Avelumab injection

What is this medication?

AVELUMAB (a VEL ue mab) is a monoclonal antibody. It is used to treat Merkel cell carcinoma, renal cell cancer, and urothelial cancer.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): BAVENCIO

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• autoimmune diseases like Crohn's disease, ulcerative colitis, or lupus
• have had or planning to have an allogeneic stem cell transplant (uses someone else's stem cells)
• heart disease
• high blood pressure
• high cholesterol
• history of organ transplant
• nervous system problems like myasthenia gravis or Guillain-Barre syndrome
• an unusual or allergic reaction to avelumab, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

This medicine is for infusion into a vein. It is given by a health care professional in a hospital or clinic setting.

A special MedGuide will be given to you before each treatment. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 12 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

What may interact with this medication?

Interactions have not been studied.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Your condition will be monitored carefully while you are receiving this medicine.

You may need blood work done while you are taking this medicine.

Do not become pregnant while taking this medicine or for at least 1 month after stopping it. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information. Do not breast-feed an infant while taking this medicine or for at least 1 month after the last dose.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• back pain
• black, tarry stools
• bloody or watery diarrhea
• breathing problems
• changes in emotions or mood
• changes in vision
• chest pain or chest tightness
• constipation
• cough
• fast or irregular heart beat
• feeling faint or lightheaded
• hair loss
• increased hunger or thirst
• increased urination
• joint pain
• muscle weakness
• nausea, vomiting
• redness, blistering, peeling or loosening of the skin, including inside the mouth
• signs and symptoms of kidney injury like trouble passing urine or change in the amount of urine
• signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin
• stomach pain
• swelling in your legs and feet
• sweating
• tiredness
• weight loss

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• bone pain
• decreased appetite
• headache
• muscle pain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

This drug is given in a hospital or clinic and will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.