Description and Brand Names

Información sobre medicamentos proporcionada por: IBM Micromedex

US Brand Name

  1. BAVENCIO

Descriptions


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). This medicine is given to patients who have received other cancer medicines (eg, platinum) that did not work well.

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.

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

This product is available in the following dosage forms:

  • Solution

Before Using

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.

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.

Drug Interactions

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.

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
  • 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.
  • 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

A nurse or other trained health professional will give you or your child this medicine. 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.

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

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 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.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you or your child have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or a skin rash, sores or ulcers on the skin, or fever or chills with this medicine.

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.

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 fatigue, irregular heartbeat, swelling of the face, fingers, feet, or lower legs, troubled breathing, or 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

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

  1. Back pain
  2. bloating or swelling of the face, arms, hands, lower legs, or feet
  3. blurred vision
  4. chills
  5. clay-colored stools
  6. confusion
  7. constipation
  8. cough
  9. dark urine
  10. decreased appetite
  11. depressed mood
  12. dizziness
  13. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  14. dry skin and hair
  15. feeling warm or cold
  16. fever
  17. hair loss
  18. headache
  19. hives or welts, itching, or skin rash
  20. hoarseness
  21. irritation
  22. joint pain, stiffness, or swelling
  23. muscle cramps and stiffness
  24. nausea
  25. nervousness
  26. pounding in the ears
  27. rapid weight gain
  28. redness of the face, neck, arms, and occasionally, upper chest
  29. redness, swelling, or pain of the skin
  30. scaling of the skin on the hands and feet
  31. slow or fast heartbeat
  32. stomach pain
  33. sweating
  34. swelling of the eyelids, face, lips, hands, or feet
  35. tightness in the chest
  36. tingling of the hands or feet
  37. troubled breathing or swallowing
  38. ulceration of the skin
  39. unusual tiredness or weakness
  40. unusual weight gain or loss
  41. vomiting
  42. yellow eyes or skin

Less common

  1. Bloody urine
  2. chest pain
  3. decreased frequency or amount of urine
  4. general feeling of discomfort or illness
  5. increased thirst
  6. lower back or side pain
  7. pain in the chest, groin, or legs, especially the calves
  8. severe, sudden headache
  9. slurred speech
  10. sneezing
  11. sore throat
  12. stomach cramps
  13. sudden loss of coordination
  14. sudden, severe weakness or numbness in the arm or leg
  15. swelling of the face, fingers, lower legs
  16. thickening of bronchial secretions
  17. vision changes
  18. watery or bloody diarrhea

Rare

  1. Blistering, peeling, or loosening of the skin
  2. chest discomfort
  3. cloudy urine
  4. darkening of the skin
  5. diarrhea
  6. difficulty in speaking
  7. double vision
  8. drowsiness
  9. dry mouth
  10. fainting
  11. flushed, dry skin
  12. fruit-like breath odor
  13. inability to move the arms, legs, or facial muscles
  14. inability to speak
  15. increased hunger
  16. increased urination
  17. indigestion
  18. loss of appetite
  19. loss of consciousness
  20. muscle pain
  21. pains in the stomach, side, or abdomen, possibly radiating to the back
  22. red skin lesions, often with a purple center
  23. red, irritated eyes
  24. sensitivity to heat
  25. slow speech
  26. sores, ulcers, or white spots in the mouth or on the lips
  27. trouble sleeping
  28. unexplained weight loss
  29. 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

  1. Bone pain
  2. cracked lips
  3. decreased weight
  4. difficulty in moving
  5. 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.