350 mg concentrate for infusion solution
cemiplimab
What LIBTAYO is and what it is used for
LIBTAYO is a cancer medicine and 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 (CSCC)
- a type of skin cancer called advanced basal cell carcinoma (BCC) for which you have been treated with an inhibitor of the so-called Hedgehog signaling pathway (HHI) where this treatment did not work well or was not well tolerated.
- a type of lung cancer called advanced non- small cell lung cancer (NSCLC).
LIBTAYO helps your immune system fight cancer.
What you need to know before using 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 are not sure, talk to your doctor before giving LIBTAYO.
Warnings and cautions
Talk to your doctor or nurse before giving LIBTAYO if:
- you have an autoimmune disease (a condition in which the body attacks its own cells)
- you have undergone an organ transplant or if you have had or are planning to have a bone marrow transplant with bone marrow from another person ( allogeneic hematopoietic stem cell transplant )
- you have lung or breathing problems
- you have liver problems
- you have kidney problems
- you have diabetes
- you have another medical condition.
Talk to your doctor or nurse if you have any of the above signs/symptoms or if you are unsure before receiving LIBTAYO.
Be aware of the side effect s
LIBTAYO can cause serious side effects that you must tell your doctor immediately. These problems can occur at any time during treatment and even after your treatment has ended. You can get more than one side effect at a time.
These serious side effects are:
- Skin problems
- Pneumonia ( pneumonitis )
- Inflammation of the intestines ( colitis )
- Inflammation of the liver ( hepatitis )
- Problems with hormone-producing glands – especially the thyroid gland , pituitary gland , adrenal glands and pancreas
- Type 1 diabetes
- Kidney problems (kidney inflammation and kidney failure )
- Central nervous system problems (such as meningitis )
- Reaction in connection with infusion
- Problems in other parts of the body (see “Possible side effects”).
- Muscle problems ( inflammation of the muscles called myositis).
Be aware of these side effects when you receive LIBTAYO. See section 4 “Possible side effects”. Tell your doctor immediately if you get any of these side effects.
Your doctor may give you other medicines to prevent more severe reactions and reduce the symptoms. Your doctor may also delay the next dose of LIBTAYO or stop treatment with LIBTAYO completely.
Children and young people
LIBTAYO should not be used by children and adolescents under 18 years of age.
Other medicines and LIBTAYO
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
If you take or have taken any of the following, tell your doctor in particular:
- a cancer drug containing idelalisib
- drugs that inhibit the immune system, such as corticosteroids e.g. prednisone. Such drugs may affect the effect of LIBTAYO. However, your doctor may give you corticosteroids to reduce the side effects that may occur with LIBTAYO, after you start treatment 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 taking this medicine.
- LIBTAYO can harm your unborn baby.
- Tell your doctor immediately if you become pregnant during treatment with LIBTAYO.
- If you are a woman of childbearing potential , you must use an effective contraceptive:
- while you are being treated with LIBTAYO and
- at least 4 months after you have been treated with the last dose of one.
- Talk to your doctor about effective contraceptives that you must use during treatment.
Breast-feeding
- If you are breast-feeding or planning to breast-feed, ask your doctor for advice before taking this medicine.
- Do not breast-feed while you are being treated with LIBTAYO and for at least 4 months after you have been treated with the last dose .
- It is not known if LIBTAYO is excreted in human milk.
Driving and using machines
LIBTAYO has no or little effect on the ability to drive and use machines. Do not drive or use machines if you feel tired, wait until you feel better.
How to give LIBTAYO
- LIBTAYO is given to you in a hospital or clinic under the supervision of an experienced doctor.
- LIBTAYO is given to you as a drip into a vein ( intravenous infusion ).
- Infusion is given for about 30 minutes.
- LIBTAYO is usually given every three weeks.
How much LIBTAYO is given
The recommended dose of LIBTAYO is 350 mg.
Your doctor will decide how much LIBTAYO you should receive and how many treatments you will need.
During the treatment, you will have to submit blood samples to check certain blood values.
If you forgot a treatment period
If you miss an appointment, ask your doctor when you can make an appointment for the next dose. You mustn’t miss a dose of the medicine.
If you stop using LIBTAYO
Do not end treatment with LIBTAYO without first discussing it with your doctor. Discontinuation of treatment may cause the effect of the drug to disappear.
Patient warning card The
information in this leaflet can be found in the patient warning card provided by your doctor. You must keep the patient warning card and show it to your partner or healthcare provider.
If you have any further questions on the use of this product, ask your doctor.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Your doctor will discuss this with you and explain the risks and benefits of the treatment.
LIBTAYO affects your immune system and can cause inflammation in parts of your body (see section 2 “Warnings and precautions”). Inflammation can cause serious damage to your body and may need treatment or require you to stop treatment with LIBTAYO. Some inflammatory conditions can be life-threatening.
Seek emergency medical care immediately if you get any of these side effects, or if they get worse:
- Skin problems such as rash or itching , cracked blisters on the skin, sores in the mouth or sores in other mucous membranes.
- Lung problems ( pneumonia ) such as new or worsening cough, difficulty breathing or chest pain.
- Inflammation of the intestines ( colitis ) such as frequent diarrhea often mixed with blood, more stools than usual, black or tar-like stools, severe stomach pain or sore stomach.
- Inflammation of the liver ( hepatitis ) such as yellowing of the skin or whites of the eyes, severe nausea or vomiting, pain on the right side of the stomach (intestines), fatigue, dark-colored urine (tea-colored), easier bruising or bleeding than usual and less appetite than usual .
