cemiplimab (Libtayo)

Brand Names: Libtayo

Generic Name: cemiplimab

• What is cemiplimab (Libtayo)?
• What are the possible side effects of cemiplimab (Libtayo)?
• What is the most important information I should know about cemiplimab (Libtayo)?
• What should I discuss with my healthcare provider before receiving cemiplimab (Libtayo)?
• How is cemiplimab given (Libtayo)?
• What happens if I miss a dose (Libtayo)?
• What happens if I overdose (Libtayo)?
• What should I avoid while receiving cemiplimab (Libtayo)?
• What other drugs will affect cemiplimab (Libtayo)?
• Where can I get more information (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.

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.

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.

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.

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.

SLIDESHOW

Skin Cancer Symptoms, Types, Images See Slideshow

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

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

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

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.

Your pharmacist can provide more information about cemiplimab.

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