Avelumab injection is used to treat a certain type of skin cancer that has spread to other parts of the body in adults and children 12 years of age and older. Avelumab injection is also used to treat urothelial cancer (cancer of the lining of the bladder and other parts of the urinary tract) that has spread to nearby tissues or other parts of the body in people whose cancer worsened during or after it was treated with other chemotherapy medications. Avelumab injection is also used in combination with axitinib (Inlyta) as a first treatment for renal cell carcinoma (RCC; cancer that begins in the kidney) that has spread or cannot be removed by surgery. Avelumab injection is in a class of medications called monoclonal antibodies. It works by helping the body to slow or stop the growth of cancer cells.
HOW should this medicine be used?
Avelumab injection comes as a solution (liquid) to be injected intravenously (into a vein) over 60 minutes by a doctor or nurse in a medical facility or infusion center. It is usually given once every 2 weeks. Your doctor will decide how often you are to receive avelumab based on your body's response to this medication.
Avelumab injection may cause serious reactions during the infusion of the medication. You may be given other medications to treat or help prevent reactions to avelumab. A doctor or nurse will monitor you carefully while you are receiving the medication. Tell your doctor or nurse immediately if you experience any of the following symptoms during the infusion: chills or shaking, hives, fever, flushing, back pain, shortness of breath, wheezing, or stomach pain. Your doctor may need to slow down your infusion or delay or permanently stop your treatment if you experience these side effects.
Your doctor may also permanently or temporarily stop your treatment, or treat you with other medications if you experience other side effects. Be sure to tell your doctor how you are feeling during your treatment with avelumab injection.
Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with avelumab injection and each time you receive the medication. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.
Are there OTHER USES for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What SPECIAL PRECAUTIONS should I follow?
Before receiving avelumab injection,
tell your doctor and pharmacist if you are allergic to avelumab, any other medications, or any of the ingredients in avelumab injection. Ask your pharmacist for a list of the ingredients.
tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
tell your doctor if you have or have ever had diabetes, Crohn's disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever), ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum), an organ transplant, or liver, lung, or kidney disease.
tell your doctor if you are pregnant or plan to become pregnant. Use a reliable method of birth control to prevent pregnancy during your treatment and for 1 month after your final dose of avelumab. Talk to your doctor about birth control methods that will work for you. If you become pregnant while receiving avelumab, call your doctor immediately. Avelumab may harm the fetus.
tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed while receiving avelumab and for 1 month after your final dose.
What SPECIAL DIETARY instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do IF I FORGET to take a dose?
If you miss an appointment to receive avelumab, call your doctor as soon as possible.
What SIDE EFFECTS can this medicine cause?
Avelumab may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
muscle, bone, or joint pain
loss of appetite
Some side effects can be serious. If you experience any of these symptoms or those listed in the HOW section, call your doctor immediately or get emergency medical treatment:
new or worsening cough; shortness of breath; or chest pain
nausea; vomiting; pain in right side of abdomen; dark (tea-colored) urine; extreme tiredness; or unusual bruising or bleeding
rapid heartbeat; constipation; increased sweating; voice changes; weight changes; feeling more thirsty than usual; dizziness or fainting; hair loss; nausea; vomiting; changes in mood; stomach pain; or feeling cold
diarrhea; blood in stools; dark, tarry, sticky stools; or stomach area pain or tenderness
feeling dizzy or faint
swelling of feet and legs
chest pain and tightness
fever or other flu-like symptoms
rash, blistering or peeling skin
difficulty breathing or swallowing
decreased urination; blood in urine; swelling in ankles; or loss of appetite
unusual bleeding or bruising
frequent, painful, or urgent urination
Avelumab injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online ( Web Site ) or by phone (1-800-332-1088).
What should I do in case of OVERDOSE?
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at Web Site. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
What OTHER INFORMATION should I know?
Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests before and during your treatment to check your body's response to avelumab.
Ask your pharmacist any questions you have about avelumab injection.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
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