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.

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.

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.

Usual Adult Dose for Squamous Cell Carcinoma:

350 mg IV over 30 minutes every 3 weeks until disease progression or unacceptable toxicity

Use: For the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation

Usual Adult Dose for Basal Cell Carcinoma:

350 mg IV over 30 minutes every 3 weeks until disease progression or unacceptable toxicity

Uses:
-For locally advanced basal cell carcinoma (laBCC) previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate
-For metastatic BCC (mBCC) previously treated with a hedgehog pathway inhibitor or for whom a hedgehog pathway inhibitor is not appropriate

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.

Cemiplimab may harm an unborn baby. Use effective birth control to prevent pregnancy while you are using cemiplimab 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.

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

Since cemiplimab 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.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes, 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.

Cemiplimab may cause serious side effects. Call your doctor at once if you have:

• 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.

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

Common side effects of cemiplimab 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.

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.