WHAT IS THIS MEDICINE AND WHAT IS IT USED FOR?
Nilonix contains nilotinib, a targeted cancer medicine designed to treat
chronic myeloid leukaemia (CML) — a cancer of the white blood cells caused by a
specific genetic abnormality called the Philadelphia chromosome. This
chromosome creates a faulty fused gene called BCR-ABL, which produces an
overactive protein that tells blood cells to grow out of control.
Nilotinib is a second-generation BCR-ABL tyrosine kinase inhibitor —
meaning it was designed to work even better than the first-generation medicine
imatinib and to work in cases where imatinib has stopped being effective.
It is used in adults and children (over 2 years of age) for: newly
diagnosed chronic phase CML; chronic phase or accelerated phase CML that has
become resistant to or cannot be tolerated on previous treatment (including
imatinib).
3. HOW TO TAKE THIS MEDICINE
The usual adult dose is 300mg twice daily for newly diagnosed CML, or
400mg twice daily for resistant or intolerant CML. Doses are taken
approximately 12 hours apart — for example, once in the morning and once in the
evening.
Capsules must be taken on an empty stomach — at least 2 hours after
eating and at least 1 hour before the next meal. Food dramatically increases
the absorption of nilotinib and raises blood levels to potentially dangerous
heights. Swallow capsules whole with water. Do not open or crush them.
The twice-daily fasting requirement is the single most important
instruction for nilotinib. Many patients find it easiest to take the morning
dose first thing when they wake up (before breakfast) and the evening dose at
least 2 hours after their evening meal. Set phone reminders for both doses to
help maintain this schedule consistently.
⚠ PATIENT TIP: Avoid grapefruit and grapefruit
juice entirely — they inhibit an enzyme in the gut and liver that processes
nilotinib, causing drug levels to rise dangerously. Also avoid Seville oranges
and starfruit for the same reason. If you need to take antacids or heartburn
medicines, take them at least 2 hours before or after your nilotinib capsule.
4. POSSIBLE SIDE EFFECTS
|
How Common? |
Side Effects |
|
Very Common |
Rash, itching, nausea,
headache, fatigue, constipation, muscle pain, joint pain, raised blood sugar
(hyperglycaemia) |
|
Common |
Low white blood cell
count (neutropenia), low platelet count (thrombocytopenia), anaemia, raised
liver enzymes, raised lipase levels (indicating possible pancreatic
irritation), fluid retention, hair thinning |
|
Serious — Tell Your
Doctor Right Away |
QT prolongation (a
change in the heart's electrical activity that can cause dangerous rhythm
problems — palpitations, fainting, or sudden cardiac arrest). Peripheral
arterial occlusive disease (pain or cramping in the legs when walking — a
sign that arteries are narrowing). Heart attack or stroke. Liver problems:
jaundice, dark urine, right upper tummy pain. Pancreatitis: severe persistent
tummy pain, particularly around the middle or back. |
5. WHO SHOULD NOT TAKE THIS MEDICINE
Nilonix should not be used if you have low potassium or magnesium levels
that cannot be corrected, or if you have a heart rhythm condition called long
QT syndrome. It must be used with great caution in patients with a history of
heart disease, pancreatitis, liver disease, or peripheral arterial disease.
It is not safe during pregnancy — effective contraception is essential.
Tell your doctor about all your conditions before starting.
⚠ FASTING IS CRITICAL: Food — especially a
high-fat meal — can increase nilotinib absorption by up to 80%, potentially
causing dangerously high blood levels and severe side effects. Always take on a
completely empty stomach: at least 2 hours after eating and at least 1 hour
before eating again.
⚠ HEART RHYTHM (QT PROLONGATION): Nilotinib can
affect the heart's electrical activity. An ECG (heart trace) is required before
starting, at 7 days after starting, and periodically during treatment.
Potassium and magnesium levels must be corrected before starting if low. Avoid
other medicines that prolong QT interval.
⚠ CARDIOVASCULAR RISK: Nilotinib is associated
with a risk of narrowing of the arteries (atherosclerosis) with long-term use.
Report any new leg pain when walking, pain at rest, or cold feet to your
haematologist — these may be early signs of peripheral arterial disease.
