Lenvatinib Sandoz: Uses, Dosage & Side Effects
Tyrosine Kinase Inhibitor (TKI) — Oral Capsule
Lenvatinib Sandoz is a prescription oral tyrosine kinase inhibitor (TKI) containing the active ingredient lenvatinib (as mesilate). It is a generic version of the originator product Lenvima. Lenvatinib works by blocking multiple receptor tyrosine kinases involved in tumor blood vessel formation (angiogenesis) and cancer cell growth. It is approved for the treatment of progressive, locally advanced or metastatic differentiated thyroid cancer (DTC) refractory to radioactive iodine, unresectable hepatocellular carcinoma (HCC), advanced endometrial carcinoma (in combination with pembrolizumab), and advanced renal cell carcinoma (RCC, in combination with pembrolizumab or everolimus). Lenvatinib Sandoz is available as 4 mg hard capsules and is taken once daily by mouth. Treatment must be initiated and supervised by a physician experienced in cancer therapy.
Quick Facts: Lenvatinib Sandoz
Key Takeaways
- Lenvatinib Sandoz is a multi-kinase inhibitor that blocks VEGFR1-3, FGFR1-4, PDGFRα, RET, and KIT, simultaneously inhibiting tumor angiogenesis and cancer cell proliferation across multiple cancer types.
- It is approved for four major oncology indications: radioactive iodine-refractory differentiated thyroid cancer (monotherapy), unresectable hepatocellular carcinoma, advanced endometrial carcinoma (with pembrolizumab), and advanced renal cell carcinoma (with pembrolizumab or everolimus).
- Hypertension is the most common serious side effect, requiring blood pressure monitoring before and throughout treatment; most patients will need antihypertensive medication during therapy.
- Lenvatinib Sandoz is a generic equivalent of Lenvima, containing the same active ingredient and meeting the same regulatory standards for quality, safety, and efficacy.
- Treatment is contraindicated during pregnancy due to teratogenic risk; both women and men of reproductive potential must use effective contraception during treatment and for at least 30 days (women) or 1 week (men) after the last dose.
What Is Lenvatinib Sandoz and What Is It Used For?
Lenvatinib Sandoz contains the active substance lenvatinib (as lenvatinib mesilate), a potent oral multi-kinase inhibitor that belongs to the class of tyrosine kinase inhibitors (TKIs). Tyrosine kinases are enzymes inside cells that act as molecular switches, transmitting signals that tell cells to grow, divide, and form new blood vessels. In many cancers, these signaling pathways become abnormally active, driving uncontrolled tumor growth and the formation of new blood vessels that supply the tumor with oxygen and nutrients (a process called angiogenesis). By blocking these overactive kinases, lenvatinib disrupts the key processes that tumors depend on for survival and growth.
The mechanism of action of lenvatinib is notable for its ability to simultaneously inhibit multiple receptor tyrosine kinases. Specifically, lenvatinib inhibits vascular endothelial growth factor receptors 1, 2, and 3 (VEGFR1, VEGFR2, VEGFR3), which are the primary drivers of tumor angiogenesis. By blocking these receptors, lenvatinib starves the tumor of its blood supply. Additionally, lenvatinib inhibits fibroblast growth factor receptors 1 through 4 (FGFR1, FGFR2, FGFR3, FGFR4), which play crucial roles in tumor cell proliferation, survival, and resistance to anti-VEGF therapies. This dual VEGFR/FGFR inhibition is considered one of the key pharmacological advantages of lenvatinib over other TKIs that target only VEGFR.
Beyond VEGFR and FGFR inhibition, lenvatinib also blocks platelet-derived growth factor receptor alpha (PDGFRα), which is involved in supporting the stability of tumor blood vessels and recruiting pericytes (cells that wrap around blood vessels). By inhibiting PDGFRα, lenvatinib further destabilizes the tumor vasculature. Lenvatinib additionally inhibits the RET and KIT proto-oncogenes. RET is an important oncogenic driver in certain cancers, particularly thyroid cancers where RET mutations or rearrangements are frequently found. KIT is a receptor tyrosine kinase involved in various cellular signaling pathways relevant to tumor biology.
