WHAT IS THIS MEDICINE AND WHAT IS IT USED FOR?
Nivolunix contains nivolumab, a type of cancer treatment called an immune
checkpoint inhibitor. To understand how it works, it helps to know that cancer
cells often 'hide' from the immune system by activating a molecular 'off
switch' — a protein called PD-1 — on immune cells called T-cells. By switching
T-cells off, cancer cells avoid being recognised and destroyed.
Nivolumab is an antibody that blocks PD-1, effectively releasing the
immune system's 'brakes' and allowing T-cells to recognise and attack cancer
cells again.
It may be prescribed — often in combination with other immunotherapy
medicines or chemotherapy — for many cancer types including:
· non-small cell lung cancer (NSCLC),
· melanoma (skin cancer),
· kidney cancer (renal cell carcinoma),
· bladder cancer (urothelial
carcinoma),
· head and neck cancers,
· oesophageal cancer,
· liver cancer (hepatocellular
carcinoma),
· gastric or gastro-oesophageal
junction cancer, and certain blood cancers (classical Hodgkin lymphoma, diffuse
large B-cell lymphoma).
The specific indication will be confirmed by your oncologist.
3. HOW TO TAKE THIS MEDICINE
Nivolunix is given as a slow drip into a vein (intravenous infusion) by a
nurse in a hospital or cancer centre. It is not taken as a tablet or
self-injected. The dose and schedule depend on your cancer type, your body
weight, and whether nivolumab is being given alone or in combination with other
medicines.
Common schedules include: 240mg every 2 weeks, 480mg every 4 weeks, or
weight-based dosing (3mg/kg every 2 weeks). Each infusion takes approximately
30 to 60 minutes. Your oncology team will give you your specific schedule.
Before each infusion, your care team will assess your general health,
review any new symptoms you have noticed since the last dose, and may perform
blood tests. It is extremely important to report any new symptoms — however
seemingly unrelated to cancer — between infusions. Immune-related side effects
can affect any organ and often develop between clinic visits.
⚠ PATIENT TIP: Immunotherapy works very
differently from chemotherapy. Instead of attacking cancer cells directly, it
boosts your immune system — and sometimes the immune system can become
overactive and start attacking healthy organs as well. Any new symptom — a
rash, diarrhoea, a cough, joint pain, or feeling unusually tired — should be
reported to your oncology team promptly, even if it does not seem connected to
your cancer treatment.
4. POSSIBLE SIDE EFFECTS
|
How Common? |
Side Effects |
|
Common |
Tiredness (fatigue),
rash or itching, diarrhoea, nausea, decreased appetite, joint or muscle pain,
shortness of breath, cough |
|
Immune-Related Side
Effects (can affect any organ) |
Immune-mediated
pneumonitis (lung inflammation — breathlessness, dry cough), immune-mediated
colitis (bowel inflammation — severe diarrhoea, abdominal pain),
immune-mediated hepatitis (liver inflammation — jaundice, dark urine),
immune-mediated endocrinopathies (thyroid problems, adrenal problems,
pituitary problems — causing fatigue, weight changes, or hormonal symptoms),
immune-mediated nephritis (kidney inflammation — reduced urine output,
swelling), skin reactions (severe rash, blistering) |
|
Serious — Seek Urgent
Medical Help |
Severe breathing
difficulty or chest pain (pneumonitis or cardiac involvement). Severe or
bloody diarrhoea (colitis). Yellowing of skin or eyes (hepatitis). Inability
to pass urine or very dark urine (nephritis). Severe skin blistering. Severe
headache with visual changes (pituitary inflammation). Any rapidly worsening
symptom — immune-related reactions can escalate quickly and require urgent
steroid treatment. |
5. WHO SHOULD NOT TAKE THIS MEDICINE
There are no absolute contraindications based on a specific disease, but
nivolumab requires very careful consideration in patients with pre-existing
autoimmune conditions (such as rheumatoid arthritis, Crohn's disease, lupus, or
multiple sclerosis), as it can trigger severe flares of these conditions.
It should be used with caution in patients who have had organ
transplants, as it may trigger rejection. Pregnancy — nivolumab can harm an
unborn baby. Effective contraception is essential during treatment and for at
least 5 months after the last dose.
⚠ IMMUNE-RELATED ADVERSE EVENTS (irAEs): The
biggest risk with nivolumab is that the activated immune system attacks healthy
organs. This can affect the lungs, bowel, liver, kidneys, skin, hormonal
glands, heart, and nervous system. These reactions can be severe and
life-threatening but are usually reversible with prompt corticosteroid
(steroid) treatment. They can appear at any time — even months after treatment
has ended.
