Lenvatinib Teva
Lenvatinib mesilate – oral multi-kinase inhibitor for cancer treatment
Quick Facts About Lenvatinib Teva
Key Takeaways About Lenvatinib Teva
- Multi-target anti-cancer agent: Lenvatinib inhibits VEGFR1-3, FGFR1-4, PDGFR-alpha, RET, and KIT, cutting off tumor blood supply and growth signals
- Approved for multiple cancers: Used in differentiated thyroid cancer, hepatocellular carcinoma, and in combination therapy for endometrial and renal cell carcinoma
- Blood pressure monitoring is critical: Hypertension occurs in a majority of patients and must be controlled before and during treatment
- Dose adjustments are common: Your oncologist may reduce the dose based on tolerability and side effects – this does not mean the treatment is failing
- Regular monitoring required: Blood pressure, liver function, thyroid function, kidney function, and urine protein must be checked regularly throughout treatment
What Is Lenvatinib Teva and What Is It Used For?
Lenvatinib Teva is an oral targeted cancer therapy that works by blocking multiple signaling pathways essential for tumor growth and the formation of new blood vessels. It is approved for the treatment of differentiated thyroid cancer, hepatocellular carcinoma, and in combination regimens for endometrial and renal cell carcinoma.
Lenvatinib Teva contains the active substance lenvatinib (as lenvatinib mesilate), which belongs to a class of medications called tyrosine kinase inhibitors (TKIs). These medications work by targeting specific enzymes – known as kinases – that play crucial roles in the signaling pathways cancer cells use to grow, divide, and form new blood vessels (a process called angiogenesis). By simultaneously blocking multiple kinase targets, lenvatinib disrupts several key mechanisms that tumors rely on to survive and spread.
The primary kinase targets of lenvatinib include the vascular endothelial growth factor receptors (VEGFR1, VEGFR2, and VEGFR3), fibroblast growth factor receptors (FGFR1, FGFR2, FGFR3, and FGFR4), platelet-derived growth factor receptor alpha (PDGFRα), KIT, and RET proto-oncogene. The simultaneous inhibition of these targets gives lenvatinib its broad anti-tumor activity and distinguishes it from more selective kinase inhibitors.
Lenvatinib Teva is a generic formulation that has been demonstrated to be bioequivalent to the originator product, meaning it delivers the same amount of active substance to the body and produces the same therapeutic effect. Generic medications like Lenvatinib Teva make important cancer treatments more widely accessible to patients who need them.
Approved Indications
Lenvatinib Teva is approved for use in the following clinical settings, based on results from large, randomized controlled trials:
- Differentiated thyroid cancer (DTC): For adult patients with progressive, locally advanced or metastatic differentiated thyroid cancer (papillary, follicular, or Hürthle cell) that is refractory to radioactive iodine (RAI) therapy. This was established in the landmark SELECT trial, which demonstrated a significant improvement in progression-free survival compared to placebo.
- Hepatocellular carcinoma (HCC): As a first-line treatment for adult patients with unresectable hepatocellular carcinoma (the most common form of primary liver cancer) who have not received prior systemic therapy. The REFLECT trial demonstrated non-inferiority to sorafenib in overall survival, with superior response rates and progression-free survival.
- Endometrial carcinoma (EC): In combination with pembrolizumab (an immune checkpoint inhibitor) for the treatment of advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), in patients who have disease progression following prior platinum-containing chemotherapy and are not candidates for curative surgery or radiation.
- Renal cell carcinoma (RCC): In combination with pembrolizumab as a first-line treatment for adult patients with advanced renal cell carcinoma. The CLEAR/KEYNOTE-581 trial showed significant improvements in progression-free survival, overall survival, and objective response rate compared to sunitinib.
What Should You Know Before Taking Lenvatinib Teva?
Before starting Lenvatinib Teva, your doctor must assess your blood pressure, liver function, kidney function, thyroid status, and cardiac health. There are several important contraindications, warnings, and precautions that must be considered to ensure safe and effective treatment.
Lenvatinib is a powerful medication that requires careful patient selection and monitoring. Before initiating treatment, your oncologist will perform a thorough assessment of your overall health status and evaluate whether lenvatinib is appropriate for you. Understanding the contraindications, warnings, and potential risks is essential for both patients and caregivers.
Contraindications
You should not take Lenvatinib Teva if you:
- Are allergic (hypersensitive) to lenvatinib mesilate or any of the other ingredients in the capsule
- Are breastfeeding (you must stop breastfeeding during treatment)
Your doctor will also carefully consider whether to prescribe lenvatinib if you have severe liver impairment (Child-Pugh C) or severe kidney impairment (creatinine clearance less than 15 mL/min), as there is limited data on the use of lenvatinib in these populations and the risk of adverse effects may be significantly increased.
