Frequently Asked Questions about Bavencio® (avelumab)
Class: Biological Therapy
Generic Name: avelumab
Trade Name: Bavencio®
For which conditions is Bavencio approved for? Bavencio is approved for patients with a certain type of skin cancer called Merkel cell carcinoma. It is also approved for patients with bladder or urinary tract cancer that has spread and cannot be removed by surgery, and if the patient has been treated with a platinum-based chemotherapy that did not work or is no longer working.
What is the mechanism of action? Bavencio is a PD-L1 inhibitor. It works by blocking certain proteins on cancer cells which help the cells avoid detection by the immune system. Blocking these proteins helps the immune system find and attack the cancer cells.
How is Bavencio typically given (administered)? Bavencio is administered by intervenous (IV) infusion usually every two weeks. The patient’s healthcare provider will determine how many treatments are needed.
How are patients monitored? Patients will usually have scheduled meetings with their healthcare provider while they are being treated with Bavencio. Typically, blood will be drawn before and after treatment to monitor functions of some organ systems, such as the kidneys or liver. Patients may also undergo physical examinations, scans, or other measures to assess side effects and response to therapy.
What are the most common side effects of treatment with Bavencio?
For people with skin cancer:
- Swelling in hands, feet or ankles
- Muscle and bone pain
- Decreased appetite
- Skin rash
- Infusion-related reaction
For people with bladder or urinary tract cancer:
- Infusion-related reaction
- Muscle and bone pain
- Decreased appetite
- Urinary tract infection
What are some of the less common but potentially serious side effects of Bavencio?
- Liver problems (hepatitis)
- Intestinal problems (colitis)
- Hormone gland problems
- Kidney problems ( including nephritis)
- Other organ problems
- Severe infusion reactions
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 should you tell your healthcare provider before starting treatment with Bavencio?
Tell your healthcare provider if you:
- Have immune system problems such as Crohn’s disease or ulcerative colitis.
- Have had an organ transplant.
- Have had lung or breathing problems.
- Have had liver or kidney problems.
- Have diabetes.
- Have fever, chills, or any other sign of infection.
- Have any other medical conditions.
- Are pregnant or plan to become pregnant. Bavencio can harm your unborn baby.
- Are breastfeeding or plan to breastfeed.
Tell your health care provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Bavencio and other medicines may affect each other causing side effects. Know the medicines you take. Keep a list of them to show your health care provider or pharmacist when you get a new medicine.
When should patients notify their physician?
Contact your healthcare professional immediately in case of any of the following:
- You have symptoms of lung problems. These include: new or worsening cough, shortness of breath, chest pain.
- You have symptoms of liver problems. These include: yellowing of the skin or the whites of your eyes, dark or brown colored urine, feeling very tired, loss of appetite, pain on the right side of your stomach area, bleeding or bruising more easily than usual.
- You have symptoms of intestinal problems. These include: diarrhea, frequent bowel movements, blood in stools or dark, sticky, tar-like stools, severe abdomen pain or tenderness.
- You have symptoms of hormone gland problems. These include: rapid heartbeat, increased sweating, extreme tiredness, weight gain or weight loss, feeling more hungry or thirsty, hair loss, changes in mood or behavior, feeling cold, constipation, deeper voice, very low blood pressure, frequent urination, dizziness or fainting, nausea or vomiting, abdomen pain.
- You have symptoms of kidney problems. These include: urinate less than usual, blood in urine, swelling in ankles, loss of appetite.
- You have symptoms of other organ problems. These include: severe muscle weakness, severe muscle or joint pain, trouble breathing, skin rash, blisters or peeling, irregular heartbeat, pounding heart, tiredness, swelling of feet and legs, dizziness or fainting, fever, changes in eyesight.
- You have symptoms of infusion reactions. These include: chills or shaking, hives, flushing, shortness of breath or wheezing, low blood pressure, fever, back pain, abdominal pain.
- You become pregnant.
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.
Important Limitations of Use
The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.
As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment kin selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.
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The prescribing physician is solely responsible for making all decisions relating to appropriate patient care including, but not limited to, drugs, regimens, dose, schedule, and any supportive care.