cemiplimab (Libtayo)

Brand Names: Libtayo

Generic Name: cemiplimab

What is cemiplimab (Libtayo)?

Cemiplimab is used to treat certain cancers of the skin or lungs.

Cemiplimab is often used when the cancer has spread to other parts of the body (metastatic), or cannot be treated with other cancer drugs, radiation, or surgery.

Your doctor may perform a biopsy to test your cancer for a protein called "PD-L1," or a specific genetic marker (an abnormal "EGFR," "ALK," or "ROS1" gene).

Cemiplimab may also be used for purposes not listed in this medication guide.

What are the possible side effects of cemiplimab (Libtayo)?

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Some side effects may occur during the injection. Tell your caregiver right away if you feel dizzy, shaky, light-headed, nauseated, chilled or feverish, itchy, tingly, or have a rash, neck or back pain, trouble breathing, or swelling in your face.

Cemiplimab strengthens your immune system to help your body fight against cancer cells. This may cause the immune system to attack normal healthy tissues or organs. When this happens, you may develop serious or life-threatening medical problems.

Call your doctor at once if you have:

  • new or worsening cough, shortness of breath;
  • chest pain, fast or irregular heartbeats;
  • swollen glands;
  • a seizure;
  • severe headache, confusion, hallucinations, eye pain or redness, vision problems (your eyes may be more sensitive to light);
  • severe muscle pain or weakness, neck stiffness;
  • severe stomach pain, nausea, vomiting, diarrhea, bloody or tarry stools;
  • unusual bruising;
  • transplant rejection--mouth sores, stomach pain, feeling sick or uneasy, rash, pain or swelling near your transplanted organ;
  • kidney problems--swelling in your ankles, blood in your urine, little or no urination;
  • liver problems--right-sided upper stomach pain, loss of appetite, drowsiness, easy bruising or bleeding, dark urine, jaundice (yellowing of the skin or eyes);
  • signs of a hormonal disorder--frequent or unusual headaches, dizziness, feeling very tired, mood or behavior changes, hoarse or deepened voice, increased hunger or thirst, increased urination, constipation, hair loss, sweating, feeling cold, weight gain, or weight loss.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

  • tiredness;
  • muscle or bone pain;
  • rash, itching; or
  • nausea, diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about cemiplimab (Libtayo)?

Cemiplimab strengthens your immune system to help your body fight against cancer cells. This may cause the immune system to attack normal healthy tissues or organs. When this happens, you may develop serious or life-threatening medical problems.

Call your doctor at once if you have new or worsening symptoms such as: chest pain, cough, breathing problems, swelling, nausea, vomiting, changes in appetite or weight, stomach pain, easy bruising or bleeding, mood or behavior changes, severe weakness, vision problems, hair loss, increased or decreased urination, blood in your urine, dark urine, or yellowing of the skin or eyes.

What should I discuss with my healthcare provider before receiving cemiplimab (Libtayo)?

Tell your doctor if you have ever had:

  • an immune system disorder such as lupus, ulcerative colitis, or Crohn's disease;
  • a nerve-muscle disorder such as myasthenia gravis, Guillain-Barré syndrome,
  • diabetes; or
  • an organ transplant or stem cell transplant.

You may need to have a negative pregnancy test before starting this treatment.

Cemiplimab may harm an unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 4 months after your last dose. Tell your doctor if you become pregnant.

Do not breastfeed while using this medicine, and for at least 4 months after your last dose.

How is cemiplimab given (Libtayo)?

Cemiplimab is given as an infusion into a vein. A healthcare provider will give you this injection.

This medicine must be given slowly, and the infusion can take at least 30 minutes to complete.

Cemiplimab is usually given once every 3 weeks until your body no longer responds to the medication.

You will need frequent medical tests.


Skin Cancer Symptoms, Types, Images See Slideshow

What happens if I miss a dose (Libtayo)?

Call your doctor for instructions if you miss an appointment for your cemiplimab injection.

What happens if I overdose (Libtayo)?

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid while receiving cemiplimab (Libtayo)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What other drugs will affect cemiplimab (Libtayo)?

Other drugs may affect cemiplimab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information (Libtayo)?

Your pharmacist can provide more information about cemiplimab.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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Reviewed on 10/12/2022

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