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Lenvatinib is an oral targeted anti-cancer drug that is a multi-kinase inhibitor. It works by inhibiting several kinases that promote tumor growth and angiogenesis.
Lenvatinib is mainly used to treat the following cancers:
1. Differentiated thyroid cancer (DTC):For the treatment of patients with locally recurrent or metastatic, progressive differentiated thyroid cancer that is refractory to radioactive iodine.
2. Renal cell carcinoma (RCC):In combination with pembrolizumab, it is a first-line treatment for adults with advanced renal cell carcinoma. Alternatively, in combination with everolimus, for the treatment of adult patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy.
3. Hepatocellular carcinoma (HCC):For the treatment of patients with unresectable hepatocellular carcinoma.
Lenvatinib is a tyrosine kinase inhibitor whose main targets include vascular endothelial growth factor receptor (VEGFR1-3), fibroblast growth factor receptor (FGFR1-4), platelet-derived growth factor receptor α (PDGFRα), RET and KIT, etc. By inhibiting the activity of these kinases, lenvatinib blocks the signaling pathways required for tumor cell growth and inhibits the neogenesis of tumor blood vessels (anti-angiogenesis), thereby inhibiting tumor growth and spread.
Lenvatinib is in capsule form and needs to be swallowed whole. It is usually taken once a day at a fixed time and can be taken with or without food.
Differentiated Thyroid Cancer (DTC): The recommended dose is 24 mg once daily.
Renal cell carcinoma (RCC):
Combined with pembrolizumab: The recommended dose is 20 mg of lenvatinib once daily, combined with pembrolizumab as an intravenous infusion every 3 weeks.
In combination with everolimus: The recommended dose is 18 mg of lenvatinib once daily and 5 mg of everolimus once daily.
Hepatocellular Carcinoma (HCC): Recommended dosage is based on patient weight. For patients weighing 60 kg or more, the recommended dose is 12 mg once daily; for patients weighing less than 60 kg, the recommended dose is 8 mg once daily.
Dose adjustment: Based on the severity of the patient's side effects (such as hypertension, proteinuria, liver function damage, kidney function damage, heart failure, gastrointestinal perforation, etc.), the doctor will instruct the patient to suspend the dose, reduce the dose, or permanently discontinue the drug. Patients must strictly follow the doctor's instructions to adjust the dosage and cannot change it on their own. Lenvatinib is available in 4 mg and 10 mg capsule sizes for dose adjustment.
Lenvatinib treatment may cause a variety of side effects, the frequency and severity of which vary depending on the individual, indications and combination regimens. Common side effects include:
1. Hypertension: It is very common and requires close monitoring of blood pressure and usually requires the use of antihypertensive drugs to control it.
2. Fatigue: Feeling unusually tired or weak.
3. Diarrhea: Increased stool frequency or loose stools.
4. Loss of appetite and weight loss: Loss of appetite, leading to weight loss.
5. Nausea and vomiting: Stomach discomfort or vomiting.
6. Stomatitis/oral mucositis:Pain, inflammation or ulcers in the mouth.
7. Proteinuria: The protein content in the urine increases and requires regular urine testing and monitoring.
8. Hand and foot skin reaction: Redness, swelling, pain, peeling, blisters or numbness on the palms or soles of the feet.
9. Difficulty in pronunciation: The voice is hoarse or changed.
10. Abdominal pain: Abdominal pain or discomfort.
11. Headache: Pain in the head.
12. Bleeding: It may include nose bleeding, gum bleeding, etc. In severe cases, internal bleeding may occur.
13 Abnormal thyroid function: It may lead to hypothyroidism or hyperthyroidism, and thyroid function needs to be monitored.
14. Abnormal liver function indicators: Such as elevated alanine aminotransferase (ALT) and aspartate aminotransferase (AST).
