Cemiplimab (Libtayo®) is a type of anti-cancer treatment called immunotherapy. The benefits of treatment are different for each person. For some people, immunotherapy can help stop the cancer coming back. For others, it can help control the cancer and ease its symptoms.

Your doctor will talk to you about the treatment that is right for you. This may be immunotherapy, another treatment, or a combination of treatments. If you have any questions, please ask your doctor or nurse. They will be happy to help. You may also find the booklet ‘Immunotherapy, a guide’ helpful. It explains immunotherapy and the possible side effects in more detail.

Your treatment

Your doctor or nurse clinician has prescribed a treatment called cemiplimab (Libtayo®).

The treatment is given as an infusion (drip) into a vein over 30 minutes. The treatment is usually given once every 3 weeks for up to 96 weeks, as long as you are getting a benefit.

You will usually be seen by a doctor or nurse clinician and have a routine blood test before the start of each cycle of treatment.

If you are taking any other medicines

Please tell your doctor if you are taking medicines for any other condition.

Some medicines can react/interfere with cemiplimab, so always tell your doctor about any other medicines you are taking. Make sure your doctor knows if you:

  • have any autoimmune disease

  • have ever had any inflammation of the lungs (pneumonitis), HIV or hepatitis

Infusion-related reactions

Sometimes side effects can happen while you are having the infusion. These may include feeling cold, having a fever or shivering. If you notice any of these side effects please, tell your nurse straight away. Your nurse will be checking on you regularly.

Rarely, you may get an allergic reaction to the drip. If this happens, the drip may need to be slowed down or stopped. Reactions may include:

  • skin rash

  • headache

  • sore throat

  • feeling sick

  • swelling around the eyes or face

  • feeling dizzy or faint

  • difficulty breathing during the treatment

You may feel tired or have a headache. These side effects are related to your treatment and usually go away when the infusion has finished. If you have any reactions to your treatment, we may be able to give you medication to help prevent it from happening at your next infusion.

Possible side effects

However, many patients do not get any side effects with cemiplimab, although there are a wide range of them. If side effects do happen, for most patients they are mild and can be safely managed at home.

The most common side effects are related to the way that the drug treats the cancer by boosting the immune system. They are generally different from the side effects which occur following chemotherapy. Some are more likely to occur than others.

Everyone is different, so side effects can vary from person to person. Some people have mild side effects, while others may have more serious ones. Most serious side effects can be treated with steroid medicines, either as tablets and through a drip. In some cases, a stay in hospital may be needed to treat severe immune-related side effects.

It is very important to tell any doctor, nurse or hospital treating you that you have had cemiplimab. Immunotherapy side effects can sometimes happen several months after treatment has finished. If you are treated at another hospital, the healthcare team can contact The Christie at any time for advice.

Common side effects (more than 1 in 10)

Fatigue

Cemiplimab may make you feel tired and lacking in energy. It can be frustrating when you feel unable to cope with routine tasks. If you do feel tired, take rest and get help with household chores. If necessary, take time off work. Gentle exercise such as walking can be beneficial.

If you feel extremely tired, when you do not feel able to get out of bed or feel dizzy or faint, contact The Christie Hotline on 0161 446 3658. This may be related to inflammation of the hormone-producing glands and could require urgent assessment.

Skin rashes and itching

This can vary from mild to severe. Contact The Christie Hotline on 0161 446 3658 or your medical team if:

  • the rash covers more than half of your body

  • if it is very itchy or painful

  • if you develop blisters or peeling skin

  • you have sores in your mouth

Diarrhoea

If diarrhoea occurs, you should take loperamide. Take 2 capsules as soon as the first liquid stool occurs. Then take 1 capsule with each liquid stool up to a maximum of 8 in 24 hours.

If you continue to have more than 3 liquid stools a day, if you are having diarrhoea at night or if the diarrhoea continues for more than 3 days contact The Christie Hotline number on 0161 446 3658 for advice. You should also contact The Hotline if you have any blood or mucus in your stools, or they become a darker colour.

