Tofaxen
Generic Name
Tofacitinib
Manufacturer
Incepta Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| tofaxen 5 mg tablet | ৳ 48.00 | N/A |
Description
Overview of the medicine
Tofacitinib is an oral Janus kinase (JAK) inhibitor used to treat certain autoimmune diseases such as rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis. It works by blocking the activity of JAK enzymes, which are involved in inflammation.
Uses & Indications
Dosage
Adults
Rheumatoid Arthritis/Psoriatic Arthritis: 5 mg twice daily. Ulcerative Colitis: Induction 10 mg twice daily for 8 weeks, then 5 mg twice daily. Maintenance 5 mg twice daily.
Elderly
No specific dosage adjustment required, but monitor for adverse effects.
Renal_impairment
Moderate renal impairment (CrCl 30-59 mL/min): 5 mg once daily. Severe renal impairment (CrCl <30 mL/min): Not recommended.
How to Take
Take orally with or without food. Swallow the tablet whole; do not crush, split, or chew.
Mechanism of Action
Tofacitinib selectively inhibits Janus kinase (JAK) enzymes, particularly JAK1 and JAK3, which are crucial for the signaling of several cytokines and growth factors involved in inflammation and immune function. By inhibiting JAKs, it interferes with the intracellular signaling pathway that leads to gene transcription and subsequent immune responses.
Pharmacokinetics
Onset
Clinical effects typically observed within 2-8 weeks, depending on the indication.
Excretion
Approximately 70% renally excreted (primarily as metabolites) and 30% via hepatic metabolism and fecal excretion.
Half life
Approximately 3.2 hours.
Absorption
Rapidly and well absorbed after oral administration, with peak plasma concentrations occurring within 0.5-1 hour.
Metabolism
Primarily metabolized by cytochrome P450 (CYP3A4) with minor contribution from CYP2C19. Metabolites are not pharmacologically active.
Side Effects
Contraindications
- Severe active infection (e.g., active tuberculosis)
- Known hypersensitivity to tofacitinib or any component of the formulation
- Severe hepatic impairment
- Absolute lymphocyte count <500 cells/mm³
- Absolute neutrophil count <1000 cells/mm³
- Hemoglobin <9 g/dL
Drug Interactions
Live Vaccines
Avoid during treatment.
Potent CYP3A4 Inducers (e.g., rifampin)
Decrease tofacitinib exposure; avoid co-administration.
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; generally not recommended for co-administration.
Storage
Store at room temperature (20°C to 25°C), away from moisture and light. Keep out of reach of children.
Overdose
Limited data. Management is supportive, including monitoring for signs of infection or myelosuppression. Hemodialysis is not expected to significantly remove tofacitinib due to high protein binding.
Pregnancy & Lactation
Pregnancy Category C. Not recommended during pregnancy unless potential benefit outweighs risk. Avoid breastfeeding during treatment and for at least 18 hours after the last dose.
Side Effects
Contraindications
- Severe active infection (e.g., active tuberculosis)
- Known hypersensitivity to tofacitinib or any component of the formulation
- Severe hepatic impairment
- Absolute lymphocyte count <500 cells/mm³
- Absolute neutrophil count <1000 cells/mm³
- Hemoglobin <9 g/dL
Drug Interactions
Live Vaccines
Avoid during treatment.
Potent CYP3A4 Inducers (e.g., rifampin)
Decrease tofacitinib exposure; avoid co-administration.
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; generally not recommended for co-administration.
Storage
Store at room temperature (20°C to 25°C), away from moisture and light. Keep out of reach of children.
Overdose
Limited data. Management is supportive, including monitoring for signs of infection or myelosuppression. Hemodialysis is not expected to significantly remove tofacitinib due to high protein binding.
Pregnancy & Lactation
Pregnancy Category C. Not recommended during pregnancy unless potential benefit outweighs risk. Avoid breastfeeding during treatment and for at least 18 hours after the last dose.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 to 36 months from the date of manufacture when stored properly.
Availability
Available in pharmacies and hospitals worldwide
Approval Status
Approved by FDA and other regulatory bodies globally
Patent Status
Patent expired for original innovator; generic versions available
Clinical Trials
Extensive clinical trials (ORAL series for RA, OCTAVE for UC, OPAL for PsA) have demonstrated efficacy and safety across various indications. Post-marketing surveillance continues to monitor long-term effects, including cardiovascular events and malignancies.
Lab Monitoring
- Complete Blood Count (CBC) including lymphocyte, neutrophil, and hemoglobin levels (at baseline and periodically)
- Liver function tests (LFTs) (at baseline and periodically)
- Lipid panel (at baseline and 4-8 weeks post-initiation, then periodically)
- TB screening before initiation
- Hepatitis B and C screening before initiation
Doctor Notes
- Screen for tuberculosis and viral hepatitis before initiating therapy.
- Monitor CBC, LFTs, and lipids at baseline and periodically.
- Caution in patients with a history of diverticulitis, cardiac risk factors, or malignancy.
- Consider dose adjustment for moderate renal impairment or concomitant use of strong CYP3A4 inhibitors.
- Educate patients on symptoms of serious infection, thrombosis, and malignancy.
Patient Guidelines
- Report any signs of infection (fever, chills, sore throat) immediately.
- Avoid live vaccines during treatment.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
- Regular blood tests will be required to monitor your response and for potential side effects.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not double the dose to make up for a missed one.
Driving Precautions
Tofacitinib is not known to impair the ability to drive or operate machinery. However, if you experience dizziness or other side effects that could affect concentration, avoid these activities.
Lifestyle Advice
- Maintain good hygiene to reduce infection risk.
- Follow a balanced diet and engage in regular, moderate exercise as advised by your doctor.
- Avoid smoking and excessive alcohol consumption.
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