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Adverse reactions of Lenvatinib

Lenvatinib may cause severe adverse reactions, which mainly fall into the following categories:

Hypertension

Hypertension is a common and potentially severe side effect of lenvatinib. Your blood pressure must be well controlled before you start taking the medication. During the treatment course, healthcare providers should monitor your blood pressure on a regular basis. If any blood pressure abnormalities occur, they may prescribe antihypertensive drugs for intervention.

Cardiac Disorders

Lenvatinib can trigger life-threatening severe cardiac problems. If you experience symptoms related to heart issues, such as shortness of breath or ankle swelling, contact your healthcare provider immediately.

Vascular (Arterial) Thromboembolic Events

Seek emergency medical attention right away if you have any of the following symptoms:

Severe chest pain or pressure.

Pain in the arms, back, neck or jaw.

Shortness of breath.

Unilateral numbness or weakness of the body.

Speech disorders.

Sudden severe headache.

Sudden changes in vision.

Hepatic Impairment

Lenvatinib may induce liver problems, which can progress to liver failure and even death in severe cases. Healthcare providers will conduct liver function tests before and during the treatment. Inform your healthcare provider immediately if you notice any of the following symptoms:

Yellowing of the skin or the whites of the eyes (jaundice)

Darkened urine (resembling strong tea in color)

Light-colored stools

Drowsiness, confusion or loss of consciousness

Renal Impairment

Fatal cases of renal failure have been reported in patients receiving lenvatinib treatment. Healthcare providers should perform regular blood tests to monitor your renal function.

Elevated Urinary Protein (Proteinuria)

Proteinuria is a common and potentially severe side effect of lenvatinib. Healthcare providers will test the protein content in your urine before and during the treatment.

Diarrhea

Diarrhea is a common and potentially severe side effect of lenvatinib. If you develop diarrhea, consult your healthcare provider for appropriate medications. It is crucial to replenish adequate fluids during episodes of diarrhea. If you are unable to take in enough liquids and the diarrhea is difficult to control, notify your healthcare provider or go to the emergency department at once.

Gastrointestinal Perforation or Fistula Formation

Gastrointestinal perforation refers to a rupture in the wall of the stomach or intestines, while a fistula is an abnormal passage that forms between two or more organs in the body. Seek emergency medical care immediately if you suffer from severe abdominal pain.

QT Prolongation (Abnormal Cardiac Electrical Activity)

QT prolongation can lead to life-threatening arrhythmias. Before and during treatment, healthcare providers will conduct blood tests to monitor your serum potassium, magnesium and calcium levels, and may also perform electrocardiogram (ECG) examinations to assess cardiac electrical activity.

Hypocalcemia

During the treatment period, healthcare providers will monitor your blood calcium levels. If hypocalcemia occurs, calcium supplements may be recommended.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS)

Contact your healthcare provider immediately if you experience symptoms such as severe headache, seizures, body weakness, confusion or vision loss/changes.

Hemorrhagic Events

Lenvatinib may cause fatal severe bleeding. Inform your healthcare provider during treatment if you have any signs or symptoms of bleeding, including:

Severe and persistent nosebleeds.

Vomiting blood.

Red or tarry black stools.

Blood in the urine.

Coughing up blood or blood clots in the sputum.

Increased vaginal bleeding or new-onset vaginal bleeding.

Abnormal Thyroid Hormone Levels

Healthcare providers should check your thyroid hormone levels before the initiation of treatment and on a monthly basis during the treatment course.

Impaired Wound Healing

Some patients taking lenvatinib have experienced difficulties in wound healing. If you plan to undergo any surgery before or during the treatment, inform your healthcare provider in advance.

Lenvatinib should be discontinued at least one week prior to the scheduled surgery.

The timing of resuming the medication after surgery must follow the guidance of your healthcare provider.

Severe Jaw Disorders (Osteonecrosis of the Jaw)

A number of patients receiving lenvatinib have developed severe jaw problems. Certain risk factors can increase the likelihood of this condition, such as the use of bisphosphonates or denosumab, a history of oral diseases, or undergoing invasive dental procedures. Healthcare providers will examine your oral cavity before and during treatment. When visiting a dentist, you should proactively inform them that you are taking lenvatinib. Maintaining good oral hygiene is essential during the treatment period. If you have symptoms related to jaw disorders, such as jaw pain, toothache or gum ulcers, notify your healthcare provider immediately. If you intend to undergo any dental procedures before or during treatment, you should also inform your healthcare provider in advance. Invasive dental operations should be avoided as much as possible during lenvatinib treatment. Discontinuing bisphosphonates before invasive dental procedures may help reduce the risk of jaw-related complications.

Lenvatinib should be stopped at least one week before planned dental surgery or invasive dental procedures.

The time to restart the medication after dental procedures must comply with the instructions of your healthcare provider.

Effects on Fertility

Lenvatinib may impair fertility in both males and females. If you have concerns about this, consult your healthcare provider for professional advice.

If any of the above specific side effects occur, your healthcare provider may need to adjust the dosage of lenvatinib, or delay or completely terminate the treatment.

The above list does not include all potential side effects of lenvatinib. If you experience any discomfort, seek medical attention and consult for professional advice. It is essential to inform your healthcare provider of any side effects that occur during the treatment process.

Common Side Effects in the Treatment of Different Cancers

When used for thyroid cancer treatment:

The most common side effects include fatigue, arthralgia and myalgia, decreased appetite, weight loss, nausea, oral ulcers, headache, vomiting, rash, palmar-plantar erythrodysesthesia (redness, itching or peeling of the skin on hands and feet), abdominal pain, and hoarseness.

When used in combination with everolimus for renal cell carcinoma treatment:

The most common side effects include fatigue, arthralgia and myalgia, decreased appetite, vomiting, nausea, oral ulcers, peripheral edema, cough, abdominal pain, dyspnea, rash, weight loss, and bleeding.

When used for hepatocellular carcinoma treatment:

The most common side effects include fatigue, decreased appetite, arthralgia and myalgia, weight loss, abdominal pain, rash, palmar-plantar erythrodysesthesia (redness, itching or peeling of the skin on hands and feet), hoarseness, bleeding, decreased thyroid hormone levels, and nausea.

from FDA,2024.06

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