Lenvatinib Accord: Uses, Dosage & Side Effects
A multi-kinase inhibitor targeting VEGFR, FGFR, PDGFR, KIT, and RET for the treatment of thyroid cancer, hepatocellular carcinoma, renal cell carcinoma, and endometrial carcinoma
Lenvatinib Accord is a generic formulation of lenvatinib, a multi-targeted tyrosine kinase inhibitor (TKI) used to treat several types of cancer. Lenvatinib works by blocking specific proteins (kinases) involved in tumor growth and the formation of new blood vessels that feed tumors. It is approved for differentiated thyroid cancer that has progressed despite radioactive iodine treatment, as first-line treatment for unresectable hepatocellular carcinoma (liver cancer), advanced renal cell carcinoma (kidney cancer) in combination with other immunotherapy or targeted agents, and advanced endometrial carcinoma in combination with pembrolizumab. Lenvatinib Accord is taken as a once-daily oral capsule and is bioequivalent to the originator product Lenvima, meaning it delivers the same therapeutic effect at the same dose.
Quick Facts: Lenvatinib Accord
Key Takeaways
- Lenvatinib Accord is a multi-kinase inhibitor that blocks VEGFR1-3, FGFR1-4, PDGFRα, KIT, and RET, suppressing tumor growth and the blood vessel formation that tumors need to grow and spread.
- It is approved for differentiated thyroid cancer (after radioactive iodine failure), hepatocellular carcinoma (first-line), renal cell carcinoma (with pembrolizumab or everolimus), and endometrial carcinoma (with pembrolizumab).
- Hypertension is the most common and clinically significant side effect – blood pressure must be well controlled before starting treatment and monitored regularly throughout therapy, with antihypertensive medications adjusted as needed.
- The recommended dose varies by indication: 24 mg daily for thyroid cancer, 8 mg or 12 mg daily for liver cancer (based on body weight), and 20 mg daily for kidney and endometrial cancer. Dose reductions are common and do not necessarily indicate treatment failure.
- Women of childbearing potential must use highly effective contraception during treatment and for at least 30 days after the last dose; lenvatinib has been shown to cause embryotoxicity and teratogenicity in animal studies.
What Is Lenvatinib Accord and What Is It Used For?
Lenvatinib Accord contains the active substance lenvatinib (as lenvatinib mesilate), a powerful multi-targeted tyrosine kinase inhibitor. Tyrosine kinases are enzymes that play critical roles in cell signaling pathways controlling cell growth, division, and the formation of new blood vessels (angiogenesis). By inhibiting several of these kinases simultaneously, lenvatinib attacks tumors through multiple mechanisms, making it harder for cancer cells to develop resistance to treatment.
The kinase targets of lenvatinib include 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), the KIT proto-oncogene (c-KIT), and the RET proto-oncogene. VEGF receptors are central to angiogenesis – the process by which tumors recruit new blood vessels to supply oxygen and nutrients for growth. FGFR signaling is involved in both angiogenesis and direct tumor cell proliferation. By inhibiting these pathways, lenvatinib starves the tumor of its blood supply while simultaneously blocking cancer cell division.
Lenvatinib Accord is a generic version of the originator product Lenvima, which was first approved by the European Medicines Agency (EMA) in 2015 and by the U.S. Food and Drug Administration (FDA) in the same year. As a generic medicine, Lenvatinib Accord has been demonstrated to be bioequivalent to Lenvima, meaning that it is absorbed into the body at the same rate and to the same extent, producing identical therapeutic effects. Generic medicines undergo rigorous regulatory review to ensure they meet the same quality, safety, and efficacy standards as the originator product.
Lenvatinib Accord is approved by the European Medicines Agency (EMA) for the following indications:
- Differentiated thyroid cancer (DTC): Lenvatinib is used as monotherapy in adult patients with progressive, locally advanced or metastatic differentiated thyroid cancer (papillary, follicular, or Hürthle cell) that is refractory to radioactive iodine (RAI). The pivotal SELECT trial demonstrated a dramatic improvement in progression-free survival: a median of 18.3 months with lenvatinib compared to 3.6 months with placebo, representing a 79% reduction in the risk of disease progression or death.