If you develop any tenderness or pain in your abdomen, ring The Christie Hotline.

Uncommon side effects (less than 1 in 10)

Inflammation of the liver

We will be checking your liver blood tests before each infusion but contact The Christie Hotline if you develop yellowing of the skin or eyes (jaundice) have very dark urine or pain on the right side of your stomach.

Immune-related kidney problems

This is caused when the kidneys become inflamed and can stop working properly. We will be monitoring your kidney function carefully but contact The Christie Hotline if you find that you are very tired or if you notice that you are passing less urine than usual.

Inflammation of the hormone-producing glands

Sometimes cemiplimab may cause inflammation of the glands that produce vital hormones (especially the pituitary, adrenal and thyroid glands) which in turn can affect the way they work. Contact The Christie if you develop any of the following; headaches, blurred or double vision, profound tiredness, decreased sexual drive or if you become irritable or forgetful.

Cemiplimab can also cause development of type 1 diabetes. This results in a high blood sugar which can cause symptoms including feeling more hungry or thirsty than usual, needing to urinate more often, weight loss and tiredness. Your blood glucose will be monitored during your treatment but if you develop these symptoms please contact The Christie.

Inflammation of the lungs

Uncommonly cemiplimab can cause inflammation of the lungs. This usually does not cause symptoms, and may be seen on routine scans. If you develop shortness of breath or a cough, contact The Christie Hotline.

Sore mouth

This can range from mild to severe. If you develop pain which affects your ability to eat and drink or any ulcers in the mouth please contact The Christie.

Muscle and joint pains

Sometimes cemiplimab can cause muscle and joint pain. If this does not respond to simple pain relief such as paracetamol, please contact The Christie.

Rare side effects (less than 1 in 100)

Inflammation of the nerves

Contact The Christie if you develop muscle weakness, numbness or tingling in your hands or feet or any dizziness or loss of consciousness.

Inflammation of the eyes

Sometimes cemiplimab can cause the eyes to become inflamed. Contact The Christie if you develop any redness or pain in your eye or you develop any problems with your vision.

Inflammation of the bowel leading to bowel perforation

Rarely the bowel can become very inflamed and this can lead to a small hole developing in the wall of the bowel (perforation). You will be closely monitored for this but if you develop diarrhoea as described above, any abdominal pain or blood or mucus in the stools, contact The Christie Hotline on 0161 446 3658 immediately.

Inflammation of the heart muscle

Rarely the heart muscle or its covering (the pericardium) can become inflamed. If you develop chest pain please contact The Christie Hotline, if the pain is severe please dial 999.

Serious and potentially life-threatening side effects

In a small proportion of patients immunotherapy can result in very severe side effects which may rarely result in death. The team caring for you will discuss the risk of these side effects with you.

Sex, contraception and fertility

It is important that you do not get pregnant, or attempt to get someone pregnant, while on immunotherapy.

These drugs can harm an unborn baby. During sex, it is important to use a barrier form of contraception, such as condoms, while on this treatment and for at least 4 months after.

If you are breastfeeding you should stop while being treated with cemiplimab since it is unknown if the medication is passed into breast milk.

Fertility

We do not know if cemiplimab affects fertility. Please speak to your clinical team if this is a concern for you.

Late side effects

Long-term possible side effects of treatment with cemiplimab are not yet known. Speak with your doctor if you wish to discuss this further.

Flu vaccinations

It’s safe to have a flu jab, but depending on the sort of chemotherapy you have had, it may not give quite as much protection against infection as usual. Some patients may need 2 vaccinations. However, if you’re thinking of having any other vaccinations, do check with your Christie doctor first, because some vaccines should be avoided.

COVID-19 vaccinations

We advise that all patients receive a COVID-19 vaccination when this is offered. Your doctor will discuss with you the best time to have this.

Contacts

If you have any general questions or concerns about your treatment, please ring:

  • Administration enquiries: 0161 918 7606/7610

  • Chemotherapy nurse: 0161 918 7171

For urgent advice, ring The Christie Hotline on 0161 446 3658 (24 hours a day, 7 days a week).