Cemiplimab-rwlc Injection

WHY is this medicine prescribed?

Cemiplimab-rwlc injection is used to treat certain types of cutaneous squamous cell carcinoma (CSCC; skin cancer) that has spread to nearby tissues or to other parts of the body and cannot be treated well with surgery or radiation therapy. It is also used to treat basal cell carcinoma that has spread to nearby tissues or to other parts of the body after treatment with another medication, or if that medication cannot be used. Cemiplimab-rwlc injection is also used alone or in combination with platinum-containing chemotherapy to treat a certain type of non-small cell lung cancer (NSCLC) that has spread to nearby tissues and cannot be removed by surgery or treated with chemotherapy or radiation or has spread to other parts of the body. Cemiplimab-rwlc injection is in a class of medications called monoclonal antibodies. It works by killing cancer.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Cemiplimab-rwlc injection comes as a solution (liquid) to inject intravenously (into a vein) over 30 minutes by a doctor or nurse in a medical facility or infusion center. It is usually given every 3 weeks.

Your doctor may need to slow down your infusion, or interrupt or stop your treatment if you experience certain side effects. Tell your doctor immediately if you experiences any of the following symptoms during or after your infusion: chills or shaking, fever, itching, rash, feeling faint, flushing, nausea, vomiting, back or neck pain, shortness of breath, dizziness, wheezing, or face swelling.

Your doctor may delay, or stop your treatment with cemiplimab-rwlc injection depending on your response to the medication and any side effects that you experience. Talk to your doctor about how you are feeling during and after your treatment.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with cemiplimab-rwic injection and each time you receive a dose. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

What SPECIAL PRECAUTIONS should I follow?

Before receiving cemiplimab-rwlc injection,

• tell your doctor and pharmacist if you are allergic to cemiplimab-rwlc injection, any other medications, or any of the ingredients in cemiplimab-rwlc injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic) or have ever had an organ transplant. Also, tell your doctor if you have or have ever been treated with radiation therapy to your chest or if you have or ever have had diabetes, Crohn's disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever), ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum), lupus (a disease in which the body attacks many of its own organs), a nervous system disease such as myasthenia gravis (a disorder of the nervous system that causes muscle weakness) or Guillain-Barré syndrome (GBS; weakness, tingling, and possible paralysis due to sudden nerve damage), a lung disease or breathing problems, or thyroid, liver or kidney disease.

• tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while you are receiving cemiplimab-rwlc injection. You will need to have a pregnancy test before you begin receiving this medication. Use effective birth control during your treatment with cemiplimab-rwlc injection and for 4 months after your final dose. If you become pregnant while receiving cemiplimab-rwlc injection, call your doctor. Cemiplimab-rwlc injection may harm the fetus.

• tell your doctor if you are breastfeeding. Your doctor will tell you not to breastfeed during your treatment with cemiplimab-rwlc injection and for 4 months after your final dose.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What SIDE EFFECTS can this medicine cause?

Cemiplimab-rwlc injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• constipation
• hair loss
• muscle, joint, bone, or back pain

Some side effects can be serious. If you experience any of these symptoms or those in the HOW section, call your doctor immediately or get emergency medical treatment:

• cough; irregular heartbeat; chest pain; or shortness of breath
• diarrhea; stools that are black, tarry, sticky, or have blood or mucus; or abdominal pain or tenderness
• yellow eyes or skin; severe nausea or vomiting; dark urine; loss of appetite; unusual bleeding or bruising; or pain or discomfort in right upper stomach area
• rash; blistering skin; itching; swollen lymph nodes; fever or flu-like symptoms; or painful sores or ulcers in mouth or nose, throat, or genital area
• decreased urine amount; swelling in your ankles; blood in urine; loss of appetite
• headaches that won't go away or unusual headaches; feeling more hungry or thirsty than usual; increased sweating; extreme tiredness; frequent urination; or weight changes
• double vision, blurry vision, eye sensitivity to light, eye pain, or changes in vision
• feeling cold; deepening of voice or hoarseness; hair loss; irritability; dizziness or fainting; fast heartbeat; forgetfulness; or changes in sexual desire
• confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, or tingling or numbness of arms or legs
• persistent muscle pain or weakness or muscle cramps

Cemiplimab-rwlc injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. If you are being treated for NSCLC, your doctor will order a lab test before you begin your treatment to see whether your cancer can be treated with cemiplimab-rwlc. Your doctor will order certain lab tests to check your body's response to cemiplimab-rwlc injection.

Ask your pharmacist any questions you have about cemiplimab-rwlc injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.