What is BAVENCIO?
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.
- a type of cancer in the bladder or urinary tract called urothelial carcinoma (UC). BAVENCIO may be used when your cancer has spread or cannot be removed by surgery (advanced UC), and you have received chemotherapy that contains platinum, and it did not work or is no longer working.
- a type of kidney cancer called renal cell carcinoma (RCC). BAVENCIO may be used with the medicine axitinib as your first treatment when your kidney cancer has spread or cannot be removed by surgery (advanced RCC).
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What is the most important information I should know about BAVENCIO ?
BAVENCIO can cause serious side effects. These serious side effects include:
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BAVENCIO 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 and can affect the way they work. These problems can sometimes become serious or life-threatening 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, including hepatitis. Signs and symptoms of liver problems may include:
- yellowing of your skin or the whites of your eyes
- severe nausea or vomiting
- pain on the right side of your stomach-area (abdomen)
- bleeding or bruising more easily than normal
- dark urine (tea colored)
- drowsiness
- 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 adrenal glands, thyroid, and pancreas). Signs and symptoms that your hormone glands are not working properly may include:
- rapid heart beat
- extreme tiredness
- weight gain or weight loss
- feeling more hungry or thirsty than usual
- dizziness or fainting
- nausea or vomiting
- stomach area (abdomen) pain
- feeling cold
- increased sweating
- hair loss
- changes in mood or behavior, such as irritability or forgetfulness
- your voice gets deeper
- very low blood pressure
- urinating more often than usual
- Kidney problems, including nephritis. Signs and symptoms of kidney problems may include:
- decrease in your amount of urine
- blood in your urine
- swelling in your ankles
- loss of appetite
- Problems in other organs. Signs and symptoms may include:
- severe muscle weakness
- severe or persistent muscle or joint pains
- chest pain and tightness
- trouble breathing
- skin rash, blisters or peeling
- changes in heartbeat, such as beating fast, or seeming to skip a beat, or pounding sensation
- tiredness, sleepiness
- swelling of the feet and legs
- dizziness or fainting
- fever, flu like symptoms
- changes in eyesight
- Severe infusion reactions. Signs and symptoms of severe infusion reactions may include:
- chills or shaking
- hives
- low blood pressure
- fever
- flushing
- back pain
- shortness of breath or wheezing
- abdominal pain
- Heart problems. When BAVENCIO is used with the medicine axitinib, severe heart problems can happen and can lead to death. Signs and symptoms of heart problems may include:
- swelling of your stomach-area, legs, hands, feet or ankles
- shortness of breath
- nausea or vomiting
- chest discomfort, including pain or pressure
- weight gain
- pain or discomfort in your arms, back, neck, or jaw
- breaking out in a cold sweat
- feeling lightheaded or dizzy
- The most common side effects of BAVENCIO in people with MCC include:
- feeling tired
- infusion-related reaction including chills, fever and back pain
- muscle and bone pain
- rash
- diarrhea
- decreased appetite
- nausea
- swelling in your hands, feet, or ankles
- The most common side effects of BAVENCIO in people with UC include:
- feeling tired
- infusion-related reaction including chills, fever, back pain, redness and shortness of breath
- muscle and bone pain
- nausea
- decreased appetite
- urinary tract infection
- The most common side effects of BAVENCIO when given with axitinib in people with RCC include:
- diarrhea
- hoarseness
- feeling tired
- decreased appetite
- high blood pressure
- low levels of thyroid hormone
- muscle and bone pain
- rash
- nausea
- shortness of breath
- mouth sores
- cough
- liver problems
- stomach-area (abdomen) pain
- blisters or rash on the palms of your hands and soles of your feet
- headache
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 2 weeks.
- Your healthcare provider will give you medicines before the first 4 infusions and then 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.
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Important Safety Information
- If you are able to become pregnant, you should use an effective method of birth control during your treatment and for at least 1 month after the last dose of BAVENCIO
- It is not known if BAVENCIO passes into your breast milk. Do not breastfeed during treatment and for at least 1 month after the final dose of BAVENCIO.
Ask your healthcare provider if you do not know.
What should I tell my healthcare provider before taking BAVENCIO?
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 or ulcerative colitis
- have had an organ transplant
- have lung or breathing problems
- have liver or kidney problems
- have diabetes
- have heart problems or high blood pressure
- have a high cholesterol level in your blood
- are pregnant or plan to become pregnant. BAVENCIO can harm your unborn baby.
- are breastfeeding or plan to breastfeed.
Tell your healthcare provider about all the medicines you take, including prescription and overthe-counter medicines, vitamins, and herbal supplements.
It is not known if BAVENCIO is safe and effective in children under the age of 12.
General information about BAVENCIO
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. If you would like more information about BAVENCIO, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about BAVENCIO that is written for health professionals
What are the ingredients in BAVENCIO?
Active ingredient: Avelumab
Other ingredient: D-mannitol, glacial acetic acid, polysorbate 20, sodium hydroxide, and Water for Injection