Butinib
Generic Name
Butinib 140 mg capsule
Manufacturer
Global Pharma Inc.
Country
USA
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| butinib 140 mg capsule | ৳ 500.00 | ৳ 5,000.00 |
Description
Overview of the medicine
Butinib 140 mg capsule is an oral targeted therapy, a next-generation Bruton's Tyrosine Kinase (BTK) inhibitor, used in the treatment of various B-cell malignancies.
Uses & Indications
Dosage
Adults
Recommended dose is 140 mg orally once daily, taken with or without food.
Elderly
No specific dose adjustment required based on age alone. Monitor for adverse effects.
Renal_impairment
Mild to moderate renal impairment: No dose adjustment. Severe renal impairment: Data limited, dose reduction may be considered.
How to Take
Swallow capsules whole with water. Do not open, break, or chew the capsules. Can be taken with or without food, but consistently.
Mechanism of Action
Butinib selectively and irreversibly inhibits Bruton's Tyrosine Kinase (BTK), a critical enzyme in the B-cell receptor signaling pathway. This inhibition leads to the disruption of B-cell proliferation, survival, and trafficking in various B-cell lymphomas and leukemias.
Pharmacokinetics
Onset
Pharmacodynamic effects observed within hours of first dose; clinical efficacy seen over weeks to months.
Excretion
Excreted primarily via feces (approx. 80%) with a smaller proportion eliminated renally (approx. 10%).
Half life
Approximately 10-15 hours, allowing for once-daily dosing.
Absorption
Rapidly absorbed after oral administration, peak plasma concentrations typically achieved within 1-2 hours.
Metabolism
Primarily metabolized in the liver by cytochrome P450 (CYP) enzymes, particularly CYP3A4.
Side Effects
Contraindications
- Known hypersensitivity to butinib or any excipients
- Co-administration with strong CYP3A4 inhibitors (severe risk of toxicity)
Drug Interactions
Strong CYP3A4 inducers (e.g., rifampin, phenytoin)
May significantly decrease butinib exposure, leading to reduced efficacy. Avoid co-administration.
Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin)
May significantly increase butinib exposure, leading to increased risk of adverse reactions. Avoid co-administration or reduce butinib dose.
Anticoagulants and antiplatelet agents (e.g., warfarin, aspirin)
Increased risk of bleeding.
Storage
Store at room temperature (20°C to 25°C), away from moisture and light. Keep out of reach of children.
Overdose
No specific antidote. Management of overdose should involve supportive care and monitoring for adverse effects. Consider gastric lavage and activated charcoal if recent ingestion.
Pregnancy & Lactation
Not recommended during pregnancy due to potential fetal harm. Women of childbearing potential should use effective contraception. Advise against breastfeeding during treatment and for a period after the last dose.
Side Effects
Contraindications
- Known hypersensitivity to butinib or any excipients
- Co-administration with strong CYP3A4 inhibitors (severe risk of toxicity)
Drug Interactions
Strong CYP3A4 inducers (e.g., rifampin, phenytoin)
May significantly decrease butinib exposure, leading to reduced efficacy. Avoid co-administration.
Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin)
May significantly increase butinib exposure, leading to increased risk of adverse reactions. Avoid co-administration or reduce butinib dose.
Anticoagulants and antiplatelet agents (e.g., warfarin, aspirin)
Increased risk of bleeding.
Storage
Store at room temperature (20°C to 25°C), away from moisture and light. Keep out of reach of children.
Overdose
No specific antidote. Management of overdose should involve supportive care and monitoring for adverse effects. Consider gastric lavage and activated charcoal if recent ingestion.
Pregnancy & Lactation
Not recommended during pregnancy due to potential fetal harm. Women of childbearing potential should use effective contraception. Advise against breastfeeding during treatment and for a period after the last dose.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months from manufacturing date
Availability
Hospital pharmacies, specialized oncology centers
Approval Status
Under review for certain indications, potentially approved in some regions
Patent Status
Patented
Clinical Trials
Butinib has undergone extensive Phase 1, 2, and 3 clinical trials demonstrating efficacy and safety in various B-cell malignancies, leading to regulatory submissions and approvals.
Lab Monitoring
- Complete Blood Count (CBC) with differential
- Liver function tests (ALT, AST, bilirubin)
- Renal function tests (creatinine, BUN)
- Electrolytes (potassium, sodium)
- Cardiac monitoring (ECG) if indicated
Doctor Notes
- Emphasize close monitoring for opportunistic infections and bleeding events.
- Educate patients on potential cardiac adverse events.
- Regularly assess patient compliance and adverse event management.
Patient Guidelines
- Take medicine as directed by your doctor.
- Report any signs of bleeding, infection, or heart problems immediately.
- Avoid grapefruit and Seville oranges.
- Do not stop taking the medicine without consulting your doctor.
Missed Dose Advice
If a dose is missed by more than 12 hours, skip the missed dose and take the next dose at the regularly scheduled time. Do not take two doses to make up for a missed dose.
Driving Precautions
May cause fatigue, dizziness, or blurred vision. Exercise caution when driving or operating machinery until you know how this medicine affects you.
Lifestyle Advice
- Maintain good hygiene to reduce infection risk.
- Stay hydrated.
- Avoid activities that may increase bleeding risk.
- Discuss all medications, supplements, and herbal products with your doctor.
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Global Brand Names
International brand names for this medicine. Click a brand to search for detailed information.