Tofacit(Tofacitinib 5mg)

ofacitinib

Indication

Tofacitinib is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. It can be used as monotherapy or in combination with methotrexate or other nonbiologic Disease Modifying Antirheumatic Drugs (DMARDs). Dosage and administration : The recommended dose of Tofacitinib is 5 mg twice daily. Or, as directed by the registered physician.

Pharmacology

Rheumatoid arthritis is an autoimmune disease characterized by dysregulation of pro-inflammatory cytokines, including IL7, IL15, IL21, IL6, IFNα and IFNβ. (3) Cytokine signaling stimulates the recruitment and activation of immune cells through the janus kinase signaling pathway, leading to tissue inflammation and joint damage.

Tofacitinib is a reversible partial janus kinase (JAK) inhibitor that prevents the body from responding to cytokine signals. By inhibiting JAK, tofacitinib prevents phosphorylation and activation of STAT. The JAKSTAT signaling pathway is involved in the transcription of cells involved in hematopoietic and immune cell functions. Tofacitinib plays a therapeutic role by inhibiting the JAKSTAT pathway to reduce inflammation. However, there is evidence that it may also be effective in other ways.

Dosage & Administration

Rheumatoid Arthritis: Tofacitinib 5 mg twice daily or Tofacitinib 11 mg once daily. Recommended dosage in patients with moderate and severe renal impairment or moderate hepatic impairment is Tofacitinib 5 mg once daily.

Psoriatic Arthritis (in combination with nonbiologic DMARDs): Tofacitinib 5 mg twice daily or Tofacitinib 11 mg once daily.  Recommended dosage in patients with moderate and severe renal impairment or moderate hepatic impairment is Tofacitinib 5 mg once daily.

Ulcerative Colitis: Tofacitinib 10 mg twice daily for at least 8 weeks; then 5 or 10 mg twice daily. Discontinue after 16 weeks of 10 mg twice daily, if adequate therapeutic benefit is not achieved. Use the lowest effective dose to maintain response.

Interaction

• Potent inhibitors of Cytochrome P450 3A4 (CYP3A4) (e.g., Ketoconazole)
• Recommended dose is Tofacitinib 5 mg once daily: One or more concomitant medications that result in both moderate inhibition of CYP3A4 and potent inhibition of CYP2C19 (e.g., fluconazole)
• Recommended dose is Tofacitinib 5 mg once daily Potent CYP inducers (e.g.Rifampin): May result in loss of or reduced clinical response.

Contraindications

It is contraindicated in patients with hypersensitivity to Tofacitinib or any other components of this product.

Side Effects

The most common side effects are: diarrhoea, nasopharyngitis, upper respiratory tract infection, headache and hypertension.

Pregnancy and lactation

Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Tofacitinib should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether this medicine is excreted in human milk. Caution should be exercised when this product is administered to a nursing woman.

Precautions & Warnings

Use of Tofacitinib should be avoided in patients with an active, infection, including localized infections. Patients with latent tuberculosis should be treated with standard antimycobacterial therapy before administering Tofacitinib.

Therapeutic Class

Immunosuppressant

Storage Conditions

Store below 250 C in a dry place

Pharmaceutical Name

Delta Pharma Ltd.