lenvatinib

Trade Name:

Lenvima®

Appearance:

capsule

in various strengths, shapes and colours

Monograph Name:

lenvatinib

Monograph Body:

Drug Monograph

A - Drug Name

lenvatinib

COMMON TRADE NAME(S): Lenvima®

B - Mechanism of Action and Pharmacokinetics

Lenvatinib is a multiple receptor tyrosine kinase inhibitor (TKI) that selectively inhibits vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR) and VEGFR3 (FLT4) as well as other proangiogenic and oncogenic pathway-related receptors.

Absorption

Lenvatinib is rapidly absorbed with a tmax reached 1 to 4 hours post-dose. Food slows the rate of absorption, but does not affect the extent of absorption.

Bioavailability

data from a mass-balance study suggests about 85%

Distribution

PPB	98-99% (mainly to albumin)

Metabolism

Active metabolites

yes

Inactive metabolites

yes

Elimination

Plasma concentrations decline bi-exponentially following C_max.

Half-life

28 hours (terminal)

Feces

64%

Urine

25%

C - Indications and Status

Health Canada Approvals:

For the treatment of patients with locally recurrent or metastatic, progressive, radioactive-iodine refractory differentiated thyroid cancer (DTC).
In combination with everolimus for the treatment of advanced renal cell carcinoma (RCC) following prior vascular endothelial growth factor (VEGF)-targeted therapy.
For the first-line treatment of adult patients with unresectable hepatocellular carcinoma (HCC).*

*Efficacy and safety data for Child-Pugh Class B and Class C are not available.

D - Adverse Effects

Emetogenic Potential:

Moderate – Consider prophylaxis daily

Extravasation Potential: Not applicable

The following table lists adverse effects that occurred in ≥5% of patients in the phase III SELECT trial in DTC patients comparing lenvatinib vs placebo, where there was at least a 5% difference between arms. Severe adverse events from other studies or post-marketing are also included.

ORGAN SITE	SIDE EFFECT* (%)	ONSET**
Cardiovascular	Arrhythmia (rare)	E
	Arterial thromboembolism (5%) (may be severe)	E
	Bradycardia (11%)	E
	Cardiotoxicity (5%)	E D
	Hypertension (73%) (44% severe)	E
	Hypotension (9%)	E
	Other - Artery dissection or aneurysm (rare)	L
	QT interval prolonged (12%) (2% severe)	E
	Venous thromboembolism (3%) (severe)	E
Dermatological	Alopecia (12%)	E
	Hand-foot syndrome (32%)	E
	Other (7%) - hyperkeratosis	E
	Rash (19%)	E
Gastrointestinal	Abdominal pain (31%)	E
	Anorexia, weight loss (54%)	E
	Constipation (29%)	E
	Dehydration (9%) (may be severe)	E
	Diarrhea (67%) (9% severe)	E
	Dry mouth (17%)	E
	Dyspepsia (13%)	E
	GI obstruction (rare)	E
	GI perforation (2% fistulas; may be severe)	E
	Mucositis (41%) (5% severe)	E
	Nausea, vomiting (47%) (may be severe)	E
General	Edema - limbs (21%)	E
	Fatigue (43%)	E
	Wound dehiscence (rare)	E
Hematological	Hemorrhage (35%) (2% severe)	E
	Myelosuppression (14%)	E D
Hepatobiliary	↓ albumin (49%)	E
	↑ Amylase / lipase (12%) (may be severe)	E
	Cholecystitis (rare)	E
	Hepatotoxicity (8%) (including hepatic encephalopathy)	E
	↑ LFTs (52%) (4% severe)	E
	Pancreatitis (rare)	E
Hypersensitivity	Hypersensitivity (rare)	E
Infection	Infection (12%)	E
Metabolic / Endocrine	Abnormal electrolyte(s) (40%) (low Ca, K, Na, Mg; 9% severe)	E
	Hyperglycemia (53%) (<1% severe)	E
	Hypoglycemia (19%) (mild to moderate)	E
	Hypothyroidism (21%)	E D
	Other - ↑ TSH (61%)	E D
	↑ Triglycerides (15%)	E
Musculoskeletal	Fracture (rare)	D L
	Musculoskeletal pain (26%)	E
	Rhabdomyolysis (rare)	E
Neoplastic	Secondary malignancy (adenocarcinoma; rare)	D L
Nervous System	Dizziness (15%)	E
	Dysgeusia (18%)	E
	Headache (38%)	E
	Insomnia (12%)	E
	Posterior reversible encephalopathy syndrome (PRES) (rare)	E
	Seizure (rare)	E
Ophthalmic	Retinal vascular disorder (retinal vein thrombosis; rare)	E
Renal	Creatinine increased (87%) (3% severe)	E
	Proteinuria (34%) (may be severe)	E
Respiratory	Cough, dyspnea (24%)	E
	Dysphonia (31%)	E

* "Incidence" may refer to an absolute value or the higher value from a reported range.
"Rare" may refer to events with < 1% incidence, reported in post-marketing, phase 1 studies,
isolated data or anecdotal reports.

** I = immediate (onset in hours to days) E = early (days to weeks)
D = delayed (weeks to months) L = late (months to years)

The most common side effects for lenvatinib include creatinine increased, hypertension, diarrhea, anorexia, weight loss, hyperglycemia, ↑ LFTs, ↓ albumin, nausea, vomiting, fatigue and mucositis.

Hypertension was commonly reported and may be severe. Median time to onset was 16-35 days. Serious complications, including aortic dissection, have been reported secondary to poorly controlled hypertension.

Cardiac failure was reported in in less than 1% of DTC patients, but decreases in left ventricular ejection fraction (LVEF) were seen in 5% of DTC patients and 10% of RCC patients receiving combination treatment. Arterial thromboembolic events were reported as well, including fatal cases.

Severe cases of artery dissection (with or without hypertension) and artery aneurysm (including rupture) have been reported in patients using VEGFR TKIs.

QT prolongation has been reported and may lead to severe ventricular arrhythmias, including Torsades de pointes.

Grade 3 or 4 renal failure was reported in up to 3% of patients, with the primary risk factor being dehydration secondary to diarrhea or vomiting. HCC Patients with baseline renal impairment had a higher incidence of fatigue, hypothyroidism, dehydration, diarrhea, decreased appetite, proteinuria and hepatic encephalopathy. These patients also had a higher incidence of renal reactions and arterial thromboembolic events.

Proteinuria was common and may be severe. The median time to onset for RCC patients was 6 weeks for any grade and 20 weeks for grades 3 or 4.

