Tofaxen 5 mg (Tofacitinib) – 60 Tablets

Description

Tofaxen tablet: Each film-coated tablet contains Tofacitinib Citrate INN equivalent to Tofacitinib 5 mg.

Product Features:

Indication of  Tofaxen Tablet

Tofaxen is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis, psoriatic arthritis, ulcerative colitis (UC) who have had an inadequate response or intolerance to methotrexate. It may be used as monotherapy or in combination with methotrexate or other nonbiologic disease-modifying antirheumatic drugs (DMARDs).

Mechanism of  Action 

Tofaxen is a Janus Kinase (JAK) inhibitor. JAKs are intracell­ular enzymes which transmit signals arising from cytokine or growth factor-receptor interactions on the cellular membrane to influence cellular processes of hematopoiesis and immune cell function. Tofacitinib modulates the signaling pathway at the point of JAKs, preventing the phosphorylation and activation of STATs

Dosage and Administration

Administration Instructions: Do not initiate TOFAXEN if absolute lymphocyte count <500 cells/mm3, an absolute neutrophil count (ANC) <1000 cells/mm3 or hemoglobin <9 g/dL.

Recommended Dosage

Rheumatoid Arthritis and Psoriatic Arthritis (in combination with nonbiologic DMARDs)

• Tofacitinib (Tofaxen) 5 mg twice daily.
• For patients with moderate and severe renal impairment or moderate hepatic impairment, the recommended dosage is Tofacitinib 5 mg (TOFAXEN) once daily.

Ulcerative Colitis

• The recommended dose is 10 mg Tofacitinib (Tofaxen) given orally twice daily for induction for 8 weeks and 5 mg given twice daily for maintenance.
• Patients who do not achieve adequate therapeutic benefit by week 8 can extend the induction dose of 10 mg twice daily for an additional 8 weeks (16 weeks total), followed by 5 mg twice daily for maintenance. Doctors should discontinue Tofacitinib induction therapy in any patient who shows no evidence of therapeutic benefit by week 16.
• In patients with moderate and severe renal impairment or moderate hepatic impairment, the recommended dosage is half of the total daily dose.

Overdose

There is no specific antidote for overdose with Tofacitinib. If an overdose occurs, it is recommended to monitor the patient for signs and symptoms of adverse reactions.

Side effects

Most common adverse reactions are: upper respiratory tract infection, nasopharyngitis, diarrhea, headache, elevated choles­terol levels, increased blood creatine phosphokinase, rash and herpes zoster.

Drug interactions

Co-administering Tofacitinib with potent inhibitors of cytochrome P450 (CYP) 3A4 (e.g., ketoconazole) and CYP2C19 (e.g., fluconazole) increases Tofacitinib exposure. Doctors do not recommend using Tofacitinib in combination with biologic DMARDs or potent immune suppressants like azathioprine and cyclosporine.

It is advisable to avoid taking Tofacitinib with grapefruit juice. Additionally completely refrain from consuming grapefruit juice during treatment.

Pregnancy and Lactation

Pregnancy Category C. There are no adequate and well­ controlled studies in pregnant women. However, use Tofacitinib during pregnancy only if the potential benefit outweighs the potential risk to the fetus. It is uncertain whether this medicine excrete in human milk. Exercise caution when administering this product to a nursing woman.

Storage Condition

Store below 25°C. Do not remove desiccant. Keep out of the reach and sight of children.

Reference: Everest Pharmaceuticals Limited

For more arthritis medicine, visit our SHOP