Cosibelimab-ipdl Injection

WHY is this medicine prescribed?

Cosibelimab-ipdl 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. Cosibelimab-ipdlis is in a class of medications called monoclonal antibodies. It works by helping your immune system to slow or stop the growth of cancer cells.

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?

Cosibelimab-ipdl comes as a solution (liquid) to be injected into a vein over 60 minutes by a doctor or nurse in a hospital or medical facility. It is usually injected once every 3 weeks. The length of your treatment will be decided by your doctor and depends on how well your body responds to the medication and the side effects that you experience.

Cosibelimab-ipdl injection may cause serious or life-threatening infusion reactions. A doctor or nurse will watch you closely while receiving the infusion. Tell your doctor immediately if you experience any of the following symptoms during or after your infusion: chills or shaking, fever, itching, rash, feeling faint, flushing, nausea, back or neck pain, shortness of breath, dizziness, or wheezing.

Your doctor may need to temporarily or permanently stop your treatment, or treat you with additional medications, depending on your response to the medication and the side effects that you experience. It is important for you to tell your doctor how you are feeling during your treatment with cosibelimab-ipdl injection.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with cosibelimab-ipdl 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 (https://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 cosibelimab-ipdl injection,

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

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

• 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, including corneal 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 cosibelimab-ipdl injection. You may need to have a pregnancy test before you begin receiving this medication. Use effective birth control during your treatment with cosibelimab-ipdl injection and for 4 months after your final dose. If you become pregnant while receiving cosibelimab-ipdl injection, call your doctor. Cosibelimab-ipdl injection may harm the fetus.

• tell your doctor if you are breastfeeding or plan to breastfeed. Your doctor will tell you not to breastfeed during your treatment with cosibelimab-ipdl 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 should I do IF I FORGET to take a dose?

If you miss an appointment to receive cosibelimab-ipdl injection, call your doctor as soon as possible.

What SIDE EFFECTS can this medicine cause?

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

• muscle or bone pain
• feeling tired or weak
• nausea
• constipation
• swelling of arms, hands, feet, or lower legs
• headache

Some side effects can be serious. If you experience any of these symptoms or those listed 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 or peeling 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, or 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

Cosibelimab-ipdl injection may cause other side effects. Call your doctor if you have any unusual problems while taking 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 (https://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. Your doctor will order certain lab tests to check your body's response to cosibelimab-ipdl 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.