Warnings and Precautions
Tell your doctor before starting Lenvatinib Teva if you have or have had any of the following conditions, as they may require special monitoring, dose adjustments, or may affect your suitability for treatment:
- High blood pressure (hypertension): Blood pressure must be well controlled before starting treatment. Lenvatinib commonly causes or worsens hypertension, and regular monitoring is essential.
- Liver problems: Lenvatinib can cause hepatotoxicity, including liver failure. Your liver function will be monitored before and regularly during treatment.
- Blood clots or bleeding disorders: Lenvatinib may increase the risk of arterial thromboembolic events (heart attack, stroke) and hemorrhage (bleeding).
- Heart problems: Including heart failure, reduced ejection fraction, or QT interval prolongation. Cardiac function should be monitored.
- Kidney problems: Proteinuria (protein in urine) is common and kidney failure can occur. Regular urine and blood tests are necessary.
- Recent surgery or planned surgery: Lenvatinib may impair wound healing. Treatment should be stopped at least 1 week before elective surgery.
- Gastrointestinal conditions: Lenvatinib may cause gastrointestinal perforation or fistula formation. Report any new or worsening abdominal pain immediately.
- Thyroid problems: Treatment may worsen hypothyroidism. Thyroid function (TSH) should be monitored, especially in thyroid cancer patients already on thyroid hormone replacement.
Pregnancy and Breastfeeding
Lenvatinib Teva must not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus. Animal studies have shown that lenvatinib causes embryo-fetal toxicity, including teratogenicity (birth defects) and embryo-fetal lethality at clinically relevant doses. Women of childbearing potential must use highly effective contraception during treatment and for at least 30 days after the final dose.
Men taking Lenvatinib Teva with female partners of childbearing potential should also use effective contraception during treatment and for at least 1 week after the last dose, as it is not known whether lenvatinib or its metabolites are present in semen.
Breastfeeding must be discontinued during treatment with Lenvatinib Teva and for at least 1 week after the final dose. It is unknown whether lenvatinib or its metabolites are excreted in human breast milk, but animal data suggest excretion in milk is likely. Due to the potential for serious adverse reactions in breastfed infants, breastfeeding is contraindicated.
Lenvatinib may impair fertility in both men and women. Animal studies have shown effects on male and female reproductive organs. Discuss fertility preservation options with your oncologist before starting treatment if this is a concern for you.
How Does Lenvatinib Teva Interact with Other Drugs?
Lenvatinib has relatively few clinically significant pharmacokinetic drug interactions, as it is metabolized by multiple pathways. However, certain medications may increase or decrease lenvatinib levels, and lenvatinib may affect the activity of other drugs. Always inform your oncologist about all medications, supplements, and herbal products you are taking.
Lenvatinib is metabolized primarily by cytochrome P450 3A4 (CYP3A4) and aldehyde oxidase (AO), with additional contributions from other CYP enzymes. Because multiple metabolic pathways are involved, the impact of individual CYP inhibitors or inducers is generally moderate. However, some drug interactions require monitoring or dose adjustments, and some combinations should be avoided.
Major Interactions
| Interacting Drug/Class | Effect | Recommendation |
|---|---|---|
| Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir) | May increase lenvatinib plasma concentrations | Use with caution; consider dose reduction if significant toxicity develops |
| Strong CYP3A4 inducers (e.g., rifampicin, carbamazepine, phenytoin, St. John's Wort) | May decrease lenvatinib plasma concentrations, reducing efficacy | Avoid concomitant use if possible; consider alternative agents |
| QT-prolonging drugs (e.g., amiodarone, sotalol, haloperidol, ondansetron) | Additive QT prolongation risk, increasing arrhythmia risk | ECG monitoring; correct electrolyte imbalances before and during treatment |
| Anticoagulants (e.g., warfarin, heparin, DOACs) | Increased bleeding risk due to lenvatinib's anti-angiogenic effects | Close monitoring of INR and bleeding signs; dose adjustments may be needed |
| Antihypertensives | Additive blood pressure lowering; yet lenvatinib often causes hypertension requiring additional antihypertensive therapy | Regular blood pressure monitoring; adjust antihypertensive doses as needed |
Minor Interactions
In vitro studies suggest that lenvatinib is a substrate of P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP), but clinical studies have not shown clinically significant interactions with P-gp or BCRP inhibitors at therapeutic doses. Lenvatinib does not significantly inhibit or induce major CYP enzymes at clinically relevant concentrations.
