What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Black triangle. This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: EU/1/19/1376/001 .


LIBTAYO 350 mg concentrate for solution for infusion

Package leaflet: Information for the patient

LIBTAYO® 350 mg concentrate for solution for infusion

cemiplimab

▼This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • It is important that you keep the Patient Alert Card with you during treatment.
  • If you have any further questions, ask your doctor.
  • If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What LIBTAYO is and what it is used for
2. What you need to know before you use LIBTAYO
3. How you are given LIBTAYO
4. Possible side effects
5. How to store LIBTAYO
6. Contents of the pack and other information

1. What LIBTAYO is and what it is used for

LIBTAYO is an anti-cancer medicine that contains the active substance cemiplimab, which is a monoclonal antibody.

LIBTAYO is used in adults to treat a type of skin cancer called advanced cutaneous squamous cell carcinoma or CSCC.

LIBTAYO works by helping your immune system fight your cancer.

2. What you need to know before you are given LIBTAYO

You should not be given LIBTAYO if:

  • you are allergic to cemiplimab or any of the other ingredients of this medicine (listed in section 6).
  • If you think you may be allergic, or you are not sure, talk to your doctor before you are given LIBTAYO.

Warnings and precautions

Talk to your doctor or nurse before you are given LIBTAYO if:

  • you have an autoimmune disease (a condition where the body attacks its own cells)
  • you have had an organ transplant
  • you have lung or breathing problems
  • you have liver problems
  • you have diabetes
  • you have any other medical conditions.

If any of the above apply to you, or you are not sure, talk to your doctor or nurse before you are given LIBTAYO.

Look out for side effects

LIBTAYO can cause some serious side effects that you need to tell your doctor about immediately. You may have more than one side effect at the same time.

These serious side effects include:

  • Skin problems
  • Lung problems (pneumonitis)
  • Gut problems (colitis)
  • Liver problems (hepatitis)
  • Hormone gland problems - especially thyroid, pituitary, adrenal glands and the pancreas
  • Kidney problems (nephritis and kidney failure)
  • Infusion-related reactions
  • Central nervous system problems (such as meningitis)
  • Problems in other parts of the body.

Look out for these side effects while you are having LIBTAYO. See ‘Possible side effects’ section in section 4. If you have any of these effects, talk to your doctor immediately.

Your doctor may give you other medicines in order to stop more severe reactions and reduce your symptoms. Your doctor also may delay your next dose of LIBTAYO or stop your treatment.

Children and adolescents

LIBTAYO should not be used in children and adolescents below 18 years of age.

Other medicines and LIBTAYO

Tell your doctor if you are taking, have recently taken or might take any other medicines.

In particular, tell your doctor if you are taking or have ever taken any of the following medicines:

  • a cancer medicine called idelalisib
  • medicines that make your immune system weak - examples include corticosteroids, such as prednisone. These medicines may interfere with the effect of LIBTAYO. However, once you are treated with LIBTAYO, your doctor may give you corticosteroids to reduce the side effects that you may have with LIBTAYO.

Pregnancy

If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine.

  • LIBTAYO can harm your unborn baby.
  • Tell your doctor immediately if you become pregnant while you are being treated with LIBTAYO.
  • If you are able to become pregnant, you must use an effective method of contraception to avoid becoming pregnant:
    • while you are being treated with LIBTAYO and
    • for at least 4 months after the last dose.
  • Talk to your doctor about the contraception methods that you must use during this time.

Breast-feeding

  • If you are breast-feeding or plan to breast-feed, ask your doctor for advice before you are given this medicine.
  • Do not breast-feed while you are being treated with LIBTAYO and for at least 4 months after the last dose.
  • It is not known if LIBTAYO passes into your breast milk.

Driving and using machines

LIBTAYO has no or minor influence on your ability to drive and use machines. If you feel tired, do not drive or use machines until you feel better.

3. How you are given LIBTAYO

  • LIBTAYO will be given to you in a hospital or clinic
    • supervised by a doctor experienced in cancer treatment.
  • LIBTAYO is given as a drip into a vein (intravenous infusion).
  • The infusion will last about 30 minutes.
  • LIBTAYO is usually given every 3 weeks.

How much you will receive

The recommended dose of LIBTAYO is 350 mg.

Your doctor will decide how much LIBTAYO you will receive and how many treatments you will need.

Your doctor will test your blood for certain side effects during your treatment.

If you miss an appointment

Call your doctor as soon as possible to make another appointment. It is very important that you do not miss a dose of this medicine.

If you stop receiving LIBTAYO

Do not stop treatment of LIBTAYO unless you have discussed this with your doctor. This is because stopping your treatment may stop the effect of the medicine.

Patient Alert Card

The information in this Package Leaflet can be found in the Patient Alert Card you have been given by your doctor. It is important that you keep this Patient Alert Card and show it to your partner or caregivers.

If you have any questions about your treatment, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Your doctor will discuss these with you and will explain the risks and benefits of your treatment.

LIBTAYO acts on your immune system and may cause inflammation in parts of your body (see the conditions listed in ‘Look out for side effects’ in section 2).

Inflammation may cause serious damage to your body. Some inflammatory conditions may also lead to death and need treatment, or you may need to stop treatment with LIBTAYO.

