Pronunciation:

a-VEL-ue-mab

Brand Names:

• BAVENCIO

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Monoclonal Antibody

Uses of This Medicine:

Avelumab injection is used to treat a kind of skin cancer called Merkel cell carcinoma (MCC) that has spread.

Avelumab injection is also used to treat urothelial carcinoma (a type of urinary tract cancer), that has spread throughout the body (metastatic) or cannot be removed by surgery (locally advanced). This medicine is given to patients who have received other cancer medicines (eg, platinum) that did not work well. It is also used as first-line maintenance treatment for urothelial carcinoma that has spread in patients who have responded well with platinum-containing cancer medicines.

Avelumab injection is also used in combination with other medicines (eg, axitinib) as first-line treatment of advanced renal cell carcinoma (RCC), a type of kidney cancer.

Avelumab belongs to the group of medicines called antineoplastics. It helps change the immune system to help control the growth of cancer cells.

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of avelumab injection in children 12 years of age and older. However, safety and efficacy have not been established in children younger than 12 years of age.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of avelumab injection in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Bacillus of Calmette and Guerin Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Monkeypox Vaccine
• Typhoid Vaccine
• Varicella Virus Vaccine
• Yellow Fever Vaccine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adenovirus Vaccine Type 4, Live
• Adenovirus Vaccine Type 7, Live
• Cholera Vaccine
• Ebola Zaire Vaccine, Live
• Influenza Virus Vaccine, Live
• Rotavirus Vaccine, Live

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Adrenal gland problems or
• Colitis (inflammation of the bowels) or
• Diabetic ketoacidosis or
• Heart attack, history of or
• Heart failure or
• Hepatitis (inflammation of the liver) or
• Hyperthyroidism (high levels of thyroid hormone) or
• Hypophysitis (inflammation of the pituitary gland) or
• Hypothyroidism (low levels of thyroid hormone) or
• Immune system problems or
• Nephritis (inflammation of the kidneys) or
• Nervous system problems (eg, Guillain-Barré syndrome, myasthenia gravis) or
• Pneumonitis (inflammation of the lungs) or
• Thyroid problems or
• Type 1 diabetes—Use with caution. May make these conditions worse.

• Diabetes or
• Dyslipidemia (high cholesterol in the blood) or
• Hypertension (high blood pressure)—Use with caution. May increase risk for more side effects.

• Organ transplant or tissue transplant (eg, cornea transplant), recent—Use with caution. May increase risk for organ or tissue transplant rejection.

• Patients who have had allogeneic hematopoietic stem cell transplant (HSCT)—Use with caution. May cause side effects to become worse.

Proper Use of This Medicine:

A nurse or other trained health professional will give you or your child this medicine in a medical facility. It is given through an IV catheter that is placed into one of your veins. It must be given slowly, so the IV will have to remain in place for at least 60 minutes. The infusion will be given every 2 weeks.

This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Your doctor may give you other medicines (eg, allergy medicine, fever medicine) before the first 4 infusions of this medicine to prevent unwanted effects.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress closely and at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Receiving this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 1 month after the last dose. If you think you have become pregnant while receiving the medicine, tell your doctor right away.

This medicine may cause infusion-related reactions, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you start to have a skin rash, dizziness, trouble breathing, chest tightness, swelling in your face or hands, or fever or chills while you are receiving this medicine.

Tell your doctor right away if you have a cough, trouble breathing, chest tightness, or any type of breathing problem with this medicine. These could be symptoms of a serious lung problem.

Check with your doctor right away if you or your child have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Colitis (swelling of the colon or bowel) may occur with this medicine. Tell your doctor right away if you or your child have stomach pain or tenderness, watery or bloody diarrhea, or a fever after receiving this medicine.

Serious problems with the adrenal, pituitary, or thyroid glands (hormone glands) may occur while you or your child are receiving this medicine. Tell your doctor if you start to have continuing or unusual headaches, changes in mood or behavior (eg, being irritable or forgetful), lightheadedness, dizziness, or fainting, unusual sluggishness, or an increase in weight.

This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.