- Problems with hormone-producing glands such as disappearing headaches or unusual headaches, fast heartbeats, increased sweating,, feeling more frozen or hot than usual, severe fatigue, dizziness or fainting, weight gain or weight loss, increased hunger or thirst, hair loss, constipation, darkening voice, very low blood pressure , need to urinate more often, nausea or vomiting, abdominal pain, altered mood or behavior (such as decreased sexual desire, being irritated or forgetful).
- Symptoms of type 1 diabetes such as increased appetite and excessive thirst, need to urinate more often, weight loss and feeling tired.
- Kidney problems (kidney inflammation and kidney failure ) such as having to urinate less often than usual, blood-mixed urine, swollen feet or lower legs and decreased appetite.
- Infusion- related reactions (may be severe or life-threatening) such as chills, tremors or fever, itching or rash, reddened or swollen face, difficulty breathing or wheezing, dizziness or fainting and back or neck pain, nausea, vomiting or abdominal pain.
- Problems in other parts of the body such as:
- Nervous system problems such as headache or neck stiffness, fever, tiredness or weakness, chills, vomiting, confusion, memory or tiredness problems, twitching (seizures), seeing and hearing things that are not real (hallucinations), severe muscle weakness, tingling, numbness, weakness or burning pain in the arms and legs, paralysis of the extremities are
- Muscle and joint problems such as joint pain or swelling, muscle pain, weakness or stiffness
- Eye problems such as vision change, eye pain or red eyes, photosensitivity
- Heart and circulation problems such as altered heartbeat, fast heartbeat, feeling of the heart skipping a heartbeat or a throbbing sensation, chest pain, shortness of breath
- Other: dryness in several places on the body such as dry mouth , dry eyes, dry nose, throat and dry skin, bruising on the skin or bleeding.
The following adverse reactions have been reported in clinical trials in patients treated with cemiplimab:
Very common (may affect more than 1 user in 10):
- muscle pain or skeletal pain
- feeling tired
- rash
- diarrhea (watery, loose or soft stools).
- itching
- decreased number of red blood cells
- weak feeling of hunger
- cough
- nausea
- constipation
- upper respiratory tract infection
Common (may affect up to 1 in 10 people):
- respiratory distress
- abdominal pain (abdominal pain)
- headache
- problems in hormone-producing glands (thyroid gland ( hyperthyroidism and hypothyroidism )
- vomiting
- high blood pressure
- urinary tract infection
- elevated liver enzyme levels in the blood
- cough, pneumonia
- reactions at the infusion site
- hepatitis
- inflammation of the intestines (diarrhea, more frequent bowel movements than usual, stools that are black or tarry, severe stomach (abdominal) pain or tenderness)
- abnormal kidney function test
- inflammation of the mouth
- inflammation of the nerves that causes tingling, numbness, weakness or burning pain in the arms or legs.
- inflammation of the kidneys
- joint pain, swelling, polyarthritis and joint shedding
Uncommon (may affect up to 1 in 100 people):
- myocarditis, which can manifest as shortness of breath, irregular heartbeat, feeling tired or chest pain
- thyroiditis
- reduced secretion of hormones produced by the adrenal glands
- muscle weakness
- inflammation of the pituitary gland one found in the lower part of the brain
- pericarditis
- dryness in several parts of the body such as dry mouth , dry eyes, dry nose, throat and dry skin
- inflammation of the membranes that cover the brain and spinal cord that can be caused by an infection
- type 1 diabetes that can make you hungrier or thirsty than normal, need to urinate more often, weight loss and feeling tired
- eye pain, irritation, itching or red eyes, discomfort, photosensitivity
- muscle pain or stiffness (rheumatic polymyalgia)
- inflammation in muscles that may include muscle pain or weakness (myositis)
- bruising of the skin or bleeding
- temporary inflammation of the nerves causing pain, weakness and paralysis of the arms and legs
- a disease state in which the muscles become weak and quickly tired
Other side effects that have been reported (no known frequency):
- Rejection of transplanted organ
- Inflammation of the bladder. Signs and symptoms may include frequent and / or painful urination, urge to urinate, blood in the urine, pain or pressure in the lower abdomen.
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 expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C – 8 ° C).
Do not freeze.
Store in the original package. Sensitive to light.
Reconstituted infusion solution stored at room temperature up to 25 ° C should be used within 8 hours or within 24 hours for refrigerator storage (2 ° C – 8 ° C). If the vials and/or infusion bags are stored in a refrigerator, they must reach room temperature before use.
Do not save unused infusion fluid for reuse. Any unused product or waste material should be disposed of by local requirements.
Contents of the package and other information
Content declaration
The active substance is cemiplimab.
- 1 ml of concentrate contains 50 mg of cemiplimab.
- Each 7 ml vial contains 350 mg of cemiplimab.
The other ingredients are L-histidine, L-histidine monohydrochloride monohydrate, L- proline, sucrose, polysorbate 80, and water for injections.
What the medicine looks like and contents of the pack
LIBTAYO concentrate for solution for infusion (sterile concentrate) is a clear to slightly opalescent, colorless to a light yellow sterile solution which may contain traces of transparent to white particles.
Each pack contains 1 vial of 7 ml concentrate.
Marketing Authorisation Holder
Regeneron Ireland Designated Activity Company (DAC)
One Warrington Place,
Dublin 2, D02 HH27
Ireland
Manufacturer
Regeneron Ireland DAC
Raheen Business Park
Limerick
Ireland
For any information about this medicine, please contact the local representative of the Marketing Authorization Holder
for sale:
Sanofi AB
Tel: +46 (0) 8 634 50 00