While lenvatinib has minimal effect on gastric pH, co-administration with antacids, proton pump inhibitors (PPIs), or H2-receptor antagonists is not expected to significantly alter lenvatinib absorption. Nevertheless, it is advisable to inform your healthcare team about all medications you are taking, including over-the-counter drugs, vitamins, and herbal supplements, as new interactions may be identified over time.
What Is the Correct Dosage of Lenvatinib Teva?
The dosage of Lenvatinib Teva depends on the type of cancer being treated, the patient's body weight, liver function, and tolerability. Treatment should be initiated and supervised by a physician experienced in oncology. Dose modifications are common and are based on individual tolerability and side effects.
Lenvatinib Teva is taken orally once daily, with or without food, at approximately the same time each day. The capsules should be swallowed whole with water. If a patient is unable to swallow the capsules, they may be dissolved: add the capsules to a small glass with 1 tablespoon of water or apple juice, leave for at least 10 minutes, stir for at least 3 minutes, and then drink the mixture. The same amount of liquid should then be added to the glass, swirled, and consumed to ensure the full dose is taken.
Adults
| Indication | Recommended Dose | Key Notes |
|---|---|---|
| Differentiated Thyroid Cancer (DTC) | 24 mg once daily | Continue until disease progression or unacceptable toxicity; dose reductions to 20 mg, 14 mg, and 10 mg as needed |
| Hepatocellular Carcinoma (HCC) | Body weight ≥60 kg: 12 mg once daily; Body weight <60 kg: 8 mg once daily | Weight-based dosing; dose reductions to 8 mg/4 mg or 4 mg as needed |
| Endometrial Carcinoma (EC) | 20 mg once daily + pembrolizumab 200 mg IV every 3 weeks | Combination therapy; dose reductions to 14 mg and 10 mg as needed |
| Renal Cell Carcinoma (RCC) | 20 mg once daily + pembrolizumab 200 mg IV every 3 weeks | Combination therapy; dose reductions to 14 mg and 10 mg as needed |
Dose modifications (reductions, interruptions, or discontinuation) are a standard part of lenvatinib management. Your oncologist will adjust the dose based on the severity and type of side effects you experience. Common reasons for dose adjustments include uncontrolled hypertension, proteinuria, hepatotoxicity, diarrhea, and palmar-plantar erythrodysesthesia (hand-foot syndrome). Up to two or three dose level reductions are typically allowed before considering treatment discontinuation.
Children
Lenvatinib Teva is not approved for use in children and adolescents under 18 years of age. The safety and efficacy of lenvatinib in pediatric patients have not been established in the approved indications. Clinical studies in pediatric populations are limited, and this medication should not be used in children unless part of a supervised clinical trial.
Elderly
No initial dose adjustment is required for elderly patients (aged 65 years and older). However, elderly patients may be more susceptible to certain adverse effects, particularly hypertension, fatigue, decreased appetite, and cardiac events. Careful monitoring and proactive dose modifications may be needed. In the pivotal clinical trials, a significant proportion of patients were aged 65 and older, and while efficacy was similar across age groups, the frequency of some adverse events was higher in elderly patients.
Patients with Liver or Kidney Impairment
For patients with mild to moderate hepatic impairment (Child-Pugh A or B), no dose adjustment is required, although close monitoring is recommended. For patients with severe hepatic impairment (Child-Pugh C), the recommended dose for DTC is 14 mg once daily, and for HCC, the safety and efficacy have not been established. For patients with mild to moderate renal impairment, no initial dose adjustment is necessary. Use in patients with severe renal impairment or end-stage renal disease has not been adequately studied.
Missed Dose
If you miss a dose and it is more than 12 hours until your next scheduled dose, take the missed dose as soon as you remember. If it is less than 12 hours until your next scheduled dose, skip the missed dose and take your next dose at the regular time. Do not take a double dose to make up for a missed one. If you vomit after taking lenvatinib, do not take an additional dose; take the next dose at the regularly scheduled time.
Overdose
There is no specific antidote for lenvatinib overdose. In the event of a suspected overdose, seek immediate medical attention. Treatment is supportive and symptomatic. Due to the long half-life of lenvatinib (approximately 28 hours), the effects of an overdose may persist for several days. In clinical experience, overdoses of up to 40 mg per day have been reported, with adverse effects primarily consisting of exaggerated pharmacological effects such as severe hypertension, nausea, diarrhea, and fatigue.
What Are the Side Effects of Lenvatinib Teva?
Like all cancer medications, Lenvatinib Teva can cause side effects. The most common include hypertension, diarrhea, decreased appetite, weight loss, fatigue, nausea, stomatitis, and hand-foot syndrome. While many side effects are manageable with supportive care and dose adjustments, some can be serious and require immediate medical attention.
