Avelumab is used to treat a type of skin cancer called Merkel cell carcinoma in adults and children at least 12 years old, when the cancer has spread to other parts of the body (metastatic).

Avelumab is also used to treat a certain type of cancer of the bladder or urinary tract that has spread or cannot be removed with surgery. Avelumab is given for this condition after platinum cancer medicines did not work or have stopped working.

Avelumab is also used alone or in combination with another medicine called axitinib to treat advanced kidney cancer that has spread or cannot be removed with surgery.

Avelumab may also be used for purposes not listed in this medication guide.

Avelumab works by causing your immune system to attack tumor cells. Avelumab may cause your immune system to attack healthy organs and tissues in your body. This could lead to serious or life-threatening side effects on your lungs, liver, pancreas, kidneys, intestines, thyroid, or adrenal glands.

Call your doctor at once if you have symptoms such as: fever, cough, flu symptoms, muscle pain or weakness, vision changes, chest pain, trouble breathing, severe stomach pain or diarrhea, skin rash, swelling in your ankles, increased or decreased urination, blood in your urine or stools, weight changes, hair loss, unusual bleeding, dark urine, or jaundice (yellowing of your skin or eyes).

Avelumab is given as an infusion into a vein, usually once every 2 weeks. A healthcare provider will give you this injection.

Avelumab must be given slowly and the IV infusion can take at least 60 minutes to complete.

You may be given other medication to prevent certain side effects that may occur during the infusion.

You may need frequent medical tests to check your heart or liver function, and to help your doctor determine how long to treat you with avelumab.

Tell your doctor if you have ever had:

• a condition that affects your nervous system such as myasthenia gravis or Guillain-Barré syndrome;

• an immune system disorder such as ulcerative colitis or Crohn's disease;

• lung problems or a breathing disorder;

• liver or kidney disease;

• heart problems or high blood pressure;

• high cholesterol;

• diabetes;

• an organ transplant; or

• if you have received or will receive a transplant of stem cells from a donor.

You should not use avelumab if you are pregnant. It could harm the unborn baby or cause birth defects. Use effective birth control to prevent pregnancy while you are using avelumab and for at least 1 month after your last dose.

You should not breastfeed while using this medicine and for at least 1 month after your last dose.

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

Since avelumab 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.

Some side effects may occur during the injection. Tell your caregiver right away if you feel light-headed, itchy, feverish, chilled, or have stomach or back pain, trouble breathing, or flushing (warmth, redness, or tingly feeling).

Avelumab works by causing your immune system to attack tumor cells. Avelumab may cause your immune system to attack healthy organs and tissues in your body. This could lead to serious or life-threatening side effects on your lungs, liver, pancreas, kidneys, intestines, thyroid, or adrenal glands.

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

• sudden chest pain or discomfort;

• severe stomach pain, diarrhea, bloody or tarry stools;

• blistering or peeling skin rash;

• pounding heartbeats or fluttering in your chest;

• flu-like symptoms;

• pain or burning when you urinate;

• joint pain, weakness;

• vision changes;

• liver problems--loss of appetite, upper stomach pain, tiredness, easy bruising or bleeding, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• heart problems--chest pain or pressure, pain spreading to your jaw or shoulder, sweating;

• kidney problems--little or no urination, red or pink urine, swelling in your feet or ankles; or

• signs of a hormonal disorder--feeling light-headed or very tired, rapid heartbeats, mood or behavior changes, deepened voice, increased hunger or thirst, increased urination, constipation, vomiting, hair loss, sweating, feeling cold, weight gain, or weight loss.

Common side effects of avelumab may include:

• hoarse voice;

• cough, shortness of breath;

• trouble speaking;

• pain, blisters, bleeding, or severe rash on the palms of your hands or the soles of your feet;

• sores or white patches in or around your mouth, trouble swallowing or talking, dry mouth, bad breath, altered sense of taste;

• severe headache, blurred vision, pounding in your neck or ears;

• painful urination;

• stomach pain, nausea, diarrhea, loss of appetite;

• feeling tired;

• chills, fever;

• muscle pain, back pain, bone pain;

• rash;

• swelling in your hands or feet;

• redness or swelling where the injection was given;

• liver problems; or

• symptoms of underactive thyroid--tiredness, depressed mood, dry skin, thinning hair, decreased sweating, weight gain, puffiness in your face, feeling more sensitive to cold temperatures.

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 avelumab, 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.