not initiate); risk factors for venous thromboembolism (high doses)
Side effects
Common or very common Abdominal pain (more common in patients with juvenile idiopathic arthritis); anaemia; cough (more common in patients with juvenile idiopathic arthritis); diarrhoea; dyspepsia; fatigue; fever (more common in patients with juvenile idiopathic arthritis); gastrointestinal disorders; headache (more common in patients with juvenile idiopathic arthritis); hypertension; increased risk of infection; influenza (more common in patients with juvenile idiopathic arthritis); joint disorders; nausea (more common in patients with juvenile idiopathic arthritis); peripheral oedema; pharyngitis (more common in patients with juvenile idiopathic arthritis); sinusitis (more common in patients with juvenile idiopathic arthritis); skin reactions; vomiting (more common in patients with juvenile idiopathic arthritis) Uncommon Decreased leucocytes; dehydration; dyslipidaemia; dyspnoea; embolism and thrombosis; hepatic steatosis; insomnia; ligament sprain; muscle strain; musculoskeletal pain; myocardial infarction; neoplasms; neutropenia; paraesthesia; sinus congestion; tendinitis; viral infection (more common in patients with juvenile idiopathic arthritis); weight increased Rare or very rare Meningitis; sepsis Frequency not known Angioedema; BK virus infection; cardiovascular event; interstitial lung disease (including fatal cases); malignancy; reactivation of infections; ulcerative colitis aggravated
Interactions
**Severe interactions:**
- Immuno-suppressants (Ciclosporin, Tacrolimus, Sirolimus, Tofacitinib): Fluconazole significantly increases the concentration and AUC of ciclosporin.
**Other interactions (1):**
- Exposure of tofacitinib is increased when tofacitinib is co-administered with fluconazole therefore, it is recommended to reduce tofacitinib dose to 5 mg once daily.
Pregnancy
Manufacturer advises avoid-toxicity in animal studies.
Breast feeding
Manufacturer advises avoid-present in milk in animal studies.
Hepatic impairment
Manufacturer advises caution in moderate impairment; avoid in severe impairment. Dose adjustments Manufacturer advises dose reduction in moderate impairment-consult product literature.
Renal impairment
Dose adjustments Manufacturer advises reduce dose in severe impairment-consult product literature.
Medicinal forms
Tablet,Tablet
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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