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 life-threatening, and can lead to death.
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 delay or completely stop treatment with BAVENCIO if you have severe side effects.
Call or see your healthcare provider right away if you get any symptoms of the following problems, or if these symptoms get worse.
BAVENCIO can cause serious side effects, including:
- Lung problems (pneumonitis)–signs and symptoms may include new or worsening cough, shortness of breath, and chest pain
- Liver problems (hepatitis)–signs and symptoms 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), drowsiness, dark urine (tea colored), bleeding or bruising more easily than normal, and feeling less hungry than usual
- Intestinal problems (colitis)–signs and symptoms may include diarrhea (loose stools) or more bowel movements than usual, blood in your stools or dark, tarry, sticky stools, and 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, extreme tiredness, weight gain or weight loss, feeling more hungry or thirsty than usual, hair loss, changes in mood or behavior (such as irritability or forgetfulness), feeling cold, constipation, your voice getting deeper, very low blood pressure, urinating more often than usual, dizziness or fainting, nausea or vomiting, and stomach area (abdomen) pain
- Kidney problems including nephritis–signs and symptoms may include urinating less than usual, blood in your urine, swelling in your ankles, and loss of appetite
- Problems in other organs–signs and symptoms may include severe muscle weakness; severe or persistent muscle or joint pain; chest pain and tightness; trouble breathing; skin rash; blisters or peeling; changes in heartbeat such as beating fast, seeming to skip a beat, or a pounding sensation; tiredness; sleepiness; swelling of the feet and legs; dizziness or fainting; fever; flu-like symptoms; and changes in eyesight
- Severe infusion reactions–signs and symptoms may include chills or shaking, hives, flushing, shortness of breath or wheezing, low blood pressure, fever, and back or abdominal pain
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; or 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 1 month after the last dose of BAVENCIO
- 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 include:
- feeling tired
- muscle and bone pain
- infusion-related reaction
- swelling in your hands, feet, or ankles
- decreased appetite
- skin rash
These are not all the possible side effects of BAVENCIO. Ask your healthcare provider or pharmacist for more information. You may report side effects to EMD Serono at 1-800-283-8088 ext 5563. You may also report side effects to the FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.
Please see full Prescribing Information, including Medication Guide, for patients.