Biganib
Generic Name
Biganib 90 mg Tablet
Manufacturer
Innovate Pharma Inc.
Country
Global
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| biganib 90 mg tablet | ৳ 1,400.00 | ৳ 14,000.00 |
Description
Overview of the medicine
Biganib 90 mg Tablet is a targeted oral therapy used in the treatment of certain types of cancer. It works by inhibiting specific tyrosine kinases involved in cancer cell growth and survival.
Uses & Indications
Dosage
Adults
The recommended dose is 90 mg once daily, taken orally. May be taken with or without food. Adjustments may be made based on tolerability and efficacy.
Elderly
No specific dose adjustment is required for elderly patients based on age alone. Monitor for age-related decline in organ function.
Renal_impairment
No dose adjustment is necessary for mild to moderate renal impairment. Use with caution in severe renal impairment; data is limited.
How to Take
Take the tablet orally once daily, at approximately the same time each day. It can be taken with or without food. Swallow the tablet whole with water; do not crush, chew, or split it.
Mechanism of Action
Biganib is a potent, selective orally available tyrosine kinase inhibitor (TKI) that targets multiple receptor tyrosine kinases, including XYZ-R1, ABC-R2, and DEF-R3, crucial for cancer cell proliferation, angiogenesis, and survival. By inhibiting these pathways, Biganib effectively slows down or stops tumor growth.
Pharmacokinetics
Onset
Pharmacodynamic effects observed within days; clinical response may take weeks.
Excretion
Excreted predominantly in feces (approximately 85%), with a small amount excreted in urine (approximately 10%).
Half life
Elimination half-life is approximately 15-20 hours.
Absorption
Rapidly absorbed after oral administration, with peak plasma concentrations reached within 2-4 hours. Bioavailability is approximately 70-80%.
Metabolism
Primarily metabolized in the liver by cytochrome P450 3A4 (CYP3A4) enzyme. Minor metabolites also formed.
Side Effects
Contraindications
- Hypersensitivity to biganib or any component of the formulation.
- Severe hepatic impairment.
Drug Interactions
QT-prolonging agents (e.g., amiodarone, quinidine)
Increased risk of QT prolongation. Avoid concomitant use or monitor ECG closely.
Strong CYP3A4 Inducers (e.g., rifampin, phenytoin)
May decrease biganib plasma concentrations, reducing efficacy. Avoid concomitant use.
Strong CYP3A4 Inhibitors (e.g., ketoconazole, clarithromycin)
May increase biganib plasma concentrations, increasing risk of adverse effects. Consider dose reduction or alternative therapy.
Storage
Store at room temperature (20-25°C), away from moisture and light. Keep out of reach of children.
Overdose
There is no specific antidote for Biganib overdose. In case of an overdose, discontinue Biganib and initiate general supportive measures. Monitor vital signs, ECG, and blood counts. Manage symptoms as clinically indicated.
Pregnancy & Lactation
Pregnancy Category D. Biganib can cause fetal harm. Avoid use during pregnancy. Advise women of reproductive potential to use effective contraception during treatment and for at least 3 months after the last dose. It is unknown if biganib is excreted in human milk; due to the potential for serious adverse reactions in breastfed infants, advise lactating women not to breastfeed during treatment and for 2 weeks after the last dose.
Side Effects
Contraindications
- Hypersensitivity to biganib or any component of the formulation.
- Severe hepatic impairment.
Drug Interactions
QT-prolonging agents (e.g., amiodarone, quinidine)
Increased risk of QT prolongation. Avoid concomitant use or monitor ECG closely.
Strong CYP3A4 Inducers (e.g., rifampin, phenytoin)
May decrease biganib plasma concentrations, reducing efficacy. Avoid concomitant use.
Strong CYP3A4 Inhibitors (e.g., ketoconazole, clarithromycin)
May increase biganib plasma concentrations, increasing risk of adverse effects. Consider dose reduction or alternative therapy.
Storage
Store at room temperature (20-25°C), away from moisture and light. Keep out of reach of children.
Overdose
There is no specific antidote for Biganib overdose. In case of an overdose, discontinue Biganib and initiate general supportive measures. Monitor vital signs, ECG, and blood counts. Manage symptoms as clinically indicated.
Pregnancy & Lactation
Pregnancy Category D. Biganib can cause fetal harm. Avoid use during pregnancy. Advise women of reproductive potential to use effective contraception during treatment and for at least 3 months after the last dose. It is unknown if biganib is excreted in human milk; due to the potential for serious adverse reactions in breastfed infants, advise lactating women not to breastfeed during treatment and for 2 weeks after the last dose.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
24 months from the date of manufacture.
Availability
Hospitals, Specialty Pharmacies
Approval Status
Approved (Hypothetical for a novel targeted therapy)
Patent Status
Patented
Clinical Trials
Biganib has been evaluated in several Phase I, II, and III clinical trials, demonstrating efficacy and safety in specific cancer types. Post-marketing surveillance is ongoing to gather further real-world data.
Lab Monitoring
- Complete Blood Count (CBC) with differential: Before treatment and every 2-4 weeks during treatment.
- Liver Function Tests (LFTs) including ALT, AST, bilirubin: Before treatment and every 2-4 weeks.
- Electrocardiogram (ECG) and serum electrolytes (potassium, magnesium): Before treatment and periodically as clinically indicated due to QT prolongation risk.
Doctor Notes
- Prioritize patient education on adherence and adverse event reporting.
- Consider dose modifications based on patient tolerability and renal/hepatic function.
- Emphasize the importance of regular monitoring of blood counts, LFTs, and ECG.
Patient Guidelines
- Take Biganib exactly as prescribed by your doctor, do not alter the dose or stop the medication without consultation.
- Report any new or worsening side effects, especially fever, unusual bleeding/bruising, severe diarrhea, or yellowing of skin/eyes, to your doctor immediately.
- Attend all scheduled doctor appointments and lab tests.
Missed Dose Advice
If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose (e.g., within 12 hours), 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
Biganib may cause fatigue, dizziness, or vision disturbances. Patients should be cautioned about driving or operating machinery if they experience these side effects.
Lifestyle Advice
- Avoid consuming grapefruit or grapefruit juice while taking Biganib.
- Maintain good hydration, especially if experiencing diarrhea.
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