Lenvatinib impairs exogenous thyroid suppression and may elevate thyroid stimulating hormone (TSH) levels in both DTC and RCC patients. TSH should be monitored regularly and thyroid medication adjusted as required.

Diarrhea was reported more commonly in RCC patients on combination treatment (81%; 19% grade 3, 4).

Serious gastrointestinal perforation or fistulas have been reported, mainly in patients with prior surgery or radiotherapy. Reports of non-GI fistulae (e.g. respiratory, genitourinary, cutaneous) have been observed across various indications.

Wound healing complications, including fistula formation and wound dehiscence, may occur.

Severe tumour-related hemorrhage, including fatal intracranial hemorrhage in patients with brain metastases has been reported. Epistaxis and hematuria were the most frequently reported hemorrhagic events.

Posterior-reversible encephalopathy syndrome (PRES) has been reported rarely and may be associated with hypertension.

E - Dosing

Refer to protocol by which the patient is being treated.

Lenvatinib is associated with a moderate emetic potential; antiemetics may be considered to prevent nausea and vomiting.

Blood pressure should be well controlled and electrolyte abnormalities should be corrected prior to starting treatment.

Adequate washout period is required between lenvatinib and other systemic anticancer treatments (e.g. sorafenib). In DTC and RCC studies, the minimum washout period was 3 weeks. In HCC, washout period from prior locoregional therapies was 4 weeks.

Adults:

DTC patients:

lenvatinib 24 mg PO daily

RCC patients:

lenvatinib 18 mg PO daily in combination with everolimus 5 mg PO daily

HCC patients:

In patients with body weight (BW) of ≥60 kg: lenvatinib 12 mg PO daily

In patients with body weight (BW) of <60 kg: lenvatinib 8 mg PO daily

Dosage with Toxicity:

The dosing and dose modifications described here relate to lenvatinib use only.

Refer to the everolimus drug monograph for dosage modifications for RCC patients. For toxicities related to both lenvatinib and everolimus, reduce the lenvatinib dose first and then the everolimus dose.

Reduced doses should not be increased.

Dose Levels:

Dose level	Lenvatinib DTC / RCC monotherapy dose (mg daily)	Lenvatinib RCC dose when in combination with everolimus (mg daily)	≥60 kg BW Lenvatinib HCC dose (mg daily, unless otherwise stated)	<60 kg BW Lenvatinib HCC dose (mg daily, unless otherwise stated)
0	24	18	12	8
-1	20	14	8⁺	4⁺
-2	14	10	4	4 every other day
-3	10	8	4 every other day	Discontinue
-4	Discontinue			N/A

⁺No dose adjustment required for first occurrence of hematologic toxicity or proteinuria

No recommendations are available for resuming lenvatinib in patients with grade 4 adverse reactions that resolve.

Toxicity	Severity	Action
Hypertension	≥ 140/90	Treat with anti-hypertensives
	Grade 3 that persists despite optimal antihypertensive therapy	Hold until recovery to ≤ grade 2; resume at 1 dose level ↓.*
	Grade 4, life-threatening	Discontinue
Cardiotoxicity or hemorrhage	Grade 3	Hold until recovery to ≤ grade 1 or baseline; resume at 1 dose level ↓* or discontinue depending on severity and persistence.
Cardiotoxicity or hemorrhage	Grade 4	Discontinue
Nephrotoxicity or hepatotoxicity	Grade 3	Hold until recovery to ≤ grade 1 or baseline; resume at 1 dose level ↓* or discontinue depending on severity and persistence.
Nephrotoxicity or hepatotoxicity	Grade 4	Discontinue
Hepatic failure	Grade 3 or 4	Discontinue
Proteinuria	≥ 2 g proteinuria / 24 h (≥ 2+ on urine dipstick)	Hold until proteinuria < 2 g / 24 h; resume at 1 dose level ↓.*^†
Proteinuria	Nephrotic syndrome	Discontinue
Nausea, vomiting, diarrhea**	Persistent and intolerable Grade 2 or Grade 3	Hold until recovery to ≤ grade 1 or baseline; resume at 1 dose level ↓.
Nausea, vomiting, diarrhea**	Grade 4 despite medical management	Discontinue
QT prolongation	Grade 3 or 4	Hold until recovery to ≤ grade 1 or baseline; resume at 1 dose level ↓.*
PRES	Any	Hold until resolved; resume at 1 dose level ↓* or discontinue depending on the severity and persistence of neurologic symptoms.
Arterial thromboembolism		Discontinue
GI perforation or fistula
Wound healing complications
Other treatment-related toxicity	Persistent and intolerable Grade 2 Or Grade 3 Or Grade 4 lab abnormalities considered non-life-threatening	Medically manage. Hold until recovery to ≤ grade 1 or baseline; resume at 1 dose level ↓.*^†
Other treatment-related toxicity	Grade 4 (except lab abnormalities considered non-life-threatening)	Discontinue
Major surgery		Hold at least 6 days prior to scheduled surgery, resume after adequate wound healing.

*For each occurrence of toxicity, reduce dose in succession based on the previous dose level (see dose levels table).

**Initiate prompt medical management in order to reduce the risk of development of renal impairment or failure.

^†For patients with HCC and hematologic toxicity or proteinuria, may restart when recovery to ≤ Grade 2.

Dosage with Hepatic Impairment:

Lenvatinib exposure increases in severe hepatic impairment.

Childs classification of hepatic impairment	Starting dose DTC / RCC monotherapy (mg daily)	Starting dose RCC when in combination with everolimus (mg daily)	Starting Dose HCC (≥60 kg BW) (mg daily)	Starting Dose HCC (<60 kg BW) (mg daily)
A	24	18	12	8
B	24	18	No data
C	14	10	No data: not recommended for use

Dosage with Renal Impairment:

Lenvatinib exposure increases with severe renal impairment.

Creatinine clearance (ml/min)	Starting dose DTC / RCC monotherapy (mg daily)	Starting dose RCC when in combination with everolimus (mg daily)	Starting Dose HCC (≥60 kg BW) (mg daily)	Starting Dose HCC (<60 kg BW) (mg daily)
50-80	24	18	12	8
30-49	24	18	12	8
< 30	14	10	No data
End stage renal failure	No data: not recommended for use		No data

Dosage in the elderly:

No dosage adjustment is recommended. Use with caution and monitor patients closely.

In the DTC study, patients aged 75 and older had a higher incidence of toxicity, including severe and fatal adverse events, compared to younger patients, leading to treatment discontinuation (21% vs 14%). Patients 75 years or older were more likely to experience grade 3-4 hypertension, proteinuria, decreased appetite, and dehydration compared to patients < 65 years old.

