Product introduction
Lenvatinib Capsule is used to treat certain types of cancers like differentiated thyroid cancer, liver cancer, kidney cancer, and endometrial cancer. It works by blocking specific proteins that promote cancer cell growth and spread, and reducing tumor size in affected individuals.
Lenvatinib Capsule can be taken with or without food, but try to have it at the same time every day to get the most benefits. Your doctor will determine the right dose and how often you should take it. This will depend on what you are being treated for. The dosage may change over time. You should take it exactly as your doctor has advised. Taking it the wrong way or taking too much can cause very serious side effects.
Common side effects of this medicine include high blood pressure, bleeding, and diarrhea. It might also cause severe headaches and loss of appetite. If any of these side effects persist or worsen, consult your doctor. They may be able to suggest ways to manage the side effects.
Before taking Lenvatinib Capsule, tell your doctor if you have heart disease, liver, or kidney problems, or are taking any medicines to treat infections. Many other medicines can affect or be affected by this medicine, so let your doctor know about all the medicines you are taking. Pregnant and breastfeeding women should consult their doctors before starting this medicine, as it may cause harm to the developing baby.
Uses of Lenvatinib Capsule
- Differentiated Thyroid cancer
- Treatment of Kidney cancer
- Liver cancer
- Treatment of Endometrial cancer
Benefits of Lenvatinib Capsule
In Differentiated Thyroid cancer
Side effects of Lenvatinib Capsule
Common side effects of Lenvatinib
- High blood pressure
- Diarrhea
- Increased bleeding tendency
How to use Lenvatinib Capsule
How Lenvatinib Capsule works
Safety advice

Alcohol

Pregnancy

Breast feeding

Driving

Kidney

Liver
What if you forget to take Lenvatinib Capsule?
Quick tips
- Take it with or without food, preferably at the same time each day.
- Use a reliable contraceptive method to prevent pregnancy while you are taking this medicine and for a month after you stop taking it.
- Monitor your blood pressure regularly while taking this medication. Inform your doctor if you notice symptoms of very high blood pressure, such as severe headache, confusion, problems with your eyesight, nausea, or vomiting.
- It may cause serious bleeding problems. Inform your doctor if you get headaches or stomach pain or if you notice blood in your urine or stools.
- Consult your doctor if you are pregnant, planning to conceive, or breastfeeding.
FAQs
How will I know if Lenvatinib Capsule is working?
What are the most serious side effects of Lenvatinib Capsule I should watch out for?
Can I stop taking Lenvatinib Capsule if my symptoms have improved?
Who should avoid taking Lenvatinib Capsule?
Will I need regular check-ups or tests while taking Lenvatinib Capsule?
How long do I have to continue taking Lenvatinib Capsule?
Does Lenvatinib Capsule affect my fertility?
What other precautions should I take during Lenvatinib Capsule treatment?
References:-
European Medicines Agency (EMA)
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Lenvima (Lenvatinib) – EPAR (European Public Assessment Report)
Official dossier covering indications (differentiated thyroid carcinoma, hepatocellular carcinoma, and endometrial carcinoma in combination), mechanism of action, safety data, dosing, and more.
https://www.ema.europa.eu/en/medicines/human/EPAR/lenvima European Medicines Agency (EMA) -
Kisplyx (Lenvatinib) – EPAR
Regulatory assessment for Lenvatinib when used in combination therapies for advanced renal cell carcinoma (e.g., with everolimus or pembrolizumab), including dosage and administration guidelines.
https://www.ema.europa.eu/en/medicines/human/EPAR/kisplyx European Medicines Agency (EMA) -
EMA Paediatric Investigation Plans (PIP)
Modifications and status of pediatric study requirements for Lenvima/Kisplyx in various cancers.-
Decision on PIP modification: https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001119-pip03-19-m03 European Medicines Agency (EMA)
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Decision on PIP modification for additional indications: https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-001119-pip02-12-m08 European Medicines Agency (EMA)
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U.S. FDA
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FDA Approval – Lenvatinib for Unresectable Hepatocellular Carcinoma (Lenvima Capsules)
U.S. FDA approval announcement for Lenvatinib capsules in this indication, based on the REFLECT trial outcomes.
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lenvatinib-unresectable-hepatocellular-carcinoma U.S. Food and Drug Administration -
FDA Approval – Lenvatinib + Everolimus for Advanced Renal Cell Carcinoma
Official announcement of FDA authorization for the combination therapy following prior VEGF-targeted treatments.
https://www.fda.gov/drugs/resources-information-approved-drugs/lenvatinib-combination-everolimus U.S. Food and Drug Administration -
FDA Approval – Lenvatinib + Pembrolizumab for Advanced RCC
Details official approval for the first-line combination treatment in advanced renal cell carcinoma.
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lenvatinib-plus-pembrolizumab-advanced-renal-cell-carcinoma U.S. Food and Drug Administration -
FDA Approval – Pembrolizumab + Lenvatinib for Advanced Endometrial Carcinoma
Regulatory confirmation of this combination for advanced endometrial cancer not responsive to earlier treatments.
https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-regular-approval-pembrolizumab-and-lenvatinib-advanced-endometrial-carcinoma U.S. Food and Drug Administration -
FDA Drug Trials Snapshot – Lenvima
Snapshot summarizing clinical trial demographics and efficacy outcomes that supported FDA approval for thyroid carcinoma.
https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshot-lenvima U.S. Food and Drug Administration -
FDA Drug Approval Package (Lenvima Capsules)
A comprehensive archive including approval letters, label PDFs, and detailed review documentation of the original approval.
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206947Orig1s000TOC.cfm


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