Patient Medication Information: uses, side effects, how to take - Libtayo (Regeneron Canada)
Serious Warnings and Precautions Box
Serious Warnings and Precautions
Severe and fatal immune-mediated adverse reactions have been observed in patients treated with LIBTAYO. Fatal and life-threatening immune-mediated adverse reactions include pneumonitis, hepatitis, Stevens-Johnson syndrome /toxic epidermal necrolysis, nephritis, myocarditis, myositis, paraneoplastic encephalomyelitis, meningitis, and pancreatitis, as well as toxicities in other organ systems [see 7 Warnings and Precautions, Immune].
For early identification and management of immune-mediated adverse reactions [see sections 7 Warnings and Precautions and 4 Dosage and Administration].
What LIBTAYO is used for:
LIBTAYO is a prescription medicine used to treat:
Cutaneous Squamous Cell Carcinoma
adult patients with a type of skin cancer called cutaneous squamous cell carcinoma (CSCC) when your cancer:
- has spread or grown, and
- your tumour cannot be removed by surgery or treated with radiation, or
- to help prevent CSCC from coming back after it has been removed by surgery and radiation.
Non-Small Cell Lung Cancer
adult patients with a type of lung cancer called non-small cell lung cancer (NSCLC) and your cancer:
- has spread, or grown and you are not a candidate to undergo surgery or be treated with chemotherapy and radiation
- your tumour was tested, and found to express a specific protein called programmed death-ligand 1 (PD-L1) in 50% or more of the tumour cells, and
- your tumour does not have an abnormal epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or c-ROS oncogene 1 (ROS1) gene.
adult patients with NSCLC, in combination with chemotherapy that contains platinum based medicine, and your cancer:
- has spread or grown and you are not a candidate to undergo surgery or be treated with chemotherapy and radiation, and
- your tumour does not have an abnormal EGFR, ALK, or ROS1 gene.
Basal Cell Carcinoma
patients with a type of skin cancer called basal cell carcinoma (BCC) when your cancer:
- has been previously treated with a drug called a hedgehog pathway inhibitor.
Cervical Cancer
- adult patients with cervical cancer when the cancer has worsened on or after chemotherapy.
How LIBTAYO works:
LIBTAYO works by helping your immune system fight your cancer.
The ingredients in LIBTAYO are:
Medicinal ingredients: Cemiplimab
Non-medicinal ingredients: L-histidine, L-histidine monohydrochloride monohydrate, L-proline, Polysorbate 80, Sucrose, Water for injection
LIBTAYO comes in the following dosage form:
LIBTAYO comes in a 10mL glass vial containing 350 mg of cemiplimab.
Do not use LIBTAYO if:
- You are allergic to cemiplimab or any of the other ingredients in this medicine. Talk to your health care professional if you are not sure.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take LIBTAYO. Talk about any health conditions or problems you may have, including if you:
- Have an autoimmune disease (a condition where your body attacks its own cells)
- Have had an organ transplant, including stem cell transplant that uses donor stem cells (allogeneic)
- Have lung or breathing problems
- Have liver problems
- Have kidney problems
- Have diabetes
- Have any other medical conditions
- Have a history of taking idelalisib (a medication to treat cancer)
- Are taking other medicines that make your immune system weak. Examples of these may include steroids, such as prednisone
Other warnings you should know about:
Pregnancy:
- If you are pregnant, or are planning to have a baby, tell your healthcare professional before taking this medicine. You must not use LIBTAYO if you are pregnant unless your healthcare professional specifically recommends it.
- LIBTAYO can cause harm to your unborn baby.
- If you are a woman who could become pregnant, you must use effective birth control while you are being treated with LIBTAYO and for at least 4 months after your last dose.
Breastfeeding:
- If you are breast-feeding, or plan to breast-feed, tell your healthcare professional.
- Do not breast-feed while receiving LIBTAYO and for at least 4 months after your last dose.
- It is unknown if LIBTAYO passes into your breast milk. A risk to the breast-fed infant cannot be excluded.
Children and adolescents:
- LIBTAYO should not be used in children and adolescents below 18 years of age.
Driving and using machines
- It is not known whether LIBTAYO affects your ability to drive or use tools or machines. However, if you feel tired, do not drive or use tools or machines until you feel better.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with LIBTAYO:
- There are no known drug-drug interaction with LIBTAYO. However, steroids may reduce the effectiveness of LIBTAYO and other drugs in this class (PD-1 inhibitors).
How to take LIBTAYO:
- You will receive LIBTAYO in a hospital or clinic under the supervision of an experienced healthcare professional.
- You will receive LIBTAYO as a drip into a vein (intravenous infusion).
- It will last about 30 minutes.
- LIBTAYO is usually given every 3 weeks or every 6 weeks depending on the dose of LIBTAYO you are receiving. Your doctor may choose to treat you with an every 2 week regimen if more appropriate for you.