In the RCC, study patients aged 65 and older had a higher incidence of cough, dyspnea, lethargy, nausea, peripheral swelling and vomiting compared to younger patients.

In the HCC study, patients ≥75 years appeared to have lower tolerability and were more likely to experience hypertension, proteinuria, decreased appetite, asthenia, dehydration, dizziness and hepatic encephalopathy. Arterial thromboembolic events also occurred at an increased incidence in this age group.

Body weight

In patients with DTC and RCC, no adjustment of starting dose is required based on body weight. In the DTC study, patients with body weight <60 kg had a higher incidence of hand-foot syndrome, proteinuria, severe electrolyte abnormalities and a trend towards severe anorexia.

Lenvatinib PK was affected by body weight in patients with HCC. Refer to the dosing section for starting doses.

Dosage based on gender:

No adjustment of starting dose is required based on gender.

In the DTC study, females had a higher incidence of hypertension (including severe hypertension), proteinuria and hand-foot syndrome, while males had a higher incidence of cardiotoxicity, GI perforation and fistulas.

In the RCC study, females had a higher incidence of hepatotoxicity, while males had a higher incidence of hemorrhage, nephrotoxicity, proteinuria and hand-foot syndrome.

In HCC patients, females had a higher incidence of hypertension, fatigue and ECG QT prolongation. Hepatic failure events were observed in male patients only.

Dosage based on ethnicity:

No adjustment of starting dose is required based on race.

In the DTC study, Asian patients had a higher incidence of peripheral edema, hypertension, fatigue, hand-foot syndrome, proteinuria, thrombocytopenia and elevated TSH levels compared to Caucasian patients.

In HCC patients, Asian patients had a higher incidence of proteinuria and hand-foot syndrome compared to Caucasian patients, while Caucasian patients had a higher incidence of fatigue, hepatic encephalopathy and acute kidney injury, anxiety, asthenia, thrombocytopenia, and vomiting.

Children:

Safety and efficacy have not been established in pediatric patients. Animal studies suggest the potential for impaired bone growth in children. Lenvatinib should not be used in children younger than 2 years of age.

F - Administration Guidelines

Lenvatinib should be taken at the same time daily, with or without food.
Capsules should be swallowed whole with water.
If the patient has difficulty swallowing, capsule(s) may be added (without breaking or crushing) to a tablespoon of water or apple juice in a small glass. Capsule(s) should be left in the liquid for at least 10 minutes and stirred for at least 3 minutes to allow the capsule shell(s) to dissolve. The entire suspension should then be swallowed. After drinking, the glass should be filled with the same amount of water or apple juice, swirled a few times, then additional liquid should be swallowed.
If a dose is missed and it cannot be taken within 12 hours, then that dose should be skipped and the next dose should be taken at the usual time.
Lenvatinib should be stored between 15-30^oC.

G - Special Precautions

Contraindications:

Patients who have a hypersensitivity to this drug or to any ingredient in the formulation or component of the container.

Other Warnings/Precautions:

The degree of tumour invasion of major blood vessels should be considered prior to treatment given the potential risk of hemorrhage associated with tumour shrinkage.
Lenvatinib is not recommended in patients with congenital long QT syndrome or those who are taking medications known to prolong the QT interval.
Use with caution in patients at risk of prolonged QT, including females, aged ≥ 65 years, family history of sudden cardiac death at < 50 years of age, pre-existing cardiac disease, history of arrhythmias, electrolyte disturbances or conditions leading to electrolyte disturbances, bradycardia, acute neurological events, diabetes mellitus and autonomic neuropathy.
Use lenvatinib with caution in patients who are at risk for, or have a history of cardiac events or arterial thromboembolism. The drug has not been studied in patients who have had an arterial thromboembolic event within the previous 6 months.
Patients with prior surgery or radiotherapy are at increased risk of GI perforation or fistulas.

Other Drug Properties:

Carcinogenicity: Unknown

Carcinogenicity studies have not been conducted.

Pregnancy and Lactation:

Embryotoxicity: Yes
Fetotoxicity: Yes
Teratogenicity: Yes

Lenvatinib is not recommended for use in pregnancy as it's likely to cause fetal harm. Highly effective contraception (including barrier method) should be used by both sexes during treatment, and for at least 1 month after the last dose.
Excretion into breast milk: Likely

Observed in animal studies.

Breastfeeding is not recommended.
Fertility effects: Likely

Animal studies suggest decreased male and female fertility.

H - Interactions

Lenvatinib is extensively metabolized by CYP3A4. In vitro studies indicate that lenvatinib inhibits CYP 2C8, 1A2, 2B6, 2C9, 2C19, 2D6 and 3A4. Lenvatinib inhibited UGT1A1 and UGT1A4 as well as OAT1, OAT3, OCT1, OCT2, OATP1B1 and BSEP. It is not considered a strong inducer or inhibitor P450 or UGT enzymes.

Lenvatinib may be co-administered with CYP3A4 inhibitors and inducers, PGP inducers and inhibitors, BRCP inhibitors and drugs that effect gastric pH without dosage adjustment.

AGENT	EFFECT	MECHANISM	MANAGEMENT
Use of lenvatinib immediately following sorafenib or other anticancer drugs	Potential for additive toxicities	Additive	For DTC and RCC, use a minimum washout period of 3 weeks. For HCC, use a minimum washout period of 4 weeks after locoregional therapies
Drugs decrease heart rate and/or prolong PR interval (e.g. antiarrhythmics, beta blockers, non-dihydropyridine Ca channel blockers, digoxin, some HIV protease inhibitors, sphingosine-1 phosphate receptor modulators)	Decreased heart rate, prolonged PR interval	Additive	Avoid if possible; monitor closely if used together
Drugs that may prolong QT (i.e. amiodarone, procainamide, sotalol, venlafaxine, amitriptyline, sunitinib, methadone, chloroquine, clarithromycin, haloperidol, fluconazole, moxifloxacin, domperidone, ondansetron, etc)	Prolonged QT, Torsades de pointes	Additive	Avoid if possible; monitor closely if used together
CYP3A4 substrates (e.g. cyclosporine, pimozide, tacrolimus, triazolo-benzodiazepines, dihydropyridine calcium-channel blockers, certain HMG-CoA reductase inhibitors)	Reduced efficacy of substrate	Lenvatinib may induce CYP3A4	Use with caution with substrates that have a narrow therapeutic index
P-glycoprotein substrates (i.e. verapamil, digoxin, morphine, ondansetron)	Reduced efficacy of substrate	Lenvatinib may induce PgP	Use with caution with substrates that have a narrow therapeutic index
Drugs that disrupt electrolyte levels (i.e. loop/thiazide diuretics, laxatives, amphotericin B, high dose corticosteroids)	Increased risk of arrhythmias	Additive	Avoid if possible; monitor closely if used together

I - Recommended Clinical Monitoring

Treating physicians may decide to monitor more or less frequently for individual patients but should always consider recommendations from the product monograph.

