Tocit-XR
Generic Name
Tofacitinib extended-release
Manufacturer
Incepta Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| tocit xr 11 mg tablet | ৳ 75.00 | ৳ 1,050.00 |
Description
Overview of the medicine
Tofacitinib is a Janus kinase (JAK) inhibitor used for the treatment of various autoimmune diseases like rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and ankylosing spondylitis. The XR formulation provides extended release, allowing for once-daily dosing.
Uses & Indications
Dosage
Adults
RA/PsA/AS: 11 mg once daily. UC: 11 mg once daily.
Elderly
No dose adjustment generally required, but caution due to increased risk of infection.
Renal_impairment
Moderate (eGFR 30-60 mL/min): Reduce dose to 5 mg once daily (standard formulation). Severe (eGFR <30 mL/min): Not recommended for XR form.
How to Take
Take orally, once daily, with or without food. Swallow the tablet whole; do not chew, crush, or split.
Mechanism of Action
Tofacitinib inhibits the activity of Janus kinases (JAK1, JAK2, JAK3, and TYK2), which are enzymes that play a crucial role in signaling pathways involved in immune and inflammatory responses. By inhibiting JAKs, tofacitinib prevents the phosphorylation and activation of STATs (Signal Transducers and Activators of Transcription), thereby modulating gene expression and inflammatory processes.
Pharmacokinetics
Onset
Clinical response seen within 2-8 weeks.
Excretion
Primarily excreted renally (approximately 70%) and hepatically (approximately 30%).
Half life
Terminal half-life is approximately 6.4 hours (for XR).
Absorption
Rapidly absorbed after oral administration, bioavailability is ~74%. Peak plasma concentration (Tmax) for XR is ~4-6 hours.
Metabolism
Primarily metabolized in the liver by cytochrome P450 enzymes (mainly CYP3A4 and to a lesser extent CYP2C19).
Side Effects
Contraindications
- Known hypersensitivity to tofacitinib or any component of the formulation.
- Active serious infections (e.g., tuberculosis, severe fungal infections).
- Severe hepatic impairment.
Drug Interactions
Live Vaccines
Avoid concurrent administration.
Potent CYP3A4 inducers (e.g., rifampin)
May decrease tofacitinib exposure.
Potent CYP3A4 inhibitors (e.g., ketoconazole)
May increase tofacitinib exposure.
Immunosuppressants (e.g., azathioprine, cyclosporine)
Concomitant use is not recommended due to increased risk of immunosuppression and infection.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
No specific antidote. Management should be symptomatic and supportive. In cases of overdose, monitor patients for signs and symptoms of adverse reactions and provide appropriate treatment.
Pregnancy & Lactation
Pregnancy Category C. Data on pregnant women are insufficient to inform drug-associated risks. Use only if potential benefit justifies potential risk to the fetus. Not recommended during breastfeeding due to potential for serious adverse reactions in breastfed infants.
Side Effects
Contraindications
- Known hypersensitivity to tofacitinib or any component of the formulation.
- Active serious infections (e.g., tuberculosis, severe fungal infections).
- Severe hepatic impairment.
Drug Interactions
Live Vaccines
Avoid concurrent administration.
Potent CYP3A4 inducers (e.g., rifampin)
May decrease tofacitinib exposure.
Potent CYP3A4 inhibitors (e.g., ketoconazole)
May increase tofacitinib exposure.
Immunosuppressants (e.g., azathioprine, cyclosporine)
Concomitant use is not recommended due to increased risk of immunosuppression and infection.
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
No specific antidote. Management should be symptomatic and supportive. In cases of overdose, monitor patients for signs and symptoms of adverse reactions and provide appropriate treatment.
Pregnancy & Lactation
Pregnancy Category C. Data on pregnant women are insufficient to inform drug-associated risks. Use only if potential benefit justifies potential risk to the fetus. Not recommended during breastfeeding due to potential for serious adverse reactions in breastfed infants.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
36 months
Availability
Pharmacies, Hospitals
Approval Status
FDA Approved
Patent Status
Patent protected (brand specific)
Clinical Trials
Extensive clinical trials have demonstrated efficacy and safety in RA, PsA, UC, and AS. Ongoing trials explore long-term safety and new indications.
Lab Monitoring
- Complete Blood Count (CBC) including lymphocyte count: baseline and periodically.
- Lipid Panel: baseline and periodically.
- Liver Function Tests (LFTs): baseline and periodically.
- Renal Function Tests: baseline and periodically.
- Tuberculosis (TB) screening: prior to initiation and periodically.
- Viral hepatitis screening (HBV/HCV): prior to initiation.
Doctor Notes
- Prior to initiation, screen patients for latent tuberculosis and viral hepatitis.
- Monitor CBC, LFTs, and lipid panel periodically during treatment.
- Counsel patients on the serious risks, including infection, malignancy, MACE, and thrombosis.
Patient Guidelines
- Take as directed by your doctor. Do not stop without consulting your doctor.
- Report any signs of infection (fever, chills, sore throat) immediately.
- Avoid live vaccines during treatment.
- Inform your doctor if you have a history of blood clots.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. If it is almost time for the next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
May cause dizziness or visual disturbances. If affected, avoid driving or operating heavy machinery.
Lifestyle Advice
- Maintain good hygiene to reduce infection risk.
- Avoid contact with individuals who have active infections.
- Discuss potential exercise limitations with your doctor.
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Global Brand Names
International brand names for this medicine. Click a brand to search for detailed information.