6. MEDICINES THAT INTERACT WITH THIS TREATMENT
Strong CYP3A4 inhibitors (ketoconazole, voriconazole, clarithromycin,
ritonavir, grapefruit) significantly raise nilotinib blood levels — avoid these
combinations.
Strong CYP3A4 inducers (rifampicin, carbamazepine, phenytoin, St. John's
Wort) significantly reduce nilotinib levels, risking treatment failure.
QT-prolonging medicines (haloperidol, amiodarone, sotalol, certain antibiotics)
increase the risk of dangerous heart rhythm problems.
Medicines that reduce stomach acid (proton pump inhibitors like
omeprazole, H2 blockers) should be separated from nilotinib dosing by at least
2 hours, or avoided where possible. Always tell your haematologist and
pharmacist about every medicine you take.
7. HOW TO STORE THIS MEDICINE
Store below 30°C. Keep in the original pack away from moisture and light.
Keep out of reach of children.
8. PRESCRIPTION REQUIREMENT
|
Field |
Details |
|
Status |
Prescription Only
Medicine (POM) — Specialist (haematology) prescription required |
9. GUIDANCE FOR PATIENTS & CAREGIVERS
Take your capsules twice a day, 12 hours apart, on an empty stomach — at
least 2 hours after any food and at least 1 hour before eating again. Set phone
alarms for both doses to help you stay consistent.
Avoid grapefruit, grapefruit juice, Seville oranges, and starfruit.
Attend all ECG appointments and blood test checks. Report any new leg pain when
walking, chest pain, palpitations, or fainting to your haematologist promptly.
Use effective contraception throughout treatment. Tell every doctor and
pharmacist you see that you are taking nilotinib before accepting any new
medicine.
10. PHARMACIST & PRESCRIBER NOTES
|
Field |
Details |
|
Clinical Dispensing
Notes |
CRITICAL: Fasting
administration — 2 hours post-meal, 1 hour pre-meal. Food increases AUC by up
to 82% — non-compliance is a major safety risk. ECG required before treatment
initiation, at day 7, then every 3 months — QTc must be below 480ms before
continuing. Correct electrolytes (K+ and Mg2+) before initiation. Screen for
QT-prolonging drug interactions comprehensively. CYP3A4 interaction screening
essential — avoid strong inhibitors and inducers. Grapefruit counselling
mandatory. Cardiovascular risk monitoring: baseline lipids, blood glucose,
and cardiovascular risk assessment; monitor for peripheral arterial disease
during treatment. FBC, LFTs, lipase, blood glucose monitoring per
haematologist schedule. Embryo-fetal toxicity — effective contraception required.
No opening/crushing of capsules. |
11. FREQUENTLY ASKED QUESTIONS
Q: Why must it be taken on a completely empty stomach?
Food — especially fatty food — dramatically increases how much nilotinib
your body absorbs. Too much in the bloodstream raises the risk of dangerous
side effects, particularly heart rhythm problems. Taking it on a completely
empty stomach (2 hours after eating and 1 hour before eating) keeps blood
levels predictable and safe.
Q: What is QT prolongation and why does it matter?
QT prolongation is a change in the electrical activity of the heart that
can, in rare cases, trigger a dangerous and potentially fatal irregular heart
rhythm. Nilotinib can cause this, which is why an ECG (heart tracing) is done
before and during treatment. Keeping potassium and magnesium levels normal also
protects against this risk.
Q: Why can't I eat grapefruit?
Grapefruit contains compounds that block an enzyme in your gut and liver
that normally breaks down nilotinib. Without that enzyme working, much more
nilotinib enters your bloodstream than intended, potentially causing serious
side effects. Seville oranges and starfruit have the same effect.
Q: Do I need contraception?
Yes — nilotinib can harm an unborn baby. Both men and women should use
effective contraception during treatment. Women who wish to become pregnant
should discuss this with their haematologist — there may be alternative
treatments that are safer in pregnancy.
Q: How will I know if the treatment is working?
Your haematologist will monitor your response using blood tests (full
blood count), chromosome testing (cytogenetic response), and molecular testing
(PCR — looking for the BCR-ABL gene in the blood). These tests track how much
the cancer is reducing and whether remission is being achieved.