Acetaminophen: A type of medicine that reduces pain and fever.
Adaptive immune system: The part of our immune system that develops in response to microorganisms that cause disease. Special immune cells remember what these foreign invaders look like and they are able to respond in the future to help prevent those particular diseases.
Antibody: A protective protein produced by the body's immune system that can detect harmful substances, including bacteria and viruses, and defend the body against them.
Antihistamine: A type of medicine that treats symptoms of allergies, such as itching, sneezing, runny nose, and watery eyes, caused by a substance the body makes when exposed to allergy triggers called histamines. An antihistamine may be given before treatment with BAVENCIO® (avelumab) immunotherapy as a way to help prevent side effects related to the infusion.
Biopsy: A procedure that removes fluid or tissue samples to be tested for disease.
Chemotherapy: Cancer drugs that travel in your bloodstream to kill cancer cells throughout your body.
Clinical trials: A type of research that assesses how well health tests or treatments work in people.
Computerized axial tomography (CAT) scan: A procedure that uses a computer linked to an x-ray to take 3D images of the inside of the body. CAT scans, also called computerized tomography (CT) scans, can be used to diagnose a disease, plan treatment, or find out how well a treatment is working.
Cystoscopy: An examination of the bladder and urethra using a cystoscope. A cystoscope is a tube-shaped instrument that uses light and a lens for viewing the urinary tract.
Immune system: A network of cells, tissues, organs, and the substances they make that helps your body fight infections and diseases.
Immunotherapy: A type of cancer treatment, like BAVENCIO that works with the body’s immune system to fight cancer.
Innate immune system: Immunity that is present at birth and lasts a person’s entire life. Innate immunity is the first response of the immune system against harmful foreign substances such as bacteria, viruses, or disease.
Intravenous infusion: A way to dose medication directly into a vein to travel through the bloodstream.
Locally advanced: Cancer that has grown outside of the body part where it started but has not yet spread to other parts of the body.
Magnetic resonance imaging (MRI): A procedure that uses radio waves and a powerful magnet linked to a computer to take images of the inside of the body. MRIs are useful for getting detailed images of organs and soft tissue.
Maintenance treatment: Medicine that may be given after your cancer has responded or stabilized from a first round of medication, such as platinum-based chemotherapy, to help you keep fighting your cancer.
Merkel cell carcinoma (MCC): A rare type of skin cancer that tends to grow fast and spread quickly to other parts of the body.
Metastases: Cancer cells that break away from the main tumor and spread to other parts of the body forming a new “metastatic” tumor in other organs or tissues of the body.
Overall survival: The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that the patients are still alive.
PD-L1: A protein that normally helps keep immune cells from attacking healthy cells in the body. In some cancer types, when cancer cells have high amounts of PD-L1, they can trick the immune system and avoid being attacked as harmful substances.
Platinum-containing chemotherapy: A type of chemotherapy that contains platinum and kills cancer cells.
Radiation therapy: A treatment that uses high-energy waves, similar to x-rays, to kill cancer cells.
Targeted therapy: A cancer treatment that may target and focus on attacking specific types of cancer cells.
Urothelial carcinoma (UC): The most common type of bladder cancer that begins in cells called urothelial cells that line the bladder and other parts of the urinary tract.
Important Safety Information
BAVENCIO® (avelumab) is a medicine that may treat certain cancers by working with your immune system. BAVENCIO can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended.
Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with BAVENCIO. Your healthcare provider may treat you with corticosteroids or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with BAVENCIO if you have severe side effects.
