cemiplimab

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

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.

What is cemiplimab?

Cemiplimab is used to treat certain cancers of the skin.

Cemiplimab is also used alone or in combination with other cancer drugs to treat lung cancer that has not spread outside your chest.

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 should I discuss with my healthcare provider before receiving cemiplimab?

Tell your doctor if you have ever had:

• an immune system disorder such as lupus, ulcerative colitis, or Crohn's disease;
• a nervous system problem, such as myasthenia gravis or Guillain-Barré syndrome;
• radiation treatment to your chest area; or
• an organ transplant.

Tell your doctor if you have received or plan to receive a stem cell transplant using donor stem cells.

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

How is cemiplimab given?

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.

What happens if I miss a dose?

What happens if I overdose?

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?

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

What are the possible side effects of cemiplimab?

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.

• new or worsening cough, shortness of breath;
• painful sores in your nose or genital area;
• chest pain, fast or irregular heartbeats;
• swollen glands;
• severe headache, confusion, memory problems, hallucinations;
• eye pain or redness, vision problems (your eyes may be more sensitive to light);
• severe muscle pain or weakness, neck stiffness, problems with balance;
• 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); or
• 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.

Common side effects may include:

• tiredness;
• hair loss;
• numbness, pain, tingling or burning in your hands or feet;
• muscle or bone pain;
• rash; or
• nausea, diarrhea, loss of appetite.

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 other drugs will affect cemiplimab?

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?

Your pharmacist can provide more information about cemiplimab.