Lenvatinib Sandoz is approved by regulatory authorities for the following indications, either as monotherapy or in combination with other anticancer agents:
- Differentiated thyroid cancer (DTC): Lenvatinib is used as monotherapy for the treatment of adult patients with progressive, locally advanced or metastatic differentiated thyroid cancer (papillary, follicular, or Hürthle cell) that is refractory to radioactive iodine (RAI). The landmark SELECT trial demonstrated that lenvatinib significantly prolonged progression-free survival compared with placebo (18.3 months vs. 3.6 months; hazard ratio 0.21), establishing it as a standard of care for RAI-refractory DTC.
- Hepatocellular carcinoma (HCC): Lenvatinib is approved for the first-line treatment of adult patients with unresectable hepatocellular carcinoma who have not received prior systemic therapy. The REFLECT trial demonstrated non-inferiority of lenvatinib compared with sorafenib for overall survival, with superior progression-free survival and objective response rate. Lenvatinib may also be used in combination with pembrolizumab for first-line HCC treatment based on the LEAP-002 data and regulatory approvals in certain regions.
- Endometrial carcinoma (EC): In combination with pembrolizumab, lenvatinib is approved for the treatment of adult patients with advanced endometrial carcinoma that is not microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), who have disease progression following prior platinum-based systemic therapy and are not candidates for curative surgery or radiation. The Study 309/KEYNOTE-775 trial demonstrated significant improvements in both progression-free survival and overall survival with the combination versus chemotherapy.
- Renal cell carcinoma (RCC): In combination with pembrolizumab, lenvatinib is approved as first-line treatment for adult patients with advanced renal cell carcinoma. The CLEAR/KEYNOTE-581 trial demonstrated superior progression-free survival, overall survival, and objective response rate compared with sunitinib. Lenvatinib in combination with everolimus is also approved for patients with advanced RCC following one prior anti-angiogenic therapy, based on Study 205.
Lenvatinib Sandoz is a generic version of Lenvima (manufactured by Eisai). Generic medicines contain the same active ingredient, in the same dose and pharmaceutical form, and must demonstrate bioequivalence to the originator product. This means Lenvatinib Sandoz delivers the same amount of lenvatinib to the body as Lenvima. Generic medicines undergo rigorous regulatory review to ensure they meet the same quality, safety, and efficacy standards as the original branded product.
What Should You Know Before Taking Lenvatinib Sandoz?
Contraindications
Lenvatinib Sandoz must not be used if you have a known hypersensitivity (allergy) to lenvatinib, lenvatinib mesilate, or any of the other ingredients listed in the capsule formulation. Signs of a severe allergic reaction may include difficulty breathing, swelling of the face, lips, tongue, or throat, severe rash, or anaphylaxis. If you experience any of these symptoms, seek emergency medical attention immediately.
Lenvatinib is also contraindicated during pregnancy. Animal studies have shown that lenvatinib causes embryo-fetal toxicity and teratogenicity (birth defects) at doses below the recommended human dose. Women of childbearing potential must have a negative pregnancy test before starting treatment and must use highly effective contraception during treatment and for at least 30 days after the last dose.
Warnings and Precautions
Hypertension (high blood pressure) is one of the most common and clinically significant adverse effects of lenvatinib, occurring in over 40% of patients. Blood pressure must be well controlled before starting treatment. Monitor blood pressure weekly for the first 2 months and at least monthly thereafter. Uncontrolled hypertension can lead to hypertensive crisis, which may be life-threatening. Dose reduction, interruption, or permanent discontinuation may be necessary.
Before and during treatment with Lenvatinib Sandoz, your doctor should be informed about any of the following conditions, as special monitoring and dose adjustments may be required:
- Cardiac dysfunction: Cardiac failure, decreased left ventricular ejection fraction, and cardiomyopathy have been reported with lenvatinib. Cardiac function should be monitored before and during treatment. Signs and symptoms of cardiac decompensation include shortness of breath, ankle swelling, fatigue, and reduced exercise tolerance. Treatment may need to be withheld or discontinued for Grade 3 or higher cardiac events.