- Hepatocellular carcinoma (HCC): Lenvatinib is approved as first-line monotherapy for unresectable hepatocellular carcinoma in patients who have not received prior systemic therapy. The REFLECT trial established lenvatinib as non-inferior to sorafenib in overall survival, with superior progression-free survival and objective response rates. Lenvatinib is also approved in combination with pembrolizumab for the first-line treatment of unresectable or advanced HCC.
- Renal cell carcinoma (RCC): In combination with pembrolizumab, lenvatinib is approved as first-line treatment for advanced renal cell carcinoma. The CLEAR trial demonstrated significantly improved progression-free survival and overall survival compared with sunitinib. Lenvatinib in combination with everolimus is also approved for advanced RCC following one prior anti-angiogenic therapy.
- Endometrial carcinoma (EC): In combination with pembrolizumab, lenvatinib is approved for the treatment of advanced endometrial carcinoma in adult patients with disease progression on or after prior platinum-based chemotherapy, who are not candidates for curative surgery or radiation. The KEYNOTE-775 trial demonstrated significant improvements in both progression-free survival and overall survival.
Thyroid cancer is the most common endocrine malignancy worldwide, and differentiated thyroid cancer accounts for approximately 90% of all thyroid cancer cases. While the majority of patients with DTC have an excellent prognosis with surgery and radioactive iodine therapy, a subset of patients develop RAI-refractory disease, where the cancer no longer responds to radioactive iodine. For these patients, lenvatinib represents a significant therapeutic advance. Hepatocellular carcinoma is the sixth most common cancer globally and a leading cause of cancer-related death, particularly in regions with high rates of hepatitis B and C infection. Renal cell carcinoma accounts for approximately 90% of all kidney cancers, and endometrial carcinoma is the most common gynecological malignancy in developed countries.
Lenvatinib Accord is a generic version of Lenvima. Generic medicines contain the same active substance at the same dose and are bioequivalent to the originator product. They undergo rigorous regulatory review to ensure identical quality, safety, and efficacy. The clinical evidence supporting the use of lenvatinib applies equally to all approved generic formulations, including Lenvatinib Accord.
What Should You Know Before Taking Lenvatinib Accord?
Contraindications
Lenvatinib Accord must not be used if you are hypersensitive (allergic) to lenvatinib mesilate or to any of the other ingredients in the capsules. If you have experienced a severe allergic reaction to lenvatinib in the past, including rash, swelling of the face or throat, or difficulty breathing, you must not take this medicine again.
Warnings and Precautions
Before and during treatment with Lenvatinib Accord, your doctor needs to be aware of certain conditions and risks. Lenvatinib has a broad side effect profile that requires careful monitoring and proactive management. The following warnings and precautions are particularly important:
Hypertension is very common with lenvatinib and can be severe. Blood pressure must be well controlled before starting treatment. Your doctor will monitor your blood pressure regularly and may start or adjust antihypertensive medications. If blood pressure cannot be adequately controlled despite optimal medical management, lenvatinib may need to be reduced in dose or discontinued. Severe uncontrolled hypertension can lead to hypertensive crisis, stroke, or other serious cardiovascular events.
- Hepatotoxicity: Lenvatinib can cause liver damage, including elevated liver enzymes (ALT, AST, bilirubin) and, in rare cases, liver failure. Liver function tests should be performed before starting treatment, then at least every 2 weeks for the first 2 months, and monthly thereafter. If you develop jaundice (yellowing of the skin or eyes), dark urine, or severe abdominal pain, contact your doctor immediately. Patients with hepatocellular carcinoma may be at increased risk due to underlying liver disease.
- Proteinuria and renal impairment: Protein in the urine (proteinuria) is common with lenvatinib. Your doctor will check your urine for protein before and during treatment. In severe cases, nephrotic syndrome (a serious kidney condition) may develop. Kidney function should be monitored, and dose adjustments may be necessary if kidney function declines.
- Cardiac dysfunction: Lenvatinib may cause decreased cardiac ejection fraction or heart failure. Heart function should be assessed before and during treatment. Report any new or worsening shortness of breath, swelling of the ankles, persistent cough, fatigue, or difficulty lying flat to your doctor.
- Arterial thromboembolic events: Blood clots in arteries (including heart attack and stroke) have been reported with lenvatinib. Patients with a history of cardiovascular disease are at increased risk. Seek immediate medical attention if you experience chest pain, sudden weakness or numbness on one side of the body, difficulty speaking, or sudden severe headache.