Recommended Clinical Monitoring

Monitor Type	Monitor Frequency
Blood pressure	Baseline, after 1 week, then every 2 weeks for the first 2 months, monthly thereafter while on treatment
CBC	Baseline and at each visit
ECG	Baseline and as clinically indicated
Liver function tests	Baseline, every 2 weeks for the first 2 months, then monthly during treatment
Renal function tests	Baseline and at each visit
Urine protein	Baseline and at each visit
TSH levels	Baseline and monthly during treatment
Serum calcium and electrolytes	Baseline, at least monthly and as clinically indicated
Clinical toxicity assessment for GI effects, infection, wound healing complications, bleeding, hypertension, thromboembolism, cardiac and neurologic effects	At each visit

Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version

J - Supplementary Public Funding

Exceptional Access Program (EAP Website)

lenvatinib - For the treatment of patients with locally recurrent or metastatic, progressive, radioactive-iodine-refractory differentiated thyroid cancer (DTC) according to criteria
lenvatinib - For the treatment of unresectable advanced hepatocellular carcinoma according to clinical criteria
lenvatinib - In Combination with Pembrolizumab for First-Line Advanced or Metastatic Renal Cell Carcinoma
lenvatinib - In Combination with Pembrolizumab for Advanced Endometrial Cancer

K - References

Lenvatinib product monograph, Eisai Limited. December 19, 2018

Schlumberger M, Tahara M, Wirth LJ, et al. Lenvatinib versus placebo in radioiodine-refractory thyroid cancer. N Engl J Med. 2015 Feb 12;372(7):621-30.

Scott LJ. Lenvatinib: first global approval. Drugs 2015;75:553-560

Product Monograph Update: Vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR TKIs). Health Canada InfoWatch, June 2020.

September 2023 Updated elimination section

L - Disclaimer

Refer to the New Drug Funding Program or Ontario Public Drug Programs websites for the most up-to-date public funding information.

The information set out in the drug monographs, regimen monographs, appendices and symptom management information (for health professionals) contained in the Drug Formulary (the "Formulary") is intended for healthcare providers and is to be used for informational purposes only. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects of a particular drug, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for a given condition. The information in the Formulary is not intended to constitute or be a substitute for medical advice and should not be relied upon in any such regard. All uses of the Formulary are subject to clinical judgment and actual prescribing patterns may not follow the information provided in the Formulary.

The format and content of the drug monographs, regimen monographs, appendices and symptom management information contained in the Formulary will change as they are reviewed and revised on a periodic basis. The date of last revision will be visible on each page of the monograph and regimen. Since standards of usage are constantly evolving, it is advised that the Formulary not be used as the sole source of information. It is strongly recommended that original references or product monograph be consulted prior to using a chemotherapy regimen for the first time.

Some Formulary documents, such as the medication information sheets, regimen information sheets and symptom management information (for patients), are intended for patients. Patients should always consult with their healthcare provider if they have questions regarding any information set out in the Formulary documents.

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Info Sheet Name:

lenvatinib (patient)

Info Sheet Introduction:

For treating certain types of thyroid, kidney or liver cancers, and may be used to treat other types of cancer

Info Sheet Date: Monday, March 13, 2023 Info Sheet body:

Medication Information Sheet

lenvatinib (len VA ti nib)

This document provides general information about your medication. It does not replace the advice of your health care professional. Always discuss your therapy with your health care professional and refer to the package insert for more details.

Other Name: Lenvima

Appearance:

capsule

in various strengths, shapes and colours

What is this medication for?

For treating certain types of thyroid, kidney or liver cancers, and may be used to treat other types of cancer

What should I do before I have this medication?

Tell your health care team if you have or had significant medical condition(s), especially if you have or had:
- high blood pressure
- liver, kidney or heart problems (including an irregular heartbeat)
- diabetes or nerve problems,
- headaches, seizures, or vision problems
- any bleeding problems
- a history of blood clots, including stroke
- a history of a tear in your stomach or intestine
- previous radiotherapy or
- any allergies.
Tell your health care team if you have an eating disorder, are following a strict diet, or have conditions that may change salt levels in your blood such as severe vomiting or diarrhea.
Tell your health care team if you have recently had or will have surgery.
Your blood pressure should be well controlled before starting lenvatinib. Your health care team will check your blood pressure regularly when you start treatment.

Remember to:

Tell your health care team about all of the other medications you are taking.
Keep taking other medications that have been prescribed for you, unless you have been told not to by your health care team.

You will have a blood test to check for hepatitis B before starting treatment. See the Hepatitis B and Cancer Medications pamphlet for more information.

How will this medication affect sex, pregnancy and breastfeeding?

Talk to your health care team about:

How this medication may affect your sexual health.
How this medication may affect your ability to have a baby, if this applies to you.

This medication may harm an unborn baby. Tell your health care team if you or your partner are pregnant, become pregnant during treatment, or are breastfeeding.

If there is any chance of pregnancy happening, you and your partner together must use 2 effective forms of birth control at the same time for at least 1 month after your last dose. Talk to your health care team about which birth control options are best for you.
Do not breastfeed while using this medication.
This medication may affect fertility (ability to get pregnant).

How is this medication given?

This medication is usually taken once daily by mouth, with or without food. Talk to your health care team about how and when to take your medication.
Swallow lenvatinib capsules whole with a glass of water. Do NOT open, chew, crush, or split the capsules.
If you have trouble swallowing capsules, talk to your health care team about how to make a lenvatinib mixture in a small glass of water or apple juice without crushing or breaking the capsules.
You may be given this treatment along with other medication(s) to prevent nausea and vomiting. Make sure you take them as directed by your doctor
If you miss a dose of lenvatinib, take it if it is within 12 hours of the missed dose. Do not take lenvatinib if it has been more than 12 hours since you missed your dose. Take your next dose as scheduled. Do not double the dose to make up for the forgotten one.
If you vomit (throw up) after taking your medication, talk to your health care team about what to do.
If you take too much of your medication by accident, or if you think a child or a pet may have swallowed your medication, you must call the Ontario Poison Control Center right away.

What else do I need to know while on this medication?

