Avelumab (Intravenous route)
Uses of This Medicine:
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). This medicine 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). This medicine is given to patients who have received other cancer medicines (eg, platinum) but did not work well.
This medicine is to be given only by or under the immediate 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:
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.
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.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of avelumab injection in the elderly.
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.
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.
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 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 This Medicine:
A nurse or other trained health professional will give you or your child this medicine. This medicine 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.
This medicine 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.
This medicine 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 This Medicine:
It is very important that your doctor check your or your child's progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Using this medicine 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 this medicine. If you think you have become pregnant while using the medicine, tell your doctor right away.
This medicine 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 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, 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 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 the 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 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.
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.
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 this medicine.
Side Effects of This Medicine:
- More common
- Abdominal or stomach pain
- back pain
- bloating or swelling of the face, arms, hands, lower legs, or feet
- blurred vision
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- feeling of warmth
- hives or welts, itching, or skin rash
- joint pain, stiffness, or swelling
- 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
- 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
- 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
- Blistering, peeling, or loosening of the skin
- bloody or cloudy urine
- chest discomfort
- dark urine
- darkening of the skin
- dry mouth
- 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
- trouble sleeping
- unexplained weight loss
- unusual tiredness or weakness
- upper right abdominal or stomach pain
- weight loss
- yellow eyes and skin
- More common
- Decreased appetite
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:
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:
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.
Last Updated: 9/4/2017