- Arterial thromboembolic events: Lenvatinib has been associated with an increased risk of arterial thromboembolic events including myocardial infarction (heart attack) and cerebrovascular accident (stroke). Patients with recent arterial thromboembolic events (within the previous 6 months) were excluded from clinical trials. Use caution in patients with risk factors for these events, and discontinue lenvatinib permanently if an arterial thromboembolic event occurs.
- Hepatotoxicity: Liver injury, including hepatic failure and death, has been reported. The most common liver-related adverse reactions are increased alanine aminotransferase (ALT), increased aspartate aminotransferase (AST), and increased blood bilirubin. Liver function tests should be performed before starting treatment, every 2 weeks for the first 2 months, and then monthly thereafter. Lenvatinib should be withheld for Grade 3 or higher hepatotoxicity and permanently discontinued for hepatic failure.
- Renal impairment and failure: Renal impairment, including renal failure and death, has been reported. Monitor renal function before and during treatment. Dose modifications may be required for patients with severe renal impairment.
- Proteinuria: Proteinuria (protein in the urine) has been reported frequently. Monitor urine protein regularly. Lenvatinib should be withheld for proteinuria of 2 g or more per 24 hours and discontinued for nephrotic syndrome.
- Diarrhea: Diarrhea is very common with lenvatinib and can sometimes be severe, leading to dehydration and electrolyte imbalances. Prompt medical management of diarrhea is essential. Dose modifications may be required for persistent or severe diarrhea.
- Gastrointestinal perforation and fistula formation: Cases of gastrointestinal perforation or fistula have been reported. Monitor patients for symptoms of peritonitis including abdominal pain, nausea, vomiting, and fever. Lenvatinib should be permanently discontinued in patients who develop gastrointestinal perforation or life-threatening fistula.
- QT interval prolongation: QT/QTc interval prolongation has been reported at higher rates in lenvatinib-treated patients compared with placebo. Monitor ECGs in patients with congenital long QT syndrome, congestive heart failure, bradyarrhythmias, or those taking drugs known to prolong the QT interval. Electrolyte abnormalities (hypokalemia, hypomagnesemia, hypocalcemia) should be corrected before and during treatment.
- Hypocalcemia: Hypocalcemia (low blood calcium) has been reported frequently, sometimes severe. Monitor calcium levels at least monthly and replace calcium as necessary. Dose interruption and adjustment may be needed for severe hypocalcemia.
- Reversible posterior leukoencephalopathy syndrome (RPLS): Also known as posterior reversible encephalopathy syndrome (PRES), this rare but serious condition has been reported. Symptoms include headache, seizures, visual disturbances, confusion, and altered mental function, often accompanied by high blood pressure. MRI is required for confirmation. Withhold lenvatinib and manage blood pressure if RPLS is suspected; discontinue permanently if confirmed.
- Hemorrhagic events: Serious hemorrhagic events, including fatal hemorrhage, have been reported. Assess bleeding risk before starting treatment. Lenvatinib should not be given to patients with or at risk for severe hemorrhage until the bleeding has resolved. Signs of hemorrhage include unexpected bleeding, blood in stool or urine, coughing up blood, and severe or persistent nosebleeds.
- Thyroid dysfunction: Hypothyroidism has been reported frequently. Monitor thyroid function before starting treatment and periodically during treatment. Patients already receiving thyroid hormone replacement (particularly those with thyroid cancer who have had thyroidectomy) may require dose adjustments of their thyroid medication.
- Impaired wound healing: Lenvatinib may impair wound healing. Withhold lenvatinib for at least 6 days before elective surgery. Do not administer for at least 2 weeks following major surgery and until adequate wound healing is confirmed. The safety of resuming lenvatinib after resolution of wound healing complications has not been established.
Your doctor will perform regular blood tests, urine tests, blood pressure measurements, ECGs, and clinical assessments throughout your treatment to monitor for these potential complications.
Pregnancy and Breastfeeding
Lenvatinib Sandoz must not be used during pregnancy. Based on its mechanism of action and findings from animal studies, lenvatinib can cause fetal harm when administered to a pregnant woman. Animal studies have demonstrated embryotoxicity and teratogenicity, including skeletal and external malformations, at doses below the recommended human dose. If lenvatinib is used during pregnancy or if the patient becomes pregnant while taking the drug, the patient should be informed of the potential hazard to the fetus.
Women of childbearing potential must use highly effective contraception during treatment with lenvatinib and for at least 30 days after the last dose. A pregnancy test should be performed before starting treatment. If a patient becomes pregnant during treatment, the treating oncologist should be informed immediately to discuss the risks and benefits of continuing therapy.
It is not known whether lenvatinib or its metabolites are excreted in human breast milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in breastfed infants, breastfeeding should be discontinued during treatment with lenvatinib and for at least 1 week after the last dose.
Male patients with female partners of childbearing potential should use effective contraception during treatment and for at least 1 week after the last dose. Lenvatinib may impair male fertility based on findings from animal studies showing effects on male reproductive organs.
Lenvatinib may impair fertility in both males and females. Animal studies have shown adverse effects on male and female reproductive organs. The reversibility of these effects is not known. Discuss fertility preservation options with your oncologist before starting treatment.
How Does Lenvatinib Sandoz Interact with Other Drugs?
Drug interactions with lenvatinib can affect its efficacy and safety. Lenvatinib is metabolized through multiple pathways, primarily via CYP3A4 and aldehyde oxidase, with minor contributions from other CYP enzymes. Understanding these interactions is crucial for safe and effective treatment. Patients should inform their doctor about all medications, supplements, and herbal products they are currently taking or plan to take.
Major Interactions
| Drug / Class | Type | Effect | Recommendation |
|---|---|---|---|
| Strong CYP3A4 inhibitors (ketoconazole, itraconazole, clarithromycin, ritonavir) | Pharmacokinetic | May increase lenvatinib plasma levels and risk of toxicity | Use with caution; monitor closely for adverse effects; consider dose reduction if toxicity occurs |
| Strong CYP3A4 inducers (rifampicin, phenytoin, carbamazepine, St. John’s wort) | Pharmacokinetic | May decrease lenvatinib plasma levels, potentially reducing efficacy | Avoid combination if possible; if unavoidable, consider increasing lenvatinib dose based on tolerability |
| QT-prolonging drugs (amiodarone, sotalol, haloperidol, ondansetron, certain fluoroquinolones) | Pharmacodynamic | Additive risk of QT/QTc prolongation and cardiac arrhythmias | Monitor ECG and electrolytes regularly; correct hypokalemia, hypomagnesemia, and hypocalcemia before and during treatment |
| Anticoagulants (warfarin, heparin, direct oral anticoagulants) | Pharmacodynamic | Increased risk of hemorrhage due to additive bleeding risk with lenvatinib | Monitor for signs of bleeding; check INR regularly if on warfarin; use with caution |
Minor Interactions
| Drug / Class | Type | Effect | Recommendation |
|---|---|---|---|
| Antihypertensives (ACE inhibitors, ARBs, calcium channel blockers, beta-blockers) | Pharmacodynamic | Concurrent use often necessary to manage lenvatinib-induced hypertension | Most patients require antihypertensive therapy; optimize blood pressure management; no dose adjustment of lenvatinib needed |
| Thyroid hormone replacement (levothyroxine) | Pharmacodynamic | Lenvatinib may cause or worsen hypothyroidism; thyroid hormone requirements may change | Monitor TSH regularly; adjust levothyroxine dose as needed; particularly important in thyroid cancer patients post-thyroidectomy |
| Moderate CYP3A4 inhibitors (erythromycin, fluconazole, diltiazem, grapefruit juice) | Pharmacokinetic | Possible modest increase in lenvatinib levels | Use with caution; monitor for increased adverse effects |
| Proton pump inhibitors (omeprazole, esomeprazole, pantoprazole) | Pharmacokinetic | No clinically significant interaction; lenvatinib absorption is not pH-dependent | Can be co-administered without dose adjustment |
When lenvatinib is used in combination with pembrolizumab (for endometrial carcinoma, renal cell carcinoma, or hepatocellular carcinoma), the prescribing information for pembrolizumab should also be consulted for potential drug interactions and overlapping toxicities, particularly immune-related adverse events. Similarly, when combined with everolimus (for renal cell carcinoma), the everolimus prescribing information should be reviewed, as everolimus is a strong CYP3A4 substrate and interactions with other CYP3A4-affecting drugs may have additional clinical significance.