Will this medication interact with other medications or natural health products?

This medication can interact with other medications, vitamins, foods and natural health products. Interactions can make the treatment not work as well or cause severe side effects.
Tell your health care team about all of your:
- prescription and over-the-counter (non-prescription) medications and all other drugs, such as marijuana (medical or recreational)
- natural health products such as vitamins, herbal teas, homeopathic medicines, and other supplements
Check with your health care team before starting or stopping any of them.

If you take medication(s) to help with your blood pressure, your health care team may monitor your blood pressure and may change your dose.

What should I do if I feel unwell, have pain, a headache or a fever?

Always check your temperature to see if you have a fever before taking any medications for fever or pain (such as acetaminophen (Tylenol) or ibuprofen (Advil)).
- Fever can be a sign of infection that may need treatment right away.
- If you take these medications before you check for fever, they may lower your temperature and you may not know you have an infection.

How to check for fever:

Keep a digital (electronic) thermometer at home and take your temperature if you feel hot or unwell (for example, chills, headache, mild pain).

You have a fever if your temperature taken in your mouth (oral temperature) is:
- 38.3°C (100.9°F) or higher at any time
  
  OR
- 38.0°C (100.4°F) or higher for at least one hour.

If you do have a fever:

Try to contact your health care team. If you are not able to talk to them for advice, you MUST get emergency medical help right away.
Ask your health care team for the Fever pamphlet for more information.

If you do not have a fever but have mild symptoms such as headache or mild pain:

Ask your health care team about the right medication for you. Acetaminophen (Tylenol®) is a safe choice for most people.
Talk to your health care team before you start taking Ibuprofen (Advil®, Motrin®), naproxen (Aleve®) or ASA (Aspirin®), as they may increase your chance of bleeding or interact with your cancer treatment.
Talk to your health care team if you already take low dose aspirin for a medical condition (such as a heart problem). It may still be safe to take.

What to DO while on this medication:

DO check with your health care team before getting any vaccinations, surgery, dental work or other medical procedures. You may need to stop this drug before surgery (lenvatinib might affect how your wounds heal). Only take it again after surgery once you have been told to do so by your health care team.

DO talk to your health care team about your risk of getting other cancers and heart problems after this treatment.

What NOT to DO while on this medication:

DO NOT smoke or drink alcohol while on treatment without talking to your health care team first. Smoking and drinking can make side effects worse and make your treatment not work as well.

How should I safely store this medication?

Do not throw out any unused medications at home. Bring them to your pharmacy to be thrown away safely.
Keep this medication in the original packaging at room temperature in a dry place, away from heat and light. Keep out of sight and reach of children and pets.
How to safely touch oral anti-cancer medications

If you are a patient:
- Wash your hands before and after touching your oral anti-cancer medication.
- Swallow each pill whole. Do not crush or chew your pills.
If you are a caregiver:
- Wear nitrile or latex gloves when touching tablets, capsules or liquids.
- Wash your hands before putting on your gloves and after taking them off, even if your skin did not touch the oral anti-cancer medication.
- Throw out your gloves after each use. Do not re-use gloves.
- Do not touch oral anti-cancer medications if you are pregnant or breastfeeding.
What to do if oral anti-cancer medication gets on your skin or in your eyes

If medication gets on your skin:
- Wash your skin with a lot of soap and water.
- If your skin gets red or irritated, talk to your health care team.
If medication gets in your eyes:
- Rinse your eyes with running water right away. Keep water flowing over your open eyes for at least 15 minutes.

What are the side effects of this medication?

The following table lists side effects that you may have when getting lenvatinib. The table is set up to list the most common side effects first and the least common last.

It is unlikely that you will have all of the side effects listed and you may have some that are not listed. Read over the side effect table so that you know what to look for and when to get help. Keep this paper during your treatment so that you can refer to it if you need to.

Very Common Side Effects (50 or more out of 100 people)
Side effects and what to do	When to contact health care team
Abnormal kidney lab tests (Rarely may be severe) Your health care team may check your kidney function regularly with a blood test What to look for? Signs of a kidney problem include: Swelling Passing very little or no pee New unusual weight gain Nausea (feeling like you need to throw up) and vomiting Loss of appetite Fatigue and weakness Muscle twitching and cramps Itchiness that won't go away What to do? If you have these signs, talk to your health care team or go to your closest emergency department. To prevent bladder or kidney problems, drink lots of water or other liquids. Your doctor may ask you to drink at least 6 to 8 cups (2 L) per day on treatment days, unless you have been told otherwise.	Talk to your health care team if it does not improve or if it is severe
High blood pressure (may be severe) What to look for? There are usually no signs of high blood pressure. Rarely, you may have headaches, shortness of breath or nosebleeds. What to do? Check your blood pressure regularly. Your doctor may prescribe medication to treat high blood pressure. If you have a severe headache get emergency help right away as it may be a sign your blood pressure is too high.	Talk to your health care team if it does not improve or if it is severe
Diarrhea (may be severe) What to look for? Loose, watery, unformed stool (poo) that may happen days to weeks after you get your treatment. What to do? If you have diarrhea: Talk to your health care team about how to stay hydrated. It is important that you do not become dehydrated. Take anti-diarrhea medication if your health care team prescribed it or told you to take it. Do not eat foods or drinks with artificial sweetener (like chewing gum or ‘diet’ drinks), coffee and alcohol. Eat many small meals and snacks instead of 2 or 3 large meals. Drink at least 6 to 8 cups of liquids each day, unless your health care team has told you to drink more or less. Talk to your health care team if you can’t drink 6 to 8 cups of liquids each day when you have diarrhea. You may need to drink special liquids with salt and sugar, called Oral Rehydration Therapy. Talk to your health care team if your diarrhea does not improve after 24 hours of taking diarrhea medication or if you have diarrhea more than 7 times in one day. Ask your health care team for the Diarrhea pamphlet for more information.	Talk to your health care team if no improvement after 24 hours of taking diarrhea medication or if severe (more than 7 times in one day)
Changes in thyroid activity Thyroid changes may happen weeks to months after you receive your treatment. Your health care team may check your thyroid activity regularly with a blood test. What to look for? Underactive thyroid (uncommon): Unusual weight gain A lack of energy or feeling tired Getting cold easily Dry skin, nails or hair that breaks easily Constipation (having bowel movements (poo) less often than normal) What to do? Your health care team may give you prescription medication to treat your underactive thyroid. If you have weight changes along with any of the other symptoms listed, talk to your health care team as soon as possible.	Talk to your health care team as soon as possible.
Low appetite What to look for? Loss of interest in food or not feeling hungry. Weight loss. What to do? Try to eat your favourite foods. Eat small meals throughout the day. You may need to take meal supplements to help keep your weight up. Talk to your health care team if you have no appetite. Ask your health care team for the Loss of Appetite pamphlet for more information.	Talk to your health care team if it does not improve or if it is severe
High blood sugar What to look for? You may feel thirsty. You may pee more often than usual. You may feel tired or sleepy. What to do? Your health care team may do a blood test to check your blood sugar level. You may be told to change your diet or given medication to lower your blood sugar. If you have diabetes, check your blood sugar regularly. Your health care team may ask you to check it more often than usual.	Talk to your health care team as soon as possible
Liver problems (may be severe) Your health care team may check your liver function with a blood test. The liver changes do not usually cause any symptoms. What to look for? Rarely, you may develop yellowish skin or eyes, unusually dark pee or pain on the right side of your belly. This may be severe. What to do? If you have any symptoms of liver problems, get emergency medical help right away.	Get emergency medical help right away

