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avelumab (Intravenous route)

a-VEL-ue-mab

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 adults and children 12 years of age and older with metastatic Merkel cell cancer (skin cancer that has already spread). avelumab helps change the immune system to help control the growth of cancer cells.

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) but did not work well.

avelumab is to be given only by or under the immediate 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.

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.

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 problems or
  • Colitis (inflammation of the intestine) or
  • Diabetes or
  • Diabetic ketoacidosis 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.

Proper Use of avelumab

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

avelumab comes with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Missed Dose

avelumab needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

Precautions While Using avelumab

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

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

avelumab may cause a rare but serious type of an allergic reaction called an infusion reaction. This 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.

Tell your doctor right away if you or your child have bloody or cloudy urine, nausea or vomiting, trouble breathing, swelling of the face, feet, or lower legs, unusual tiredness or weakness, or unusual weight gain.

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 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
  • Abdominal or stomach pain
  • back pain
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • blurred vision
  • chills
  • confusion
  • cough
  • dizziness
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • feeling of warmth
  • fever
  • headache
  • hives or welts, itching, or skin rash
  • hoarseness
  • irritation
  • joint pain, stiffness, or swelling
  • nervousness
  • pounding in the ears
  • rapid weight gain
  • redness of the face, neck, arms, and occasionally, upper chest
  • redness of the skin
  • slow or fast heartbeat
  • sweating
  • swelling of the eyelids, face, lips, hands, or feet
  • tightness in the chest
  • tingling of the hands or feet
  • troubled breathing or swallowing
  • unusual tiredness or weakness
  • unusual weight gain or loss
Less common
  • Chest pain
  • constipation
  • depressed mood
  • dry skin and hair
  • feeling cold
  • general feeling of discomfort or illness
  • hair loss
  • muscle cramps and stiffness
  • stomach cramps
  • thickening of bronchial secretions
  • watery or bloody diarrhea
  • weight gain
Rare
  • Blistering, peeling, or loosening of the skin
  • bloody or cloudy urine
  • chest discomfort
  • dark urine
  • darkening of the skin
  • diarrhea
  • drowsiness
  • dry mouth
  • fainting
  • flushed, dry skin
  • fruit-like breath odor
  • increased hunger
  • increased thirst
  • increased urination
  • light-colored stools
  • loss of appetite
  • loss of consciousness
  • muscle pain
  • nausea or vomiting
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • sensitivity to heat
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • stomachache
  • trouble sleeping
  • unexplained weight loss
  • unusual tiredness or weakness
  • upper right abdominal or stomach pain
  • weight loss
  • yellow eyes and skin

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
  • Decreased appetite

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.

Side Effects (complete list)

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