Avelumab

Avelumab works by causing your immune system to attack tumor cells. Avelumab may cause your immune system to attack healthy organs and tissues in your body. This could lead to serious or life-threatening side effects on your lungs, liver, pancreas, kidneys, intestines, thyroid, or adrenal glands.

Call your doctor at once if you have symptoms such as: fever, flu symptoms, muscle pain or weakness, vision changes, chest pain, trouble breathing, severe stomach pain or diarrhea, skin rash, increased or decreased urination, weight changes, hair loss, dark urine, or jaundice (yellowing of your skin or eyes).

Avelumab is an antineoplastic agent.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• If you need to store avelumab at home, talk with your doctor, nurse, or pharmacist about how to store it.

(a VEL ue mab)

• Antineoplastic Agent, Anti-PD-L1 Monoclonal Antibody
• Antineoplastic Agent, Monoclonal Antibody

Note: Premedicate with an antihistamine and acetaminophen prior to the first 4 infusions; consider premedication for subsequent infusions based on clinical judgment and the presence and/or severity of infusion-related reactions with previous infusions.

Merkel cell carcinoma, metastatic: Children ≥12 years and Adolescents: IV: 10 mg/kg once every 2 weeks until disease progression or unacceptable toxicity.

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience bone pain, diarrhea, constipation, nausea, vomiting, abdominal pain, lack of appetite, or weight loss. Have patient report immediately to prescriber signs of high blood sugar (confusion, fatigue, increased thirst, increased hunger, polyuria, flushing, fast breathing, or breath that smells like fruit), signs of infusion reaction, signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), signs of thyroid, pituitary, or adrenal gland problems (mood changes, behavioral changes, weight changes, constipation, deeper voice, dizziness, passing out, cold sensation, severe fatigue, hair loss, persistent headache, or decreased libido), signs of Stevens-Johnson syndrome/toxic epidermal necrolysis (red, swollen, blistered, or peeling skin [with or without fever]; red or irritated eyes; or sores in mouth, throat, nose, or eyes), signs of a severe pulmonary disorder (lung or breathing problems like difficulty breathing, shortness of breath, or a cough that is new or worse), signs of bowel problems (black, tarry, or bloody stools; fever; mucus in stools; vomiting; vomiting blood; severe abdominal pain; constipation; or diarrhea), signs of kidney problems (urinary retention, hematuria, change in amount of urine passed, or weight gain), signs of pancreatitis (severe abdominal pain, severe back pain, severe nausea, or vomiting), signs of low sodium (headache, difficulty focusing, memory impairment, confusion, weakness, seizures, or change in balance), signs of severe cerebrovascular disease (change in strength on one side is greater than the other, difficulty speaking or thinking, change in balance, or vision changes), angina, tachycardia, abnormal heartbeat, burning or numbness feeling, severe muscle pain, severe muscle weakness, severe joint pain, bruising, bleeding, vision changes, severe loss of strength and energy, chills, flushing, back pain, severe abdominal pain, swelling of arms or legs, dizziness, passing out, severe headache, or signs of a urinary tract infection (hematuria, burning or painful urination, polyuria, fever, lower abdominal pain, or pelvic pain) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Applies to avelumab: intravenous solution

Along with its needed effects, avelumab 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 while taking avelumab:

• 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

• 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

• 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 of avelumab 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:

• Decreased appetite

Data not available

Data not available