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Cemiplimab-rwlc (Intravenous)

Medically reviewed by Last updated on May 3, 2022.

Commonly used brand name(s)

In the U.S.

  • Libtayo

Available Dosage Forms:

  • Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Cemiplimab

Uses for cemiplimab-rwlc

Cemiplimab-rwlc injection is used to treat a type of skin cancer called cutaneous squamous cell carcinoma (CSCC) that has spread (metastatic) or cannot be cured by surgery or radiation (locally advanced).

Cemiplimab-rwlc injection is also used to treat a type of skin cancer called basal cell carcinoma (BCC) that cannot be removed by surgery (locally advanced) or that has spread (metastatic) in patients who have received previous treatment with a hedgehog pathway inhibitor (HHI) or who cannot receive treatment with a HHI.

Cemiplimab-rwlc injection is also used as a first-line treatment for non-small cell lung cancer (NSCLC) that has not spread and cannot be removed by surgery or radiation (locally advanced), or that has spread (metastatic) in patients whose tumors express high PD-L1 and do not have an abnormal EGFR, ALK , or ROS1 gene. Your doctor will perform a test to check for the PD-L1 tumor before you receive cemiplimab-rwlc.

Cemiplimab-rwlc is an antineoplastic agent (cancer medicine). It interferes with the growth of cancer cells, which are eventually destroyed by the body.

Cemiplimab-rwlc is to be given only by or under the supervision of your doctor.

Before using cemiplimab-rwlc

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For cemiplimab-rwlc, the following should be considered:


Tell your doctor if you have ever had any unusual or allergic reaction to cemiplimab-rwlc or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Appropriate studies have not been performed on the relationship of age to the effects of cemiplimab-rwlc injection in the pediatric population. Safety and efficacy have not been established.


Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of cemiplimab-rwlc injection in the elderly.


There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with food/tobacco/alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems

The presence of other medical problems may affect the use of cemiplimab-rwlc. Make sure you tell your doctor if you have any other medical problems, especially:

  • Adrenal gland problem or
  • Colitis (inflammation of the colon) or
  • Crohn’s disease or
  • Diabetic ketoacidosis or
  • Hepatitis (inflammation of the liver) or
  • Hyperthyroidism (high levels of thyroid hormone) or
  • Hypophysitis (inflammation of the pituitary gland) or
  • Hypothyroidism (low levels of thyroid hormone) or
  • Lupus or
  • Nephritis (inflammation of the kidneys) or
  • Nervous system problems (eg, Guillain-Barré syndrome, myasthenia gravis) or
  • Organ transplant, recent or
  • Pneumonitis (inflammation of the lungs) or
  • Type 1 diabetes or
  • Ulcerative colitis—Use with caution. May make these conditions worse.
  • Patients who have had allogeneic hematopoietic stem cell transplant (HSCT)—Use with caution. May cause side effects to become worse.

Proper use of cemiplimab-rwlc

A nurse or other trained health professional will give you cemiplimab-rwlc in a medical facility. It is given through a needle placed into a vein. The medicine must be given slowly, so the needle will have to remain in place for at least 30 minutes.

Medicines used to treat cancer are very strong and can have many side effects. Before receiving cemiplimab-rwlc, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

Cemiplimab-rwlc comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Missed dose

Cemiplimab-rwlc needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

Precautions while using cemiplimab-rwlc

It is very important that your doctor check your progress closely to make sure cemiplimab-rwlc is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using cemiplimab-rwlc while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control to keep from getting pregnant during treatment with cemiplimab-rwlc and for at least 4 months after the last dose. If you think you have become pregnant while using cemiplimab-rwlc, tell your doctor right away.

Tell your doctor right away if you have a cough, chest tightness, or any type of breathing problem with cemiplimab-rwlc. These could be symptoms of a serious lung problem.

Colitis (inflammation of the bowels) may occur with cemiplimab-rwlc. Tell your doctor right away if you have stomach pain or tenderness, watery or bloody diarrhea, or fever after receiving the medicine.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, a loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Serious problems with the adrenal, pituitary, or thyroid glands (hormone glands) may occur while you are receiving cemiplimab-rwlc. Tell your doctor if you start having continuing or unusual headaches, changes in mood or behavior (eg, being irritable or forgetful), lightheadedness, dizziness, or fainting, unusual sluggishness, or an increase in weight.

Cemiplimab-rwlc may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.

Tell your doctor right away if you have bloody or cloudy urine, nausea, vomiting, trouble breathing, swelling of the face, feet, or lower legs, unusual tiredness or weakness, or unusual weight gain. These may be symptoms of nephritis (inflammation of the kidney).

Tell your doctor right away if you have changes in your eyesight, severe or persistent muscle or joint pain, or severe muscle weakness after receiving cemiplimab-rwlc.

Serious skin reactions (eg, exfoliative dermatitis, Stevens-Johnson syndrome, drug rash with eosinophilia and systemic syndrome (DRESS), or toxic epidermal necrolysis) can occur with cemiplimab-rwlc. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions, often with a purple center, severe acne or skin rash, sore throat, sores or ulcers on the skin, mouth, or lips, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness with cemiplimab-rwlc.

Cemiplimab-rwlc may cause inflammation of the heart muscle (myocardium) called myocarditis. Check with your doctor right away if you have chest pain or discomfort, fever, chills, a fast heartbeat, or trouble breathing.

Call your doctor right away if you have difficulty with breathing, swallowing, or talking, muscle weakness, severe tiredness, or sudden numbness and weakness in the arms or legs. These could be symptoms of a nervous system problem.

Check with your doctor right away if you have severe headache, drowsiness, confusion, general feeling of illness, or stiff neck or back while you are receiving cemiplimab-rwlc. These may be symptoms of meningitis.

Cemiplimab-rwlc may cause infusion-related reactions, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you start to have a fever, chills or shaking, dizziness, trouble breathing, itching or rash, lightheadedness or fainting after receiving cemiplimab-rwlc.

Cemiplimab-rwlc may increase your risk for possible organ transplant rejection. Talk to your doctor about this risk.

Cemiplimab-rwlc side effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

  • Chills
  • cough
  • diarrhea
  • fever
  • hoarseness
  • itching, skin rash
  • lower back or side pain
  • painful or difficult urination

Less common

  • Bladder pain
  • bloody or cloudy urine
  • blurred vision
  • body aches or pain
  • chest pain, discomfort, or tightness
  • confusion
  • dark urine
  • dizziness
  • ear congestion
  • fainting
  • frequent urge to urinate
  • general feeling of discomfort or illness
  • headache
  • light-colored stools
  • lightheadedness
  • loss of voice
  • muscle or bone pain
  • muscle weakness
  • nausea
  • nervousness
  • pain, redness, swelling, tenderness, or warmth on the skin
  • pale skin
  • pounding in the ears
  • rapid, shallow breathing
  • runny or stuffy nose
  • slow or fast heartbeat
  • sneezing
  • sore throat
  • stiff neck or back
  • thickening of bronchial secretions
  • trouble breathing
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • upper right stomach pain
  • vomiting
  • yellow eyes and skin


  • Blistering, peeling, or loosening of the skin
  • difficulty in moving
  • joint or muscle pain
  • muscle aches, cramps, or stiffness
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • sores, ulcers, or white spots in the mouth or on the lips
  • swollen glands
  • swollen joints

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Constipation
  • decreased appetite

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Frequently asked questions

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.