BAVENCIO® Patient

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 a high cholesterol level in your blood
are pregnant or plan to become pregnant. BAVENCIO can harm your unborn baby
- Females who 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. Talk to your healthcare provider about birth control methods that you can use during this time
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 final 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
nausea
infusion-related reactions including chills, fever, and back pain
rash
decreased appetite
swelling in your hands, feet, or ankles

The most common side effects of BAVENCIO as maintenance treatment in people with UC whose cancer responded or stabilized after platinum-containing chemotherapy as first treatment include:

feeling tired
muscle and bone pain
urinary tract infection
rash

The most common side effects of BAVENCIO in people with UC after platinum-containing chemotherapy that did not work, or is no longer working, include:

feeling tired
infusion-related reactions including chills, fever, back pain, redness, and shortness of breath
muscle and bone pain
nausea
decreased appetite
urinary tract infection

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.

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

This indication is approved under accelerated approval based on a clinical trial that measured how many patients responded and how long they responded. Continued approval may depend on benefit demonstrated in ongoing clinical trials.

a type of cancer in the bladder or urinary tract called urothelial carcinoma (UC) when it has spread or cannot be removed by surgery (advanced UC). BAVENCIO may be used:
- as maintenance treatment when your cancer has responded or stabilized after you have received platinum-containing chemotherapy as your first treatment
- when you have received platinum-containing chemotherapy, and it did not work or is no longer working

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

Please see full Prescribing Information, including Medication Guide for patients.

Important Safety Information

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

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

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 a high cholesterol level in your blood
are pregnant or plan to become pregnant. BAVENCIO can harm your unborn baby
- Females who 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. Talk to your healthcare provider about birth control methods that you can use during this time
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 final 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
nausea
infusion-related reactions including chills, fever, and back pain
rash
decreased appetite
swelling in your hands, feet, or ankles

The most common side effects of BAVENCIO as maintenance treatment in people with UC whose cancer responded or stabilized after platinum-containing chemotherapy as first treatment include:

feeling tired
muscle and bone pain
urinary tract infection
rash

The most common side effects of BAVENCIO in people with UC after platinum-containing chemotherapy that did not work, or is no longer working, include:

feeling tired
infusion-related reactions including chills, fever, back pain, redness, and shortness of breath
muscle and bone pain
nausea
decreased appetite
urinary tract infection

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.

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

a type of cancer in the bladder or urinary tract called urothelial carcinoma (UC) when it has spread or cannot be removed by surgery (advanced UC). BAVENCIO may be used:
- as maintenance treatment when your cancer has responded or stabilized after you have received platinum-containing chemotherapy as your first treatment
- when you have received platinum-containing chemotherapy, and it did not work or is no longer working

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

Please see full Prescribing Information, including Medication Guide for patients.

BRING ON

Metastatic Merkel Cell Carcinoma

BAVENCIO can be used for patients with a type of skin cancer called Merkel cell carcinoma (MCC) that has spread

Another Tumor Type

For use in combination in the treatment of another type of tumor

Important Safety Information

Indications

Important Safety Information

Indications

BRING ON

Metastatic Merkel Cell Carcinoma BAVENCIO can be used for patients with a type of skin cancer called Merkel cell carcinoma (MCC) that has spread

Another Tumor Type For use in combination in the treatment of another type of tumor

Important Safety Information

Indications

Important Safety Information

Indications

Metastatic Merkel Cell Carcinoma

BAVENCIO can be used for patients with a type of skin cancer called Merkel cell carcinoma (MCC) that has spread

Another Tumor Type

For use in combination in the treatment of another type of tumor