- Hemorrhage: Serious and sometimes fatal bleeding events have occurred with lenvatinib, including gastrointestinal bleeding, pulmonary hemorrhage, and intracranial hemorrhage. Tell your doctor immediately if you notice any unusual bleeding, such as vomiting blood, black or bloody stools, coughing up blood, or any unexplained bruising.
- Gastrointestinal perforation and fistula: Lenvatinib may cause holes (perforations) in the wall of the stomach or intestines, or abnormal connections between organs (fistulas). These are serious and potentially life-threatening complications. Seek urgent medical attention if you develop severe abdominal pain, fever, nausea, or vomiting.
- QT interval prolongation: Lenvatinib may prolong the QT interval on an electrocardiogram (ECG), which can lead to dangerous heart rhythm disturbances. ECG monitoring is recommended, particularly in patients taking other QT-prolonging medications. Electrolyte abnormalities (hypokalemia, hypomagnesemia, hypocalcemia) should be corrected before and during treatment.
- Hypothyroidism: Worsening of existing hypothyroidism or new onset of thyroid dysfunction is common with lenvatinib. Thyroid function should be monitored before starting and regularly during treatment. Thyroid hormone replacement may need to be started or adjusted.
- Adrenal insufficiency: Impaired adrenal function has been reported, particularly when lenvatinib is used in combination with pembrolizumab. Symptoms include extreme fatigue, weakness, dizziness, nausea, and low blood pressure. Report these symptoms to your doctor.
- Wound healing complications: Lenvatinib may impair wound healing due to its anti-angiogenic properties. Treatment should be withheld for at least 1 week before elective surgery and should not be resumed until adequate wound healing has occurred. The decision to resume lenvatinib after surgery should be based on clinical judgment.
- Posterior reversible encephalopathy syndrome (PRES): PRES is a rare but serious condition involving brain swelling that can present with headache, seizures, visual disturbances, confusion, or altered mental status. If PRES is suspected, lenvatinib should be withheld and supportive care provided.
Pregnancy and Breastfeeding
Lenvatinib Accord should not be used during pregnancy. Animal studies have shown that lenvatinib causes embryotoxicity and teratogenicity (birth defects), including skeletal abnormalities, external and visceral malformations, and increased embryo-fetal mortality at exposures below the clinical dose. There are no adequate data on the use of lenvatinib in pregnant women.
Women of childbearing potential must use highly effective contraception during treatment with lenvatinib and for at least 30 days after the last dose. If you become pregnant while taking lenvatinib, tell your doctor immediately. Your doctor will discuss the potential risks to the unborn child and help you decide on the appropriate course of action.
It is not known whether lenvatinib or its metabolites are excreted in human breast milk. Because many drugs are excreted in breast 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 one week after the last dose.
Male patients with female partners of childbearing potential should use effective contraception during treatment and for at least one week after the last dose of lenvatinib.
Driving and Operating Machinery
Lenvatinib Accord may cause side effects such as fatigue and dizziness that can impair your ability to drive or operate machinery. If you experience these symptoms, do not drive or use machines until they have resolved. Discuss with your doctor if you have any concerns about your ability to perform these activities safely while on treatment.
How Does Lenvatinib Accord Interact with Other Drugs?
Drug interactions with lenvatinib are clinically important because the drug has a narrow therapeutic window and is metabolized through multiple pathways. Lenvatinib is primarily metabolized by CYP3A4 and aldehyde oxidase, with minor contributions from other CYP enzymes. In vitro studies indicate that lenvatinib is also a substrate of P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP). Understanding these interactions helps ensure both the efficacy and safety of treatment.
