Lenvakin
Generic Name
Lenvatinib
Manufacturer
Eisai Co., Ltd.
Country
Japan
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Price Details
Current market pricing information
| Variant | Unit Price | Strip Price |
|---|---|---|
| lenvakin 10 mg capsule | ৳ 1,500.00 | ৳ 10,500.00 |
Description
Overview of the medicine
Lenvatinib is a kinase inhibitor indicated for the treatment of various types of cancer, including differentiated thyroid cancer, renal cell carcinoma, and hepatocellular carcinoma. It works by blocking several protein kinases that are involved in cancer cell growth and blood vessel formation in tumors.
Uses & Indications
Dosage
Adults
DTC: 24 mg orally once daily. RCC: 18 mg orally once daily in combination with everolimus 5 mg orally once daily, or 24 mg orally once daily as monotherapy. HCC: 8 mg or 12 mg orally once daily depending on body weight. Endometrial Carcinoma: 20 mg orally once daily in combination with pembrolizumab.
Elderly
No specific dose adjustment based on age is required, but monitor elderly patients for increased susceptibility to adverse reactions.
Renal_impairment
For severe renal impairment (CrCl < 30 mL/min), a dose reduction is recommended (e.g., 14 mg for DTC, 10 mg for RCC/HCC). No dose adjustment is needed for mild to moderate renal impairment.
How to Take
Take orally once daily with or without food, at approximately the same time each day. Swallow the capsule whole with water; do not open, crush, or chew the capsule.
Mechanism of Action
Lenvatinib is a multi-targeted receptor tyrosine kinase (RTK) inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1, VEGFR2, and VEGFR3, in addition to other proangiogenic and oncogenic RTKs including fibroblast growth factor (FGF) receptors FGFR1, 2, 3, and 4, platelet derived growth factor receptor alpha (PDGFRα), KIT, and RET. By inhibiting these kinases, it suppresses tumor growth and angiogenesis.
Pharmacokinetics
Onset
Clinical effects are typically observed within weeks of initiation of therapy, depending on the specific indication.
Excretion
Mainly excreted via feces (approximately 64% of the dose), with a smaller portion excreted renally (approximately 25% of the dose).
Half life
Approximately 28 hours (range 23-40 hours), allowing for once-daily dosing.
Absorption
Rapidly absorbed, with peak plasma concentrations (Cmax) reached 1-4 hours post-dose. Absolute bioavailability is not determined but appears to be high.
Metabolism
Primarily metabolized by CYP3A4 and aldehyde oxidase. Other minor metabolic pathways are also involved.
Side Effects
Contraindications
- Hypersensitivity to lenvatinib or any excipients in the formulation.
- Pre-existing severe and uncontrolled hypertension.
Drug Interactions
Drugs that prolong QT interval
Caution with coadministration due to potential for additive QT prolongation.
Strong CYP3A4 inducers (e.g., rifampin, phenytoin, St. John's Wort)
May decrease lenvatinib plasma concentrations, potentially reducing efficacy. Avoid coadministration if possible.
Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir)
May increase lenvatinib plasma concentrations, potentially increasing toxicity. Monitor closely for adverse reactions.
Storage
Store below 30°C (86°F) in a dry place, protected from light and moisture. Keep out of reach of children. Do not store in the bathroom.
Overdose
Symptoms of overdose could include hypertension, cardiac events, diarrhea, and vomiting. In case of an overdose, management should be supportive with symptomatic treatment. There is no specific antidote for lenvatinib overdose.
Pregnancy & Lactation
Pregnancy Category D. Lenvatinib may cause fetal harm when administered to a pregnant woman. Women of reproductive potential should be advised to use effective contraception during treatment and for at least 1 week after the last dose. It is not known whether lenvatinib is excreted in human milk; due to the potential for serious adverse reactions in breastfed infants, advise lactating women to discontinue breastfeeding during treatment and for at least 1 week after the last dose.
Frequently Asked Questions
Common questions about this medicine
Pack Sizes
Shelf Life
Typically 24 to 36 months from the date of manufacture, refer to packaging for exact date.
Availability
Pharmacies, hospitals
Approval Status
FDA approved
Patent Status
Patented (until approx. 2028-2030)
Clinical Trials
The efficacy and safety of lenvatinib have been established through several pivotal clinical trials, including the SELECT study (for DTC), the REFLECT study (for HCC), the CLEAR study (for RCC), and Study 309/KEYNOTE-146 (for Endometrial Carcinoma in combination with pembrolizumab). These trials demonstrated significant improvements in progression-free survival and overall response rates.
Lab Monitoring
- Blood pressure monitoring (at baseline, after 1 week, then every 2 weeks for the first 2 months, and monthly thereafter).
- Urinalysis for proteinuria (at baseline and periodically during treatment).
- Thyroid function tests (TSH, free T4) (at baseline and monthly).
- Liver function tests (ALT, AST, bilirubin) (at baseline and periodically).
- Renal function tests (creatinine, BUN) (at baseline and periodically).
- Electrolytes (calcium, potassium, magnesium) (at baseline and periodically).
Doctor Notes
- Crucial to monitor blood pressure closely and manage hypertension proactively, especially during the initial weeks of therapy. Dose reduction or interruption may be necessary.
- Patients should be advised on early recognition and management of diarrhea and hand-foot syndrome to maintain treatment adherence.
- Baseline and regular monitoring of thyroid, hepatic, and renal function is mandatory due to potential for significant adverse events.
- Assess for potential drug interactions, especially with strong CYP3A4 inhibitors/inducers and QT-prolonging agents.
Patient Guidelines
- Take Lenvakin exactly as prescribed by your doctor.
- Report any new or worsening side effects, especially high blood pressure, severe diarrhea, or any bleeding, to your doctor immediately.
- Do not stop taking the medicine or change your dose without consulting your doctor.
- Monitor your blood pressure regularly at home as instructed by your healthcare provider.
- Stay hydrated and manage diarrhea with anti-diarrheal medication if advised by your doctor.
Missed Dose Advice
If a dose is missed, and it is less than 12 hours until the next scheduled dose, take the missed dose as soon as possible. If it is more than 12 hours, skip the missed dose and resume the regular dosing schedule. Do not take two doses at the same time to make up for a missed dose.
Driving Precautions
Lenvatinib may cause fatigue, dizziness, or blurred vision. Patients should exercise caution when driving or operating machinery until they know how lenvatinib affects them.
Lifestyle Advice
- Maintain a balanced diet and adequate hydration to help manage common side effects like fatigue and diarrhea.
- Avoid grapefruit and grapefruit juice as they may interact with lenvatinib.
- Discuss any over-the-counter medications, herbal supplements, or vitamins with your doctor before taking them.
- Consider regular light exercise if tolerated, and ensure sufficient rest.
- Manage any skin reactions (e.g., hand-foot syndrome) with moisturizers or as advised by your doctor.
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