WHAT IS THIS MEDICINE AND WHAT IS IT USED FOR?
Regonix contains regorafenib, a targeted cancer medicine that blocks a
large number of proteins (receptor tyrosine kinases) involved in tumour blood
vessel formation, tumour growth, and the tumour's local environment.
By attacking these multiple targets simultaneously, regorafenib inhibits
tumour growth and cuts off the blood supply tumours need to survive.
It is used in adults for: metastatic colorectal cancer (bowel cancer that
has spread) — after failure of standard chemotherapy and targeted therapies;
gastrointestinal stromal tumours (GIST) — a type of bowel tumour — that have
progressed on imatinib and sunitinib; and hepatocellular carcinoma (liver
cancer) — as second-line treatment after sorafenib.
3. HOW TO TAKE THIS MEDICINE
The standard dose is 160mg (four 40mg tablets) once daily for the first
21 days of each 28-day cycle — 3 weeks on, then 1 week off. Take all four
tablets together, once daily, with a low-fat breakfast (less than 30% fat
content — such as toast with jam, or cereal with skimmed milk). Do not take on
an empty stomach or with a high-fat meal — food affects absorption
significantly. Swallow tablets whole — do not crush or chew. Take at the same
time each day.
Regorafenib must be taken with a low-fat breakfast — not fasting, but
specifically with a low-fat meal. A high-fat meal increases exposure by up to
50%, while fasting reduces it. The low-fat breakfast requirement is not
optional. A typical suitable breakfast: two slices of white toast with jam and
a glass of juice — avoiding butter, eggs, cheese, or fried foods.
⚠ PATIENT TIP: Hand-foot skin reaction
(palmar-plantar erythrodysaesthesia) is one of the most common and potentially
debilitating side effects — redness, tenderness, thickening, and blistering of
the palms and soles. Start preventative measures from day 1: moisturise palms
and soles with a thick cream (urea-based preferred) twice daily before any
symptoms appear. Wear well-cushioned, comfortable footwear. Avoid activities
that create friction or pressure on the hands and feet.
4. POSSIBLE SIDE EFFECTS
|
How Common? |
Side Effects |
|
Very Common |
Hand-foot skin
reaction (palmar-plantar erythrodysaesthesia — redness, blistering, pain of
palms and soles), fatigue, diarrhoea, reduced appetite, high blood pressure
(hypertension), raised liver enzymes, nausea, hoarseness of voice, pain,
weight loss, infection |
|
Common |
Mucositis (mouth
sores), skin rash, hair colour changes, hypothyroidism (underactive thyroid),
raised lipase (risk of pancreatitis), fever, thrombocytopenia |
|
Serious — Tell Your
Doctor Promptly |
Severe liver toxicity
(hepatotoxicity): jaundice, dark urine, severe right upper abdominal pain —
can be fatal; requires urgent LFT review and possible drug discontinuation.
Gastrointestinal perforation or fistula: sudden severe abdominal pain —
medical emergency. Severe hypertensive crisis: seek emergency care. Serious
bleeding events. Skin infections complicating hand-foot reaction
(cellulitis). Posterior reversible encephalopathy syndrome (PRES): headache,
visual disturbance, seizures, confusion — rare but serious. |
5. WHO SHOULD NOT TAKE THIS MEDICINE
Regorafenib must not be used during pregnancy — highly teratogenic.
Effective contraception is essential during treatment and for at least 2 months
after the last dose. It should not be used in patients with severe liver
impairment (Child-Pugh C). Use with great caution in patients with high blood
pressure, a history of bleeding, or recent major surgery.
⚠ LIVER TOXICITY IS THE PRIMARY SAFETY CONCERN:
Regorafenib causes significant liver toxicity in a proportion of patients —
including fatal cases. LFT monitoring is essential before each cycle. Report
jaundice, dark urine, or severe abdominal pain to your oncologist immediately —
do not wait until your next appointment.
⚠ BLOOD PRESSURE MUST BE MONITORED DAILY:
Hypertension develops in many patients. Monitor blood pressure at home every
day and keep a log. Contact your oncology team if BP consistently exceeds
150/100 mmHg — antihypertensive treatment will likely be needed.
⚠ HAND-FOOT SKIN REACTION — START PREVENTION
EARLY: Begin thick moisturising cream on palms and soles from day 1 of
treatment, before any symptoms appear. Protective insoles and soft footwear
from the start. Report Grade 2 or 3 reactions (blistering, inability to walk or
use hands) to your oncologist — dose reduction may be required.
