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Avelumab Injection

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Why is this medication prescribed?

Avelumab injection is used to treat Merkel cell carcinoma (MCC; a kind of skin cancer) in adults and children 12 years of age and older that has progressed to other parts of the body. Avelumab injection is also used to treat urothelial cancer (cancer of the lining of the bladder and other urinary tract) in patients whose cancer worsened while receiving platinum chemotherapy or within a year of finishing treatment. This cancer has spread to nearby tissues or other parts of the body. In order to preserve the response to platinum chemotherapy, it is also used as a continuous treatment for urothelial cancer that has progressed to neighbouring tissues or other areas of the body. As a first line of treatment for renal cell carcinoma (RCC; cancer that starts in the kidney) that has spread or cannot be surgically removed, avelumab injection is also used in conjunction with axitinib (Inlyta). Avelumab injection belongs to the group of drugs known as monoclonal antibodies. It functions by assisting the body in reducing or halting the growth of cancer cells.

How should this medicine be used?

A doctor or nurse will administer avelumab injection intravenously (into a vein) over the course of 60 minutes in a hospital or infusion centre. Usually, it’s administered once every two weeks. Avelumab dosage frequency will be determined by your doctor based on how your body reacts to the drug.

When the medication is being infused, avelumab injection may result in serious side effects. To treat or assist prevent adverse reactions to avelumab, other drugs can be prescribed to you. As you take the drug, a doctor or nurse will keep a close eye on you. If you have any of the following symptoms while receiving the infusion, contact your doctor or nurse right away: chills or trembling, hives, fever, flushing, back pain, shortness of breath, wheezing, dizziness, feeling faint, or stomach ache. If you have these side effects, your doctor may decide to reduce the rate of your infusion, postpone your treatment, or totally stop it.

If you encounter further adverse effects, your doctor may potentially decide to permanently or temporarily cease your therapy or replace it with another medicine. When receiving an avelumab injection for treatment, be careful to let your doctor know how you are feeling.

When you start treatment with avelumab injectable and after each dose, your doctor or pharmacist will give you the manufacturer’s patient information leaflet (Medication Guide). If you have any questions, carefully read the material and contact your doctor or pharmacist. The Medication Guide is also available on the manufacturer’s website or the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm).

Other uses for this medicine

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before receiving avelumab injection,

  • If you have an allergy to avelumab, any other drugs, or any of the ingredients in avelumab injection, let your doctor and pharmacist know right once. Request a list of the components from your pharmacist.
  • Inform your doctor and pharmacist about any additional prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products you are now taking or intend to use. Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
  • Tell your doctor if you’ve received a bone marrow or organ transplant; radiation treatment to the chest region. Diabetes, thyroid issues, high blood pressure, high cholesterol, autoimmune diseases (conditions in which the immune system attacks a healthy part of the body) like Crohn’s disease (in which the body attacks the lining of the digestive tract and results in pain, diarrhoea, weight loss, and fever), ulcerative colitis (in which the lining of the colon [large intestine] and rectum experiences swelling and sores), or lupus (condition in which the immune system attacks a healthy part of the body;  any condition that affects your nervous system, such as myasthenia gravis (a nervous system disorder that results in muscle weakness) or Guillain-Barré syndrome (weakness, tingling, and potentially paralysis due to sudden nerve damage); any form of lung disease or breathing issues; liver, heart, or kidney disease; or any condition that affects your lungs. Inform your physician whether you now have or have ever had cytomegalovirus (CMV; a viral infection that may cause symptoms in patients with weak immune systems).
  • If you are pregnant or want to become pregnant, let your doctor know. Use a trustworthy method of birth control to avoid getting pregnant while receiving avelumab medication and for one month following the last dosage. Discuss effective birth control options with your doctor. If you conceive while taking avelumab, contact your doctor right away. The foetus could suffer from avelumab.
  • If you are currently breastfeeding or intend to do so, let your doctor know. While using avelumab and for a month following your last dose, you shouldn’t breastfeed.

What special dietary instructions should I follow?

Keep eating normally unless your doctor instructs you otherwise.

What should I do if I forget a dose?

Call your physician as soon as you can if you are unable to keep an avelumab appointment.

What side effects can this medication cause?

Avelumab might have negative effects. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Joint, muscle, or bone pain
  • Headache
  • Constipation
  • Nausea
  • Vomiting
  • Loss of weight
  • Tiredness

Some adverse effects can be very harmful. Call your doctor right away or seek emergency medical attention if you have any of these symptoms or those in the HOW section:

  • Chest pain, a new or worsening cough, or shortness of breath
  • Yellowing of the skin or eyes, nausea, vomiting, stomach pain on the upper right side, dark (tea-colored) urine, excessive exhaustion, or unusual bruising or bleeding are all symptoms to watch out for.
  • Constipation, rapid heartbeat, voice changes, weight changes, feeling more hungry or thirsty than usual, dizziness or fainting, hair loss, vomiting, changes in mood or behaviour, such as a decrease in sex drive or feeling agitated, confused, or forgetful; stomach pain; or feeling cold are all symptoms to watch out for.
  • Diarrhea, blood in the faeces, tarry, black, sticky stools, or discomfort or tenderness in the lower abdomen
  • Persistent muscle pain, weakness, or muscle cramps
  • Feeling lightheaded or weak
  • Neck discomfort
  • Swelling of hands, feet, ankles, or legs
  • Irregular heartbeat, tightness in the chest, arm, back, neck, or jaw pain, and chilly sweats
  • Fever or other influenza-like symptoms
  • Double or blurry vision, light sensitivity, or other vision issues
  • Skin that is rashes, blisters, or peels
  • Throat, mouth, nose, or genital sores
  • Enlarged glands
  • Reduced urination, blood in the urine, ankle edoema, or loss of appetite
  • Uncommon bruising or bleeding
  • Urination that is frequent, unpleasant, or urgent

Other negative effects from avelumab injection are possible. If you have any strange side effects while taking this medicine, call your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

What other information should I know?

Keep all of your appointments with your physician and the lab. To monitor your body’s reaction to avelumab, your doctor will request specific lab tests both before and after your therapy.

If you have any inquiries about avelumab injection, ask your pharmacist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Bavencio®
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