Major Interactions
| Interacting Drug | Effect | Clinical Significance |
|---|---|---|
| Warfarin and other anticoagulants | Increased risk of hemorrhage due to additive effects on hemostasis | Monitor closely for bleeding; consider dose adjustment of anticoagulant |
| QT-prolonging drugs (amiodarone, sotalol, ondansetron, haloperidol) | Additive QT prolongation, increased risk of cardiac arrhythmias | Avoid combination if possible; monitor ECG and electrolytes closely |
| Strong CYP3A4 inducers (rifampicin, carbamazepine, phenytoin, St. John’s Wort) | May decrease lenvatinib plasma levels, potentially reducing efficacy | Avoid concomitant use if possible; no specific dose adjustment recommended |
| NSAIDs (ibuprofen, naproxen, aspirin) | Increased risk of gastrointestinal bleeding and perforation | Use with extreme caution; monitor for GI symptoms |
Minor Interactions
| Interacting Drug | Effect | Clinical Significance |
|---|---|---|
| Strong CYP3A4 inhibitors (ketoconazole, itraconazole, clarithromycin) | Possible modest increase in lenvatinib exposure | No dose adjustment needed based on clinical data; monitor for increased side effects |
| Antihypertensive agents (ACE inhibitors, ARBs, calcium channel blockers) | Additive blood pressure lowering – typically beneficial | Often co-administered to manage lenvatinib-induced hypertension; monitor blood pressure |
| Thyroid hormone replacement (levothyroxine) | Lenvatinib may worsen hypothyroidism; dose of thyroid replacement may need adjustment | Monitor TSH regularly; adjust levothyroxine dose as needed |
| Acid-reducing agents (proton pump inhibitors, H2 blockers, antacids) | No significant effect on lenvatinib absorption demonstrated | Can be used concomitantly without dose adjustment |
When lenvatinib is used in combination with pembrolizumab (for RCC, EC, or HCC), the potential drug interactions of both agents must be considered. Pembrolizumab is a monoclonal antibody and does not have pharmacokinetic interactions with lenvatinib, but the combination may increase the risk of certain immune-related adverse events, including hepatotoxicity, adrenal insufficiency, and thyroid dysfunction. When used with everolimus (for RCC), the CYP3A4 interaction profile of everolimus should be considered, as everolimus is a sensitive CYP3A4 substrate.
What Is the Correct Dosage of Lenvatinib Accord?
Lenvatinib Accord should only be prescribed by a physician experienced in the use of anticancer therapies. The capsules are taken orally, once daily, at approximately the same time each day, with or without food. Treatment should continue for as long as clinical benefit is observed or until unacceptable toxicity develops. Dose modifications (reductions, interruptions, or discontinuations) may be necessary to manage side effects and are a normal part of treatment with lenvatinib.
Adults
Differentiated Thyroid Cancer (DTC)
Dose: 24 mg once daily (two 10 mg capsules + one 4 mg capsule)
Duration: Continue until disease progression or unacceptable toxicity
Dose reductions: First reduction to 20 mg, then 14 mg, then 10 mg daily. If further reduction is needed below 10 mg, discontinue treatment.
Hepatocellular Carcinoma (HCC) – Monotherapy
Dose: Body weight ≥60 kg: 12 mg once daily. Body weight <60 kg: 8 mg once daily
Duration: Continue until disease progression or unacceptable toxicity
Dose reductions: For patients starting at 12 mg: first to 8 mg, then 4 mg. For patients starting at 8 mg: first to 4 mg. Discontinue if unable to tolerate 4 mg.
Hepatocellular Carcinoma (HCC) – With Pembrolizumab
Dose: Body weight ≥60 kg: 12 mg lenvatinib once daily + pembrolizumab 200 mg IV every 3 weeks. Body weight <60 kg: 8 mg lenvatinib once daily + pembrolizumab 200 mg IV every 3 weeks
Duration: Continue until disease progression or unacceptable toxicity, up to 24 months for pembrolizumab
Renal Cell Carcinoma (RCC) – With Pembrolizumab
Dose: 20 mg lenvatinib once daily + pembrolizumab 200 mg IV every 3 weeks
Duration: Continue until disease progression or unacceptable toxicity, up to 24 months for pembrolizumab
Dose reductions: First to 14 mg, then 10 mg daily. Discontinue if unable to tolerate 10 mg.
Renal Cell Carcinoma (RCC) – With Everolimus
Dose: 18 mg lenvatinib once daily + 5 mg everolimus once daily
Duration: Continue until disease progression or unacceptable toxicity
Dose reductions: First to 14 mg, then 10 mg daily for lenvatinib. Everolimus may be reduced to 5 mg every other day.
Endometrial Carcinoma (EC) – With Pembrolizumab
Dose: 20 mg lenvatinib once daily + pembrolizumab 200 mg IV every 3 weeks
Duration: Continue until disease progression or unacceptable toxicity, up to 24 months for pembrolizumab
Dose reductions: First to 14 mg, then 10 mg daily. Discontinue if unable to tolerate 10 mg.
