Avelumab Intravenous Advanced Patient Information - Drugs.com

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# Avelumab (Intravenous)

Medically reviewed by Drugs.com. Last updated on Jul 21, 2022.

## Commonly used brand name(s)

In the U.S.

- BAVENCIO

Available Dosage Forms:

- Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Monoclonal Antibody

## Uses for avelumab

Avelumab injection is used to treat metastatic Merkel cell carcinoma (skin cancer that has already spread).

Avelumab injection is also used to treat urothelial carcinoma, a type of bladder cancer, that has spread throughout the body (metastatic) or cannot be removed by surgery (advanced). Avelumab 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 with urothelial carcinoma that has spread in patients who have responded well with platinum-containing cancer medicines.

Avelumab injection is also used together 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.

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

## Before using avelumab

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 avelumab, the following should be considered:

### Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to avelumab 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.

### Pediatric

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.

### Geriatric

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

### Breastfeeding

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.

### Interactions with 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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

### Interactions with food/tobacco/alcohol

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 avelumab. 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
- Immune system problems or
- Nephritis (inflammation of the kidneys) or
- Pneumonitis (inflammation of the lungs) or
- Thyroid problems or
- Type 1 diabetes—Use with caution. May make these conditions worse.

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

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

## Proper use of avelumab

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

Avelumab 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 avelumab to prevent unwanted effects.

Detailed Avelumab dosage information

## Precautions while using avelumab

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

Receiving avelumab 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.

Avelumab may cause a rare but serious type of an allergic reaction called an infusion reaction, 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, fever or chills while you are receiving avelumab.

Tell your doctor right away if you have a cough, trouble breathing, chest tightness, or any type of breathing problem with avelumab. 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, a loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

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

Serious problems with the adrenal, pituitary, or thyroid glands (hormone glands) may occur while you or your child are receiving avelumab. Tell your doctor if you start having 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.

Avelumab 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 syndrome (DRESS), or toxic epidermal necrolysis) can occur with avelumab. 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 avelumab.

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 problem.

Avelumab 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 avelumab. 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 avelumab. These may be symptoms of meningitis.

Pancreatitis (swelling of the pancreas) may occur while you are receiving avelumab. 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 would 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 avelumab.

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

## Avelumab side effects

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
- 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
- tightness in the chest
- 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.

Avelumab side effects (more detail)

## Frequently asked questions

- Who makes Bavencio and where is it made?
- What type of drug is Bavencio?

## More about avelumab

- Check interactions
- Reviews (1)
- Side effects
- Dosage information
- During pregnancy
- Drug class: anti-PD-1 monoclonal antibodies
- Breastfeeding
- En español

### Patient resources

- Drug Information

#### Other brands

Bavencio

### Professional resources

- Prescribing Information

### Related treatment guides

- Urothelial Carcinoma
- Merkel Cell Carcinoma
- Renal Cell Carcinoma

## Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer