Libtayo is a medicine used to treat skin cancer by working with your immune system.

Libtayo is used to treat a certain type of skin cancer called cutaneous squamous cell carcinoma (CSCC) that has spread to other parts of the body or cannot be treated with radiation or surgery.

Libtayo is used to treat a type of skin cancer called basal cell carcinoma (BCC) that cannot be removed by surgery (locally advanced BCC), or has spread to other parts of the body (metastatic BCC), and you have received treatment with a hedgehog pathway inhibitor (HHI), or if you cannot receive treatment with a HHI.

Libtayo is also used to treat a type of lung cancer called non-small cell lung cancer (NSCLC) as a first treatment when the cancer has not spread outside the chest (locally advanced NSCLC) and you cannot have surgery or chemotherapy with radiation, or when the cancer has spread to other areas of the body (metastatic NSCLC) and the tumor does not have an abnormal "EGFR", "ALK" or "ROS1" gene. It is used in combination with chemotherapy that contains a platinum medicine, or as a single agent when your tumor also tests positive for high “PD-L1”.

Libtayo can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. These problems may happen anytime during treatment or even after your treatment has ended.

Libtayo 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.

Libtayo 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.

Libtayo 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

Usual Adult Dose for Non-Small Cell Lung Cancer:

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

Uses:
-in combination with platinum-based chemotherapy for the first-line treatment of adult patients with locally advanced (where patients are not candidates for surgical resection or definitive chemoradiation) or metastatic non-small cell lung cancer (NSCLC) with no EGFR, ALK or ROS1 aberrations
-as single agent for the first-line treatment of adult patients with locally advanced (where patients are not candidates for surgical resection or definitive chemoradiation) or metastatic NSCLC whose tumors have high PD-L1 expression [Tumor Proportion Score (TPS) = 50%] as determined by an FDA-approved test, with no EGFR, ALK or ROS1 aberrations

To make sure Libtayo is safe for you, 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 Libtayo.

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 Libtayo, and for at least 4 months after your last dose.

Call your doctor for instructions if you miss an appointment for your Libtayo 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.

Get emergency medical help if you have signs of an allergic reaction to Libtayo: 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-rwlc 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;

• 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 Libtayo 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.

Other drugs may interact with cemiplimab-rwlc , 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.