6. MEDICINES THAT INTERACT WITH THIS TREATMENT
Strong CYP3A4 inhibitors (ketoconazole, itraconazole, clarithromycin,
ritonavir, grapefruit juice) significantly increase regorafenib exposure —
avoid.
Strong CYP3A4 inducers (rifampicin, phenytoin, carbamazepine, St. John's
Wort) significantly reduce regorafenib levels — avoid. Regorafenib inhibits
UGT1A1 (an enzyme that processes bilirubin and some drugs) — it can raise
bilirubin levels and interfere with metabolism of drugs such as irinotecan and
rosuvastatin.
Warfarin: closely monitor INR — regorafenib can affect warfarin
metabolism.
7. HOW TO STORE THIS MEDICINE
Store below 30°C. Keep in original blister pack. Do not store in damp
places (e.g. bathroom cabinet). Use within 7 weeks of opening the blister. Keep
out of reach of children.
8. PRESCRIPTION REQUIREMENT
|
Field |
Details |
|
Status |
Prescription Only
Medicine (POM) — Specialist (oncology) prescription required |
9. GUIDANCE FOR PATIENTS & CAREGIVERS
Take four 40mg tablets once daily with a low-fat breakfast — not fasting,
and not with a high-fat or fried meal. Stick to simple, low-fat foods (toast,
cereal, fruit) with each daily dose. Monitor your blood pressure every day and
keep a log.
Start thick moisturiser on your palms and soles from day 1 — before any
skin symptoms appear. Attend all liver blood test appointments without fail.
Report yellow skin or eyes, dark urine, or severe tummy pain immediately. Avoid
grapefruit and grapefruit juice. Use effective contraception throughout
treatment and for 2 months after your last dose.
10. PHARMACIST & PRESCRIBER NOTES
|
Field |
Details |
|
Clinical Dispensing
Notes |
Low-fat breakfast
administration is mandatory — not fasting, not high-fat. Specifically low-fat
(<30% fat content). LFT monitoring: before each cycle and as clinically
indicated — hepatotoxicity can be fatal; Grade 3+ ALT/AST requires dose
interruption. BP monitoring: daily home monitoring; antihypertensive
treatment initiated promptly if BP >150/100 mmHg. Hand-foot skin reaction
(HFSR) prevention: proactive counselling from day 1 — urea-based emollient to
palms and soles, pressure-relieving footwear. Grade 2 HFSR requires dose
interruption; Grade 3 requires dose reduction. CYP3A4 inhibitor/inducer
screening — grapefruit avoidance. UGT1A1 inhibitor: bilirubin elevation
expected (may be pharmacological, not hepatotoxic — interpret in context of
ALT/AST). Warfarin INR monitoring. 3-weeks-on, 1-week-off cycle — counsel
clearly. Blister: use within 7 weeks of opening. Embryo-fetal toxicity:
contraception during and 2 months post-treatment. |
11. FREQUENTLY ASKED QUESTIONS
Q: What is hand-foot skin reaction and how do I prevent it?
Hand-foot skin reaction (also called palmar-plantar erythrodysaesthesia)
is a common side effect where the palms and soles become red, sore, tender,
thickened, or blistered. The key is prevention: start applying a thick,
urea-based moisturiser to your palms and soles twice daily from day 1 — before
any symptoms appear. Wear well-cushioned, comfortable footwear with soft
insoles and avoid activities that create friction or pressure on your hands and
feet.
Q: Why are liver blood tests so important?
Regorafenib can cause significant and occasionally fatal liver toxicity.
Regular liver function tests before each cycle allow your oncologist to detect
problems early and adjust your dose if needed. Never skip these blood tests,
and report any yellow colouring of your skin or eyes, dark urine, or persistent
severe upper tummy pain immediately.
Q: How often do I take the medicine?
Regorafenib is taken in cycles of 3 weeks on, 1 week off. During the
3-week 'on' period, take four 40mg tablets once daily with a low-fat breakfast,
at the same time each day. During the 1-week 'off' period, do not take any
regorafenib — this break helps the body recover.
Q: What should I do if I get severe tummy pain suddenly?
Seek emergency medical help immediately. Regorafenib carries a risk of
bowel perforation — a hole forming in the intestinal wall — which is a
life-threatening emergency. Sudden severe abdominal pain needs a same-day
emergency assessment.