Children
The safety and efficacy of lenvatinib in children and adolescents below 18 years of age have not been established. Lenvatinib Accord is not recommended for use in the pediatric population.
Elderly
No initial dose adjustment is required for elderly patients (65 years and older). However, elderly patients may be more susceptible to certain side effects, including hypertension, fatigue, proteinuria, and dehydration. The clinical data in patients aged 75 years and older is limited. Close monitoring and proactive dose modification are particularly important in this population.
Dose Adjustments for Organ Impairment
- Hepatic impairment: No dose adjustment is needed for mild hepatic impairment (Child-Pugh A). For moderate hepatic impairment (Child-Pugh B), the recommended starting dose for DTC is 14 mg once daily, and for RCC/EC is 10 mg once daily. Lenvatinib is not recommended in patients with severe hepatic impairment (Child-Pugh C). For HCC patients, dose is based on body weight regardless of underlying liver function, but careful monitoring is essential.
- Renal impairment: No dose adjustment is needed for mild or moderate renal impairment. For severe renal impairment (creatinine clearance <30 mL/min), the recommended starting dose for DTC is 14 mg once daily, and for RCC/EC is 10 mg once daily. Lenvatinib has not been studied in patients requiring dialysis.
Missed Dose
If you miss a dose and it cannot be taken within 12 hours from the scheduled time, skip the missed dose and take the next dose at your usual time. Do not take a double dose to make up for the forgotten one. Taking more than the prescribed amount increases the risk of serious side effects.
Overdose
If you accidentally take too many capsules or someone else takes your medicine, contact your doctor or go to your nearest emergency department immediately. Overdose may lead to severe and potentially life-threatening side effects. There is no specific antidote for lenvatinib overdose. Treatment is supportive and symptomatic, and may include management of hypertension, cardiac monitoring, and correction of electrolyte abnormalities. Lenvatinib is not expected to be removed by hemodialysis due to its high protein binding.
How to Take Lenvatinib Accord Capsules
Take the capsules once daily at approximately the same time each day, with or without food. Swallow the capsules whole with a glass of water. If you cannot swallow the capsules whole, you may prepare a suspension by placing the capsules (without opening or crushing them) in a tablespoon (approximately 15 mL) of water or apple juice. Leave the capsules in the liquid for at least 10 minutes, then stir for at least 3 minutes to dissolve the capsule shells. Drink the entire mixture. After drinking, add the same amount of liquid to the glass, swirl, and drink to ensure you receive the full dose.
Dose reductions are a normal and expected part of treatment with lenvatinib. Approximately 60–70% of patients require at least one dose reduction during the course of treatment. Dose reductions do not necessarily mean the treatment is failing – they are an important strategy for managing side effects and allowing patients to continue treatment for as long as possible.
What Are the Side Effects of Lenvatinib Accord?
Like all medicines, Lenvatinib Accord can cause side effects, although not everyone gets them. The side effect profile can vary depending on the indication and whether lenvatinib is used alone or in combination with other drugs such as pembrolizumab or everolimus. Your medical team will monitor you closely and can help manage most side effects with dose adjustments and supportive care.
