Generic Name: avelumab
Dosage Form: Injection
Date of Approval: March 23, 2017
Company: EMD Serono Inc.
Treatment for: Merkel Cell Carcinoma
FDA Approves Bavencio
The U.S. Food and Drug Administration (FDA) has granted accelerated approval for Bavencio (avelumab) injection, a programmed death ligand-1 (PD-L1) blocking antibody indicated for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC).
Read this Medication Guide before you start, and each time you receive treatment. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or treatment.
Bavencio is a medicine that may treat your type of skin cancer (Merkel cell carcinoma) by working with your immune system. Bavencio can cause your immune system to attack normal organs and tissues in many areas of your body and can affect the way they work. These problems can sometimes become serious or lifethreatening and can lead to death.
Call or see your healthcare provider right away if you get any symptoms of the following problems or these symptoms get worse:
- Lung problems (pneumonitis). Signs and symptoms of pneumonitis may include:
- new or worsening cough
- shortness of breath
- chest pain
- Liver problems (hepatitis). Signs and symptoms of hepatitis may include:
- yellowing of your skin or the whites of your eyes
- dark urine (tea colored)
- severe nausea or vomiting
- bleeding or bruising more easily than normal
- pain on the right side of your stomach area (abdomen)
- feeling less hungry than usual
- Intestinal problems (colitis). Signs and symptoms of colitis may include:
- diarrhea (loose stools) or more bowel movements than usual
- blood in your stools or dark, tarry, sticky stools
- severe stomach area (abdomen) pain or tenderness
- Hormone gland problems (especially the thyroid, adrenal glands and pancreas). Signs and symptoms that your hormone glands are not working properly may include:
- rapid heart beat
- increased sweating
- your voice gets deeper
- extreme tiredness
- very low blood pressure
- weight gain or weight loss
- urinating more often than usual
- feeling more hungry or thirsty than usual
- dizziness or fainting
- hair loss
- nausea or vomiting
- changes in mood or behavior, such as irritability or forgetfulness
- stomach area (abdomen) pain
- feeling cold
- Kidney problems, including nephritis. Signs and symptoms of kidney problems may include:
- urinate less than usual
- blood in your urine
- swelling in your ankles
- loss of appetite
- Problems in other organs. Signs and symptoms may include:
- severe muscle weakness
- tiredness, sleepiness
- severe or persistent muscle or joint pains
- swelling of the feet and legs
- chest pain and tightness
- dizziness or fainting
- trouble breathing
- skin rash, blisters or peeling
- fever, flu like symptoms
- changes in eyesight
- changes in heartbeat, such as beating fast, or seeming to skip a beat, or pounding sensation
- Severe infusion reactions. Signs and symptoms of severe infusion reactions may include:
- chills or shaking
- low blood pressure
- back pain
- shortness of breath or wheezing
- abdominal pain
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. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may delay or completely stop treatment if you have severe side effects.
What is Bavencio?
Bavencio is a prescription medicine used to treat a type of skin cancer called Merkel cell carcinoma, and may be used when your skin cancer has spread.
It is not known if this medicine is safe and effective in children under the age of 12.
Before you receive treatment, tell your healthcare provider about all of your medical conditions, including if you:
- have immune system problems such as Crohn’s disease or ulcerative colitis
- have had an organ transplant
- have lung or breathing problems
- have liver or kidney problems
- have diabetes
- are pregnant or plan to become pregnant. Bavencio can harm your unborn baby. If you are able to become pregnant, you should use an effective method of birth control during your treatment and for at least one month after your last dose.
- 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 one month after your last dose.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How will I receive Bavencio?
- Your healthcare provider will give you Bavencio into your vein through an intravenous (IV) line over 60 minutes.
- Bavencio is usually given every two weeks.
- Your healthcare provider will give you medicines before the first four infusions and subsequently as needed to help reduce infusion reactions.
- Your healthcare provider will decide how many treatments you need.
- Your healthcare provider will do blood tests to check you for certain side effects.
- If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.
Bavencio side effects
Bavencio can cause serious side effects, including:
- See Important information.
The most common side effects include:
- feeling tired
- swelling in your hands, feet, or ankles
- muscle and bone pain
- decreased appetite
- skin rash
These are not all the possible side effects. Ask your healthcare provider or pharmacist for more information.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of Bavencio
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider for information that is written for health professionals.
What are the ingredients in Bavencio?
Active ingredient: avelumab
Inactive ingredients: D-mannitol, glacial acetic acid, polysorbate 20, sodium hydroxide, water for injection