Bavencio

Bavencio is a prescription medication used to treat metastatic (advanced) Merkel cell carcinoma (MCC), which is a rare, aggressive form of skin cancer. 

This medication is also used to treat cancer in the bladder or urinary tract. 

Bavencio belongs to a group of drugs called monoclonal antibodies. Monoclonal antibodies work by targeting a specific molecule for the immune system to attack. Bavencio works by targeting a protein found on some cancer cells called programmed death ligand-1 (PD-L1), which helps the body's immune system attack these cells. 

Bavencio comes in an injectable form and is given by slowly injecting the solution directly into a vein through an intravenous (IV) line over 60 minutes. Bavencio must be administered by a health care professional.

Common side effects of Bavencio include fatigue, musculoskeletal pain, diarrhea, and nausea. Bavencio can cause fatigue. Do not drive or operate heavy machinery until you know how Bavencio affects you. 

Bavencio is a prescription medication used to treat Merkel cell carcinoma (MCC), a rare, aggressive form of skin cancer, in adults and pediatric patients 12 years and older. Bavencio may be used if the skin cancer has spread (metastatic). 

This medication is also used to treat cancer in the bladder or urinary tract called urothelial cancer. This medication may be used when your cancer:

• has spread or cannot be removed by surgery (advanced urothelial cancer), and
• you have received chemotherapy that contains a platinum-containing drug and it did not work or is no longer working.

It is not known if this medication is safe and effective in children under the age of 12.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information. 

Serious side effects have been reported with Bavencio. See the "Bavencio Precautions" section. 

Common side effects of Bavencio include the following: 

• Fatigue
• Bone and muscle pain
• Nausea
• Infusion-related reaction
• Decreased appetite
• Urinary tract infection

This is not a complete list of Bavencio side effects. Ask your doctor or pharmacist for more information. Tell your doctor if you have any side effect that bothers you or that does not go away. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. 

No drug interactions have been determined by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported. 

Serious side effects have been reported with Bavencio including the following:

Lung problems (pneumonitis) – Report any signs and symptoms of pneumonitis to your doctor right away. Signs and symptoms of pneumonitis may include:

• new or worsening cough
• shortness of breath
• chest pain 

Liver problems (hepatitis) – Report any signs and symptoms of hepatitis to your doctor right away. Signs and symptoms of hepatitis 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
• feeling less hungry than usual 

Intestinal problems (colitis) – Report any signs and symptoms of colitis to your doctor right away. 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). These include problems with the thyroid gland, adrenal gland, and pancreas. Report any signs and symptoms of endocrinopathies to your doctor right away. 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 gets deeper
• very low blood pressure
• urinating more often than usual
• dizziness or fainting
• nausea or vomiting
• stomach area (abdomen) pain 

Kidney problems (nephritis) and renal dysfunction – Signs and symptoms of kidney problems may include:

• urinate less than usual
• blood in your urine 
• swelling in your ankles loss of appetite 

Problems with other organs – Report any signs and symptoms of problems with other organs to your doctor right away. 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 

Infusion-related reactions – Your health care provider will monitor for infusion-related reactions and will interrupt or slow the rate of infusion for mild or moderate infusion-related reactions. Your health care provider will stop the infusion and permanently discontinue Bavencio for severe or life-threatening infusion-related reactions. Signs and symptoms of severe infusion reactions may include: 

• chills or shaking
• hives 
• flushing
• shortness of breath or wheezing
• low blood pressure fever
• back pain
• abdominal pain 

Embryo-fetal toxicity – Bavencio can cause fetal harm. Use effective contraception and contact your doctor right away if you suspect you have become pregnant while using Bavencio. 

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Bavencio, there are no specific foods that you must exclude from your diet when receiving this medication. 

Before taking Bavencio, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Bavencio or to any of its ingredients
• have or have had immune system problems such as Chrohn's disease or ulcerative colitis
• have had an organ transplant
• have lung or breathing problems
• have liver problems
• have kidney problems
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed 

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. 

Tell your doctor if you 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 of Bavencio.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Bavencio passes into breast milk. 

Since many drugs, including antibodies, are excreted in human milk, women should not breastfeed during treatment with Bavencio and for at least one month after the last dose due to the potential for serious adverse reactions in breastfed infants. 

Bavencio comes in an injectable form. 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.

To help reduce infusion reactions, your doctor may prescribe acetaminophen (Tylenol) and an antihistamine such as diphenhydramine (Benadryl) to be taken prior to the first four infusions and subsequently as needed. 

Take this medication exactly as prescribed by your doctor. 

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• how you respond to this medication
• your weight

The recommended dose of Bavencio is based on your weight at 10 mg/kg and is given as an intravenous infusion over 60 minutes every 2 weeks.

Your healthcare provider will decide how many treatments you need and will do blood tests to check for certain side effects.

If Bavencio is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.