What is the most important information I should know about avelumab?
Avelumab works by causing your immune system to attack tumor cells. Avelumab may cause your immune system to attack healthy organs and tissues in your body. This could lead to serious or life-threatening side effects on your lungs, liver, pancreas, kidneys, intestines, thyroid, or adrenal glands.
Call your doctor at once if you have symptoms such as: fever, flu symptoms, muscle pain or weakness, vision changes, chest pain, trouble breathing, severe stomach pain or diarrhea, skin rash, increased or decreased urination, weight changes, hair loss, dark urine, or jaundice (yellowing of your skin or eyes).
What is avelumab?
Avelumab is a cancer medicine that interferes with the growth and spread of cancer cells in the body.
Avelumab is used to treat a type of skin cancer called Merkel cell carcinoma that has spread to other parts of the body. This medicine is for use in adults and children who are at least 12 years old.
Avelumab is also used to treat a certain type of cancer of the bladder or urinary tract that has spread or cannot be removed with surgery. Avelumab is given for this condition after other cancer medicines such as cisplatin or carboplatin have been tried without success.
Avelumab was approved by the US Food and Drug Administration (FDA) on an "accelerated" basis. In clinical studies, tumors responded to this medicine. However, further studies are needed.
Avelumab may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before receiving avelumab?
You should not be treated with avelumab if you are allergic to it.
To make sure avelumab is safe for you, tell your doctor if you have ever had:
- an immune system disorder such as ulcerative colitis or Crohn's disease;
- lung problems or a breathing disorder;
- liver or kidney disease;
- diabetes; or
- if you have had an organ transplant.
You should not use avelumab if you are pregnant. It could harm the unborn baby or cause birth defects. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 1 month after your last dose.
It is not known whether avelumab passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine and for at least 1 month after your last dose.
How is avelumab given?
Avelumab is injected into a vein through an IV. A healthcare provider will give you this injection.
This medicine is usually given once every 2 weeks.
Avelumab must be given slowly and the IV infusion can take at least 60 minutes to complete.
You may be given other medication to prevent certain side effects that may occur during the infusion.
You may need frequent medical tests to help your doctor determine how long to treat you with avelumab.
What happens if I miss a dose?
Call your doctor for instructions if you miss an appointment for your avelumab injection.
What happens if I overdose?
Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.
What should I avoid while receiving avelumab?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
What are the possible side effects of avelumab?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Some side effects may occur during the injection. Tell your caregiver right away if you feel light-headed, itchy, feverish, chilled, or have stomach or back pain, trouble breathing, or flushing (warmth, redness, or tingly feeling).
Avelumab works by causing your immune system to attack tumor cells. Avelumab may cause your immune system to attack healthy organs and tissues in your body. This could lead to serious or life-threatening side effects on your lungs, liver, pancreas, kidneys, intestines, thyroid, or adrenal glands.
Call your doctor at once if you have:
- sudden chest pain or discomfort, new or worsening cough, feeling short of breath;
- severe stomach pain, diarrhea, bloody or tarry stools;
- blistering or peeling skin rash;
- pounding heartbeats or fluttering in your chest;
- fever, flu-like symptoms;
- joint pain, severe muscle pain or weakness;
- vision changes;
-
liver problems --loss of appetite, upper stomach pain, tiredness, easy bruising or bleeding, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
-
kidney problems --little or no urination, red or pink urine, swelling in your feet or ankles; or
-
signs of a hormonal disorder --feeling light-headed or very tired, rapid heartbeats, mood or behavior changes, hoarse or deepened voice, increased hunger or thirst, increased urination, constipation, vomiting, hair loss, sweating, feeling cold, weight gain, or weight loss.
Common side effects may include:
- nausea, diarrhea, loss of appetite;
- feeling tired;
- bone pain;
- muscle pain;
- rash; or
- swelling in your hands or feet.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect avelumab?
Other drugs may interact with avelumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.
Where can I get more information?
Your pharmacist can provide more information about avelumab.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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