Jaktor
Generic Name
Tofacitinib 5 mg Tablet
Manufacturer
Square Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
jaktor 5 mg tablet | ৳ 48.00 | ৳ 480.00 |
Description
Overview of the medicine
Jaktor 5 mg Tablet contains Tofacitinib, a Janus kinase (JAK) inhibitor used to treat moderate to severe active rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis in adults who have had an inadequate response or intolerance to one or more TNF blockers. It works by blocking specific enzymes involved in the inflammatory process.
Uses & Indications
Dosage
Adults
Rheumatoid Arthritis/Psoriatic Arthritis: 5 mg twice daily. Ulcerative Colitis: Initial: 10 mg twice daily for at least 8 weeks. Maintenance: 5 mg twice daily.
Elderly
No dose adjustment required based on age alone, but monitor for renal/hepatic impairment.
Renal_impairment
Moderate (CrCl 30-60 mL/min): 5 mg once daily. Severe (CrCl <30 mL/min): Not recommended.
How to Take
Administer orally with or without food. Swallow the tablet whole; do not crush, split, or chew.
Mechanism of Action
Tofacitinib is a Janus Kinase (JAK) inhibitor. It modulates the JAK-STAT signaling pathway, which is involved in cellular immune function. By inhibiting JAK enzymes (primarily JAK1 and JAK3), Tofacitinib prevents the phosphorylation and activation of STATs, thereby reducing the expression of genes involved in inflammation and immune function.
Pharmacokinetics
Onset
Clinical improvement seen within 2-8 weeks depending on indication.
Excretion
Approximately 70% renally excreted (primarily as metabolites), and 30% via hepatic metabolism and fecal excretion.
Half life
Approximately 3.2 hours for immediate-release formulation.
Absorption
Rapidly absorbed, peak plasma concentrations reached within 0.5-1 hour. Bioavailability is approximately 74%.
Metabolism
Primarily hepatic, mainly via CYP3A4, with minor contribution from CYP2C19.
Side Effects
Contraindications
- Hypersensitivity to Tofacitinib or any component of the formulation.
- Active serious infections (e.g., active tuberculosis).
- Severe hepatic impairment.
Drug Interactions
Live vaccines
Avoid concurrent use.
Potent CYP3A4 inducers (e.g., Rifampin)
Decrease Tofacitinib exposure; not recommended for coadministration.
Potent CYP3A4 inhibitors (e.g., Ketoconazole)
Increase Tofacitinib exposure; reduce Tofacitinib dose to 5 mg once daily.
Immunosuppressants (e.g., Azathioprine, Cyclosporine)
Increased risk of immunosuppression and infections; not recommended.
Storage
Store below 30°C in a dry place, away from light. Keep out of reach of children.
Overdose
No specific antidote. Management is supportive and aimed at treating symptoms. Hemodialysis may remove Tofacitinib, but its efficacy in overdose is not established.
Pregnancy & Lactation
Pregnancy Category C. May cause fetal harm. Women of childbearing potential should use effective contraception during treatment and for at least 4 weeks after the last dose. Excreted in human milk; breastfeeding not recommended during treatment and for at least 18 hours after last dose.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24-36 months.
Availability
Pharmacies, Hospitals
Approval Status
FDA approved (for specific indications)
Patent Status
Patent protected (brand name), generic versions available
Clinical Trials
Tofacitinib has undergone extensive clinical trials (Phase 1, 2, 3, and 4) to evaluate its efficacy and safety in various indications, including rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis. Key trials include ORAL (Rheumatoid Arthritis) and OCTAVE (Ulcerative Colitis) programs.
Lab Monitoring
- Complete Blood Count (CBC) at baseline and periodically.
- Liver Function Tests (LFTs) at baseline and periodically.
- Lipid Panel at baseline and at 4-8 weeks after initiation, then periodically.
- Renal Function Tests at baseline and periodically.
- Tuberculosis (TB) screening before initiation and periodically.
Doctor Notes
- Prior to initiation, screen patients for latent tuberculosis and viral hepatitis.
- Monitor CBC, LFTs, and lipid panel at baseline and periodically.
- Consider dose adjustment in patients with moderate renal or hepatic impairment.
- Educate patients on symptoms of infection, thrombosis, and malignancy.
Patient Guidelines
- Inform your doctor about any history of infections, especially tuberculosis or herpes zoster.
- Report any signs of infection (fever, chills, cough) immediately.
- Do not receive live vaccines while on this medication.
- Monitor for symptoms of blood clots (e.g., leg swelling, shortness of breath, chest pain).
Missed Dose Advice
If a dose is missed, take it as soon as you remember, unless it is almost time for your next dose. In that case, skip the missed dose and resume your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
Jaktor generally does not impair the ability to drive or operate machinery. However, if you experience dizziness or other side effects that affect your concentration, avoid driving or operating heavy machinery.
Lifestyle Advice
- Maintain good hygiene to reduce infection risk.
- Avoid close contact with people who are sick.
- Quit smoking and limit alcohol consumption.
- Discuss any planned surgeries or vaccinations with your doctor.
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Global Brand Names
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