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LENVIMA (LENVATINIB MESYLATE)
- Differentiated thyroid carcinoma
- Endometrial carcinoma
- Liver cell carcinoma
- Renal cell carcinoma
10 mg/day (10 mg x 1) capsule
- by oral route once daily at the same time each day per package directions
12 mg/day (4 mg x 3) capsule
- by oral route once daily at the same time each day per package directions
14 mg/day(10 mg x 1-4 mg x 1) capsule
- by oral route once daily at the same time each day per package directions
18 mg/day (10 mg x 1 and 4 mg x 2) capsule
- by oral route once daily at the same time each day per package directions
20 mg/day (10 mg x 2) capsule
- by oral route once daily at the same time each day per package directions
24 mg per day (10 mg x 2 and 4 mg x 1) capsule
- by oral route once daily at the same time each day per package directions
4 mg capsule
- by oral route once daily at the same time each day per package directions
8 mg/day (4 mg x 2) capsule
- by oral route once daily at the same time each day per package directions
Differentiated thyroid carcinoma
- by oral route once daily at the same time each day per package directions
Endometrial carcinoma
- by oral route once daily at the same time each day per package directions
Liver cell carcinoma
- by oral route once daily at the same time each day per package directions
- 1 capsule (4 mg) by oral route once daily at the same time each day
- 1 capsule (4 mg) by oral route every other day at the same time each day
- by oral route once daily at the same time each day per package directions (for patients weighing greater than or equal to 60 kg)
Renal cell carcinoma
- by oral route once daily at the same time each day per package directions
- None
Contraindicated
- amiodarone
- amiodarone in dextrose,iso-osm
- artemether-lumefantrine
- clozapine
- Clozaril
- Coartem
- Cordarone
- deferiprone
- disopyramide
- dronedarone
- droperidol
- Fazaclo
- Ferriprox
- Geodon
- Multaq
- Nexterone
- Norpace
- Norpace Cr
- Orap
- Pacerone
- pimozide
- Versacloz
- ziprasidone HCl
- ziprasidone mesylate
Severe
Moderate
- Kaletra
- lopinavir-ritonavir
- Arterial aneurysm
- Arterial dissection
- Chronic kidney disease stage 5 (failure) GFr<15 ml/min
- Congenital long QT syndrome
- Gastrointestinal fistula
- Gastrointestinal perforation
- Hepatic failure
- Lactating mother
- Posterior reversible encephalopathy syndrome
- Thromboembolic disorder
Contraindicated
- Chronic heart failure
- Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min
- Hemorrhage
- Hypertension
- Hypocalcemia
- Invasive surgical procedure
- Kidney disease with likely reduction in GFR
- Pregnancy
- Prolonged QT interval
- Proteinuria
Severe
Moderate
- Hypothyroidism
LENVIMA (LENVATINIB MESYLATE)
- Differentiated thyroid carcinoma
- Endometrial carcinoma
- Liver cell carcinoma
- Renal cell carcinoma
- Hemorrhage
- Hypertension
- Hypothyroidism
- Acute abdominal pain
- Anorexia
- Arthralgias
- Diarrhea
- Dyspnea
- Epistaxis
- Fatigue
- Headache disorder
- Myalgias
- Nausea
- Palmar-plantar erythrodysesthesia
- Proteinuria
- Stomatitis
- Voice change
- Vomiting
- Weight loss
More Frequent
Severe
Less Severe
- Abnormal hepatic function tests
- Acute arterial thromboembolism
- Dehydration
- Hypokalemia
- Kidney disease with reduction in GFR
- Left ventricular failure
- Pneumonia
- Prolonged QT interval
- Pulmonary edema
- Renal failure
- Right ventricular failure
- Alopecia
- Back pain
- Constipation
- Cough
- Dizziness
- Dysgeusia
- Dyspepsia
- Gingivitis
- Hyperkeratosis
- Hypocalcemia
- Hypomagnesemia
- Hypotension
- Insomnia
- Parotitis
- Periodontal infection
- Peripheral edema
- Sialoadenitis
- Skin rash
- Sore throat
- Sore tongue
- Urinary tract infection
- Xerostomia
Less Frequent
Severe
Less Severe
Rare / Very Rare
Severe
- Cholecystitis
- Dissection of aorta
- Elevated serum amylase
- Gastrointestinal fistula
- Gastrointestinal perforation
- Hepatic failure
- Hepatitis
- Impaired wound healing
- Intracranial bleeding
- Nephrotic syndrome
- New fistula formation involving an internal organ
- Pancreatitis
- Pneumothorax
- Posterior reversible encephalopathy syndrome
- Pulmonary thromboembolism
- Tracheoesophageal fistula
- Tumor hemorrhage
Less Severe
- General weakness
Contraindicated
None
Severe Precaution
Lenvatinib
Juvenile rat studies demonstrated growth retardation and secondary delays in physical development and reproductive organ immaturity at 1.2-5 times the recommended human dose. Safety and efficacy is not established under 18 years.
- 1 Day – 18 Years
- Juvenile rat studies demonstrated growth retardation and secondary delays in physical development and reproductive organ immaturity at 1.2-5 times the recommended human dose. Safety and efficacy is not established under 18 years.
Management or Monitoring Precaution
None
Lenvatinib
- Severity Level:
D
- Additional Notes: Based on drug pharmacology and animal data dev tox may occur
Contraindicated
Lenvatinib
Insuff human data avail; potential for serious adv effects based on pharmacol
| General | Excretion Potential | Effect on Infant | Notes |
| Drug should not be given to breast feeding mothers | Unknown | Not known; no or inclusive data | Insuff human data avail; potential for serious adv effects based on pharmacol |
Precaution Exists
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
No Known Risk
None
| General | Excretion Potential | Effect on Infant | Notes |
| None |
Contraindicated
None
Precaution Exists
Lenvatinib
Cardiovascular-Aortic dissection, aortic aneurysm, and hypertension were more frequently reported in older patients. General-In clinical trials, patients > 75 years showed reduced tolerability and increased risk of dehydration and reduced appetite. Endocrine-Patients weighing <60kg may be increased risk of hypocalcemia and hyponatremia. Renal-Proteinuria was more frequently reported in patients >74 years.
| Organ / System | HEP | REN | CARD | ENDO | NEURO / PSYCH | PULM |
| Increased Risk / Adverse Effects | N | N | Y | N | N | Y |
BEERS: N HEDIS: N STOPP: N
No Known Risk
None
- None
| Differentiated thyroid carcinoma | |
| C73 | Malignant neoplasm of thyroid gland |
| Endometrial carcinoma | |
| C54.1 | Malignant neoplasm of endometrium |
| Liver cell carcinoma | |
| C22.0 | Liver cell carcinoma |
| Renal cell carcinoma | |
| C64 | Malignant neoplasm of kidney, except renal pelvis |
| C64.1 | Malignant neoplasm of right kidney, except renal pelvis |
| C64.2 | Malignant neoplasm of left kidney, except renal pelvis |
| C64.9 | Malignant neoplasm of unspecified kidney, except renal pelvis |
| 0-9 | A-Z |
|---|---|
| C22.0 | Liver cell carcinoma |
| C54.1 | Malignant neoplasm of endometrium |
| C64 | Malignant neoplasm of kidney, except renal pelvis |
| C64.1 | Malignant neoplasm of right kidney, except renal pelvis |
| C64.2 | Malignant neoplasm of left kidney, except renal pelvis |
| C64.9 | Malignant neoplasm of unspecified kidney, except renal pelvis |
| C73 | Malignant neoplasm of thyroid gland |
Formulary Reference Tool