Acubis
Generic Name
Tofacitinib
Manufacturer
Incepta Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| acubis 5 mg tablet | ৳ 10.00 | ৳ 100.00 |
Description
Overview of the medicine
Tofacitinib is an oral Janus kinase (JAK) inhibitor used for the treatment of various autoimmune diseases such as rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and ankylosing spondylitis.
Uses & Indications
Dosage
Adults
Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis: 5 mg twice daily. Ulcerative Colitis: Induction 10 mg twice daily for at least 8 weeks, then 5 mg twice daily for maintenance.
Elderly
No dose adjustment generally required, but caution due to increased risk of infection and comorbidities.
Renal_impairment
Moderate (CrCl 30-60 mL/min): 5 mg once daily. Severe (CrCl < 30 mL/min): Not recommended or further dose reduction may be required, consult physician.
How to Take
Take orally with or without food, as directed by a healthcare professional.
Mechanism of Action
Tofacitinib selectively inhibits Janus kinases (JAKs), primarily JAK1 and JAK3, which are involved in signaling pathways that regulate gene expression for various cytokines and growth factors. By inhibiting JAKs, it modulates cytokine signaling, reducing inflammation and immune responses.
Pharmacokinetics
Onset
Clinical improvement generally seen within 2-8 weeks.
Excretion
Approximately 70% eliminated via hepatic metabolism and 30% via renal excretion.
Half life
Approximately 3.2 hours.
Absorption
Rapidly absorbed, peak plasma concentration typically within 0.5-1 hour. Bioavailability is approximately 79%.
Metabolism
Primarily metabolized by CYP3A4 and to a lesser extent by CYP2C19.
Side Effects
Contraindications
- Hypersensitivity to Tofacitinib or any excipients
- Severe active infections (e.g., active tuberculosis, serious fungal infections)
- Severe hepatic impairment
- Pregnancy and lactation
Drug Interactions
Live vaccines
Avoid co-administration with live vaccines.
Strong CYP3A4 inducers
Decreases Tofacitinib exposure (e.g., Rifampin).
Strong CYP3A4 inhibitors
Increases Tofacitinib exposure, requiring dose adjustment (e.g., Ketoconazole).
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
No specific antidote for Tofacitinib overdose. Management involves symptomatic and supportive treatment. Hemodialysis may remove approximately 30% of the total Tofacitinib dose from the circulation.
Pregnancy & Lactation
Contraindicated during pregnancy. Avoid breastfeeding during treatment and for at least 18 hours after the last dose.
Side Effects
Contraindications
- Hypersensitivity to Tofacitinib or any excipients
- Severe active infections (e.g., active tuberculosis, serious fungal infections)
- Severe hepatic impairment
- Pregnancy and lactation
Drug Interactions
Live vaccines
Avoid co-administration with live vaccines.
Strong CYP3A4 inducers
Decreases Tofacitinib exposure (e.g., Rifampin).
Strong CYP3A4 inhibitors
Increases Tofacitinib exposure, requiring dose adjustment (e.g., Ketoconazole).
Storage
Store below 30°C in a dry place, away from light and moisture. Keep out of reach of children.
Overdose
No specific antidote for Tofacitinib overdose. Management involves symptomatic and supportive treatment. Hemodialysis may remove approximately 30% of the total Tofacitinib dose from the circulation.
Pregnancy & Lactation
Contraindicated during pregnancy. 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
24 to 36 months from the date of manufacture.
Availability
Pharmacies, Hospitals
Approval Status
FDA Approved
Patent Status
Generic available
Clinical Trials
Extensively studied in various clinical trials (e.g., ORAL series for RA, OCTAVE for UC, Tophacit for PsA) demonstrating efficacy and safety across its approved indications.
Lab Monitoring
- Complete Blood Count (CBC)
- Liver Function Tests (LFTs)
- Lipid Panel
- Tuberculosis screening before and during treatment
Doctor Notes
- Thoroughly screen patients for tuberculosis (TB) before initiating treatment and during therapy.
- Monitor patients for signs and symptoms of infection throughout the course of treatment.
- Consider annual skin cancer screening for patients, especially those with increased risk factors.
Patient Guidelines
- Report any signs or symptoms of infection immediately to your doctor.
- Attend all scheduled doctor appointments and laboratory tests for monitoring.
- Avoid live vaccinations during treatment with Acubis.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
Missed Dose Advice
If a dose is missed, take it as soon as you remember, unless it is almost time for your next dose. Do not double the dose to make up for a missed one.
Driving Precautions
Tofacitinib may cause dizziness. Patients should exercise caution when driving or operating machinery until they know how the medicine affects them.
Lifestyle Advice
- Practice good hygiene to minimize infection risk.
- Avoid close contact with people who are sick or have infections.
- Maintain a healthy diet and lifestyle.
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Global Brand Names
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