Seek urgent medical attention if you have any of the following signs or symptoms, or if they get worse:

  • Skin problems such as rash or itching, skin blistering and ulcers in mouth or other mucous membrane.
  • Lung problems (pneumonitis) such as new or worsening cough, being short of breath and chest pain.
  • Gut problems (colitis) such as frequent diarrhoea often with blood or mucus, more bowel movements than usual, stools that are black or tarry, and severe stomach (abdomen) pain or tenderness.
  • Liver problems (hepatitis) such as yellowing of your skin or the whites of your eyes, severe nausea or vomiting, pain on right side of your stomach (abdomen), feeling sleepy, dark urine (the colour of tea), bleeding or bruising more easily than normal and feeling less hungry than usual.
  • Hormone gland problems such as headache that will not go away or unusual headaches, fast heartbeat, increased sweating, feeling cold, very tired, dizzy or fainting, weight gain or weight loss, feeling more hungry or thirsty than usual, hair loss, constipation, your voice gets deeper, very low blood pressure, passing water more often than usual, nausea or vomiting, stomach (abdomen) pain, changes in mood or behaviour (such as decreased sex drive, being irritable or forgetful).
  • Type 1 diabetes that may include feeling more hungry or thirsty than usual, needing to urinate more often, weight loss, and feeling tired.
  • Kidney problems (nephritis and kidney failure) such as passing water less often than usual, passing blood, swollen ankles and feeling less hungry than normal.
  • Infusion-related reactions (sometimes can be severe or life-threatening) such as chills, shaking or fever, itching or rash, flushing or swollen face, being short of breath or wheezing, feeling dizzy or feel like passing out and back or neck pain.
  • Problems in other parts of the body such as headache or stiff neck, fever, feeling tired or weak, confusion, memory problems or feeling sleepy, fits (seizures), seeing or hearing things that are not really there (hallucinations), changes in eyesight, eye pain or redness, severe muscle weakness, changes in heartbeat such as beating fast or seeming to skip a beat or pounding sensation and bruises on the skin or bleeding.

The following side effects have been reported in clinical trials of patients with CSCC:

Very common (may affect more than 1 in 10 people):

  • feeling tired
  • rash, itching
  • diarrhoea (loose stools).

Common (may affect up to 1 in 10 people):

  • increased liver enzymes in blood, abnormal kidney function test
  • thyroid gland problems
  • cough, inflammation of the lungs
  • joint pain, swelling, polyarthritis and joint effusion
  • infusion-related reactions
  • inflammation of the mouth
  • inflammation of the liver
  • muscle pain.

Uncommon (may affect up to 1 in 100 people):

  • inflammation of the heart muscle, which may present as shortness of breath, irregular heartbeat, feeling tired or chest pain
  • inflammation of the covering of the heart
  • inflammation of the kidneys
  • inflammation of the pituitary gland situated at the base of the brain; decreased secretion of hormones produced by the adrenal glands; inflammation of the thyroid
  • type 1 diabetes that may include feeling more hungry or thirsty than usual, needing to urinate more often, weight loss, and feeling tired
  • a temporary inflammation of the nerves that cause pain, weakness, and paralysis in the extremities; a condition in which the muscles become weak and tire easily
  • inflammation of brain and spinal cord membranes usually caused by infection
  • dryness in many parts of the body, from mouth to eyes, nose, throat and the top layers of skin
  • eye pain, irritation, itchiness or redness; uncomfortable sensitivity to light
  • inflammation of the nerves causing tingling, numbness, weakness or burning pain of the arms or legs
  • bruises on the skin or bleeding.

Reporting of side effects

If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed below. By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard

or search for MHRA Yellow Card in the Google Play or Apple App Store

5. How to store LIBTAYO

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and vial after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2°C to 8°C).

Do not freeze.

Store in the original container in order to protect from light.

From time of preparation by diluting in an intravenous bag, LIBTAYO can be stored before use for no more than 8 hours at temperatures up to 25°C, and no more than 24 hours in a refrigerator (2°C to 8°C). If refrigerated, the vials and/or intravenous bags must be allowed to reach room temperature prior to use.

Do not store any unused portion of the infusion solution for re-use. Any unused portion of the infusion solution should not be re-used and should be disposed in accordance with local requirements.

6. Contents of the pack and other information

What LIBTAYO contains

The active substance is cemiplimab:

  • One ml of concentrate contains 50 mg of cemiplimab.
  • Each vial contains 350 mg cemiplimab in 7 ml of concentrate.

The other ingredients are L-Histidine, L-Histidine monohydrochloride monohydrate, L-proline, sucrose, polysorbate 80 and water for injections.

What LIBTAYO looks like and contents of the pack

LIBTAYO concentrate for solution for infusion (sterile concentrate) is supplied as a clear to slightly opalescent, colourless to pale yellow sterile solution that may contain trace amounts of translucent to white particles.

Each carton contains 1 glass vial with 7 ml of concentrate.

Marketing Authorisation Holder

Regeneron Ireland Designated Activity Company (DAC)
Europa House
Harcourt Centre
Harcourt Street
Dublin 2
Ireland

Manufacturer

Regeneron Ireland DAC
Raheen Business Park
Limerick
Ireland

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

United Kingdom
Sanofi
Tel: +44 (0) 845 372 7101

This leaflet was last revised in September 2019.

This medicine has been given ‘conditional approval’.

This means that there is more evidence to come about this medicine. The European Medicines Agency will review new information on this medicine at least every year and this leaflet will be updated as necessary.

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu

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