1 What is this medicine
and what is it used for?
Sorafenib is a multikinase inhibitor — an oral targeted
cancer medicine that blocks several tyrosine and serine/threonine kinase
enzymes involved in tumour cell proliferation and tumour angiogenesis (blood
vessel growth). The key kinases blocked include VEGFR-1, -2, -3, PDGFR-beta,
RAF kinases (CRAF, BRAF), KIT, FLT-3, and RET.
It is used to treat adults with:
• Hepatocellular carcinoma (HCC) —
unresectable primary liver cancer (first-line treatment).
• Advanced renal cell carcinoma (RCC) —
after failure of interferon-alfa or interleukin-2 based therapy.
• Differentiated thyroid carcinoma
(DTC) — locally advanced or metastatic, progressive, radioactive
iodine-refractory.
2 How to take this
medicine
The standard dose is 400 mg (two 200 mg tablets) taken twice
daily — morning and evening — on an empty stomach or with a low-fat meal. Do
not take with a high-fat meal as this reduces absorption by up to 29%. Swallow
tablets whole with water. Take at the same times each day.
|
Take 1 hour before or
2 hours after eating for best absorption. A plain, low-fat breakfast is
acceptable if needed. Avoid grapefruit and
grapefruit juice — they can increase sorafenib blood levels and worsen side
effects. Note your dose clearly
— 2 tablets in the morning AND 2 tablets in the evening = 800 mg total daily
dose. |
3 Possible side effects
|
Frequency |
Side Effect |
What to Do |
|
Very Common (>10%) |
Hand-foot skin
reaction (HFSR / palmar-plantar erythrodysaesthesia) |
Apply thick emollient
cream preventively from day 1. Cushioned footwear. Report to care team early
for dose adjustment. |
|
Very Common (>10%) |
Diarrhoea |
Hydrate well; use
loperamide as directed; contact team if severe (>4 stools/day above
baseline). |
|
Very Common (>10%) |
Fatigue |
Balance rest and
activity; tell team if debilitating. |
|
Very Common (>10%) |
Hypertension |
Blood pressure
monitored weekly for first 6 weeks; take prescribed antihypertensives; report
headache/visual changes. |
|
Very Common (>10%) |
Alopecia (hair loss) |
Usually reversible
after stopping. Discuss with nurse specialist. |
|
Very Common (>10%) |
Rash / skin changes |
Moisturise regularly;
avoid sun exposure; report severe rashes. |
|
Common (1–10%) |
Elevated liver enzymes |
Regular LFT
monitoring; report jaundice or dark urine. |
|
Common (1–10%) |
Haemorrhage (bleeding) |
Report any unusual
bleeding immediately. |
|
Seek help urgently |
Chest pain, shortness
of breath — possible cardiac ischaemia |
Stop sorafenib and
seek emergency medical attention. |
|
Seek help urgently |
Severe HFSR: deep
painful blisters, inability to walk |
Contact oncology team
immediately for dose interruption. |
4 Who should not take
this medicine
|
Do NOT use Sorafenib if: You are pregnant or breastfeeding —
teratogenic; effective contraception required during treatment and for 6
months after. You are taking carboplatin/paclitaxel
combination for squamous cell lung cancer — increased toxicity with no added
benefit. You have known hypersensitivity to sorafenib or
excipients. Use with extreme caution in severe hepatic
impairment (Child-Pugh C). |
Use with caution in: uncontrolled hypertension; history of
cardiac ischaemia or infarction; QT prolongation; congenital long QT syndrome;
or if taking other QT-prolonging drugs.
5 Medicines that interact
with this treatment
• Strong CYP3A4 inducers (rifampicin,
phenytoin, St John's Wort): reduce sorafenib levels significantly — avoid.
• Warfarin / anticoagulants: increased
INR and bleeding risk — monitor closely.
• Docetaxel: sorafenib increases
docetaxel exposure — use with caution.
• QT-prolonging agents: additive QT
risk — avoid or monitor ECG.
• UGT1A1/1A9 substrates (irinotecan):
sorafenib inhibits these pathways — monitor.
6 How to store this
medicine
Store below 25°C. Keep in original packaging away from
moisture. Keep out of reach of children. Do not use after the expiry date.
7 Prescription
requirement
|
PRESCRIPTION ONLY
MEDICINE (POM) — Initiated and managed by a specialist oncologist. Monitoring: BP weekly
for 6 weeks then regularly; LFTs, renal function, lipase, blood counts at
baseline and throughout treatment. |
8 Guidance for patients
& caregivers
Hand-foot skin reaction is the most common reason for dose
reductions and treatment interruptions. Prevention is far easier than
treatment: apply urea-based thick emollient cream to hands and feet from the
first day of treatment. Wear well-cushioned, comfortable footwear. Avoid
pressure on hands (gardening gloves for activities; padded insoles in shoes).
Women of childbearing potential must use effective
non-hormonal contraception during treatment and for at least 6 months after the
last dose. Male patients should also use contraception and avoid fathering a
child during treatment and for 3 months after.
Blood pressure rises in approximately 20–30% of patients —
home blood pressure monitoring is recommended. Keep a log and bring it to each
appointment.
9 Pharmacist &
prescriber notes
Sorafenib 200 mg tablets: standard dose is 400 mg (2 tablets)
twice daily = 800 mg/day. Dose reductions follow a stepwise schedule: 400 mg
twice daily → 400 mg once daily → 400 mg every other day for toxicity
management. In HCC, sorafenib remains a standard option in Child-Pugh A/B
patients.
In advanced HCC, newer agents (atezolizumab/bevacizumab,
lenvatinib) are now preferred first-line in many guidelines — confirm
indication with current NCCN/ESMO protocols. HFSR management: Grade 1 —
continue; Grade 2 — dose reduce/interrupt; Grade 3 — interrupt until resolved
to Grade 1, then reduce dose. QTc monitoring recommended at baseline and
periodically. Sorafenib inhibits UGT1A1 and UGT1A9 — monitor co-administered
drugs metabolised via these pathways.
10 Frequently asked
questions
Why must I take sorafenib on an empty stomach?
Food — particularly high-fat meals —
reduces sorafenib absorption significantly. Taking it at least 1 hour before or
2 hours after eating ensures your body absorbs the full dose.
My hands and feet are getting very sore and red — what
should I do?
This is hand-foot skin reaction — the
most common sorafenib side effect. Apply thick emollient cream (urea cream)
frequently, wear cushioned footwear, and contact your oncology team immediately
— a dose reduction or brief break in treatment may be needed.
Can I take herbal remedies or St John's Wort?
No — St John's Wort significantly
reduces sorafenib levels in the blood, potentially making your cancer treatment
ineffective. Avoid all herbal remedies unless specifically approved by your
oncologist.
What do I do if I miss a dose?
Take the missed dose as soon as you
remember the same day. If it is already the time of your next dose, skip the
missed dose. Do not double up.