Usual dose:
The recommended dose of LIBTAYO is 350 mg every 3 weeks. Your doctor will decide how much LIBTAYO you will receive, and how many treatments you will need.
| Indication | Recommended dosage of LIBTAYO as an intravenous infusion | Duration of Treatment |
|---|---|---|
| Adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) | 350 mg every 3 weeks | Until disease progression or, unacceptable toxicity, whichever occurs first. |
| Adjuvant treatment of adult patients with CSCC at high risk of recurrence after surgery and radiation | 350 mg every 3 weeks for 12 weeks, followed by 700 mg every 6 weeks Or 350 mg every 3 weeks | Until disease recurrence, unacceptable toxicity, or up to 48 weeks of total therapy. |
| Adults with locally advanced basal cell carcinoma (laBCC) or metastatic BCC (mBCC) | 350 mg every 3 weeks | Until disease progression, unacceptable toxicity, whichever occurs first. |
| Adults with non-small cell lung cancer (NSCLC) | 350 mg every 3 weeks | Until disease progression or unacceptable toxicity, whichever occurs first. |
| Adults with cervical cancer | 350 mg every 3 weeks | 96 weeks or until disease progression or unacceptable toxicity, whichever occurs first. |
Your doctor will test your blood for certain side effects during your treatment.
Overdose:
If you think you, or a person you are caring for, have taken too much LIBTAYO, contact a healthcare professional, hospital emergency department or regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
Missed Dose:
If you miss any appointments, call your healthcare professional as soon as possible to reschedule your appointment. It is very important that you do not miss a dose of this medicine.
Possible side effects from using LIBTAYO:
These are not all the possible side effects that you may have when taking LIBTAYO. If you experience any side effects not listed here, tell your healthcare professional.
These may happen anytime during treatment or even after your treatment has ended. You may have more than one side effect at the same time.
The following side effects have been reported in clinical trials when LIBTAYO is given alone:
Very common (may affect more than 1 in 10 people)
- Abdominal pain
- Constipation
- Cough
- Decreased appetite
- Diarrhea
- Feeling tired (fatigue)
- Hair loss (alopecia)
- Itching (pruritus)
- Low red blood cell count (anemia)
- Muscle and bone pain
- Nausea
- Rash
- Upper respiratory tract infection
Common (may affect less than 1 in 10, but more than 1 in 100 people)
- Abdominal swelling
- Abnormal kidney function test
- Altered sense of taste (dysgeusia)
- Changes in blood, liver, and urine laboratory values
- Changes in weight
- Chest pain
- Chills
- Difficulty breathing
- Difficulty sleeping (insomnia)
- Dizziness
- Dry mouth
- Dry skin
- Eczema
- Fever
- Flu-like symptoms
- Gastric reflux
- Headache
- High blood pressure (hypertension)
- Hypersensitivity
- Infusion-related reactions
- Mood changes
- Mouth sores
- Muscle spasms
- Numbness, tingling or pain in your feet or hands (peripheral neuropathy)
- Rapid heartbeat (tachycardia)
- Ringing in the ears (tinnitus)
- Scaly patches on the skin (actinic keratosis)
- Swelling (oedema)
- Urinary tract infection
- Vomiting
- Watering eyes (lacrimation)
Uncommon (may affect less than 1 in 100, but more than 1 in 1000 people)
- Chest pain, shortness of breath, fatigue, abdominal or leg swelling (pericarditis)
- Stomach pain or upset (gastritis)
- Type 1 diabetes
Rare (may affect more than 1 in 10,000 to less than 1 in 1000 people)
- Eye redness or pain, blurred vision (keratitis)
The following side effects have been reported in clinical trials when LIBTAYO is given in combination with chemotherapy. Ask your doctor for more information regarding side effects of your chemotherapy.
Very common (may affect more than 1 in 10 people):
- Decreased number of red blood cells
- Hair loss
- Muscle pain or bone pain
- Nausea
- Feeling tired
- Inflammation of the nerves causing tingling, numbness, weakness or burning pain of the arms or legs
- High blood sugar
- Feeling less hungry
- Increased liver enzymes in blood
- Decrease in the number of white blood cells (neutrophils)
- Constipation
- Decrease in the number of platelets
- Shortness of breath
- Rash
- Vomiting
- Weight loss
- Trouble sleeping
- Diarrhea (loose stools)
- Low levels in the blood of a protein called ‘albumin’.
