Avelumab (a-VEL-ue-mab)

Treats cancer, including bladder, kidney, and Merkel cell (skin) cancer.

Brand Name(s):

Bavencio

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through an IV placed in a vein. The medicine must be given slowly, so the IV will have to remain in place for at least 60 minutes.
• You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine.
• Your doctor may give you other medicines (including allergy medicine, fever medicine) before the first 4 infusions of this medicine to prevent unwanted effects.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. Use an effective form of birth control during treatment and for at least 1 month after your last dose.
• Do not breastfeed during treatment and for at least 1 month after the last dose.
• Tell your doctor if you have kidney disease, liver disease, heart disease, diabetes, lung or breathing problems, nervous system problems (including Guillain-Barré syndrome, myasthenia gravis), stomach or bowel problems, high blood pressure, high cholesterol, or immune system problems. Tell your doctor if you have received an organ transplant or other transplant (including cornea transplant).
• This medicine may cause the following problems:
  • Pneumonitis (inflammation of the lungs)
  • Liver problems, including hepatitis
  • Colitis (inflammation of the colon), which might damage your digestive system
  • Adrenal, pituitary, or thyroid gland problems
  • Kidney problems, which could lead to kidney failure
  • Changes in blood sugar levels
  • Serious skin reactions (including exfoliative dermatitis, Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms (DRESS), or toxic epidermal necrolysis)
  • Infusion reactions, which could be life-threatening
  • Increased risk of heart failure or heart attack
  • Increased risk of possible organ transplant rejection
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• Bloody or black, tarry stools, diarrhea, severe stomach pain
• Bloody or cloudy urine, change in how much or how often you urinate, painful or difficult urination
• Chest pain that may spread to your arms, jaw, back, or neck, chest tightness, cough, trouble breathing, unusual sweating
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Fast, slow, or uneven heartbeat
• Fever, chills, shaking
• Increased hunger or thirst, dry mouth, sweating
• Joint, muscle, or bone pain
• Lightheadedness, dizziness, fainting
• Rapid weight gain, swelling of your face, feet, or lower legs
• Weakness, unusual headaches, tiredness, weight changes, feeling cold

If you notice these less serious side effects, talk with your doctor:

• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed
• Sores or white patches on your lips, mouth, or throat
• Sore throat, voice changes

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088