Barixen
Generic Name
Baricitinib
Manufacturer
Incepta Pharmaceuticals Ltd.
Country
Bangladesh
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Price Details
Current market pricing information
Variant | Unit Price | Strip Price |
---|---|---|
barixen 2 mg tablet | ৳ 25.00 | ৳ 250.00 |
Description
Overview of the medicine
Baricitinib is a selective and reversible Janus kinase (JAK) inhibitor used to treat moderate to severe active rheumatoid arthritis, severe alopecia areata, and in certain cases, COVID-19. It works by blocking the activity of enzymes called Janus kinases, which are involved in inflammation and immune responses.
Uses & Indications
Dosage
Adults
Rheumatoid Arthritis and Alopecia Areata: 2 mg once daily. May increase to 4 mg once daily if response is inadequate. COVID-19: 4 mg once daily for 14 days or until hospital discharge, whichever comes first.
Elderly
No specific dose adjustment based solely on age, but monitor renal function carefully.
Renal_impairment
For CrCl 30 to <60 mL/min, reduce dose to 1 mg once daily. Not recommended for CrCl <30 mL/min.
How to Take
Take orally with or without food. Swallow the tablet whole; do not split, crush, or chew.
Mechanism of Action
Baricitinib selectively and reversibly inhibits Janus Kinase (JAK) 1 and JAK2, preventing the phosphorylation and activation of signal transducers and activators of transcription (STATs). This reduces the signaling of various cytokines and growth factors that are implicated in inflammatory and autoimmune diseases.
Pharmacokinetics
Onset
Clinical improvement for RA typically observed within 1-2 weeks. For alopecia areata, improvement may be seen within 24 weeks.
Excretion
Mainly renal excretion (approximately 75%), with some fecal excretion (approximately 20%).
Half life
Approximately 12-16 hours.
Absorption
Rapidly absorbed; peak plasma concentration (Cmax) reached in approximately 1 hour.
Metabolism
Primarily hepatic, with minor contribution from CYP3A4.
Side Effects
Contraindications
- Hypersensitivity to baricitinib or any component of the formulation.
- Active serious infections, including localized infections.
- Severe hepatic impairment (specific guidelines may vary).
Drug Interactions
Probenecid
Increases baricitinib exposure; consider a dose reduction of baricitinib.
Live vaccines
Avoid during treatment with baricitinib.
Strong CYP3A inhibitors (e.g., Ketoconazole)
May increase baricitinib levels, though not a major pathway.
Immunosuppressants (e.g., Biologics, other JAK inhibitors)
Avoid co-administration due to increased risk of immunosuppression and infections.
Storage
Store below 25°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
In case of overdose, there is no specific antidote. Management should include general supportive measures, monitoring of vital signs, and treatment of clinical symptoms. Hemodialysis is not expected to effectively remove baricitinib.
Pregnancy & Lactation
Pregnancy Category C. Not recommended during pregnancy due to potential fetal harm. Avoid breastfeeding during treatment and for at least 4 days after the last dose, as baricitinib is likely excreted in human milk.
Side Effects
Contraindications
- Hypersensitivity to baricitinib or any component of the formulation.
- Active serious infections, including localized infections.
- Severe hepatic impairment (specific guidelines may vary).
Drug Interactions
Probenecid
Increases baricitinib exposure; consider a dose reduction of baricitinib.
Live vaccines
Avoid during treatment with baricitinib.
Strong CYP3A inhibitors (e.g., Ketoconazole)
May increase baricitinib levels, though not a major pathway.
Immunosuppressants (e.g., Biologics, other JAK inhibitors)
Avoid co-administration due to increased risk of immunosuppression and infections.
Storage
Store below 25°C in a dry place, protected from light and moisture. Keep out of reach of children.
Overdose
In case of overdose, there is no specific antidote. Management should include general supportive measures, monitoring of vital signs, and treatment of clinical symptoms. Hemodialysis is not expected to effectively remove baricitinib.
Pregnancy & Lactation
Pregnancy Category C. Not recommended during pregnancy due to potential fetal harm. Avoid breastfeeding during treatment and for at least 4 days after the last dose, as baricitinib is likely excreted in human milk.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
2 years from the date of manufacture
Availability
Pharmacies, Hospitals
Approval Status
FDA Approved, DGDA Approved
Patent Status
Patent protected (for originator, generics available)
Clinical Trials
Baricitinib has undergone extensive clinical trials for rheumatoid arthritis, alopecia areata, atopic dermatitis, and COVID-19, demonstrating efficacy and safety in various patient populations.
Lab Monitoring
- Complete Blood Count (CBC) including lymphocyte, neutrophil, and platelet counts: At baseline, 4-8 weeks after initiation, and periodically thereafter.
- Liver Function Tests (ALT, AST, alkaline phosphatase): At baseline and periodically.
- Lipid Panel (total cholesterol, HDL, LDL): At baseline, 12 weeks after initiation, and periodically thereafter.
- Creatinine: At baseline and periodically, especially in patients with renal impairment.
- Tuberculosis (TB) screening: Prior to initiating treatment.
Doctor Notes
- Prior to initiating baricitinib, screen patients for latent tuberculosis and hepatitis B/C. Evaluate for risk factors for MACE and VTE.
- Monitor CBC, LFTs, and lipid panel at baseline and periodically during treatment. Adjust dose for renal impairment.
- Educate patients about the black box warnings, signs of serious infections, and symptoms of thrombosis, and instruct them to seek immediate medical attention if these occur.
Patient Guidelines
- Take the medicine exactly as prescribed by your doctor.
- Report any signs of infection (fever, chills, persistent cough) immediately to your doctor.
- Avoid live vaccines while on baricitinib treatment.
- 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 dose, 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
No direct effect on ability to drive or operate machinery is expected. However, if you experience dizziness or fatigue, avoid driving or operating heavy machinery.
Lifestyle Advice
- Maintain good hygiene to reduce the risk of infections.
- Avoid close contact with people who have infections.
- Follow a balanced diet and engage in regular, moderate exercise as advised by your healthcare provider.
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