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 to treat moderate to severe active rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis. It works by blocking certain enzymes that play a role in inflammation and immune responses.
Uses & Indications
Dosage
Adults
For Rheumatoid Arthritis/Psoriatic Arthritis: 11 mg orally once daily. For Ulcerative Colitis: Initially 22 mg orally once daily for 8 weeks, then 11 mg orally once daily.
Elderly
No dose adjustment is generally required for elderly patients, but monitor closely for adverse reactions.
Renal_impairment
Moderate renal impairment (CrCl 30-59 mL/min): Reduce dose to 5 mg immediate-release (XR formulation not recommended for dose reduction). Severe renal impairment (CrCl <30 mL/min): Avoid use. End-stage renal disease (ESRD): Avoid use.
How to Take
Take orally once daily with or without food. Swallow the tablet whole; do not crush, split, or chew, as this may affect the extended-release properties.
Mechanism of Action
Tofacitinib selectively inhibits Janus Kinase (JAK) enzymes, particularly JAK1 and JAK3, which are involved in the signaling pathways of various cytokines and growth factors. By inhibiting these enzymes, it modulates immune and inflammatory responses.
Pharmacokinetics
Onset
Clinical improvement often observed within 2-8 weeks of treatment.
Excretion
Approximately 70% renal excretion (30% as unchanged drug) and 30% hepatic excretion.
Half life
Approximately 3-5 hours for immediate-release Tofacitinib; the extended-release formulation provides sustained therapeutic levels.
Absorption
Well absorbed, with an absolute bioavailability of approximately 74% for immediate-release formulation. Peak plasma concentrations are reached within 1 hour.
Metabolism
Primarily hepatic metabolism via CYP3A4 (70%) and to a lesser extent CYP2C19 (10%).
Side Effects
Contraindications
- Known hypersensitivity to tofacitinib or any component of the formulation.
- Severe active infections (e.g., active tuberculosis, serious fungal infections, or other opportunistic infections).
- Severe hepatic impairment.
- Co-administration with biologic DMARDs or other potent immunosuppressants (e.g., azathioprine, cyclosporine).
Drug Interactions
Strong CYP3A4 inducers (e.g., Rifampin)
Decrease tofacitinib exposure; avoid co-administration if possible.
Strong CYP3A4 inhibitors (e.g., Ketoconazole, Ritonavir)
Increase tofacitinib exposure; consider dose adjustment.
Immunosuppressants (e.g., Azathioprine, Cyclosporine, Tacrolimus)
Increased risk of immunosuppression and infection; avoid co-administration.
Storage
Store in a cool, dry place below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
There is no specific antidote for Tofacitinib overdose. Management should include general supportive measures and monitoring of vital signs. Tofacitinib is not significantly removed by hemodialysis.
Pregnancy & Lactation
Pregnancy Category C. Use only if the potential benefit justifies the potential risk to the fetus. Avoid breastfeeding during treatment and for at least 18 hours after the last dose due to potential adverse effects on the infant.
Side Effects
Contraindications
- Known hypersensitivity to tofacitinib or any component of the formulation.
- Severe active infections (e.g., active tuberculosis, serious fungal infections, or other opportunistic infections).
- Severe hepatic impairment.
- Co-administration with biologic DMARDs or other potent immunosuppressants (e.g., azathioprine, cyclosporine).
Drug Interactions
Strong CYP3A4 inducers (e.g., Rifampin)
Decrease tofacitinib exposure; avoid co-administration if possible.
Strong CYP3A4 inhibitors (e.g., Ketoconazole, Ritonavir)
Increase tofacitinib exposure; consider dose adjustment.
Immunosuppressants (e.g., Azathioprine, Cyclosporine, Tacrolimus)
Increased risk of immunosuppression and infection; avoid co-administration.
Storage
Store in a cool, dry place below 30°C. Protect from light and moisture. Keep out of reach of children.
Overdose
There is no specific antidote for Tofacitinib overdose. Management should include general supportive measures and monitoring of vital signs. Tofacitinib is not significantly removed by hemodialysis.
Pregnancy & Lactation
Pregnancy Category C. Use only if the potential benefit justifies the potential risk to the fetus. Avoid breastfeeding during treatment and for at least 18 hours after the last dose due to potential adverse effects on the infant.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months from the date of manufacture.
Availability
Available in pharmacies nationwide
Approval Status
Approved by regulatory authorities (e.g., FDA, DGDA)
Patent Status
Brand specific patent protected
Clinical Trials
Tofacitinib has undergone extensive clinical trials (ORAL, OPAL, OCTAVE programs) demonstrating its efficacy and safety in rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis. Post-marketing studies have further evaluated long-term safety and cardiovascular risk.
Lab Monitoring
- Complete blood count (CBC) including lymphocyte count (baseline and periodically).
- Liver function tests (LFTs) (baseline and periodically).
- Lipid profile (total cholesterol, HDL, LDL) (baseline and 4-8 weeks after initiation, then periodically).
- Tuberculosis screening (latent TB test) before starting treatment.
- Viral hepatitis screening (Hepatitis B and C) before starting treatment.
Doctor Notes
- Prior to initiation, thoroughly screen patients for latent tuberculosis, viral hepatitis, and assess cardiovascular risk factors.
- Regular monitoring of CBC, LFTs, and lipid profile is crucial throughout treatment.
- Advise patients on signs of infection, malignancy, and thrombosis, and instruct them to seek immediate medical attention if these occur.
Patient Guidelines
- Report any signs of infection (fever, chills, persistent cough, skin sores) immediately to your doctor.
- Avoid live vaccines during treatment and discuss vaccination status with your healthcare provider.
- Inform your doctor about any history of diverticulitis, hepatitis B or C, or heart problems.
- Do not stop taking the medicine suddenly without consulting your doctor.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. If it is almost time for your next scheduled dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
Driving Precautions
No specific precautions for driving or operating machinery. However, if you experience dizziness or visual disturbances, avoid such activities.
Lifestyle Advice
- Maintain good hygiene to reduce the risk of infections.
- Engage in regular physical activity and a balanced diet as recommended by your doctor to support overall health.
- Regular follow-up with your doctor is essential for monitoring and managing potential side effects.
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