In vitro studies suggest that lenvatinib does not significantly inhibit or induce major CYP enzymes at clinically relevant concentrations, which limits its potential to affect the metabolism of other drugs that are CYP substrates. However, clinical judgment should always be applied when combining anticancer agents with other medications.
What Is the Correct Dosage of Lenvatinib Sandoz?
Lenvatinib Sandoz capsules are taken by mouth once daily, at approximately the same time each day, with or without food. The capsules should be swallowed whole with water. If a patient is unable to swallow the capsules whole, they may be dissolved: add the capsules (without breaking or crushing them) to a tablespoon of water or apple juice in a small glass, leave for at least 10 minutes, stir for at least 3 minutes to dissolve the capsule shells, and then drink the entire mixture. After drinking, add the same amount of liquid to the glass, swirl, and drink the remaining contents to ensure the full dose is taken.
Adults – Differentiated Thyroid Cancer (DTC)
Differentiated Thyroid Cancer (DTC)
Indication: Progressive, locally advanced or metastatic differentiated thyroid cancer refractory to radioactive iodine
Dose: 24 mg (six 4 mg capsules) taken orally once daily
Duration: Continue until disease progression or unacceptable toxicity
Note: This is the highest approved dose of lenvatinib across all indications. Dose modifications for adverse reactions follow a stepwise reduction: 20 mg → 14 mg → 10 mg → discontinuation.
Adults – Hepatocellular Carcinoma (HCC)
Hepatocellular Carcinoma (HCC) – Monotherapy
Indication: First-line treatment of unresectable hepatocellular carcinoma
Dose: 12 mg (three 4 mg capsules) once daily for patients weighing ≥60 kg; 8 mg (two 4 mg capsules) once daily for patients weighing <60 kg
Duration: Continue until disease progression or unacceptable toxicity
Note: Dose is weight-based. Patients with Child-Pugh B or C hepatic impairment were excluded from the pivotal REFLECT trial. Lenvatinib is approved only for patients with Child-Pugh A liver function.
Hepatocellular Carcinoma (HCC) – Combination with Pembrolizumab
Indication: First-line treatment of unresectable hepatocellular carcinoma (where approved)
Dose: Lenvatinib 12 mg (≥60 kg) or 8 mg (<60 kg) once daily, plus pembrolizumab 200 mg IV every 3 weeks or 400 mg IV every 6 weeks
Duration: Continue until disease progression, unacceptable toxicity, or up to 24 months for pembrolizumab
Adults – Endometrial Carcinoma (EC)
Endometrial Carcinoma (EC) with Pembrolizumab
Indication: Advanced endometrial carcinoma that is not MSI-H or dMMR, progressing after prior platinum-based therapy
Dose: Lenvatinib 20 mg (five 4 mg capsules) once daily, plus pembrolizumab 200 mg IV every 3 weeks or 400 mg IV every 6 weeks
Duration: Continue until disease progression, unacceptable toxicity, or up to 24 months for pembrolizumab
Adults – Renal Cell Carcinoma (RCC)
Renal Cell Carcinoma (RCC) with Pembrolizumab
Indication: First-line treatment of advanced renal cell carcinoma
Dose: Lenvatinib 20 mg (five 4 mg capsules) once daily, plus pembrolizumab 200 mg IV every 3 weeks or 400 mg IV every 6 weeks
Duration: Continue until disease progression, unacceptable toxicity, or up to 24 months for pembrolizumab
Renal Cell Carcinoma (RCC) with Everolimus
Indication: Advanced renal cell carcinoma following one prior anti-angiogenic therapy
Dose: Lenvatinib 18 mg (four and a half 4 mg capsules) once daily, plus everolimus 5 mg once daily
Duration: Continue until disease progression or unacceptable toxicity
Dose Modifications
Dose modifications (reductions, interruptions, or permanent discontinuation) are frequently required during lenvatinib treatment to manage adverse reactions. The approach to dose modification is indication-specific:
- DTC: Recommended dose reductions: 24 mg → 20 mg → 14 mg → 10 mg daily. Permanently discontinue if unable to tolerate 10 mg daily.
