Tofacitinib Drug & Tofacitinib brand name
Tofacitinib Drug & Tofacitinib Brand name, an FDA-approved medication, offers hope for rheumatoid arthritis patients. Are you feeling the pinch of Tofacitinib’s expense? Is the Tofacitinib Drug cost causing concern for you? Despite its efficacy, concerns persist regarding Tofacitinib price accessibility and affordability. For detailed information on the tofacitinib side effects.
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Tofacitinib Mechanism of Action
Tofacitinib inhibits Janus kinase (JAK) enzymes, crucial for signal transmission in immune cells. By blocking JAK enzymes, Tofacitinib prevents the activation of Signal Transducers and Activators of Transcription (STATs), reducing gene expression related to inflammation.
Indications and Tofacitinib FDA Approval
Tofacitinib is utilized to manage various autoimmune conditions, including:
- Rheumatoid Arthritis: Tofacitinib Effective for patients who haven’t responded well to methotrexate.
- Psoriatic Arthritis: For those not adequately treated with methotrexate.
- Ulcerative Colitis: Suitable for moderate to severe cases.
- Ankylosing Spondylitis: Approved for adults.
- Juvenile Idiopathic Arthritis: Approved for children aged 2 years and older.
Tofacitinib FDA Approval Timeline:
- November 2012: In November 2012, Tofacitinib get initial approval for the treatment of rheumatoid arthritis.
- February 2016: In February 2016, Tofacitinib get the approval of extended-released version.
- May 2018: Approval for ulcerative colitis. In May 2018, Tofacitinib get approval for the treatment of ulcerative colitis.
- September 2020: Tofacitinib get approval from FDA in September 2020. for the treatment of juvenile idiopathic arthritis.
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Tofacent 5 mg uses (Tofacitinib Dosage)
Dosage and Administration
Rheumatoid Arthritis and Psoriatic Arthritis:
- Standard Dose: 5 mg twice daily or 11 mg once daily (extended-release).
- For Renal/Hepatic Impairment: 5 mg once daily.
Ulcerative Colitis:
- Initial Dose: 10 mg twice daily for 8 weeks, then 5 mg twice daily.
- For Renal/Hepatic Impairment: Half the daily dose.
Juvenile Idiopathic Arthritis:
- Standard Dose: 5 mg twice daily (oral solution or tablet).
- Weight-Based Dosage:
- 10-20 kg: 3.2 mg twice daily.
- 20-40 kg: 4 mg twice daily.
- Over 40 kg: 5 mg twice daily.
Tofacitinib Side Effects and Warnings
Common Side Effects:
- Upper respiratory infections
- Headache
- Diarrhea
- Nasopharyngitis
Serious Risks (Boxed Warning):
- Severe infections, including tuberculosis and fungal infections.
- Increased risk of lymphoma and other malignancies.
- Risk of Epstein Barr virus-associated post-transplant lymphoproliferative disorder.
Cautionary Measures:
- Regular monitoring of lymphocytes, neutrophils, hemoglobin, liver enzymes, and lipids.
- Avoid use during active infections.
- Avoid live vaccines during treatment.
Tofacitinib Drug Interactions
- Immunosuppressants: Increased risk of infections with drugs like azathioprine and cyclosporine.
- Biologic DMARDs: Higher infection risk when combined with biologics such as etanercept and infliximab.
- Anticoagulants and Antiplatelets: Elevated bleeding risk with drugs like warfarin and aspirin.
- Strong CYP3A4 Inhibitors: Drugs like ketoconazole can increase tofacitinib levels, necessitating dosage adjustments.
- Moderate CYP3A4 Inhibitors: Medications such as fluconazole may require dosage adjustments.
- CYP3A4 Inducers: Drugs like rifampin can reduce tofacitinib levels.
- Grapefruit: Avoid grapefruit and its juice as it can raise tofacitinib blood levels.
Global Availability
It is available worldwide, including the USA, UK, Saudi Arabia, UAE, Kuwait, Qatar, Philippines, Nepal, Malaysia, Indonesia, Thailand, Poland, Peru, South Korea, New Zealand, Netherlands, Georgia, France, Egypt, Australia, Germany, Canada, Uzbekistan, Lebanon, Mexico, Singapore, Vietnam, Pakistan, Russia.