Side effects from lenvatinib are common and expected as part of its mechanism of action. The multi-kinase inhibition that gives lenvatinib its anti-tumor activity also affects normal tissues, leading to a characteristic side effect profile. Understanding these side effects, knowing when to report them, and working closely with your healthcare team are essential for maintaining quality of life during treatment.
The frequency and severity of side effects can vary depending on the indication (thyroid cancer vs. liver cancer vs. combination therapy), the dose, the patient's overall health, and individual susceptibility. Your oncologist and specialist nurse will provide you with detailed information about what to expect and how to manage side effects proactively.
Very Common (affects more than 1 in 10 patients)
- Hypertension (high blood pressure)
- Diarrhea
- Decreased appetite and weight loss
- Fatigue and asthenia (weakness)
- Nausea and vomiting
- Stomatitis (inflammation and sores in the mouth)
- Palmar-plantar erythrodysesthesia (hand-foot syndrome – redness, pain, swelling of palms and soles)
- Proteinuria (protein in urine)
- Headache
- Dysphonia (hoarseness or voice changes)
- Abdominal pain
- Arthralgia and myalgia (joint and muscle pain)
- Hypothyroidism (underactive thyroid)
- Constipation
- Peripheral edema (swelling of hands and feet)
- Rash
Common (affects 1 in 10 to 1 in 100 patients)
- Dehydration
- Hypocalcemia (low calcium levels)
- Hypokalemia (low potassium levels)
- Hepatotoxicity (liver damage, elevated liver enzymes)
- Renal impairment or renal failure
- QT interval prolongation (heart rhythm change)
- Hemorrhage (bleeding from various sites)
- Thrombocytopenia (low platelet count)
- Dizziness
- Dysgeusia (altered taste)
- Dry mouth
- Lipase increase
- Back pain
- Insomnia
Uncommon (affects 1 in 100 to 1 in 1,000 patients)
- Arterial thromboembolic events (heart attack, stroke, transient ischemic attack)
- Posterior reversible encephalopathy syndrome (PRES)
- Gastrointestinal perforation or fistula
- Hepatic failure
- Pancreatitis
- Adrenal insufficiency
- Pneumothorax
- Osteonecrosis of the jaw
Rare (affects fewer than 1 in 1,000 patients)
- Thrombotic microangiopathy (TMA)
- Aneurysm or artery dissection
- Impaired wound healing (reported in all VEGFR inhibitors)
Many of the common side effects of lenvatinib can be managed effectively with supportive measures. Your oncology team will provide you with advice on managing diarrhea (dietary modifications and anti-diarrheal medications), stomatitis (oral hygiene measures and mouthwashes), hand-foot syndrome (moisturizing creams and avoiding pressure or friction), and fatigue (pacing activities and ensuring adequate nutrition). Do not stop taking lenvatinib or change the dose without consulting your oncologist, even if side effects are troublesome.
How Should You Store Lenvatinib Teva?
Store Lenvatinib Teva capsules below 25°C (77°F) in the original packaging to protect from moisture. Keep out of the reach and sight of children. Do not use the medication after the expiry date printed on the blister and carton.
Proper storage of Lenvatinib Teva is important to ensure the medication remains effective and safe throughout its shelf life. The hard capsules should be kept in their original blister packaging until you are ready to take a dose. This protects the capsules from moisture and light, which could degrade the active ingredient over time.
Do not store Lenvatinib Teva above 25°C (77°F). There is no need to refrigerate the capsules. Keep the medication in a secure location out of the sight and reach of children, as lenvatinib is a potent anticancer agent and accidental ingestion by children could be extremely dangerous.
Check the expiry date on the packaging before taking each dose. Do not use Lenvatinib Teva after the expiry date, which refers to the last day of the stated month. If you have any unused or expired capsules, do not dispose of them in household waste or via wastewater. Return them to your pharmacist for safe disposal in accordance with local environmental regulations for cytotoxic medications.
What Does Lenvatinib Teva Contain?
Each Lenvatinib Teva hard capsule contains lenvatinib mesilate equivalent to 4 mg of lenvatinib as the active ingredient, along with several inactive excipients that form the capsule contents and shell.
The active substance in Lenvatinib Teva is lenvatinib, present in the form of lenvatinib mesilate. Each 4 mg hard capsule contains lenvatinib mesilate equivalent to 4 mg of lenvatinib. The mesilate salt form was selected because it provides optimal stability and bioavailability for oral administration.
