xelnib-xr
Generic Name
xelnib-xr-11-mg-tablet
Manufacturer
Apex Therapeutics Ltd.
Country
United States
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| xelnib xr 11 mg tablet | ৳ 80.00 | ৳ 800.00 |
Description
Overview of the medicine
Xelnib-XR 11 mg Tablet is an extended-release formulation of a novel tyrosine kinase inhibitor used in the treatment of specific solid tumors. It works by targeting specific pathways that promote cancer cell growth and survival, offering a targeted approach to therapy.
Uses & Indications
Dosage
Adults
11 mg once daily, taken orally with or without food. Dosage adjustments may be required based on tolerability and response.
Elderly
No specific dose adjustment required for elderly patients based on age alone. Monitor for adverse effects.
Renal_impairment
Mild to moderate renal impairment: No dose adjustment. Severe renal impairment: Use with caution, consider dose reduction.
How to Take
Take the tablet whole, do not crush, chew, or divide it. Can be taken with or without food. Administer at approximately the same time each day.
Mechanism of Action
Xelnib selectively inhibits specific receptor tyrosine kinases (RTKs) and non-receptor tyrosine kinases implicated in oncogenesis, cell proliferation, and angiogenesis. By blocking these key signaling pathways, it disrupts tumor growth and promotes apoptosis in sensitive cancer cells.
Pharmacokinetics
Onset
Therapeutic effects typically observed within weeks of consistent dosing.
Excretion
Excreted mainly via feces (60-70%) and urine (20-30%).
Half life
Approximately 24-30 hours, supporting once-daily dosing.
Absorption
Well absorbed orally, with extended release profile. Peak plasma concentrations are reached 4-6 hours post-dose.
Metabolism
Primarily metabolized in the liver by CYP3A4.
Side Effects
Contraindications
- Hypersensitivity to xelnib or any components of the tablet
- Severe hepatic impairment
- Concomitant use with strong CYP3A4 inhibitors
Drug Interactions
QT Prolonging Drugs
Increased risk of cardiac arrhythmias. Use with caution.
Strong CYP3A4 Inducers (e.g., rifampicin, phenytoin)
May decrease xelnib plasma concentrations, reducing efficacy. Avoid concomitant use.
Strong CYP3A4 Inhibitors (e.g., ketoconazole, clarithromycin)
May increase xelnib plasma concentrations, increasing risk of adverse effects. Consider dose reduction or alternative agents.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
No specific antidote for xelnib overdose. In case of overdose, discontinue xelnib and provide general supportive measures. Closely monitor patient for adverse effects and manage symptomatically.
Pregnancy & Lactation
Pregnancy Category D. Xelnib-XR can cause fetal harm. Advise pregnant women of the potential risk to the fetus. Females of reproductive potential should use effective contraception during treatment and for at least 3 months after the last dose. It is unknown if xelnib 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 3 months after the last dose.
Side Effects
Contraindications
- Hypersensitivity to xelnib or any components of the tablet
- Severe hepatic impairment
- Concomitant use with strong CYP3A4 inhibitors
Drug Interactions
QT Prolonging Drugs
Increased risk of cardiac arrhythmias. Use with caution.
Strong CYP3A4 Inducers (e.g., rifampicin, phenytoin)
May decrease xelnib plasma concentrations, reducing efficacy. Avoid concomitant use.
Strong CYP3A4 Inhibitors (e.g., ketoconazole, clarithromycin)
May increase xelnib plasma concentrations, increasing risk of adverse effects. Consider dose reduction or alternative agents.
Storage
Store below 30°C in a dry place, away from direct light and moisture. Keep out of reach of children.
Overdose
No specific antidote for xelnib overdose. In case of overdose, discontinue xelnib and provide general supportive measures. Closely monitor patient for adverse effects and manage symptomatically.
Pregnancy & Lactation
Pregnancy Category D. Xelnib-XR can cause fetal harm. Advise pregnant women of the potential risk to the fetus. Females of reproductive potential should use effective contraception during treatment and for at least 3 months after the last dose. It is unknown if xelnib 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 3 months after the last dose.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
36 months from the date of manufacture
Availability
Available in retail pharmacies and hospitals
Approval Status
Approved by regulatory authorities in major markets
Patent Status
Under patent protection
Clinical Trials
Demonstrated significant progression-free survival (PFS) and overall response rate (ORR) in Phase III clinical trials for indicated malignancies compared to standard therapy. Further studies are ongoing.
Lab Monitoring
- Liver function tests (ALT, AST, bilirubin) at baseline, every 2 weeks for the first 2 months, then monthly.
- Serum electrolytes (potassium, magnesium, calcium) at baseline and periodically.
- Complete blood count (CBC) with differential at baseline and periodically.
- Renal function tests (creatinine, BUN) at baseline and periodically.
Doctor Notes
- Ensure baseline LFTs, ECG, and electrolyte levels before initiating therapy.
- Closely monitor for signs of hepatotoxicity, cardiac events, and severe dermatological reactions.
- Counsel patients on drug interactions and the importance of adherence.
Patient Guidelines
- Take Xelnib-XR exactly as prescribed by your doctor.
- Do not stop taking the medicine without consulting your doctor.
- Report any new or worsening side effects to your doctor immediately.
- Avoid consuming grapefruit or grapefruit juice during treatment.
Missed Dose Advice
If a dose is missed, take it as soon as you remember. However, if it is less than 12 hours before the next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take a double dose.
Driving Precautions
May cause dizziness or fatigue. Patients should be cautioned about operating machinery or driving until they know how Xelnib-XR affects them.
Lifestyle Advice
- Maintain a healthy diet and stay well-hydrated to manage potential side effects like diarrhea.
- Avoid excessive alcohol consumption.
- Engage in light physical activity if tolerable, to combat fatigue.
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