Bavencio is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Bavencio 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).

Bavencio 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. Bavencio is given for this condition after platinum cancer medicines did not work or have stopped working.

Bavencio 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.

Bavencio 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).

Before taking this medicine

To make sure Bavencio is safe for you, 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 this medicine 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.

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

Bavencio 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 Bavencio.

Usual Adult Dose for Merkel Cell Carcinoma:

800 mg IV over 60 minutes every 2 weeks
Duration of therapy: Until disease progression or unacceptable toxicity

Usual Adult Dose for Urothelial Carcinoma:

800 mg IV over 60 minutes every 2 weeks
Duration of therapy: Until disease progression or unacceptable toxicity

Uses:
-For maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy
-Previously treated urothelial carcinoma: For treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) who: Have disease progression during or following platinum-containing chemotherapy OR have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy

Usual Adult Dose for Renal Cell Carcinoma:

800 mg IV over 60 minutes every 2 weeks in combination with axitinib 5 mg orally 2 times a day (12 hours apart) with or without food
Duration of therapy: Until disease progression or unacceptable toxicity

Use: In combination with axitinib for the first-line treatment of patients with advanced renal cell carcinoma (RCC)

Usual Pediatric Dose for Merkel Cell Carcinoma:

12 years and older:
800 mg IV over 60 minutes every 2 weeks
Duration of therapy: Until disease progression or unacceptable toxicity

Use: For metastatic Merkel cell carcinoma (MCC) in pediatric patients 12 years and older

To make sure Bavencio is safe for you, 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 this medicine 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 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 Bavencio: 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.

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 Bavencio side effects 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 interact with 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.