BAVENCIO can cause serious side effects. Call or see your healthcare provider right away if you get any new or worsening signs or symptoms, including:
Lung problems
- cough
- shortness of breath
- chest pain
Intestinal problems
- diarrhea (loose stools) or more frequent bowel movements than usual
- stools that are black, tarry, sticky, or have blood or mucus
- severe stomach-area (abdomen) pain or tenderness
Liver problems
- yellowing of your skin or the whites of your eyes
- severe nausea or vomiting
- pain on the right side of your stomach area (abdomen)
- dark urine (tea colored)
- bleeding or bruising more easily than normal
Hormone gland problems
- headache that will not go away or unusual headaches
- eye sensitivity to light
- eye problems
- rapid heartbeat
- increased sweating
- extreme tiredness
- weight gain or weight loss
- feeling more hungry or thirsty than usual
- urinating more often than usual
- hair loss
- feeling cold
- constipation
- your voice gets deeper
- dizziness or fainting
- changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness
Kidney problems
- decrease in your amount of urine
- blood in your urine
- swelling of your ankles
- loss of appetite
Skin problems
- rash
- itching
- skin blistering or peeling
- painful sores or ulcers in mouth or nose, throat, or genital area
- fever or flu-like symptoms
- swollen lymph nodes
Problems can also happen in other organs and tissues. These are not all of the signs or symptoms of immune system problems that can happen with BAVENCIO. Call or see your healthcare provider right away for any new or worsening signs or symptoms, which may include:
- Chest pain, irregular heartbeat, shortness of breath or swelling of ankles
- Confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs
- Double vision, blurry vision, sensitivity to light, eye pain, changes in eye sight
- Persistent or severe muscle pain or weakness, muscle cramps
- Low red blood cells, bruising
Infusion-related reactions can sometimes be severe or life-threatening. Signs and symptoms of infusion-related reactions may include:
- chills or shaking
- hives
- flushing
- shortness of breath or wheezing
- dizziness
- feel like passing out
- fever
- back pain
- stomach-area (abdomen) pain
Complications, including graft-versus-host-disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with BAVENCIO. Your healthcare provider will monitor you for these complications.
Before you receive BAVENCIO, tell your healthcare provider about all of your medical conditions, including if you:
- have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
- have received an organ transplant
- have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
- have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
- have heart problems or high blood pressure
- have diabetes
- have a high cholesterol level in your blood
- are pregnant or plan to become pregnant. BAVENCIO can harm your unborn baby
- You should use an effective method of birth control during your treatment and for at least 1 month after the last dose of BAVENCIO. Talk to your healthcare provider about birth control methods that you can use during this time
Females who are able to become pregnant:
- are breastfeeding or plan to breastfeed. It is not known if BAVENCIO passes into your breast milk. Do not breastfeed during treatment and for at least 1 month after the last dose of BAVENCIO
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
The most common side effects of BAVENCIO in people with Merkel cell carcinoma (MCC) include:
- feeling tired
- muscle and bone pain
- infusion-related reactions including chills, fever, and back pain
- rash
- nausea
- constipation
- cough
- diarrhea
These are not all the possible side effects of BAVENCIO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full Prescribing Information, including Medication Guide for patients.
Indications
BAVENCIO is a prescription medicine used to treat a type of skin cancer called Merkel cell carcinoma (MCC) in adults and children 12 years of age and older. BAVENCIO may be used when your skin cancer has spread.
It is not known if BAVENCIO is safe and effective in children under the age of 12.
These are not all the possible side effects of BAVENCIO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full Prescribing Information, including Medication Guide for patients.
© 2024 Merck KGaA, Darmstadt, Germany or its affiliates. All rights reserved.
EMD Serono is the Healthcare business of Merck KGaA, Darmstadt, Germany in the U.S. and Canada.
BAVENCIO and CoverOne are registered trademarks of Merck KGaA, Darmstadt, Germany or its affiliates.
US-AVE-01311 07/24
US-AVE-01312 07/24
This site contains medical information that is intended for residents of the United States only and is not meant to substitute for the advice provided by a medical professional. Always consult a physician if you have health concerns. Use and access of this site is subject to the terms and conditions as set out in our Legal Statement and Privacy Policy. This site contains information that is intended for US residents only. Canadian residents should consult the EMD Serono Canada Inc. website at www.emdserono.ca for information on products and services approved in Canada.
Important Safety Information
BAVENCIO® (avelumab) is a medicine that may treat certain cancers by working with your immune system. BAVENCIO can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after your treatment has ended.
Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with BAVENCIO. Your healthcare provider may treat you with corticosteroids or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with BAVENCIO if you have severe side effects.