- HCC (≥60 kg): 12 mg → 8 mg → 4 mg daily. Permanently discontinue if unable to tolerate 4 mg daily.
- HCC (<60 kg): 8 mg → 4 mg → 4 mg every other day. Permanently discontinue if unable to tolerate 4 mg every other day.
- EC (with pembrolizumab): 20 mg → 14 mg → 10 mg daily. Permanently discontinue if unable to tolerate 10 mg daily.
- RCC (with pembrolizumab): 20 mg → 14 mg → 10 mg daily. Permanently discontinue if unable to tolerate 10 mg daily.
- RCC (with everolimus): 18 mg → 14 mg → 10 mg daily. Permanently discontinue if unable to tolerate 10 mg daily.
Patients with severe hepatic impairment (Child-Pugh C) or severe renal impairment (creatinine clearance <30 mL/min) may require a reduced starting dose. Consult the full prescribing information for specific dose adjustments in these populations.
Missed Dose
If a dose is missed and cannot be taken within 12 hours of the usual time, that dose should be skipped and the next dose taken at the regular scheduled time. Do not take two doses at the same time to make up for a missed dose.
Overdose
There is no specific antidote for lenvatinib overdose. In case of suspected overdose, lenvatinib should be withheld and supportive care initiated. Due to its high plasma protein binding (~98–99%), lenvatinib is unlikely to be significantly removed by hemodialysis. Overdose symptoms may include exaggeration of the known adverse effects, particularly hypertension, diarrhea, and fatigue. Contact a poison control center or emergency department immediately if overdose is suspected.
What Are the Side Effects of Lenvatinib Sandoz?
Like all anticancer medicines, Lenvatinib Sandoz can cause side effects, although not everybody gets them. The frequency and severity of side effects may vary depending on the indication, the dose used, and whether lenvatinib is given as monotherapy or in combination with other agents. Many side effects are dose-dependent and can be managed with dose reductions, temporary interruptions, and supportive medications. It is important to report all new or worsening symptoms to your healthcare team promptly.
Very Common (affects more than 1 in 10 patients)
- Hypertension (high blood pressure)
- Diarrhea
- Decreased appetite
- Weight loss
- Nausea
- Fatigue and asthenia (tiredness and weakness)
- Stomatitis (mouth inflammation and sores)
- Vomiting
- Proteinuria (protein in urine)
- Palmar-plantar erythrodysesthesia syndrome (hand-foot syndrome – redness, swelling, pain, and peeling of palms and soles)
- Headache
- Dysphonia (hoarseness or voice changes)
- Abdominal pain
- Constipation
- Arthralgia and myalgia (joint and muscle pain)
Common (affects 1 to 10 in every 100 patients)
- Hypothyroidism (underactive thyroid gland)
- Hypocalcemia (low blood calcium levels)
- Hypokalemia (low blood potassium levels)
- Hepatotoxicity (liver damage, elevated liver enzymes)
- Dehydration
- Oral pain and dry mouth
- Cholecystitis (gallbladder inflammation)
- Lipase increase (elevated pancreatic enzyme)
- QT prolongation on ECG
- Dizziness
- Peripheral edema (swelling of hands, feet, or ankles)
- Rash
- Hemorrhagic events (bleeding from various sites)
- Hypomagnesemia (low magnesium levels)
- Cardiac dysfunction (decreased ejection fraction)
Uncommon (affects 1 to 10 in every 1,000 patients)
- Posterior reversible encephalopathy syndrome (PRES/RPLS)
- Osteonecrosis of the jaw
- Gastrointestinal perforation or fistula
- Hepatic failure
- Adrenal insufficiency
- Arterial thromboembolic events (heart attack, stroke)
- Pneumothorax
Rare (affects fewer than 1 in 1,000 patients)
- Nephrotic syndrome
- Thrombotic microangiopathy
Contact your doctor or go to the nearest emergency department immediately if you experience any of the following: sudden severe headache with confusion or vision changes (possible RPLS or hypertensive crisis), chest pain or sudden weakness on one side of the body (possible heart attack or stroke), severe abdominal pain with fever (possible gastrointestinal perforation), unexplained bleeding or blood in stool/urine, severe shortness of breath, or signs of severe allergic reaction (difficulty breathing, swelling of face/throat).
