乐卫玛 乐伐替尼Lenvima(lenvatinib)

[Function and indications] Lenvima (Lenvatinib) Lenvatinib is a kinase inhibitor suitable for the treatment of patients with locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer. It can also be used in combination with other targeted drugs for other cancers such as liver cancer, lung cancer, gastric cancer, etc.

[Model and specifications] Capsules: 4 mg and 10 mg

[Usage and dosage]

⑴ Recommended dose: 24 mg orally, once a day.

⑵ In patients with severe renal or liver damage, the dose is 14 mg, once a day.

[Precautions]

⑴ Hypertension: Control blood pressure before treatment with LENVIMA. Do not give LENVIMA for grade 3 hypertension despite optimized hypertension treatment. Discontinue the drug for life-threatening hypertension.

⑵ Heart failure: Monitor clinical symptoms and signs of cardiac decompensation. Do not give LENVIMA for grade 3 heart failure. Discontinue the drug for grade 4 heart failure.
⑶ Arterial Thromboembolic Events: Discontinue LENVIMA after an arterial thromboembolic event.
⑷ Hepatotoxicity: Monitor liver function tests prior to initiation of LENVIMA and periodically throughout treatment. Withhold LENVIMA for Grade 3 or greater hepatic impairment. Discontinue treatment for hepatic failure.
⑸ Proteinuria: Monitor proteinuria prior to initiation of treatment with LENVIMA and periodically throughout. Withhold LENVIMA for 24-hour proteinuria ≥2 g. Discontinue for nephrotic syndrome.
⑹ Renal Failure and Renal Impairment: Withhold LENVIMA for Grade 3 or 4 renal failure/impairment.
⑺ Gastrointestinal Perforation and Fistula Formation: Discontinue LENVIMA in patients who develop gastrointestinal perforation or life-threatening fistula.
⑻ QT Interval Prolongation: Monitor and correct electrolyte abnormalities in all patients. Withhold LENVIMA for Grade 3 or greater QT Interval Prolongation (5.8).
⑼ Hypocalcemia: Monitor serum calcium levels at least monthly and administer calcium replacement as needed.
⑽ Reversible posterior leukoencephalopathy syndrome (RPLS): Withhold LENVIMA for RPLS until complete resolution.
⑾ Bleeding events: Withhold LENVIMA for Grade 3 bleeding. Discontinue treatment for Grade 4 bleeding.
⑿ Impairment of thyroid stimulating hormone suppression: Monitor TSH levels monthly and adjust thyroid replacement medications as needed in patients with DTC.
⒀ Embryofetal toxicity: May cause fetal harm. Advise of potential risk to the fetus and use effective contraception.

[Adverse Reactions] The most common adverse reactions to LENVIMA (incidence greater than or equal to 30%) are hypertension, fatigue, diarrhea, arthralgia/myalgia, decreased appetite, weight loss, nausea, stomatitis, headache, vomiting, proteinuria, palmar-plantar erythrodysesthesia syndrome, abdominal pain, and dysphonia.

[Pregnant women] LENVIMA may cause fetal harm when administered to pregnant women. Because of the potential for serious adverse reactions in nursing infants from LENVIMA, advise women to discontinue breastfeeding during treatment with LENVIMA.

Pediatric Use: The safety and effectiveness of LENVIMA in pediatric patients have not been established.