1 What is this medicine
and what is it used for?
Lenvatinib is an oral multikinase inhibitor that selectively
blocks VEGFR1–3, FGFR1–4, PDGFRα, KIT, and RET receptor tyrosine kinases —
cutting off tumour angiogenesis (blood supply) and directly inhibiting tumour
cell proliferation.
Lenvanix is used to treat adults with:
• Differentiated thyroid cancer (DTC) —
progressive, locally advanced or metastatic, radioactive iodine
(RAI)-refractory disease. Dose: 24 mg once daily (two 10 mg + one 4 mg
capsule).
• Renal cell carcinoma (RCC) — in
combination with everolimus (second line, after one prior anti-angiogenic
therapy). Dose: 18 mg lenvatinib + 5 mg everolimus daily.
• Hepatocellular carcinoma (HCC) —
first-line, unresectable HCC (body weight ≥ 60 kg: 12 mg/day; < 60 kg: 8
mg/day).
• Endometrial carcinoma — in
combination with pembrolizumab, after prior systemic therapy, in patients who
are not candidates for curative surgery or radiation. Dose: 20 mg/day.
2 How to take this
medicine
Take once daily at the same time each day, with or without
food. Swallow whole with water. The two capsule strengths (4 mg and 10 mg) are
combined to achieve the prescribed total dose (e.g. 24 mg = two 10 mg + one 4
mg). Do not crush or chew.
|
Note which capsule sizes and how many of each
you need for your daily dose — your pharmacist will explain this at
dispensing. Both packs (4 mg and 10 mg) are usually
dispensed together to make up your prescribed daily dose. Take at the same time every day — missing doses
can reduce effectiveness. |
3 Possible side effects
|
Frequency |
Side Effect |
What to Do |
|
Very Common (>10%) |
Hypertension |
Monitor BP weekly
initially; antihypertensive therapy as needed; dose hold/reduce if
uncontrolled. |
|
Very Common (>10%) |
Diarrhoea |
Loperamide at first
sign; hydration; contact team if severe. |
|
Very Common (>10%) |
Fatigue |
Rest; assess for
anaemia or hypothyroidism. |
|
Very Common (>10%) |
Decreased appetite/weight loss |
Small frequent meals;
dietitian referral. |
|
Very Common (>10%) |
Nausea/vomiting |
Anti-emetics; take
with food if helpful. |
|
Very Common (>10%) |
Hand-foot syndrome |
Preventive emollient
cream; cushioned footwear; report early. |
|
Very Common (>10%) |
Hypothyroidism |
TSH monitored —
thyroid replacement initiated if TSH rises. |
|
Common (1–10%) |
Proteinuria |
Urine protein:
creatinine ratio or dipstick before each cycle. Dose hold if ≥ 2 g/24h. |
|
Common (1–10%) |
Haemorrhage/fistula |
Report any unusual
bleeding or abnormal connections between organs. |
|
Seek help urgently |
Hypertensive crisis
(severe headache, visual disturbance, SBP > 180) |
Emergency
antihypertensive therapy. |
|
Seek help urgently |
Arterial
thromboembolism (MI, stroke, TIA) |
Emergency medical
care. |
|
KEY SAFETY ALERTS: HYPERTENSION: Must be adequately controlled
before starting lenvatinib and monitored throughout. Persistent or severe
hypertension requires dose reduction or interruption. CARDIAC / ARTERIAL EVENTS: Discontinue
permanently if arterial thromboembolism (MI, stroke) occurs. HEPATOTOXICITY: Monitor LFTs — dose adjustment
for severe hepatic impairment. RENAL IMPAIRMENT: Dose adjustment required for
severe renal impairment (CrCl < 30 mL/min): reduce to 14 mg/day (DTC), 10
mg/day (RCC), 8 mg/day (HCC/EC). |
||
4 Contraindications
Lenvatinib should not be used in: pregnancy (teratogenic —
effective contraception required during treatment and for at least 1 month
after); breastfeeding; known hypersensitivity.
Use with caution in: hypertension; cardiac disease; hepatic
or renal impairment; risk factors for arterial thromboembolism; wound healing
issues (hold for ≥ 6 days before major surgery, restart ≥ 2 weeks after).
5 Drug interactions
• Strong CYP3A4 inhibitors: minimal
effect on lenvatinib (not primarily CYP3A4-metabolised); however, monitor for
increased exposure.
• QT-prolonging agents: lenvatinib
itself can prolong QT — additive risk with other QT-prolonging drugs.
• Warfarin / anticoagulants: bleeding
risk — monitor INR.
6 Storage
Store below 25°C. Original packaging. Keep out of reach of
children.
7 Prescription
requirement
|
PRESCRIPTION ONLY MEDICINE (POM) — Specialist
oncology/endocrinology/urology prescription. Monitoring: BP daily for first 2 weeks, then
regularly; urine protein before each cycle; LFTs and renal function; TSH
(DTC/HCC); ECG in QT risk patients. |
8 Guidance for patients
& caregivers
The two different capsule strengths (4 mg and 10 mg) are
combined to reach your total daily dose. Make sure you understand exactly how
many of each capsule to take daily before leaving the pharmacy — write it down.
For example, for a 24 mg dose you would take two 10 mg capsules and one 4 mg
capsule every day.
Blood pressure control is critical with lenvatinib —
hypertension is very common and can be dangerous if untreated. Home blood
pressure monitoring is strongly encouraged. Keep a log of readings and bring it
to every appointment.
Women of childbearing potential must use highly effective
contraception during treatment and for at least 1 month after the last dose.
Male patients with female partners of childbearing potential should also use
contraception.
9 Pharmacist &
prescriber notes
Lenvatinib is available as 4 mg and 10 mg capsules — doses
are constructed from combinations. Common total daily doses: 24 mg (DTC) = 2×10
+ 1×4; 20 mg (EC) = 2×10; 18 mg (RCC) = 1×10 + 2×4; 12 mg (HCC ≥60 kg) = 1×10 +
½×4 — but capsules should not be broken; use 1×10 + 2×1 (not available) —
confirm dose construction with oncologist.
In practice, dispensing is often 4 mg and 10 mg packs
together. TSH monitoring is essential especially in DTC patients —
RAI-refractory thyroid cancer patients may already be on levothyroxine
suppression; lenvatinib worsens hypothyroidism. Dose hold/reduction schedule:
4-step reduction from 24 mg → 20 mg → 14 mg → 10 mg → discontinue.
10 Frequently asked
questions
Can lenvatinib affect my thyroid?
Yes, in all patients, and particularly in thyroid cancer
patients. Lenvatinib commonly causes or worsens hypothyroidism. TSH will be
monitored regularly, and thyroid hormone replacement will be prescribed if needed.
What is proteinuria and why does my doctor check my urine?
Proteinuria means protein leaking into the urine — a sign
that the kidneys may be under stress from the medicine. A urine test before
each treatment cycle detects any significant kidney involvement early. If
protein levels are high, a dose pause may be needed.
Can I have surgery while taking lenvatinib?
Lenvatinib impairs wound healing. It should be stopped at
least 6 days before any major surgery and only restarted after the wound is
fully healed (at least 2 weeks post-surgery). Always inform your surgeon that
you are on this medicine.
Will I lose my hair?
Alopecia occurs in some patients but is less common than with
traditional chemotherapy. Thinning or changes in hair texture are more typical.
Your oncology nurse can discuss scalp care and options.
What happens if I miss a dose?
If you remember on the same day, take it as soon as possible.
If it is the next day, skip the missed dose and continue your regular schedule.
Never take a double dose.