Tofacitinib is an oral Janus kinase (JAK) inhibitor for the treatment of rheumatoid
arthritis and psoriatic arthritis. Tofacitinib inhibits JAK dependent cytokine
signaling. JAKs are intracellular enzymes which transmit signals arising from
cytokine or growth factor-receptor interactions on the cellular membrane. JAKs
phosphorylate and activate Signal Transducers and Activators of Transcription
(STATs) which modulate intracellular activity including gene expression. Tofacitinib
prevents the phosphorylation and activation of STATs thus downregulates the
production of cytokines by inhibiting JAK.
Each film coated tablet contains Tofacitinib Citrate INN 8 mg equivalent to Tofacitinib 5 mg.
Rheumatoid Arthritis: Arthanib/Arthanib XR Tablet is indicated for the treatment of adult patients with moderate to severe rheumatoid arthritis. It may be used as monotherapy or in combination with methotrexate or other nonbiologic disease-modifying antirheumatic drugs (DMARDs).
Psoriatic Arthritis: Arthanib/Arthanib XR Tablet is indicated for the treatment of adult patients with active psoriatic arthritis. It may be used in combination with methotrexate or other nonbiologic disease-modifying antirheumatic drugs (DMARDs).
Ulcerative Colitis: Arthanib/Arthanib XR Tablet is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis
Rheumatoid Arthritis & Psoriatic Arthritis patients: The recommended dose is Arthanib 5 mg twice daily or Arthanib XR 11 mg once daily with or without food.
Ulcerative colitis patients: The recommended dose is Arthanib10 mg twice daily for at least 8 weeks; then Arthanib 5 or 10 mg twice daily
Contraindicated in patients with known hypersensitivity to Tofacitinib or any other
component of this product. It is contraindicated in severe hepatic impaired patients.
Avoid use of Tofacitinib during an active serious infection, including localized infections.
Use with caution in patients that may be at increased risk of Gastrointestinal Perforations.
Avoid use of Tofacitinib concurrently with Immunizations - Live vaccines. Storage: Store below 300 C at dry place,
protect from light and moisture. Keep out of the reach of children.
The most commonly reported adverse reactions are upper respiratory tract
infections, headache, diarrhea and nasopharyngitis.
Tofacitinib exposure is increased when coadministered with potent inhibitors of
cytochrome P450 (CYP) 3A4 (e.g., ketoconazole) & medications that result in
both moderate inhibition of CYP3A4 and potent inhibition of CYP2C19 (e.g.,
fluconazole). Tofacitinib exposure is decreased when coadministered with potent
CYP3A4 inducers (e.g., rifampin). There is a risk of added immunosuppression
when Tofacitinib is coadministered with potent immunosuppressive drugs (e.g.,
azathioprine, tacrolimus, cyclosporine). Use of Tofacitinib in combination with
biologic DMARDs or potent immunosuppressants such as azathioprine and
cyclosporine is not recommended.
Use in pregnancy: Pregnancy Category C. There are no adequate and wellcontrolled studies in pregnant women. Tofacitinib should be used during
pregnancy only if the potential benefit justifies the potential risk to the fetus.
Use in lactation: It is not known whether Tofacitinib is excreted in human milk. A
decision should be made whether to discontinue nursing or to discontinue the
drug, taking into account the importance of the drug for the mother.
Pediatric use: The safety and effectiveness of Tofacitinib in pediatric patients
have not been established.
Hepatic impairment: No dose adjustment is required in patients with mild hepatic
impairment. For moderate hepatic impairment patients recommended dose is
Tofacitinib 5 mg once daily. Use of Tofacitinib in patients with severe hepatic
impairment is not recommended.
Renal impairment: No dose adjustment is required in patients with mild renal
impairment. For patients with moderate and severe renal impairment
recommended dose is Tofacitinib 5 mg once daily.
Each box contains 10's tablets in alu-alu blister pack.
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