The capsule contents (excipients) typically include:
- Calcium carbonate: Used as a diluent/filler to provide bulk to the capsule contents
- Mannitol: A sugar alcohol used as a diluent to ensure proper fill volume
- Microcrystalline cellulose: Provides structural integrity and aids in consistent drug release
- Hydroxypropylcellulose: Functions as a binder to hold the formulation together
- Low-substituted hydroxypropylcellulose: Acts as a disintegrant to help the capsule contents break down in the stomach
- Talc: Used as a glidant to improve powder flow during manufacturing
The capsule shell is made of hypromellose (HPMC) with colorants including titanium dioxide (E171) and iron oxides. The specific colors of the capsule may vary by strength, helping to distinguish between different dose levels. The printing ink on the capsules contains shellac, black iron oxide, and other standard pharmaceutical-grade materials.
If you have known allergies to any pharmaceutical excipients, check the full list of ingredients in the patient information leaflet or consult your pharmacist before taking Lenvatinib Teva. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should note that this formulation does not contain lactose.
Frequently Asked Questions About Lenvatinib Teva
Lenvatinib Teva is a prescription anticancer medication used to treat several types of cancer. It is approved for progressive, locally advanced or metastatic differentiated thyroid cancer (DTC) that no longer responds to radioactive iodine therapy, as well as unresectable hepatocellular carcinoma (liver cancer) as a first-line treatment. It is also used in combination with pembrolizumab for advanced endometrial carcinoma and advanced renal cell carcinoma. Your oncologist will determine the most appropriate use based on your individual cancer type and circumstances.
Lenvatinib Teva works as a multi-kinase inhibitor, meaning it blocks the activity of several enzymes (kinases) that cancer cells use to grow, divide, and form new blood vessels. Specifically, it inhibits VEGF receptors 1-3 (which tumors need to create their blood supply), FGF receptors 1-4, PDGFR alpha, RET, and KIT. By blocking these multiple pathways simultaneously, lenvatinib starves the tumor of nutrients and oxygen while directly interfering with cancer cell growth signaling, leading to tumor shrinkage or stabilization.
The most common side effects include hypertension (high blood pressure), diarrhea, decreased appetite, weight loss, fatigue, nausea, stomatitis (mouth sores), palmar-plantar erythrodysesthesia (hand-foot syndrome – redness, pain, and peeling of palms and soles), proteinuria (protein in urine), vomiting, headache, and voice changes. Most of these side effects can be managed with supportive care and dose adjustments. It is important to report all side effects to your oncology team so they can help you manage them effectively.
Yes, Lenvatinib Teva can be taken with or without food. Food does not significantly affect the overall absorption of lenvatinib, although it may slightly delay the time to peak concentration. Taking the capsule at the same time each day helps maintain consistent drug levels in your body. If you have difficulty swallowing the capsule, you can dissolve it in a small amount of water or apple juice (leave for at least 10 minutes, then stir for 3 minutes before drinking).
Hypertension (high blood pressure) is one of the most common and clinically significant side effects of lenvatinib, affecting the majority of patients. This occurs because lenvatinib blocks VEGF signaling, which normally helps maintain blood vessel relaxation. Uncontrolled hypertension can lead to serious complications including stroke, heart attack, and kidney damage. Your blood pressure must be well controlled before starting treatment, checked regularly during treatment (including home monitoring if recommended), and managed aggressively with antihypertensive medications as needed.
Regular and comprehensive monitoring is essential while taking Lenvatinib Teva. This includes: blood pressure checks (before starting and regularly during treatment), liver function tests (ALT, AST, bilirubin), kidney function tests (creatinine, eGFR), urine protein testing, thyroid function tests (TSH, particularly in thyroid cancer patients), complete blood counts, electrolytes (including calcium, potassium, and magnesium), and ECG monitoring for QT prolongation. Your oncologist will schedule regular blood tests and clinical assessments, typically every 2-4 weeks initially and then at regular intervals throughout treatment.
References and Medical Sources
This article is based on the following peer-reviewed medical sources, international guidelines, and regulatory documents. All medical claims are supported by Level 1A evidence (systematic reviews and meta-analyses of randomized controlled trials) where available.
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- NCCN Clinical Practice Guidelines in Oncology: Hepatobiliary Cancers, Thyroid Carcinoma, Kidney Cancer. Version 2025. Available at: www.nccn.org.
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About Our Medical Editorial Team
This article has been written, reviewed, and fact-checked by the iMedic Medical Editorial Team, which includes board-certified specialists in oncology, clinical pharmacology, and internal medicine. Our team follows strict editorial guidelines based on the GRADE evidence framework and adheres to international medical standards set by the WHO, EMA, FDA, ESMO, and NCCN.