⚠ REPORT ALL NEW SYMPTOMS PROMPTLY: Do not wait
until your next scheduled appointment if you develop new or worsening symptoms.
Contact your oncology helpline or go to A&E if symptoms are severe. Early
treatment of immune-related reactions significantly improves outcomes.
⚠ STEROID TREATMENT: Many immune-related
reactions are treated with high-dose steroids (prednisolone or
methylprednisolone). Understand that this is a standard and expected part of
managing immunotherapy side effects — it does not mean the treatment has failed.
6. MEDICINES THAT INTERACT WITH THIS TREATMENT
Corticosteroids (prednisolone, dexamethasone) used to treat
immune-related side effects are compatible and frequently co-administered.
Avoid high-dose systemic corticosteroids as routine prophylaxis before
treatment starts — this can reduce nivolumab's effectiveness.
Other immunosuppressants (e.g. azathioprine, ciclosporin) may reduce
nivolumab's activity and increase infection risk. Always tell all your
healthcare providers that you are on immunotherapy before starting any new
medicine or treatment.
7. HOW TO STORE THIS MEDICINE
Store in a refrigerator at 2–8°C. Do not freeze or shake. Protect from
light. Prepared infusion solutions should be used within the timeframe
specified by the hospital pharmacy. Single-use vial — discard unused portion.
8. PRESCRIPTION REQUIREMENT
|
Field |
Details |
|
Status |
Prescription Only
Medicine (POM) — Specialist (oncology) prescription required;
multidisciplinary team assessment required for most indications |
9. GUIDANCE FOR PATIENTS & CAREGIVERS
You will receive this treatment as a drip in a cancer clinic or hospital.
Each session takes approximately 30 to 60 minutes, and you will be monitored
during and after the infusion. Between sessions, pay close attention to how you
feel and report any new symptom — no matter how minor it seems — to your
oncology team promptly.
Immunotherapy side effects can affect any part of the body and can
develop at any time, including weeks after your last dose. Always carry your
oncology team's contact number and do not hesitate to call if something
changes. Tell every other doctor you see that you are on immunotherapy before
they prescribe anything new. Use effective contraception throughout treatment
and for 5 months afterwards.
10. PHARMACIST & PRESCRIBER NOTES
|
Field |
Details |
|
Clinical Dispensing
Notes |
PD-1 immune checkpoint
inhibitor — immune-related adverse event (irAE) counselling is central to
patient safety. Provide comprehensive irAE recognition and reporting guidance
(pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, myocarditis,
encephalitis). Emphasise 24/7 oncology contact and low threshold to present
to A&E for any new significant symptom. Steroid treatment protocols for
irAEs — prednisolone/methylprednisolone per local guideline. Monitor thyroid
function, LFTs, renal function, blood glucose before each cycle. Cold chain:
2–8°C. Infusion preparation by hospital pharmacy — check stability and
administration time post-preparation. Embryo-fetal toxicity: contraception
during and 5 months post-treatment. Caution in pre-existing autoimmune
conditions — MDT discussion required. Avoid high-dose prophylactic steroids
before treatment. |
11. FREQUENTLY ASKED QUESTIONS
Q: How is immunotherapy different from chemotherapy?
Chemotherapy directly kills fast-dividing cells (including cancer cells).
Immunotherapy works differently — it does not attack cancer cells directly.
Instead, it releases a 'brake' on your own immune system, allowing your body's
T-cells (infection-fighting white blood cells) to recognise and destroy the
cancer themselves. This is why immunotherapy side effects are very different
from chemotherapy side effects.
Q: Why can immunotherapy affect parts of the body that have nothing to do
with my cancer?
When the immune system's brakes are released, it becomes more active
overall — not just against cancer. In some patients, this overactive immune
response starts attacking healthy organs too. This is called an immune-related
adverse event (irAE) and it can affect almost any organ — the lungs, bowel,
liver, kidneys, thyroid, adrenal glands, and even the heart.
Q: How will I know if I am having an immune-related reaction?
Immune-related reactions can be very varied. Common warning signs
include: new or worsening breathlessness or cough (lungs), severe diarrhoea or
tummy cramps (bowel), yellow skin or eyes (liver), unusual fatigue or hormonal
symptoms (glands), reduced urine output (kidneys), or a new rash. Report any of
these to your oncology team straight away — do not wait until your next
appointment.
Q: Do I need contraception during immunotherapy?
Yes — nivolumab can harm an unborn baby. Both men and women should use
effective contraception during treatment and for 5 months after the last dose.