Serious skin reactions (eg, exfoliative dermatitis, Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms (DRESS), or toxic epidermal necrolysis) can occur with this medicine. Check with your doctor right away if you or your child have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions, often with a purple center, severe acne or a skin rash, sore throat, sores or ulcers on the skin, mouth, or lips, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness with this medicine.

Tell your doctor right away if you or your child have bloody or cloudy urine, nausea, vomiting, trouble breathing, swelling of the face, feet, or lower legs, unusual tiredness or weakness, or unusual weight gain. These may be symptoms of serious kidney problems (eg, nephritis, kidney failure).

This medicine may increase your risk for heart problems (eg, heart failure, heart attack). Check with your doctor right away if you have chest pain or tightness, decreased urine output, dilated neck veins, extreme tiredness or weakness, irregular heartbeat, swelling of the face, fingers, feet, or lower legs, trouble breathing, or weight gain.

Call your doctor right away if you have difficulty with breathing, swallowing, or talking, muscle weakness, severe tiredness, or sudden numbness and weakness in the arms or legs. These could be symptoms of a nervous system problem.

Check with your doctor if you have a headache, confusion, seizures, stiff neck, or vomiting while receiving this medicine. These may be symptoms of encephalitis.

Check with your doctor right away if you have a severe headache, drowsiness, confusion, general feeling of illness, or stiff neck or back while receiving this medicine. These may be symptoms of meningitis.

Pancreatitis (swelling of the pancreas) may occur while you are receiving this medicine. Tell your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.

Call your doctor right away if you start to have a cough that will not go away, weight loss, night sweats, fever, chills, painful or difficult urination, or flu-like symptoms, such as a runny or stuffy nose, headache, blurred vision, or feeling generally ill. These may be signs that you have an infection.

Tell your doctor right away if you or your child have a rash, changes in eyesight, severe or persistent muscle or joint pain, or severe muscle weakness after receiving this medicine.

This medicine may increase your risk for possible organ transplant rejection. Talk to your doctor about this risk.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Back pain

bloating or swelling of the face, arms, hands, lower legs, or feet

chest tightness

blurred vision

chills

clay-colored stools

confusion

constipation

cough

dark urine

decreased appetite

depressed mood

dizziness, fainting, or lightheadedness when getting up suddenly from a lying or sitting position

dry skin and hair

feeling warm or cold

fever

hair loss

headache

hives or welts, itching, or skin rash

hoarseness

irritation

joint pain, stiffness, or swelling

muscle cramps and stiffness

nausea

nervousness

pounding in the ears

rapid weight gain

redness of the face, neck, arms, and occasionally, upper chest

redness, swelling, or pain of the skin

scaling of the skin on the hands and feet

slow or fast heartbeat

stomach pain

sweating

swelling of the eyelids, face, lips, hands, or feet

tingling of the hands or feet

trouble breathing or swallowing

ulceration of the skin

unusual tiredness or weakness

unusual weight gain or loss

vomiting

yellow eyes or skin

Less common

Bloody urine

chest pain

decreased frequency or amount of urine

general feeling of discomfort or illness

increased thirst

lower back or side pain

pain in the chest, groin, or legs, especially the calves

severe, sudden headache

slurred speech

sneezing

sore throat

stomach cramps

sudden loss of coordination

sudden, severe weakness or numbness in the arm or leg

swelling of the face, fingers, lower legs

thickening of bronchial secretions

vision changes

watery or bloody diarrhea

Rare

Blistering, peeling, or loosening of the skin

chest discomfort

cloudy urine

darkening of the skin

difficulty in speaking

double vision

drowsiness

dry mouth

fruit-like breath odor

inability to move the arms, legs, or facial muscles

inability to speak

increased hunger

increased urination

indigestion

loss of appetite

loss of consciousness

muscle pain

pains in the stomach, side, or abdomen, possibly radiating to the back

red skin lesions, often with a purple center

red, irritated eyes

sensitivity to heat

slow speech

sores, ulcers, or white spots in the mouth or on the lips

swollen glands

trouble sleeping

unexplained weight loss

upper right abdominal or stomach pain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Bone pain

cracked lips

decreased weight

difficulty in moving

voice changes

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.