Common Side Effects (25 to 49 out of 100 people)
Side effects and what to do	When to contact health care team
Low amounts of protein (albumin) in your blood This may be caused by protein loss in your pee Your doctor may monitor for protein in your pee regularly What to look for? It can cause muscle weakness, swelling, fatigue, cramps and poor appetite. What to do? Talk to your health care team as soon as possible	Talk to your health care team as soon as possible
Nausea and vomiting What to look for? Nausea is feeling like you need to throw up. You may also feel light-headed. You may feel nausea within hours to days after your treatment. What to do? To help prevent nausea: It is easier to prevent nausea than to treat it once it happens. Take your anti-nausea medication(s) as prescribed, even if you do not feel like throwing up. Drink clear liquids and have small meals. Get fresh air and rest. Do not eat spicy, fried foods or foods with a strong smell. Limit caffeine (like coffee, tea) and avoid alcohol. If you have nausea or vomiting: Take your rescue (as-needed) anti-nausea medication(s) as prescribed. Talk to your health care team about how to stay hydrated. It is important that you do not become dehydrated. Ask your health care team for the Nausea & Vomiting pamphlet for more information. Talk to your health care team if: nausea lasts more than 48 hours vomiting lasts more than 24 hours or if it is severe	Talk to your healthcare team if nausea lasts more than 48 hours or vomiting lasts more than 24 hours or if it is severe
Fatigue What to look for? Feeling of tiredness or low energy that lasts a long time and does not go away with rest or sleep. What to do? Be active. Aim to get 30 minutes of moderate exercise (you are able to talk comfortably while exercising) on most days. Check with your health care team before starting any new exercise. Pace yourself, do not rush. Put off less important activities. Rest when you need to. Ask family or friends to help you with things like housework, shopping, and child or pet care. Eat well and drink at least 6 to 8 glasses of water or other liquids every day (unless your health care team has told you to drink more or less). Avoid driving or using machinery if you are feeling tired. Ask your health care team for the Fatigue pamphlet for more information.	Talk to your health care team if it does not improve or if it is severe
Mouth sores What to look for? Round, painful, white or gray sores inside your mouth that can occur on the tongue, lips, gums, or inside your cheeks. In more severe cases they may make it hard to swallow, eat or brush your teeth. They may last for 3 days or longer. What to do? To help prevent mouth sores: Take care of your mouth by gently brushing and flossing regularly. Rinse your mouth often with a homemade mouthwash. To make a homemade mouthwash, mix 1 teaspoonful of baking soda and 1 teaspoonful of salt in 4 cups (1L) of water. Do not use store-bought mouthwashes, especially those with alcohol, because they may irritate your mouth. If you have mouth sores: Avoid hot, spicy, acidic, hard or crunchy foods. Your doctor may prescribe a special mouthwash to relieve mouth sores and prevent infection. Talk to your health care team as soon as you notice mouth or lip sores or if it hurts to eat, drink or swallow. Ask your health care team for the Oral Care (Mouth Care) pamphlet for more information.	Talk to your health care team as soon as you notice mouth or lip sores or if it hurts to eat, drink or swallow
Too much or too little salt in your body What to look for? Muscle spasms, cramping, weakness, twitching, or convulsions. Irregular heartbeat, confusion or blood pressure changes. What to do? Get emergency medical help right away for severe symptoms.	Get emergency medical help right away for severe symptoms
Headache; mild joint, muscle pain or cramps What to look for? New pain in your muscles or joints, muscle cramps, or feeling achy. What to do? Take pain medication (acetaminophen or opioids such as codeine, morphine, hydromorphone, oxycodone) as prescribed. Read the above section: "What should I do if I feel unwell, have pain, a headache or a fever?" before taking acetaminophen (Tylenol®), ibuprofen (Advil®, Motrin®), naproxen (Aleve®) or Aspirin. These medications may hide an infection that needs treatment or they may increase your risk of bleeding. Rest often and try light exercise (such as walking) as it may help. Ask your health care team for the Pain pamphlet for more information.	Talk to your health care team if it does not improve or if it is severe
Unusual bleeding or bruising (may be severe) It may be due to low platelets (a type of blood cell). When platelets are low, you are at risk for bleeding and bruising. Ask your health care team for the Low Platelet Count pamphlet for more information. What to look for? Watch for signs of bleeding: bleeding from your gums unusual or heavy nosebleeds bruising easily or more than normal black coloured stools (poo) or blood in your stools (poo) coughing up red or brown coloured mucus dizziness, constant headache or changes in your vision heavy vaginal bleeding What to do? If your health care team has told you that you have low platelets: Tell your pharmacist that your platelet count may be low before taking any prescriptions or over-the-counter medication. Check with your healthcare team before you go to the dentist. Take care of your mouth and use a soft toothbrush. Try to prevent cuts and bruises. Ask your health care team what activities are safe for you. Your treatment may have to be delayed if you have low platelets. Your health care team may recommend blood transfusion. If you have signs of bleeding: If you have a small bleed, clean the area with soap and water or a saline (saltwater) rinse. Apply pressure for at least 10 minutes. If you have bleeding that does not stop or is severe (very heavy), you must get emergency medical help right away.	Talk to your health care team if you have any signs of bleeding. If you have bleeding that doesn’t stop or is severe, you MUST get emergency medical help right away
Proteins in Urine (may be severe) Your health care team may do urine tests to check for proteins in your pee. What to look for? Swelling in your face, legs, or belly. Recent weight gain that is not normal for you. Foamy, frothy, or bubbly-looking pee. What to do? Talk to your health care team if it does not improve or if it is severe.	Talk to your health care team if it does not improve or if it is severe
Rash on your hands and feet (hand-foot syndrome) What to look for? Tingling or swelling of the skin on the palms of your hands and the bottoms of your feet. This can become painful, red and numb. In worse cases your skin may start to peel and you can get blisters or sores. This may happen days or weeks after you start treatment. What to do? To help prevent Hand-foot syndrome: Do not do activities that cause rubbing or pressure on your skin, like heavy-duty washing, gripping tools, typing, playing musical instruments, and driving. Moisturize your hands and feet often, especially in the skin folds. Wear loose, comfortable footwear and clothes. Rest and try to keep off your feet. Do not let your hands and feet get too hot. Ask your health care team for the Hand-foot syndrome pamphlet for more information.	Talk to your health care team if it does not improve or if it is severe
Pains or cramps in the belly What to look for? Pain or cramps in your belly. Constipation and diarrhea can cause pain in your belly. What to do? If the pain is severe, gets worse or doesn’t go away, talk to your health care team about other possible causes.	Talk to your health care team if it does not improve or if it is severe
Hoarseness (raspy voice) What to look for? Your voice may become hoarse or raspy. What to do? Talk to your health care team if it does not improve or if it is severe.	Talk to your health care team if it does not improve or if it is severe
Constipation What to look for? Having bowel movements (going poo) less often than normal. Small hard stools (poo) that look like pellets. The need to push hard and strain to have any stool (poo) come out. Stomach ache or cramps. A bloated belly, feeling of fullness, or discomfort. Leaking of watery stools (poo). Lots of gas or burping. Nausea or vomiting. What to do? To help prevent constipation: Try to eat more fiber rich foods like fruits with skin, leafy greens and whole grains. Drink at least 6 to 8 cups of liquids each day unless your health care team has told you to drink more or less. Be Active. Exercise can help to keep you regular. If you take opioid pain medication, ask your health care team if eating more fibre is right for you. To help treat constipation: If you have not had a bowel movement in 2 to 3 days you may need to take a laxative (medication to help you poo) to help you have regular bowel movements. Ask your health care team what to do. Ask your health care team for the Constipation Pamphlet for more information.	Talk to your health care team if it does not improve or if it is severe

