Avelumab (Bavencio)

Why is Avelumab Used?

Avelumab is an immunotherapy that works by helping the body to slow or stop the growth of cancer cells. It 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,
  • urothelial cancer (cancer of the lining of the bladder and other parts of the urinary tract) that has spread to other parts of the body either during or shortly after getting platinum chemotherapy,
  • also used as ongoing (“maintenance”) treatment for urothelial cancer that has spread to other parts of the body to help maintain the response to platinum chemotherapy,
  • [in combination with axitinib (Inlyta)] for renal cell carcinoma (RCC; cancer that begins in the kidney) that has spread or cannot be removed by surgery.
How is Avelumab Given?

Avelumab is given 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.

Patient getting IV chemotherapy

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, 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 (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer’s website to obtain the Medication Guide.

Other Uses for Avelumab

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

What Special Precautions Should I Follow?
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. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you have or have ever had diabetes, 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), an organ transplant, or liver, lung, or kidney disease.
  • 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.
Any Special Dietary Instructions?

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

What If You Forget a Dose?

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

What Side Effects can Avelumab Cause?

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

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
  • nausea; vomiting; pain in right side of abdomen; dark (tea-colored) urine; extreme tiredness; or unusual bruising or bleeding
  • rapid heartbeat; constipation; increased sweating; voice changes; weight changes; feeling more thirsty than usual; dizziness or fainting; hair loss; nausea; vomiting; changes in mood; stomach pain; or feeling cold
  • pain in upper right part of the stomach; yellowing of the skin or eyes; nausea; vomiting, or easy bleeding or bruising
  • diarrhea; blood in stools; dark, tarry, sticky stools; or stomach area pain or tenderness
  • muscle weakness
  • drowsiness
  • feeling dizzy or faint
  • swelling of feet and legs
  • chest pain and tightness
  • fever or other flu-like symptoms
  • vision changes
  • heartbeat changes
  • rash, blistering or peeling skin
  • difficulty breathing or swallowing
  • 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 (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

In Case of Emergency/Overdose

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.

What Other Information Should I Know?

Keep all appointments with your doctor and the laboratory. Your doctor may 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.

Brand Names
  • Bavencio®

Last Revised – 09/15/2020 A

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