AVELUMAB
Background and Date of Approval
Avelumab is an anticancer medication belonging to the PD-L1 (programmed death ligand-1) inhibitor class. It received FDA approval on 30 June 2020 for the treatment of select cancer types.
Uses
Avelumab is an intravenously administered drug. It is used to treat Merkel cell carcinoma, a rare type of skin cancer that has spread to other body parts in adults and children 12 years and older. It is also indicated to treat urothelial carcinoma, cancer that originates in the urinary tract that has spread to nearby tissues or other body parts of the body in people whose cancer worsened during or within 12 months after it was treated with other anticancer medications. It is also used in combination with other anticancer medicines to treat renal cell carcinoma, a type of kidney cancer that has spread to other body parts.
How is it administered?
Avelumab is a prescription medicine available as an injection. It will be given to you by a doctor or nurse in a hospital or clinic setting trained in cancer chemotherapy. It is given as an intravenous infusion drip (into your vein). This will take one hour. Do not self-administer the injection. Your doctor will decide the dose and duration of the treatment based on your disease severity, body weight, and other factors.
Side Effects
The common side effects of Avelumab are increased blood pressure, swelling in the legs and feet, skin rash, abdominal pain, decreased appetite, diarrhea, nausea, decreased RBC counts, muscle pain, cough, shortness of breath, difficulty in talking, and tiredness. Other serious side effects are heart problems, severe skin reactions, thyroid problems, liver injury, visual impairment, infusion reactions.
Warnings
This medicine is intended to cause inflammation of the liver, lungs, and colon. Inform your physician if you have noticed any symptoms of liver injury, lung problems, or stomach or bowel problems. Avelumab should not be administered to pregnant women because it may cause severe birth defects. This medicine may cause cardiovascular problems in long-term use.
Precautions
Do not take avelumab if you are allergic to avelumab or any other ingredients of this medicine. Inform your physician if you have liver diseases, hepatitis B, HIV/AIDS, or other immune diseases before initiating the therapy. This medicine is not recommended for children and adolescents below 18. If you suffer from any of the reactions like infusion-related reactions, inflammation of your lungs, liver, pancreas, watery stools, or diarrhea, inform your doctor immediately and seek medical attention. Avelumab should not be used in pregnant and breastfeeding women. Inform your physician if you are pregnant or breastfeeding. Use effective contraception throughout the therapy to avoid pregnancy. Your healthcare professional may advise you to take certain blood tests to monitor the effectiveness and side effects of the therapy. Inform your healthcare provider about all your medicines, including prescription, over-the-counter, vaccinations, nutritional and vitamin supplements, and herbal products. Certain medications may interact with this injection and reduce its effectiveness by causing undesirable side effects.
Word of Advice
Store in a refrigerator at 2°C to 8°C. Do not freeze. Store in the original package to protect from light. Keep the injection out of reach of children and pets. If you have missed any dosing appointments, inform your doctor and schedule immediately. Report symptoms of infection, anaemia, or bleeding immediately to your doctor. Do not breastfeed during treatment and for 1 month after the last dose. Inform your doctor if you have kidney disease, liver disease, heart disease, diabetes, lung or breathing problems, or stomach problems before starting therapy. Do not stop taking the injection without consulting your physician. Stopping your treatment may stop the effect of the medicine. Your doctor may ask you to undergo certain tests to check the effectiveness of the therapy and to monitor any unwanted side effects.
References
Bavencio 20 mg/mL concentrate for solution for infusion - Summary of Product Characteristics (SmPC) - (emc). www.medicines.org.uk. Revised February 2022. Accessed May 4, 2023. http://www.medicines.org.uk/emc/product/8453/smpc BAVENCIO-Avelumab Injection.; Revised June 2020. Accessed May 4, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761049s009lbl.pdf Douglas F. Lake and Adrienne D. Briggs, Immunopharmacology, Langeâs Basic & Clinical Pharmacology, 14th Edition, 2018, 977-1002.
Frequently Asked Questions
How long should I have to take avelumab?
Avelumab is given as a cycle therapy. Your doctor will decide the dose and duration of the therapy based on your disease severity and condition.
Can I take vitamin supplements with avelumab?
Certain medications may interact with the effectiveness of avelumab including prescription, over-the-counter medicines, vitamin or nutritional supplements, and herbal products. Inform your physician about your medication history.
Is avelumab cardiotoxic?
Heart problems like cardiac arrest and congestive heart failure may occur in patients receiving this medicine for the long term. Inform your physician of any pre-existing heart disorders before initiating the treatment.
What is Avelumab patient information leaflet?
The FDA requires a patient information leaflet that contains a summary of the essential scientific information needed for the safe and effective use of the drug for patients. Read the information leaflet thoroughly before starting the therapy.
What are the infusion reactions of avelumab?
Signs of shortness of breath, wheezing, chills or shaking, rash, flushing, low blood pressure, dizziness, fatigue, nausea, fever, back pain, and abdominal pain are the infusion reactions that may cause due to the avelumab administration. Inform your physician and seek medical attention immediately if you face these reactions after administering the injection.