Class: Biological Therapy
Generic Name: avelumab
Trade Name: Bavencio®

How is this drug used? Bavencio is approved to treat patients with merkel cell carcinoma (MCC), urothelial carcinoma (UC), and renal cell carcinoma (RCC) as follow:

  • MCC: adults and pediatric patients 12 and older with metastatic MCC.
  • UC: Locally advanced or metastatic UC following progression after treatment with platinum-containing chemotherapy
  • RCC: first-line treatment in combination with axitinib for advanced RCC

What is the mechanism of action? Bavencio is a type of drug known as a programmed death receptor-1 (PD-1) blocking antibody. Bavencio blocks PD-1, a protein that interferes with certain types of immune responses and may enhance the ability of the immune system to fight cancer.

How is Bavencio given (administered)? Bavencio is given by intravenous infusion, usually once every two weeks.

How are patients monitored? Patients receiving Bavencio are monitored with blood work and other laboratory tests for the following immune-mediated adverse reactions:

  • Pneumonitis (inflammation of lung tissue)
  • Colitis (inflammation of the colon)
  • Hepatitis
  • Endocrinopathies
  • Nephritis with renal dysfunction
  • Dermatologic adverse reactions

Patients are also monitored for infusion-related reactions, cardiovascular events and complications related to a prior allogeneic stem cell transplant.

What are the most common side effects of treatment with Bavencio?

  • MCC: fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction, rash, decreased appetite, and peripheral edema.
  • UC Maintenance Treatment: fatigue, musculoskeletal pain, urinary tract infection, rash
  • UC Previously Treated: fatigue, infusion-related reaction, musculoskeletal pain, nausea, decreased appetite, urinary tract infection.
  • RCC (with axitinib): diarrhea, fatigue, hypertension, musculoskeletal pain, nausea, mucositis, redness of palms/soles of feet, difficulty speaking, decreased appetite, hypothyroidism, rash, hepatotoxicity, cough, shortness of breath, abdominal pain, and headache.

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This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

  • Pay careful attention to your healthcare provider’s instructions and inform your doctor of any side effects.
  • Maintain adequate rest and nutrition.

Are there any special precautions patients should be aware of before starting treatment?

  • Follow your infusion schedule for Bavencio.
  • Tell your doctor about all medication you take, prescription and over the counter.
  • Tell your doctor about any health conditions such as: Crohn’s disease, ulcerative colitis, lupus or other immune system problems Myasthenia Gravis, Guillain-Barre syndrome or other conditions that affect your nervous system Heart problems, high blood pressure, high cholesterol level
  • Tell your doctor if you have received an organ transplant or if you have received or plan to receive a stem cell transplant that uses donor stem cells.
  • Keep your scheduled appointments for blood work or other laboratory tests that monitor your response to Bavencio.
  • Patients should inform their physician if they are pregnant, breastfeeding or planning a family in the near future. You should not become pregnant during treatment with Bavencio and for at least 1 months after the last dose of Bavencio. Bavencio can harm your unborn baby. It is important to use effective birth control while undergoing treatment. It is not known if Bavencio passes into breast milk; avoid breastfeeding during treatment and for 1 months after your last dose.

When should patients notify their physician?

  • Notify your healthcare provider if you experience side effects that are bothersome or don’t go away. Tell your healthcare provider right away if you experience new or worsening symptoms including: Lung problems (pneumonitis): shortness of breath, chest pain, new or worse cough Intestinal problems (colitis): diarrhea or more bowel movements than usual: stools that are black, tarry, sticky, or have blood or mucus Liver problems: jaundice, severe nausea/vomiting, dark uring, bleeding or bruising more easily than normal, pain on the right side of your abdomen Hormone gland problems: headaches, light sensitivity, eye problems, rapid heartbeat, increased sweating, extreme tiredness, changes in weight, feeling more hungry or thirsty than usual, frequent urination, hair loss, feeling cold, constipation, deeper voice, dizziness or fainting, mood changes Kidney problems: decrease urine output, blood in your urine, ankle swelling, loss of appetite Skin problems: rash, itching, skin blistering or peeling, painful sores or ulcers, fever or flu-like symptoms, swollen lymph nodes Problems with other organs and tissues: chest pain, irregular heartbeat, shortness of breath, ankle swelling, neurologic symptoms, vision problems, persistent or severe muscle pain or weakness, cramps, bruising. Heart problems (when used with axitinib)

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Last updated on 4/21.