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Care During Chemotherapy and Beyond

Avelumab

(a VEL ue mab)

Trade Name(s): Bavencio®

Avelumab is the generic name for the trade name drug Bavencio®. In some cases, health care professionals may use the trade name Bavencio® when referring to the generic drug name avelumab.

Drug Type: Avelumab is an anti-PD-L1 monoclonal antibody. (For more detail, see "How Avelumab Works" below).

What Avelumab Is Used For

  • Treatment of a specific type of skin cancer, metastatic Merkel cell carcinoma (MCC), in adults and children at least 12 years old.
  • Treatment of locally advanced or metastatic urinary system cancer.

Note: If a drug has been approved for one use, physicians may elect to use this same drug for other problems if they believe it may be helpful.

How Avelumab Is Given

  • Avelumab is given by an infusion into the vein (intravenous or IV) through a special filter over 60 minutes every 2 weeks.
  • You will be given acetaminophen and an antihistamine for at least the first 4 infusions to reduce infusion related reactions.

The amount of avelumab that you will receive depends on several factors, including your weight and your general health or other health problems. Your doctor will determine your exact dosage and schedule.

Side Effects

Important things to remember about the side effects of avelumab:

  • Most people will not experience all the side effects listed.
  • Observed side effects below may NOT be related to avelumab.
  • Immune related side effects can occur weeks to months after discontinuation of treatment.
  • There are options to help minimize or prevent side effects.
  • There is no relationship between the presence or severity of side effects and the effectiveness of the medication.

The following side effects are common (occurring in greater than 30%) for patients taking avelumab:

These are less common side effects (occurring in 10-29%) for patients receiving avelumab:

*The following are rare but serious complications of avelumab therapy triggered by an auto-immune reaction where the immune system goes after normal cells in the body. This can happen at any time while taking, and/or after stopping avelumab. Contact your healthcare provider immediately if you have signs/symptoms of the following:

  • Pneumonitis (lung problems) identified by:
    • New or worsening cough
    • Shortness of breath
    • Chest pain
  • Hepatitis (liver problems) identified by:
    • Yellowing of your skin or the whites of your eyes
    • Severe nausea and vomiting
    • Pain on the right side of your stomach
    • Dark, tea colored urine
    • Bleeding or bruising more easily than normal
  • Colitis (intestinal problems) identified by:
    • Diarrhea
    • Blood in your stools or dark, tarry stool
    • Severe stomach pain or tenderness
  • Hormone gland problems (thyroid gland, adrenal gland, and pancreas) identified by:
    • Rapid heart beat
    • Increased sweating
    • Extreme tiredness
    • Unexpected weight gain or loss
    • Feeling more hungry or thirsty
    • High blood sugar
    • Hair loss
    • Irritability or forgetfulness
    • Constipation
    • Deepening of your voice
    • Low blood pressure
    • More frequent urination
    • Stomach pain
  • Kidney problems identified by:
    • Less frequent urination
    • Blood in your urine
    • Ankle swelling
    • Loss appetite
  • Other organ problems:
    • Severe muscle weakness or pain
    • Chest pain tightness
    • Trouble breathing
    • Skin rash
    • Change in heartbeat
    • Flu like symptoms

Not all side effects are listed above. Side effects that are very rare (occurring in less than 10% of patients) are not listed here. However, you should always inform your health care provider if you experience any unusual symptoms.

When To Contact Your Doctor or Health Care Provider

Contact your health care provider immediately, day or night, if you should experience any of the following symptoms:

  • Difficulty breathing
  • Any signs of the rare but serious complications listed above under "Side Effects"

The following symptoms require medical attention, but are not an emergency. Contact your health care provider within 24 hours of noticing any of the following:

  • Nausea (interferes with ability to eat and unrelieved with prescribed medication)
  • Vomiting (vomiting more than 4-5 times in a 24-hour period)
  • Diarrhea (4-6 episodes in a 24-hour period)
  • Constipation unrelieved by laxatives
  • Extreme fatigue (unable to carry on self-care activities)

Always inform your health care provider if you experience any unusual symptoms.

Precautions

  • Before starting avelumab treatment, make sure you tell your doctor about any allergies and other medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies, etc.) as well as you complete past medical history.
  • Do not receive any kind of immunization or vaccination without doctor's approval while taking avelumab.
  • Inform your health care professional if you are pregnant or may become pregnant prior to starting this treatment. Based on its mechanism of action, avelumab can cause fetal harm when administered to a pregnant woman. Animal studies have shown that avelumab can lead to rejection of the fetus resulting in fetal death.
  • Men and women of childbearing potential should use effective contraception and not conceive a child while taking avelumab. Barrier methods of contraception, such as condoms, as recommended during treatment with avelumab and for at least one month after the last dose of avelumab.
  • Do not breast feed while taking avelumab and for at least one month after the last dose due to the potential serious adverse reactions in breastfed infants.
  • Let all other healthcare providers, including emergency room staff, know that you are taking avelumab so they can manage your plan of care appropriately.

Self-Care Tips

  • Drink at least two to three quarts of fluid every 24 hours, unless you are instructed otherwise.
  • Wash your hands often.
  • To reduce nausea, take anti-nausea medications as prescribed by your doctor, and eat small, frequent meals.
  • In general, drinking alcoholic beverages should be kept to a minimum or avoided completely. You should discuss this with your doctor.
  • Get plenty of rest.
  • Maintain good nutrition.
  • Remain active as you are able. Gentle exercise is encouraged such as a daily walk.
  • If you experience symptoms or side effects, be sure to discuss them with your health care team. They can prescribe medications and/or offer other suggestions that are effective in managing such problems.

Monitoring and Testing While Taking Avelumab

  • You will be checked regularly by your doctor while you are taking avelumab to monitor side effects and check your response to therapy. Your kidney and liver function as well as signs and symptoms of toxicities will be monitored, and abnormal results may cause treatment to be withheld either permanently or until improvement is seen.

How Avelumab Works

Monoclonal antibodies are a relatively new type of "targeted" cancer therapy.

Antibodies are an important part of the body's immune system. Normally, antibodies are produced by the body in response to an antigen, such as protein in a germ that the body recognizes as foreign. The antibodies attach to the antigen in order to mark it for destruction by the immune system.

To make anti-cancer monoclonal antibodies in the laboratory, scientists analyze specific antigens on the surface of cancer cells which act as the targets. Then, using animal and human proteins, a specific antibody is created that will attach (like a lock and key) to the target antigen on the cancer cells.

Since monoclonal antibodies target only specific cells, they generally cause less toxicity to healthy cells. A limitation to monoclonal antibody use is that they can only be used for cancer in which antigens (and antibodies that bind them) have been identified.

PD-L1 is a specific protein on tumor cells that binds to PD-1 on our body's anti-tumor-cells which stops our body's t-cells from attacking the tumor cells. Avelumab blocks PD-L1 on tumor cells, which then frees up our antitumor t-cells and allows them to attack the cancer.

Note: We strongly encourage you to talk with your health care professional about your specific medical condition and treatments. The information contained in this website is meant to be helpful and educational, but is not a substitute for medical advice.

Resources

  • Avelumab. Lexicomp Online. [updated 11/8/2017; cited 11/15/2017]. Lexi-Drugs. Hudson, OH: LexiComp, Inc.
  • Avelumab [package insert on the internet]. Rockland, MA: EMD Serono, Inc.; [updated 5/2017; cited 11/15/2017]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761078s0001bl.pdf

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