1. Hypertension: Blood pressure needs to be strictly controlled before and during treatment. Blood pressure should be monitored during the first week after treatment is initiated and then at least monthly and more frequently as needed to monitor and adjust antihypertensive therapy. Lenvatinib should be withheld in the event of severe hypertension.
2. Heart failure: Decreased heart pumping function (reduced ejection fraction) may occur. Clinical symptoms and signs related to cardiac function need to be monitored, and lenvatinib needs to be suspended or discontinued when symptoms or signs of heart failure occur.
3. Arterial thromboembolic events: May increase the risk of myocardial infarction, stroke, etc. Lenvatinib should be discontinued if an arterial thromboembolic event occurs.
4. Hepatotoxicity: May cause severe liver damage. Liver function indicators need to be monitored regularly. Lenvatinib should be permanently discontinued in the event of hepatic failure or hepatic encephalopathy.
5. Proteinuria: Conduct regular urine tests to monitor proteinuria. Lenvatinib should be discontinued if nephrotic syndrome occurs.
6. Kidney failure and renal impairment: Acute renal failure or worsening of renal function may occur. Renal function needs to be monitored and lenvatinib should be discontinued if life-threatening renal failure occurs.
u200b7. Gastrointestinal perforation and fistula formation: There is a risk of gastrointestinal perforation or the formation of abnormal passages (fistulas). Lenvatinib should be discontinued in the event of gastrointestinal perforation or life-threatening fistula.
8. QT interval prolongation: It may cause prolongation of the QT interval in the electrocardiogram and increase the risk of ventricular arrhythmia. ECG and electrolytes (potassium, calcium, magnesium) need to be monitored. Lenvatinib should be withheld if Grade 3 or greater QT prolongation occurs.
9. Hypocalcemia: May cause a decrease in blood calcium levels. Blood calcium levels need to be monitored regularly and calcium supplements are needed if necessary.
10. Posterior reversible encephalopathy syndrome (PRES): A rare neurological disease (symptoms include headache, epilepsy, confusion, vision problems, etc.). Lenvatinib should be discontinued if PRES occurs.
11. Bleeding: Serious or even fatal bleeding events may occur. Lenvatinib should be discontinued if severe or life-threatening bleeding occurs.
12. May affect wound healing. Discontinue lenvatinib for at least 1 week before elective major surgery, and do not administer it for at least 2 weeks after major surgery until the wound has fully healed. The safety of resuming medication after resolution of wound healing complications has not been established.
13. Embryo-fetal toxicity: It is seriously harmful to the fetus and can lead to death or congenital malformations. Women of childbearing potential must use effective contraceptive measures during treatment and for at least 30 days after the last dose. Contraindicated during pregnancy.
1. Pregnant women: Disabled. There is a risk of fetal malformation.
2. Breastfeeding women: It is recommended to stop breastfeeding during treatment and at least 1 week after the last dose.
3. Men and women of childbearing age:Women of childbearing potential must use effective contraception during treatment and for at least 30 days after the last dose. Male patients who have female partners of childbearing age should also use effective contraception during treatment and within 1 week after the last dose.
4. Medication for children: Safety and effectiveness have not been established.
5. Medication for the elderly: No significant difference in overall safety was observed in patients aged 65 and above, but the incidence of certain side effects (such as diarrhea, loss of appetite, vomiting) may be higher.
6. Patients with hepatic impairment: Patients with mild hepatic impairment do not need to adjust the dose. Patients with moderate hepatic impairment (Child-Pugh class B) need to reduce the dose: when treating thyroid cancer and renal cancer, the starting dose is reduced to 14 mg/day (single agent) or 10 mg/day (combined with pembrolizumab); it is not recommended for the treatment of liver cancer. It is contraindicated in patients with severe hepatic impairment (Child-Pugh Class C).
7. Patients with renal impairment: No dose adjustment is required in patients with mild or moderate renal impairment. Patients with severe renal impairment or end-stage renal disease should use it with caution and closely monitor for adverse reactions.