Lenvatinib

Indications & Dose:

Single Agent Therapy.

Differentiated Thyroid Cancer (DTC)

DTC, The recommended dosage is 24 mg orally once daily. 

Hepatocellular Carcinoma (HCC)

HCC, The recommended dosage is based on actual body weight, 12 mg orally once daily for patients greater than or equal to 60 kg or 8 mg orally once daily for patients less than 60 kg.  

Combination Therapy.

Endometrial Carcinoma (EC)

EC, The recommended dosage is 20 mg orally once daily in combination with pembrolizumab 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks.  

Renal Cell Carcinoma (RCC)

RCC, The recommended dosage is, o 20 mg orally once daily with pembrolizumab 200 mg administered as an

intravenous infusion over 30 minutes every 3 weeks. 

o 18 mg orally once daily with everolimus 5 mg orally once daily.  

Modify the recommended daily dose for certain patients with renal or hepatic impairment. 

Contraindications:

None

Side Effects:

The most common adverse reactions are hypertension, fatigue, diarrhea, arthralgia/myalgia, decreased appetite, decreased weight, nausea, stomatitis, headache, vomiting, proteinuria, palmar-plantar erythrodysesthesia syndrome, abdominal pain, and dysphonia. 

The most common adverse reactions with pembrolizumab are fatigue, diarrhea, musculoskeletal pain, hypothyroidism, hypertension, stomatitis, decreased appetite, rash, nausea, decreased weight, dysphonia, proteinuria, palmar-plantar erythrodysesthesia syndrome, abdominal pain, hemorrhagic events, vomiting, constipation, hepatotoxicity, headache, and acute kidney injury.  

The most common adverse reactions with everolimus are diarrhea, fatigue, arthralgia/myalgia, decreased appetite, vomiting, nausea, stomatitis/oral inflammation, hypertension, peripheral edema, cough, abdominal pain, dyspnea, rash, decreased weight, hemorrhagic events, and proteinuria.  

Cautions:

Precautions:

Interaction:

Warnings:

1. Hypertension. Control blood pressure prior to treatment and monitor during treatment. Withhold for Grade 3 hypertension despite optimal antihypertensive therapy. Discontinue for Grade 4 hypertension. 

2. Cardiac Dysfunction. Monitor for clinical symptoms or signs of cardiac dysfunction. Withhold or discontinue for Grade 3 cardiac dysfunction. Discontinue for Grade 4 cardiac dysfunction. 

3. Arterial Thromboembolic Events. Discontinue following an arterial thromboembolic event.  

4. Hepatotoxicity: Monitor liver function prior to treatment and periodically during treatment. Withhold or discontinue for Grade 3 or 4 hepatotoxicity. Discontinue for hepatic failure.  

5. Renal Failure or Impairment. Withhold or discontinue for Grade 3 or 4 renal failure or impairment.  

6. Proteinuria. Monitor for proteinuria prior to treatment and periodically during treatment. Withhold for 2 or more grams of proteinuria per 24 hours. Discontinue for nephrotic syndrome

7. Diarrhea. May be severe and recurrent. Promptly initiate management for severe diarrhea. Withhold or discontinue based on severity. 

8. Fistula Formation and Gastrointestinal Perforation. Discontinue in patients who develop Grade 3 or 4 fistula or any Grade gastrointestinal perforation.

9. QT Interval Prolongation. Monitor and correct electrolyte abnormalities. Withhold for QT interval greater than 500 ms or for 60 ms or greater increase in baseline QT interval.  

10. Hypocalcemia. Monitor blood calcium levels at least monthly and replace calcium as necessary. Withhold or discontinue based on severity. 

11. Reversible Posterior Leukoencephalopathy Syndrome (RPLS). Withhold for RPLS until fully resolved or discontinue.  

12. Hemorrhagic Events. Withhold or discontinue based on severity.

13. Impairment of Thyroid Stimulating Hormone Suppression/Thyroid Dysfunction: Monitor thyroid function prior to treatment and monthly during treatment.  

14. Impaired Wound Healing. Withhold  for at least 1 week before elective surgery. Do not administer for at least 2 weeks following major surgery and until adequate wound healing. The safety of resumption of after resolution of wound healing complications has not been established.  

Adverse Effects:

Lactations:

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

Patient And Carer Advice: