Ipilimumab and nivolumab 969, A1078 and A1416

969 & A1078 & A 1416

Information leaflet on Ipilimumab and nivolumab

This leaflet provides information for patients having treatment with ipilimumab and nivolumab. The leaflet will explain what ipilimumab and nivolumab is and when and how it is given. It will also tell you about common side effects that you may experience. Contact telephone numbers and details of how to obtain further information on ipilimumab and nivolumab are given at the end of the leaflet.

What is ipilimumab and nivolumab and why am I having this treatment?

Ipilimumab and nivolumab is a treatment which helps your immune system to attack and destroy cancer cells. This is not a chemotherapy drug

How often will I receive ipilimumab and nivolumab?

For this treatment to be most effective, it is given at specific time intervals known as cycles. It is usual to have both ipilimumab and nivolumab every 3 weeks for 4 cycles.

Following the first 4 treatments you will have nivolumab only. This may be given in in 2 different ways either:

1.Nivolumab once every 2 weeks starting 3 weeks after your first 4 cycles.

Nivolumab once every 4 weeks starting 6 weeks after your first 4 cycles

However if you are on a 6 weekly cycle. You will receive –

Day 1:

On day 1 you will receive both ipilmumab and nivolumab

Day 22:

On day 22 you will receive just nivolumab

Your doctor will decide how long your treatment will continue.

How often will I see the specialist team?

You will need to be seen in the outpatient clinic before each treatment. This will be a few days before each treatment. At each outpatient clinic the medical team who prescribes your treatment will check how you are feeling and discuss any problems you may have. You may be contacted at other intervals to check your symptoms. Your team will discuss when this will be.

How is ipilimumab and nivolumab given?

Ipilimumab and nivolumab is given through a drip into a vein in the back of your hand or arm.

Where will my treatment be given?

The treatment will be given in the day case treatment areas at Velindre.

How long will I be in the hospital?

The Ipilimumab treatment is given over approximately 90 minutes. The nivolumab is given over approximately 1 hour. Therefore, when having both treatments on the same day, please allow approximately 4 hours for your appointment. When you have only the nivolumab, please allow approximately 2 hours for your treatment.

Can I bring relatives and friends with me?

You are welcome to bring someone to stay with you during your treatment. Space is limited so there is not usually room for more than one person. Treatment areas are not suitable for young children.

Reactions during the treatment

If you experience any of the following during the treatment please tell your nurse straight away:

Feeling hot and feverish
Chills or shivering
Headache
Dizziness or faintness
Problems with breathing
Rash
Feeling sick or vomiting

If any of these occur we will slow down or stop the ipilimumab or nivolumab until you feel better. The treatment can then start again, usually without any further problems.

What are the possible side effects?

Some people have very few side effects whilst others may experience more. Most of the side effects happen because Ipilimumab and nivolumab affects the immune system causing inflammation of other parts of the body such as the skin, the bowels and hormone producing glands. This can be particularly severe in about 55% of patients. Most if not all severe side effects can be controlled by the use of steroid medication immediately either as tablets or through a drip. Hospital admission may become necessary for severe immune related reactions.

It is important that if you have more severe side effects that you contact Velindre Cancer Centre. The telephone number is at the end of the leaflet.

This treatment can cause severe immune related side effects, and in some patients this could be life-threatening , therefore it is vital you inform Velindre Cancer Centre if you have side effects. Your team will discuss this with you in clinic.

Further details of when to contact Velindre are included in the individual side effects listed below.

If you are admitted to another hospital, you must inform the doctors and the nurses that you are taking Ipilimumab and nivolumab .It is possible you could be having an immune reaction and should be started on steroids. The doctors and nurses need to contact Velindre Cancer Centre for advice. They can either telephone the treatment helpline or speak to your oncologist. You will receive an alert card with your details. Show this to the doctors or nurses.

Effects on the bowels

Diarrhoea

You may have diarrhoea. If this occurs it is important that you drink plenty of fluids. We will give you medication to take if you get diarrhoea,

Please note:

If you have any of the symptoms below you must inform Velindre Cancer Centre immediately, the telephone numbers are at the end of the leaflet.

4 or more bowel movements in 24 hours above what is normal for you.

if you have any problems with diarrhoea or an increase in bowel movements which lasts for more than 3 days.
if you have stomach pains.
if you have blood or mucus in your bowel motions

There is a risk of inflammation of the bowel (colitis) or rupture of the bowel (perforation) in a small minority of patients.

Effects on your hormone glands

Ipilimumab and nivolumab can cause inflammation of the glands that produce the different hormones (chemicals that control many of the body’s functions) in the body. Symptoms will vary depending on which glands are affected.

It is important to contact Velindre cancer Centre if:

If you have a headache that will not go away.
If you have nausea and vomiting.
If you have severe mood swings.
If you feel forgetful and confused.
severe tiredness (mild to moderate tiredness is common with ipilimumab and nivolumab)

Effects on the skin

Please use a non perfumed body wash and a non perfumed moisturising cream to prevent a skin rash. You may get a sore mouth, if this happens we can recommend mouth washes.