Side Effects of Lenvatinib (All Indications)
Very Common
May affect more than 1 in 10 people
- Hypertension (high blood pressure)
- Diarrhea
- Nausea
- Vomiting
- Decreased appetite and weight loss
- Fatigue and asthenia (weakness)
- Stomatitis (mouth sores and inflammation)
- Proteinuria (protein in urine)
- Palmar-plantar erythrodysesthesia (hand-foot syndrome: redness, swelling, pain on palms and soles)
- Abdominal pain
- Dysphonia (hoarse or changed voice)
- Headache
- Constipation
- Arthralgia and myalgia (joint and muscle pain)
- Peripheral edema (swelling of hands and feet)
- Rash
- Hypothyroidism
- Elevated liver enzymes (AST, ALT)
- Hypocalcemia (low calcium)
- Urinary tract infection
Common
May affect up to 1 in 10 people
- Thrombocytopenia (low platelets)
- Lymphopenia (low lymphocytes)
- Hypercholesterolemia and hypertriglyceridemia (elevated cholesterol and triglycerides)
- Hypokalemia and hypomagnesemia (low potassium and magnesium)
- Dehydration
- Dizziness
- Dysgeusia (altered taste)
- Cardiac dysfunction (decreased ejection fraction, heart failure)
- Prolonged QT interval
- Hypotension (low blood pressure)
- Pulmonary embolism
- Dyspepsia (indigestion)
- Flatulence
- Dry mouth
- Oral pain
- Elevated bilirubin, lipase, amylase
- Alopecia (hair thinning or loss)
- Dry skin
- Back pain
- Renal impairment or failure
Uncommon
May affect up to 1 in 100 people
- Hepatic failure (liver failure)
- Pancreatitis (inflammation of the pancreas)
- Gastrointestinal perforation or fistula
- Posterior reversible encephalopathy syndrome (PRES)
- Cerebrovascular accident (stroke)
- Myocardial infarction (heart attack)
- Arterial thromboembolic events
- Adrenal insufficiency
- Osteonecrosis of the jaw
- Pneumothorax (collapsed lung)
- Wound healing complications
Rare
May affect up to 1 in 1,000 people
- Hepatorenal syndrome
- Nephrotic syndrome
- Thrombotic microangiopathy
- Aneurysm and artery dissection
Additional Side Effects in Combination Therapy
When lenvatinib is given in combination with pembrolizumab, additional immune-related side effects may occur. These include immune-mediated hepatitis, colitis, pneumonitis, endocrinopathies (thyroiditis, adrenal insufficiency, hypophysitis, type 1 diabetes), nephritis, and skin reactions. These immune-related adverse events require specific management, often including corticosteroids, and may necessitate discontinuation of pembrolizumab while lenvatinib is continued.
When lenvatinib is given in combination with everolimus, additional side effects may include increased rates of interstitial lung disease/pneumonitis, hyperglycemia (high blood sugar), hypercholesterolemia, and infections due to immunosuppression.
Seek urgent medical attention if you experience: severe or uncontrolled high blood pressure; chest pain or sudden shortness of breath; weakness, numbness, or difficulty speaking (possible stroke); vomiting blood or black stools; severe abdominal pain; confusion, seizures, or visual changes; or jaundice (yellowing of skin or eyes). These symptoms may indicate serious and potentially life-threatening complications.
If you experience any side effects, including those not listed here, tell your doctor, pharmacist, or nurse. You can also report suspected side effects to your national pharmacovigilance authority (e.g., the EMA in Europe, the FDA MedWatch program in the United States, or the MHRA Yellow Card Scheme in the United Kingdom).
How Should You Store Lenvatinib Accord?
Keep this medicine out of the sight and reach of children. Do not use Lenvatinib Accord 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.
- Temperature: Store below 25°C (77°F). No special temperature requirements beyond room temperature storage.
- Moisture protection: Store in the original package to protect from moisture.
- Light: No special precautions for light protection are required.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. Do not use this medicine if you notice any visible signs of deterioration such as discoloration or damage to the capsules.
What Does Lenvatinib Accord Contain?
Active Substance
The active substance is lenvatinib. Each Lenvatinib Accord 4 mg hard capsule contains 4 mg of lenvatinib (as lenvatinib mesilate). Lenvatinib mesilate is the mesylate salt form of lenvatinib, chosen for its favorable physicochemical properties including adequate aqueous solubility and stability.
Inactive Ingredients (Excipients)
Capsule contents:
- Calcium carbonate
- Mannitol
- Microcrystalline cellulose
- Hydroxypropylcellulose
- Low-substituted hydroxypropylcellulose
- Talc
Capsule shell:
- Hypromellose
- Titanium dioxide (E171)
- Iron oxide yellow (E172)
- Iron oxide red (E172)
Printing ink:
- Shellac
- Iron oxide black (E172)
- Potassium hydroxide
Appearance
Lenvatinib Accord 4 mg hard capsules are reddish-brown and yellow capsules printed with “4 MG” on the body. They contain a white to yellowish-white powder. Each capsule is approximately 14.3 mm in length.
Manufacturer
Lenvatinib Accord is manufactured and marketed by Accord Healthcare. As a generic medicine, it has been demonstrated to be bioequivalent to the reference product Lenvima (marketed by Eisai), following the standard regulatory pathway for generic medicines in the European Union.