The side effect profile of lenvatinib may differ when used in combination with pembrolizumab or everolimus. The combination with pembrolizumab may lead to additional immune-related adverse events such as immune-mediated colitis, pneumonitis, hepatitis, endocrinopathies (thyroid disorders, adrenal insufficiency, type 1 diabetes), and nephritis. The combination with everolimus may increase the risk of infections, pneumonitis, metabolic effects (hyperglycemia, hyperlipidemia), and stomatitis.
It is essential that patients maintain regular follow-up appointments with their oncology team throughout treatment. Many side effects can be effectively managed through early detection and intervention, including dose modifications, supportive medications (antihypertensives, antidiarrheals, antiemetics, mouth care products), and temporary treatment interruptions when needed. Patients should not adjust their lenvatinib dose or discontinue treatment without first consulting their doctor.
How Should You Store Lenvatinib Sandoz?
Lenvatinib Sandoz hard capsules should be stored at a temperature not exceeding 25°C (77°F). Keep the capsules in the original blister packaging until the time of use to protect them from moisture. Do not remove capsules from the blister until you are ready to take them.
Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP.” The expiry date refers to the last day of that month. Once a blister is opened, use the capsule immediately.
Keep this medicine out of the sight and reach of children. Store in a safe location away from direct sunlight and excessive heat. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment and prevent accidental exposure.
If you notice any visible changes in the appearance of the capsules (such as discoloration, cracking, or stickiness), do not take them and consult your pharmacist for replacement.
What Does Lenvatinib Sandoz Contain?
Active substance: Each hard capsule contains lenvatinib mesilate equivalent to 4 mg of lenvatinib. Lenvatinib mesilate is the mesilate salt form of lenvatinib, which improves the solubility and bioavailability of the active substance. The molecular formula of lenvatinib is C21H19ClN4O4, and it has a molecular weight of 426.85 g/mol (free base).
Other ingredients (excipients):
- Capsule contents: Calcium carbonate, mannitol, microcrystalline cellulose, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, and talc
- Capsule shell: Hypromellose and titanium dioxide (E171)
- Printing ink: Shellac, black iron oxide (E172), potassium hydroxide, and propylene glycol
Lenvatinib Sandoz 4 mg hard capsules are yellowish-white to pale yellowish-orange, opaque capsules with “LEN 4” or equivalent marking printed on them. They are available in blister packs. Please consult the patient information leaflet included in the product packaging for the most current and complete list of excipients, as formulations may be updated over time.
This medicine does not contain any known allergens such as gluten, lactose, soy, or peanut derivatives. However, patients with known hypersensitivity to any of the listed excipients should not take this medicine.
Frequently Asked Questions About Lenvatinib Sandoz
Lenvatinib is approved for four major cancer types. It is used as monotherapy for progressive, locally advanced or metastatic differentiated thyroid cancer (DTC) that no longer responds to radioactive iodine treatment. For hepatocellular carcinoma (HCC, liver cancer), it is approved as a first-line treatment either alone or in combination with pembrolizumab. In combination with pembrolizumab, it is used to treat advanced endometrial carcinoma (cancer of the uterine lining) that has progressed after platinum-based chemotherapy. It is also approved in combination with pembrolizumab as first-line treatment for advanced renal cell carcinoma (kidney cancer), or in combination with everolimus for patients who have received prior anti-angiogenic therapy for RCC.
Lenvatinib is a multi-kinase inhibitor, meaning it blocks several different enzymes (kinases) that cancer cells use to grow and spread. Its primary targets are VEGFR1, VEGFR2, and VEGFR3, which are receptors that drive the formation of new blood vessels that tumors need to grow (angiogenesis). It also blocks FGFR1-4, PDGFRalpha, RET, and KIT, which are involved in tumor cell proliferation, blood vessel stability, and cancer cell survival signaling. By simultaneously blocking all these pathways, lenvatinib attacks the tumor from multiple angles, making it harder for cancer cells to develop resistance compared with drugs that block only a single target.