Less Common Side Effects (10 to 24 out of 100 people)
Side effects and what to do	When to contact health care team
Cough and feeling short of breath (may rarely be severe) What to look for? You may have a cough and feel short of breath. Symptoms that commonly occur with a cough are: Wheezing or a whistling breathing Runny nose Sore throat Heartburn Weight loss Fever and chills Rarely this may be severe with chest pain, trouble breathing or coughing up blood. What to do? Check your temperature to see if you have a fever. Read the above section "What should I do if I feel unwell, have pain, a headache or a fever?". If you have a fever, try to talk to your health care team. If you are not able to talk to them for advice, you MUST get emergency medical help right away. If you have a severe cough with chest pain, trouble breathing or you are coughing up blood, get medical help right away.	Talk to your health care team. If you are not able to talk to your health care team for advice, and you have a fever or severe symptoms, you MUST get emergency medical help right away
Mild swelling What to look for? You may have mild swelling or puffiness in your arms and/or legs. Rarely, this may be severe. What to do? To help prevent swelling: Eat a low-salt diet. If you have swelling: Wear loose-fitting clothing. For swollen legs or feet, keep your feet up when sitting.	Talk to your health care team if it does not improve or if it is severe
Low blood sugar What to look for? You may feel hungry, shaky, dizzy, nervous, weak or confused. You may have pale skin or sweat What to do? Check your blood sugar if you experience these symptoms and have diabetes. To treat low blood sugar, take 3 to 4 glucose tablets, 1 tablespoon of sugar or honey or 3/4 cup of juice or regular soft drink. If you feel confused or pass out, your caregiver will need to get emergency medical help for you right away.	Talk to your health care team if it does not improve or if it is severe
Rash; dry, itchy skin What to look for? You may have cracked, rough, flaking or peeling areas of the skin. Your skin may look red and feel warm, like a sunburn. Your skin may itch, burn, sting or feel very tender when touched. What to do? To prevent and treat dry skin: Use fragrance-free skin moisturizer. Protect your skin from the sun and the cold. Use sunscreen with UVA and UVB protection and a SPF of at least 30. Avoid perfumed products and lotions that contain alcohol. Drink 6 to 8 cups of non-alcoholic, non-caffeinated liquids each day, unless your health care team has told you to drink more or less. Rash may be severe in some rare cases and cause your skin to blister or peel. If this happens, get emergency medical help right away.	Talk to your health care team if it does not improve or if it is severe
Taste changes What to look for? Food and drinks may taste different than usual. What to do? Eat foods that are easy to chew, such as scrambled eggs, pasta, soups, cooked vegetables. Taste foods at different temperatures, since the flavour may change. Try different forms of foods, like fresh, frozen or canned. Experiment with non-spicy foods, spices and seasonings.	Talk to your health care team if it does not improve or if it is severe
Dry mouth What to look for? You may have a dry or sticky feeling in your mouth or throat, Your saliva may be thick and stringy. You may have cracks in your lips or at the corners of your mouth You may have difficulty chewing, tasting, swallowing or talking What to do? Use sugar-free gum or lozenges (e.g. those that contain xylitol) to help keep your mouth moist. Suck on ice chips or sugarless popsicles to help relieve dry mouth. Rinse your mouth often (every 1 to 2 hours) with a homemade mouthwash. To make a homemade mouthwash, mix 1 teaspoon of baking soda and 1 teaspoon of salt in 4 cups (1L) of water Do not use store-bought mouthwashes, especially those with alcohol because they may irritate dry your mouth Spray your mouth with water or artificial saliva products (e.g., Moi-Stir Spray®, Biotene® products) as needed to keep it moist. Apply mouth lubricant (like Biotene Oral balance gel®) after you brush your teeth, at bedtime, and as needed. Use a steam vaporizer at night to relieve nighttime dry mouth Speak to your health care team about the right product for you. See our Mouth Care pamphlet for more information. Talk to your health care team if your dry mouth does not improve or if it is severe.	Talk to your health care team if it does not improve or if it is severe
Higher than normal cholesterol or fat levels in the blood What to look for? High cholesterol or fat levels usually do not cause any symptoms. Since your treatment may cause high cholesterol, your health care team may do regular blood tests to check your cholesterol levels. What to do? Your health care team may give you medication to treat high cholesterol or fat levels. If you already take medication for high cholesterol or fat levels, your health care team may change the amount or type of medication you take.	Talk to your health care team if it does not improve or if it is severe
Dizziness What to look for? You may feel light-headed and like you might faint (pass out). What to do? Lay down right away so you do not fall. Slowly get up and start moving once you feel better. Do not drive a motor vehicle or use machinery if you feel dizzy.	Talk to your health care team if it does not improve or if it is severe
Low neutrophils (white blood cells) in the blood (neutropenia) When neutrophils are low, you are at risk of getting an infection more easily. Ask your health care team for the Neutropenia (Low white blood cell count) pamphlet for more information. What to look for? If you feel hot or unwell (for example if you have chills or a new cough), you must check your temperature to see if you have a fever. Do not take medications that treat a fever before you take your temperature (for example, Tylenol®, acetaminophen, Advil® or ibuprofen). Do not eat or drink anything hot or cold right before taking your temperature. You have a fever if your temperature taken in your mouth (oral temperature) is: 38.3°C (100.9°F) or higher at any time OR 38.0°C (100.4°F) or higher for at least one hour. What to do? If your health care team has told you that you have low neutrophils: Wash your hands often to prevent infection. Check with your health care team before getting any vaccines, surgeries, medical procedures or visiting your dentist. Keep a digital thermometer at home so you can easily check for a fever. If you have a fever: If you have a fever, try to contact your health care team. If you are unable to talk to the team for advice, you must get emergency medical help right away.	If you have a fever, try to contact your health care team. If you are unable to talk to the team for advice, you MUST get emergency medical help right away.
Heartburn; stomach upset; bloating What to look for? Pain or burning in the middle or top part of your chest. It may get worse when you are lying down or bending over or when you swallow. A bitter or acidic taste in your mouth. What to do? Drink clear liquids and eat small meals. Do not eat acidic, fatty or spicy foods. Limit caffeine (like coffee, tea) and avoid alcohol. Avoid smoking or being around tobacco. Sit up or stand after eating. Do not lie down. Raise the head of your bed six to eight inches. You may need to use extra pillows to do this.	Talk to your health care team if it does not improve or if it is severe
Higher than normal levels of pancreas enzymes in your blood (lipase, amylase) What to look for? These changes usually do not cause any symptoms. In some cases, you may feel pain in the centre of your belly that may spread to your back. What to do? Your health care team may do blood tests to watch your levels of enzymes in the pancreas. If you have any symptoms, get emergency medical help right away.	Talk to your health care team if it does not improve or if it is severe
Hair thinning or loss What to look for? Your hair may begin to become thin or fall out during or after treatment. In most cases, your hair will grow back after treatment, but the texture or colour may change. In very rare cases, hair loss may be permanent. What to do? Use a gentle soft brush. Do not use hair sprays, bleaches, dyes and perms.	Talk to your health care team if this bothers you
Trouble Sleeping Your medications may cause trouble sleeping. It may get better once your body gets used to the medication or when your treatment ends. What to look for? You may find it hard to fall asleep or stay asleep. How well you sleep may change over your treatment. For example, you may have several nights of poor sleep followed by a night of better sleep. You may wake up too early or not feel well-rested after a night's sleep. You may feel tired or sleepy during the day. What to do? Talk to your health care team if it does not improve or if it is severe	Talk to your health care team if it does not improve or if it is severe
Heart problems What to look for? You may have an irregular heartbeat, shortness of breath, chest pain or fainting spells. Swelling in your legs, ankles and belly. Sharp pain in the centre or left side of the chest (often worsens when taking a deep breath). Extreme tiredness that prevents you from exercising or doing normal activities. What to do? Get emergency medical help right away.	Get emergency medical help right away