BAVENCIO can cause serious side effects. Call or see your healthcare provider right away if you get any new or worsening signs or symptoms, including:
Lung problems
- cough
- shortness of breath
- chest pain
Intestinal problems
- diarrhea (loose stools) or more frequent bowel movements than usual
- stools that are black, tarry, sticky, or have blood or mucus
- severe stomach-area (abdomen) pain or tenderness
Liver problems
- yellowing of your skin or the whites of your eyes
- severe nausea or vomiting
- pain on the right side of your stomach area (abdomen)
- dark urine (tea colored)
- bleeding or bruising more easily than normal
Hormone gland problems
- headache that will not go away or unusual headaches
- eye sensitivity to light
- eye problems
- rapid heartbeat
- increased sweating
- extreme tiredness
- weight gain or weight loss
- feeling more hungry or thirsty than usual
- urinating more often than usual
- hair loss
- feeling cold
- constipation
- your voice gets deeper
- dizziness or fainting
- changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness
Kidney problems
- decrease in your amount of urine
- blood in your urine
- swelling of your ankles
- loss of appetite
Skin problems
- rash
- itching
- skin blistering or peeling
- painful sores or ulcers in mouth or nose, throat, or genital area
- fever or flu-like symptoms
- swollen lymph nodes
Problems can also happen in other organs and tissues. These are not all of the signs or symptoms of immune system problems that can happen with BAVENCIO. Call or see your healthcare provider right away for any new or worsening signs or symptoms, which may include:
- Chest pain, irregular heartbeat, shortness of breath or swelling of ankles
- Confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs
- Double vision, blurry vision, sensitivity to light, eye pain, changes in eye sight
- Persistent or severe muscle pain or weakness, muscle cramps
- Low red blood cells, bruising
Infusion-related reactions can sometimes be severe or life-threatening. Signs and symptoms of infusion-related reactions may include:
- chills or shaking
- hives
- flushing
- shortness of breath or wheezing
- dizziness
- feel like passing out
- fever
- back pain
- stomach-area (abdomen) pain
Complications, including graft-versus-host-disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with BAVENCIO. Your healthcare provider will monitor you for these complications.
Before you receive BAVENCIO, tell your healthcare provider about all of your medical conditions, including if you:
- have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
- have received an organ transplant
- have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
- have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
- have heart problems or high blood pressure
- have diabetes
- have a high cholesterol level in your blood
- are pregnant or plan to become pregnant. BAVENCIO can harm your unborn baby
- You should use an effective method of birth control during your treatment and for at least 1 month after the last dose of BAVENCIO. Talk to your healthcare provider about birth control methods that you can use during this time
Females who are able to become pregnant:
- are breastfeeding or plan to breastfeed. It is not known if BAVENCIO passes into your breast milk. Do not breastfeed during treatment and for at least 1 month after the last dose of BAVENCIO
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
The most common side effects of BAVENCIO in people with Merkel cell carcinoma (MCC) include:
- feeling tired
- muscle and bone pain
- infusion-related reactions including chills, fever, and back pain
- rash
- nausea
- constipation
- cough
- diarrhea
These are not all the possible side effects of BAVENCIO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full Prescribing Information, including Medication Guide for patients.
Indications
BAVENCIO is a prescription medicine used to treat a type of skin cancer called Merkel cell carcinoma (MCC) in adults and children 12 years of age and older. BAVENCIO may be used when your skin cancer has spread.
It is not known if BAVENCIO is safe and effective in children under the age of 12.
These are not all the possible side effects of BAVENCIO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full Prescribing Information, including Medication Guide for patients.
© 2024 Merck KGaA, Darmstadt, Germany or its affiliates. All rights reserved.
EMD Serono is the Healthcare business of Merck KGaA, Darmstadt, Germany in the U.S. and Canada.
BAVENCIO and CoverOne are registered trademarks of Merck KGaA, Darmstadt, Germany or its affiliates.
US-AVE-01311 07/24
US-AVE-01312 07/24
This site contains medical information that is intended for residents of the United States only and is not meant to substitute for the advice provided by a medical professional. Always consult a physician if you have health concerns. Use and access of this site is subject to the terms and conditions as set out in our Legal Statement and Privacy Policy. This site contains information that is intended for US residents only. Canadian residents should consult the EMD Serono Canada Inc. website at www.emdserono.ca for information on products and services approved in Canada.