Avelumab Injection

Avelumab injection is used to treat Merkel cell carcinoma (MCC; a type of skin cancer) that has spread to other parts of the body in adults and children 12 years of age and older. Avelumab injection is also used to treat urothelial cancer (cancer of the lining of the bladder and other parts of the urinary tract) that has spread to nearby tissues or other parts of the body in people whose cancer worsened during or within 12 months after it was treated with platinum chemotherapy medications. It is also used as ongoing treatment for urothelial cancer that has spread to nearby tissues or other parts of the body to help maintain the response to platinum chemotherapy. Avelumab injection is also used in combination with axitinib (Inlyta) as a first treatment for renal cell carcinoma (RCC; cancer that begins in the kidney) that has spread or cannot be removed by surgery. Avelumab injection is in a class of medications called monoclonal antibodies. It works by helping the body to slow or stop the growth of cancer cells.

Avelumab injection comes as a solution (liquid) to be injected intravenously (into a vein) over 60 minutes by a doctor or nurse in a medical facility or infusion center. It is usually given once every 2 weeks. Your doctor will decide how often you are to receive avelumab based on your body's response to this medication.

Avelumab injection may cause serious reactions during the infusion of the medication. You may be given other medications to treat or help prevent reactions to avelumab. A doctor or nurse will monitor you carefully while you are receiving the medication. Tell your doctor or nurse immediately if you experience any of the following symptoms during the infusion: chills or shaking, hives, fever, flushing, back pain, shortness of breath, wheezing, dizziness, feeling faint, or stomach pain. Your doctor may need to slow down your infusion or delay or permanently stop your treatment if you experience these side effects.

Your doctor may also permanently or temporarily stop your treatment, or treat you with other medications if you experience other side effects. Be sure to tell your doctor how you are feeling during your treatment with avelumab injection.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with avelumab injection and each time you receive the medication. 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.

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

Before receiving avelumab injection,

• tell your doctor and pharmacist if you are allergic to avelumab, any other medications, or any of the ingredients in avelumab injection. Ask your pharmacist 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.
• tell your doctor if you have or have ever had an organ or bone marrow transplant; radiation therapy to your chest area. diabetes; thyroid problems; high blood pressure; high cholesterol; an autoimmune disease (condition in which the immune system attacks a healthy part of the body) such as 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), or lupus (condition in which the immune system attacks many tissues and organs including the skin, joints, blood, and kidneys); any condition that affects your nervous system such as myasthenia gravis (a disorder of the nervous system that causes muscle weakness) or Guillain-Barré syndrome (weakness, tingling, and possible paralysis due to sudden nerve damage); any type of lung disease or breathing problems; or liver, heart, or kidney disease. Also tell your doctor if you have or have ever had cytomegalovirus (CMV; a viral infection that may cause symptoms in patients with weak immune systems).
• tell your doctor if you are pregnant or plan to become pregnant. Use a reliable method of birth control to prevent pregnancy during your treatment and for 1 month after your final dose of avelumab. Talk to your doctor about birth control methods that will work for you. If you become pregnant while receiving avelumab, call your doctor immediately. Avelumab may harm the fetus.
• tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed while receiving avelumab and for 1 month after your final dose.

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

If you miss an appointment to receive avelumab, call your doctor as soon as possible.

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

• muscle, bone, or joint pain
• headache
• constipation
• nausea
• vomiting
• weight loss
• tiredness

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:

• new or worsening cough; shortness of breath; or chest pain
• yellowing of the skin or eyes; nausea; vomiting; pain in upper right side of stomach; dark (tea-colored) urine; extreme tiredness; or unusual bruising or bleeding
• headaches that won't go away or unusual headaches; rapid heartbeat; constipation; increased sweating; voice changes; weight changes; feeling more hungry or thirsty than usual; dizziness or fainting; hair loss; vomiting; changes in mood or behavior such as decreased sex drive, feeling irritable, confused, or forgetful; stomach pain; or feeling cold
• diarrhea; blood in stools; dark, tarry, sticky stools; or stomach area pain or tenderness
• persistent muscle pain, weakness, or muscle cramps
• feeling dizzy or faint
• neck stiffness
• swelling of hands, feet, ankles, or legs
• irregular heartbeat; chest pain and tightness; pain in the arms, back, neck, or jaw; breaking out in cold sweat
• fever or other flu-like symptoms
• blurry or double vision, sensitivity to light, or other vision problems
• rash, itching, blistering or peeling skin
• sores in mouth, nose, throat, or genital area
• swollen glands
• decreased urination; blood in urine; swelling in ankles; or loss of appetite
• unusual bleeding or bruising
• frequent, painful, or urgent urination

Avelumab 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 (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before and during your treatment to check your body's response to avelumab.

Ask your pharmacist any questions you have about avelumab 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.

• Bavencio^®