Hypertension: Control blood pressure prior to treatment with Lenvatinib. Withhold Lenvatinib for Grade 3 hypertension despite optimal antihypertensive therapy. Discontinue for life-threatening hypertension.
Cardiac Failure:
Monitor for clinical symptoms or signs of cardiac decompensation. Withhold Lenvatinib for Grade 3 cardiac dysfunction. Discontinue for Grade 4 cardiac dysfunction. Arterial Thromboembolic Events: Discontinue Lenvatinib following an arterial thromboembolic event. Hepatotoxicity: Monitor liver function tests before initiation of Lenvatinib and periodically throughout treatment. Withhold Lenvatinib for Grade 3 or greater liver impairment. Discontinue for hepatic failure.
Proteinuria: Monitor for proteinuria before initiation of, and periodically throughout, treatment with Lenvatinib. Withhold Lenvatinib for 2 grams of proteinuria for 24 hours. Discontinue for nephrotic syndrome.
Diarrhea: May be severe and recurrent. Use standard anti-diarrheal therapy. Withhold Lenvatinib for Grade 3 and discontinue for Grade 4 diarrhea. Renal Failure and Impairment: Withhold Lenvatinib for Grade 3 or 4 renal failure/impairment. Gastrointestinal Perforation and Fistula Formation: Discontinue Lenvatinib in patients who develop gastrointestinal perforation or lifethreatening fistula.
Hypocalcemia: Monitor blood calcium levels at least monthly and replace calcium as necessary. 1Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Withhold Lenvatinib for RPLS until fully resolved.
Hemorrhagic Events: Withhold Lenvatinib for Grade 3 hemorrhage. Discontinue for Grade 4 hemorrhage. Impairment of Thyroid Stimulating Hormone Suppression/Thyroid Dysfunction: Monitor TSH levels monthly and use thyroid replacement medication as needed.
Embryofetal Toxicity: Can cause fetal harm. Advise of potential risk to a fetus and use of effective contraception. Adverse Reactions: In DTC, the most common adverse reactions (incidence greater than or equal to 30%) for Lenvatinib are hypertension, fatigue, diarrhea, arthralgia/myalgia, decreased appetite, weight decreased, nausea, stomatitis, headache, vomiting, proteinuria, palmar-plantar erythrodysesthesia syndrome and abdominal pain.
In RCC, the most common adverse reactions (greater than 30%) for Lenvatinib + Everolimus are diarrhea, fatigue, arthralgia/myalgia, decreased appetite, vomiting, nausea, stomatitis/oral inflammation, hypertension, peripheral edema, cough, abdominal pain, dyspnea, rash, weight decreased, hemorrhagic events, and proteinuria.
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