Frequently Asked Questions About Lenvatinib Accord
Lenvatinib Accord is used to treat several types of cancer. Its approved indications include differentiated thyroid cancer that has progressed despite radioactive iodine therapy, hepatocellular carcinoma (liver cancer) as first-line treatment either alone or with pembrolizumab, renal cell carcinoma (kidney cancer) in combination with pembrolizumab or everolimus, and endometrial carcinoma in combination with pembrolizumab. The specific indication determines the dose and whether lenvatinib is used alone or in combination.
Take the capsules once daily at the same time each day, with or without food. Swallow them whole with water. If you cannot swallow the capsules, you can dissolve them by placing them in a tablespoon of water or apple juice for at least 10 minutes, then stirring for at least 3 minutes before drinking the entire mixture. Do not open, crush, or chew the capsules. If you miss a dose and it is more than 12 hours until your next scheduled dose, take it as soon as you remember. If less than 12 hours remain, skip the missed dose.
Lenvatinib Accord is a generic version of Lenvima. Both contain the same active substance (lenvatinib mesilate) at the same dose and are bioequivalent, meaning they work the same way in the body. Lenvatinib Accord was approved based on demonstrating bioequivalence to Lenvima through the standard regulatory pathway for generic medicines. The therapeutic effects, side effects, dosing recommendations, and indications are identical. The choice between the two is typically based on availability and cost considerations.
Hypertension is the most common side effect of lenvatinib, occurring in more than half of all patients. It develops because lenvatinib inhibits VEGF receptors, which play an important role in maintaining normal blood vessel function and blood pressure regulation. Uncontrolled hypertension can lead to serious complications including stroke, heart attack, and kidney damage. Your blood pressure should be well controlled before starting lenvatinib and monitored at least every 2 weeks during the first 2 months, then monthly. Most patients will need one or more antihypertensive medications during treatment.
Yes, dose reductions are very common with lenvatinib and are a normal part of treatment. In clinical trials, approximately 60–70% of patients required at least one dose reduction. This does not mean the treatment is failing. In fact, studies have shown that patients who require dose reductions often have similar or even better outcomes compared to the overall trial population. Dose reductions are an important strategy for managing side effects, improving quality of life, and enabling patients to continue treatment for longer. Your doctor will guide you through any necessary dose adjustments.
While lenvatinib is partially metabolized by CYP3A4 (the enzyme that grapefruit juice inhibits), clinical pharmacokinetic studies have shown that CYP3A4 inhibitors do not significantly increase lenvatinib levels to a clinically meaningful extent. This is because lenvatinib has multiple metabolic pathways, including aldehyde oxidase, which is not affected by grapefruit. However, as a general precaution with any anticancer medication, it is advisable to discuss consumption of grapefruit and grapefruit juice with your oncologist.
References
- European Medicines Agency (EMA). Lenvatinib – Summary of Product Characteristics. Last updated 2025. Available from: EMA EPAR.
- U.S. Food and Drug Administration (FDA). Lenvima (lenvatinib) Prescribing Information. Revised 2024. Available from: FDA Drug Label.
- Schlumberger M, Tahara M, Wirth LJ, et al. Lenvatinib versus placebo in radioiodine-refractory thyroid cancer (SELECT). 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 (REFLECT). Lancet. 2018;391(10126):1163–1173. doi:10.1016/S0140-6736(18)30207-1.
- Motzer RJ, 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.
- Makker V, Colombo N, Casado Herráez A, et al. Lenvatinib plus pembrolizumab for advanced endometrial cancer (KEYNOTE-775). N Engl J Med. 2022;386(5):437–448. doi:10.1056/NEJMoa2108330.
- Brose MS, Nutting CM, Jarzab B, et al. Sorafenib in radioactive iodine-refractory, locally advanced or metastatic differentiated thyroid cancer (DECISION). Lancet. 2014;384(9940):319–328.
- National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology: Thyroid Carcinoma. Version 1.2025.
- Filetti S, Durante C, Hartl D, et al. Thyroid cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2019;30(12):1856–1883.
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd List. Geneva: WHO; 2023.
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This article was written and reviewed by the iMedic Medical Editorial Team, comprising licensed specialist physicians with expertise in oncology, endocrinology, hepatology, and clinical pharmacology.
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