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |||
|---|---|---|---|---|---|
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |||
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |||
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |||
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |||
| Only if severe | In all cases | ||||
| Only if severe | In all cases | ||||
| Only if severe | In all cases | ||||
| Only if severe | In all cases | ||||
| Only if severe | In all cases | ||||
| Very Common | |||||
| Itching | √ | ||||
| Rash | √ | ||||
| Respiratory tract (lung) infection: runny nose, shortness of breath, fever | √ | ||||
| Common | |||||
| Arthritis: pain or swelling in the joints | √ | ||||
| Colitis (inflammation of the colon): diarrhea, stools that are black, tarry, sticky, or have blood or mucous, severe abdominal pain | √ | ||||
| Conjunctivitis (inflammation of the eye or eyelid): eye redness, watering eyes | √ | ||||
| Dyspnea (shortness of breath) | √ | ||||
| Gastritis (inflammation of the stomach lining): stomach pain, nausea, vomiting, decreased appetite | √ | ||||
| Hepatitis (inflammation of the liver): yellowing of the skin or the whites of the eyes, severe nausea or vomiting, pain on the right side of the abdomen, feeling sleepy, dark urine, bleeding or bruising more easily than normal, decreased appetite | √ | ||||
| Hyperthyroidism (overactive thyroid gland): rapid or irregular heartbeat, high blood pressure, increased sweating, feeling more hot than usual, mood swings | √ | ||||
| Hypoesthesia: total or partial loss of sensation in a part of your body | √ | ||||
| Hypothyroidism (underactive thyroid gland): feeling tired, weight gain, constipation, feeling more cold than usual, hair loss, depression | √ | ||||
| Infusion-related reactions: chills or shaking, fever, itching or rash, flushing or swollen face, shortness of breath or wheezing, dizziness, back or neck pain | √ | ||||
| Muscle weakness | √ | ||||
| Nephritis (inflammation of the kidneys): swelling of the ankles, decreased urination, decreased appetite | √ | ||||
| Peripheral neuropathy (damaged nerves): numbness, tingling or pain in your hands or feet | √ | ||||
| Pneumonia (infection in the | √ | ||||
| lungs): new or worsening cough, fever, shortness of breath | |||||
| Pneumonitis (inflammation of the lungs): new or worsening cough, shortness of breath, chest pain | √ | ||||
| Stomatitis (inflammation of the mouth): painful mouth ulcers, blisters, or peeling | √ | ||||
| Urinary tract infection: pain or burning with urination, increased urination | √ | ||||
| Uncommon | |||||
| Adrenal insufficiency (underactive adrenal gland): feeling tired, dizzy or weak, nausea, vomiting, diarrhea, low blood pressure | √ | ||||
| Hypophysitis (inflammation of the pituitary gland): headache, nausea, vomiting, increased thirst, vision changes | √ | ||||
| Myocarditis (inflammation of heart muscles): chest pain, rapid or irregular heartbeat, shortness of breath | √ | ||||
| Myositis (inflammation of the muscles): muscle pain or weakness, which could be associated with a rash (dermatomyositis), feeling tired after standing or walking | √ | ||||
| Pericarditis (inflammation of heart membrane): chest pain, shortness of breath, feeling tired, swelling of the abdomen or legs | √ | ||||
| Skin blistering | √ | ||||
| Sjogren's syndrome (disease affecting salivary and tear glands): dry eyes, nose, mouth, and throat | √ | ||||
| Thyroiditis (inflammation of the thyroid gland): irritability, rapid heartbeat, changes in weight, | √ | ||||
| feeling tired, constipation, depression | |||||
| Type 1 diabetes (blood sugar problems): hunger or thirst, increased urination, weight loss | √ | ||||
| Ulcers in mouth or other mucous membranes | √ | ||||
| Rare | |||||
| Chronic inflammatory demyelinating polyradiculoneuropathy: tingling or loss of feeling in your arms and legs, weakness | √ | ||||
| Encephalitis (inflammation of the brain): headache, fever, pain in muscles or joints, feeling tired or weak | √ | ||||
| Meningitis (inflammation of the protective covering of the brain): headache, nausea, vomiting, decreased appetite, confusion, fever, seizures | √ | ||||
| Myasthenia gravis: feeling tired or weak, double vision, difficulty speaking, swallowing or chewing | √ | ||||
| Paraneoplastic encephalomyelitis: loss of muscle tone or coordination, muscle weakness | √ | ||||
| Polymyalgia rheumatica: pain in the shoulders, neck, upper arms, buttocks or hips, stiffness, feeling tired | √ | ||||
| Hemophagocytic lymphohistiocytosis: fever, enlargement of liver or spleen, swollen lymph nodes, skin rash, jaundice (yellow colour of your skin and eyes), coughing, trouble breathing, stomach ache, vomiting, diarrhea, headache, trouble walking, visual problems, and weakness | √ | ||||
| Unknown Frequency | |||||
| Aplastic anemia: Insufficient production of new blood cells | √ | ||||
| Uveitis: eye pain, irritation, itchiness or redness, inflammation, blurred vision, uncomfortable sensitivity to light | √ | ||||
| Pancreatitis: vomiting, abdominal pain, nausea | √ | ||||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
If you want more information about LIBTAYO:
- Talk to your healthcare professional.
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (Drug Product Database: Access the database); or by calling Regeneron Medical Information at 1-844-734-6643.
Date of Authorization: 2026-06-23
LIBTAYO® is a registered trademark of Regeneron Pharmaceuticals Inc.