Other rare, but serious side effects are possible.
If you experience ANY of the following, speak to your cancer health care provider or get emergency medical help right away:

Sudden severe pain in the neck, face, back or belly. Unusual pulsating feeling in your chest or belly
Sudden weakness on one side of your body
Bloating or feeling of fullness in the belly and severe constipation
Pain, swelling or hardening of a vein in your arm or leg
Feeling confused, severe headache, problems with your vision, trouble speaking, swallowing or using your arms or legs
Severe or unusual bone pain especially in your back, hips and wrist
Severe muscle pain or weakness with dark pee
Signs of an allergy such as fever, itchiness, rash, swollen lips, face or tongue, chest and throat tightness
Wounds that do not heal well or take too long to heal

Who do I contact if I have questions or need help?

My cancer health care provider is: ______________________________________________

During the day I should contact:________________________________________________

Evenings, weekends and holidays:______________________________________________

Other Notes:

____________________________________________________________________________

March 2023 Modified "What should I do before I have this medication" section

For more links on how to manage your symptoms go to www.cancercareontario.ca/symptoms.

The information set out in the medication information sheets, regimen information sheets, and symptom management information (for patients) contained in the Drug Formulary (the "Formulary") is intended to be used by health professionals and patients for informational purposes only. The information is not intended to cover all possible uses, directions, precautions, drug interactions or side effects of a certain drug, nor should it be used to indicate that use of a particular drug is safe, appropriate or effective for a given condition.

A patient should always consult a healthcare provider if he/she has any questions regarding the information set out in the Formulary. The information in the Formulary is not intended to act as or replace medical advice and should not be relied upon in any such regard. All uses of the Formulary are subject to clinical judgment and actual prescribing patterns may not follow the information provided in the Formulary.

Info Sheet (English):

lenvatinib patient.pdf Info Sheet (French):

lenvatinib pour le patient.pdf Monograph:

lenvatinib.pdf Funding Program: Exceptional Access Program Funding Instance:

lenvatinib - For the treatment of patients with locally recurrent or metastatic, progressive, radioactive-iodine-refractory differentiated thyroid cancer (DTC) according to criteria
lenvatinib - For the treatment of unresectable advanced hepatocellular carcinoma according to clinical criteria
lenvatinib - In Combination with Pembrolizumab for First-Line Advanced or Metastatic Renal Cell Carcinoma
lenvatinib - In Combination with Pembrolizumab for Advanced Endometrial Cancer

Phonetic Spelling:

len VA ti nib

Cancer Type: Endocrine Thyroid Gastrointestinal Hepatobiliary / Liver / Bile Duct Genitourinary Renal cell / Kidney Gynecologic Endometrial Type of Content: Drug Monograph Status: Null Info Sheet Status: Null Global Date: Monday, September 18, 2023 Universal Date: 2023-09-18 00:00:00 AddThis: Title URL: lenvatinib Drug Display Status: Active Revision Summary:
Drug Monograph: Updated elimination section