Biganib
Generic Name
Biganib
Manufacturer
Investigational Drug Company
Country
Global (for clinical trials)
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| biganib 180 mg tablet | ৳ 2,000.00 | ৳ 14,000.00 |
Description
Overview of the medicine
Biganib is an investigational orally available small molecule inhibitor targeting Fibroblast Growth Factor Receptors (FGFR). It is being developed for the treatment of various cancers with FGFR alterations.
Uses & Indications
Dosage
Adults
180 mg orally once daily, with or without food, until disease progression or unacceptable toxicity. Dosage adjustments may be required based on adverse reactions.
Elderly
No specific dosage adjustment required based on age; monitor for tolerability.
Renal_impairment
No dosage adjustment needed for mild to moderate renal impairment. Data for severe renal impairment is limited; caution is advised.
Hepatic_impairment
Dosage adjustment recommended for moderate to severe hepatic impairment. Refer to clinical trial protocols for specific guidelines.
How to Take
Take orally, once daily. Swallow the tablet whole with water. Do not crush, chew, or split the tablet. Can be taken with or without food.
Mechanism of Action
Biganib selectively binds to and inhibits the activity of FGFRs (e.g., FGFR1, FGFR2, FGFR3), which are involved in cell proliferation, differentiation, and survival. By inhibiting FGFR signaling, Biganib is expected to disrupt tumor growth in cancers driven by FGFR aberrations.
Pharmacokinetics
Onset
Not fully established, but expected to inhibit target pathways within hours of administration.
Excretion
Mainly excreted via feces, with a minor portion excreted renally.
Half life
Approximately 10-15 hours, allowing for once-daily dosing.
Absorption
Rapidly absorbed after oral administration, peak plasma concentrations typically reached within 2-4 hours.
Metabolism
Primarily metabolized in the liver, likely via cytochrome P450 (CYP) enzymes, particularly CYP3A4.
Side Effects
Contraindications
- Hypersensitivity to Biganib or any of its excipients
- Severe uncorrected electrolyte abnormalities, especially hyperphosphatemia
- Concurrent use with strong CYP3A4 inhibitors or inducers (may require dose adjustment)
Drug Interactions
Phosphate-lowering agents
Use with caution; monitor phosphate levels closely.
Drugs affecting gastric pH
May alter Biganib absorption; monitor for efficacy.
Strong CYP3A4 Inducers (e.g., rifampicin, phenytoin)
May decrease Biganib exposure; concomitant use should be avoided or dose increase considered.
Strong CYP3A4 Inhibitors (e.g., ketoconazole, clarithromycin)
May increase Biganib exposure; dose reduction may be required.
Storage
Store at room temperature (20°C to 25°C), away from light and moisture. Keep out of reach of children.
Overdose
There is no specific antidote for Biganib overdose. Management should involve general supportive measures and close monitoring for adverse reactions, especially hyperphosphatemia and ocular events. Gastric lavage or activated charcoal may be considered if ingestion is recent.
Pregnancy & Lactation
Pregnancy Category D. Biganib is expected to cause fetal harm. Females of reproductive potential must use effective contraception during treatment and for at least 1 month after the last dose. It is not known if Biganib is excreted in human milk; due to the potential for serious adverse reactions in breastfed infants, women should not breastfeed during treatment and for 1 month after the last dose.
Side Effects
Contraindications
- Hypersensitivity to Biganib or any of its excipients
- Severe uncorrected electrolyte abnormalities, especially hyperphosphatemia
- Concurrent use with strong CYP3A4 inhibitors or inducers (may require dose adjustment)
Drug Interactions
Phosphate-lowering agents
Use with caution; monitor phosphate levels closely.
Drugs affecting gastric pH
May alter Biganib absorption; monitor for efficacy.
Strong CYP3A4 Inducers (e.g., rifampicin, phenytoin)
May decrease Biganib exposure; concomitant use should be avoided or dose increase considered.
Strong CYP3A4 Inhibitors (e.g., ketoconazole, clarithromycin)
May increase Biganib exposure; dose reduction may be required.
Storage
Store at room temperature (20°C to 25°C), away from light and moisture. Keep out of reach of children.
Overdose
There is no specific antidote for Biganib overdose. Management should involve general supportive measures and close monitoring for adverse reactions, especially hyperphosphatemia and ocular events. Gastric lavage or activated charcoal may be considered if ingestion is recent.
Pregnancy & Lactation
Pregnancy Category D. Biganib is expected to cause fetal harm. Females of reproductive potential must use effective contraception during treatment and for at least 1 month after the last dose. It is not known if Biganib is excreted in human milk; due to the potential for serious adverse reactions in breastfed infants, women should not breastfeed during treatment and for 1 month after the last dose.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
As per manufacturer's specifications, typically 24-36 months for investigational products.
Availability
Limited, for clinical trials only
Approval Status
Investigational / Under Clinical Development
Patent Status
Under patent protection (Investigational)
Clinical Trials
Biganib is currently undergoing Phase II and Phase III clinical trials globally for various FGFR-driven solid tumors, including cholangiocarcinoma and urothelial carcinoma.
Lab Monitoring
- Serum phosphate levels (before initiation, weekly for first month, then monthly)
- Liver function tests (baseline and periodically)
- Renal function tests (baseline and periodically)
- Electrolytes (calcium, magnesium, potassium)
Doctor Notes
- Confirm FGFR gene alteration status prior to initiation.
- Monitor serum phosphate levels rigorously and manage hyperphosphatemia promptly.
- Perform baseline and regular ophthalmological examinations.
- Educate patients on potential visual symptoms and the need for immediate reporting.
Patient Guidelines
- Take Biganib exactly as prescribed by your doctor.
- Do not stop taking Biganib without consulting your doctor.
- Report any changes in vision immediately to your healthcare provider.
- Use effective contraception during and after treatment.
- Maintain adequate hydration.
- Avoid grapefruit products.
Missed Dose Advice
If a dose is missed, take it as soon as you remember on the same day. If it is less than 12 hours until the next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses to make up for a missed dose.
Driving Precautions
Biganib may cause visual disturbances (e.g., blurred vision, floaters) which could impair your ability to drive or operate machinery. Exercise caution and avoid such activities if you experience vision changes.
Lifestyle Advice
- Maintain good oral hygiene to manage stomatitis.
- Stay hydrated by drinking plenty of fluids, especially if experiencing diarrhea.
- Report any skin or nail changes to your doctor.
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