Please contact Velindre Cancer Centre if you develop a rash or a sore mouth:

However if you get a severe skin reaction you may need to be treated in hospital.

If the following occurs:

If you have large blisters or your skin is peeling.
If your skin feels very raw.
If you have a fever.
If you have aching joints.
If you have itchy eyes.
If you have mouth ulcers.

You need to be seen immediately. Please contact Velindre Cancer Centre on the telephone number at the back of the leaflet.

Effects on the eyes

Please contact Velindre Cancer Centre:

If you have sore eyes.
If you have red eyes.
If you have blurred or double vision.

Effects on the liver

This is rare, but if you are affected you may feel more tired than usual and may also feel sick or vomit. Your doctor will give you anti sickness medicine to take, we will monitor your bloods to check your liver function in clinic.

Please contact Velindre Cancer Centre:

If you vomit more than once in 24 hours despite taking anti sickness medication.

More severe effects on the liver are very rare but can be very serious so you should contact Velindre Cancer Centre :

If you have yellowing of your skin and the whites of your eyes.
If you have darker urine than normal.
If you have unusual bruising or bleeding

Effects on the nerves

You may have numbness or tingling in your hands or feet.

Please contact Velindre Cancer Centre:

If numbness in your hands and feet is severe.
If you develop weakness in your arms or legs
If you become dizzy or giddy.
If you become very drowsy and have difficulty staying awake.

Tiredness and fatigue

Ipilimumab and nivolumab can make you feel more tired than usual. It is important to listen to your body and rest if you need to, but carry out your normal activities if you feel able. Some people find it beneficial to take gentle exercise as well as taking rest. If you are sleeping more than 50% during the daytime you need to contact Velindre Cancer Centre on the number at the back of the leaflet.

Loss of appetite

You may experience a loss of appetite and some people may feel sick whilst taking nivolumab but this can usually be well controlled with anti sickness medication. If you are sick more than once in 24 hours despite taking regular anti-sickness medicine, you should contact Velindre Cancer Centre for advice. The telephone number is at the end of the leaflet.

Myalgia (pain in the muscles)

Some patients may experience myalgia which is muscle or joint pain. If you already have painkillers at home you may find they relieve the pain. If this does not work please contact Velindre Cancer Centre. The telephone number at the end of the leaflet.

Hair loss

Nivolumab should not make you lose your hair. However, a small number of people may experience some hair thinning. We have a leaflet that tells you more about coping with hair loss. Please ask your nurse if you would like a copy.

Infection

You may be at an increased risk of picking up infections because sometimes your white blood cells which help fight infections can be reduced by this treatment. Contact Velindre Cancer Centre immediately if you develop any signs of infection, for example flu like symptoms or a temperature above 37.5°centigrade. The telephone number is at the end of the leaflet.

Blood clots

A diagnosis of cancer can increase your risk of developing a blood clot (thrombosis), and having cancer treatment may increase this risk further. It is important to tell your doctor immediately if you have symptoms such as pain, redness and swelling in your leg, or breathlessness and chest pain.

Blood clots can be very serious. However, most clots can usually be successfully treated with drugs to thin the blood. Your doctor or nurse can give you more information

Other side effects:

There are other side effects, which can affect the lung, kidney, muscles or eyes: if you have any of the side-effects below, please contact Velindre Cancer Centre:

Increased frequency of passing urine and/or thirst.
Dizziness or light headedness.
Shortness of breath, dry cough or difficulty breathing.
Decreased urine output or back pain.
Severe muscular pain
Blurred vision or red sore eyes.

Side effects may continue for 18 months and sometimes longer after treatment. If you have any side effects contact your consultant. If you are admitted to hospital or see your GP during this period, inform the doctor you have had ipilimumab and nivolumab, immunotherapy and give them your alert card.

Other information

It is important you do not become pregnant, breastfeed or father a child whilst having ipilimumab and nivolumab treatment and for a year after treatment

Sometimes cancer drugs can have very serious side effects which can be life threatening. It is important to inform Velindre Cancer Centre if you are concerned about any side-effects. This treatment has a high risk of causing life threatening side effects.

Manufacturer’s patient information leaflets

Velindre leaflets provide information about very common and commonly reported side-effects (we are unable to list all of the common side effects), for more information regarding these and the less common side-effects please refer to the manufacturers patient information leaflets, obtained from Velindre pharmacy and/or on the internet at www.medicines.org.uk. Sometimes patients may find these leaflets difficult to read however. Please ask if you would like a copy from your doctor or from Velindre pharmacy

Contact telephone numbers

Velindre Cancer Centre 029 2061 5888

If you are unwell at home and need immediate advice at any time of the day or night ask for the treatment helpline

Pharmacy department 029 2061 5888 ext 6223

Monday – Friday 9am – 5pm for queries about your medicines

Macmillan freephone Helpline 0808 808 0000

Tenovus freephone 0808 808 1010

cancer helpline

This information is also available in Welsh

This leaflet was written by health professionals. The information contained in this leaflet is evidence based. The leaflet has been approved by doctors, nurses, pharmacists and patients. It is reviewed and updated every 2 years.

Prepared January 2014

Reviewed January 2019