Yes, lenvatinib capsules can be taken either with or without food. Food does not significantly affect the overall absorption of lenvatinib, although it may slightly delay the time it takes for the drug to reach peak levels in the blood. The most important thing is to take the capsules at approximately the same time each day for consistent drug levels. If you cannot swallow the capsules whole, you may dissolve them in water or apple juice: place the intact capsules in a tablespoon of liquid, wait at least 10 minutes, stir for at least 3 minutes, and drink the entire mixture.
Blood pressure monitoring is critical during lenvatinib treatment. Before starting therapy, your blood pressure should be well controlled (below 140/90 mmHg, or lower if you have existing cardiovascular risk factors). During the first 2 months of treatment, blood pressure should be checked at least weekly. After the first 2 months, monitoring should occur at least every 2 to 4 weeks. Many oncologists recommend that patients also monitor their blood pressure at home using an automated blood pressure cuff and keep a log to share with their healthcare team. More than 40% of patients develop hypertension during lenvatinib treatment, and many will need one or more antihypertensive medications to manage it effectively.
Lenvatinib Sandoz and Lenvima both contain the same active ingredient, lenvatinib (as mesilate), at the same dose. The key difference is the manufacturer: Lenvima is the originator (branded) product developed and marketed by Eisai, while Lenvatinib Sandoz is a generic version manufactured by Sandoz. To receive regulatory approval, Lenvatinib Sandoz had to demonstrate bioequivalence to Lenvima, meaning it delivers the same amount of active drug to the body. The indications, dosing recommendations, warnings, and precautions are the same. The main practical difference is that generic versions are typically available at a lower cost, which can improve access to this important cancer treatment.
The duration of lenvatinib treatment varies from patient to patient and depends on the type of cancer, the response to treatment, and how well the patient tolerates the medication. In general, lenvatinib is taken continuously (every day) until the cancer progresses, unacceptable side effects develop, or the treating oncologist decides to stop therapy. In clinical trials, the median duration of treatment ranged from several months to over a year, but some patients have taken lenvatinib for multiple years with ongoing cancer control. Treatment should never be stopped without first discussing with your oncologist, as abrupt discontinuation could allow the cancer to progress rapidly.
References
- European Medicines Agency (EMA). Lenvima (lenvatinib) – Summary of Product Characteristics. Available at: www.ema.europa.eu/en/medicines/human/EPAR/lenvima. Accessed February 2026.
- U.S. Food and Drug Administration (FDA). LENVIMA (lenvatinib) – Prescribing Information. Available at: www.accessdata.fda.gov. Accessed February 2026.
- Schlumberger M, Tahara M, Wirth LJ, et al. Lenvatinib versus placebo in radioiodine-refractory thyroid cancer. N Engl J Med. 2015;372(7):621-630. doi:10.1056/NEJMoa1406470
- Kudo M, Finn RS, Qin S, et al. Lenvatinib versus sorafenib in first-line treatment of patients with unresectable hepatocellular carcinoma: a randomised phase 3 non-inferiority trial (REFLECT). Lancet. 2018;391(10126):1163-1173. doi:10.1016/S0140-6736(18)30207-1
- Makker V, Colombo N, Casado Herráez A, et al. Lenvatinib plus pembrolizumab for advanced endometrial cancer. N Engl J Med. 2022;386(5):437-448. doi:10.1056/NEJMoa2108330
- Motzer R, Alekseev B, Rha SY, et al. Lenvatinib plus pembrolizumab or everolimus for advanced renal cell carcinoma (CLEAR). N Engl J Med. 2021;384(14):1289-1300. doi:10.1056/NEJMoa2035716
- NCCN Clinical Practice Guidelines in Oncology: Thyroid Carcinoma, Version 2.2025. National Comprehensive Cancer Network.
- NCCN Clinical Practice Guidelines in Oncology: Hepatocellular Carcinoma, Version 1.2025. National Comprehensive Cancer Network.
- ESMO Clinical Practice Guidelines: Hepatocellular Carcinoma. Ann Oncol. 2024. European Society for Medical Oncology.
- ASCO Clinical Practice Guidelines: Advanced Renal Cell Carcinoma. American Society of Clinical Oncology. 2024.
- World Health Organization (WHO). WHO Model List of Essential Medicines, 23rd List. 2023. Available at: www.who.int.
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