Avelumab is a human monoclonal antibody that was approved by US FDA to treat metastatic Merkel-cell carcinoma and urothelial cancer.
It is also approved for use in stomach cancer in Europe.
Avelumab is a programmed death ligand-1 (PD-L1) blocking antibody which is prescribed to treat adult and pediatric patients of 12 years and older who suffer from advanced Merkel-cell carcinoma that has spread to other parts of the body. Merkel-cell carcinoma is a rare but highly aggressive form of skin cancer caused by the Merkel cell polyomavirus.
Avelumab is also used to treat urothelial cancer (cancer that occurs in the bladder, ureter, and urethra) in patients whose cancer was worsened during chemotherapy or within 12 months of chemotherapy given with surgery. It received orphan drug designation in January 2017 by the European Medicines Agency (EMA) for treating stomach cancer.
Avelumab acts either by slowing down the growth of cancer cells or stops the further development of cancer.
Avelumab should not be used in patients with the following conditions:
Allergy to avelumab
Pregnancy and breastfeeding. Women of childbearing age should be strictly advised to follow effective contraception methods during avelumab treatment and to continue for at least 1 month after the final dose of avelumab injection
Children less than 12 years because of the lack of safety and efficacy data
Type 1 Diabetes mellitus
Immune system disorders such as ulcerative colitis or Crohn's disease
The recommended dose of avelumab is 10mg/kg which is administered as an intravenous infusion over 60 minutes every two weeks until the progression of disease or intolerable toxicity.
Dose modifications are necessary when serious adverse reactions are reported. The avelumab therapy can be either withheld until the adverse reactions subside or can be permanently discontinued based on the patient condition or the severity of adverse reactions.
It is necessary to premedicate the patients with antihistamine and acetaminophen before at least the first four infusions.
Avelumab comes as an injection which has to be administered intravenously over 60 minutes. Before administering, it is important to check the solution in the vial for any presence of visible matter, change in the appearance of the solution such as cloudy or discoloration; if so, it should be discarded.
The required volume of the avelumab injection should be withdrawn from the vial and to be injected into a 250 ml infusion bag containing isotonic sodium chloride.
The infusion bag must be gently inverted to mix the diluted portion but care should be taken to avoid the formation of foam or excess shearing.
Avelumab must not be injected in the same intravenous line along with other drugs.
It is important to discard the partially used or empty vials of avelumab appropriately.
Patients should be monitored very closely for the following serious adverse reactions and the therapy should either be withheld or permanently discontinued based on the patients condition:
Endocrinopathies such as thyroid disorders, adrenal insufficiency, and type 1 diabetes mellitus
Infusion-related infections such as fever, low blood pressure or difficulty in breathing
Common: Fatigue , infusion-related reactions that include fever, chills, hypotension and wheezing, peripheral edema
Gastrointestinal: Abdominal pain, diarrhea, nausea, vomiting, constipation
Central nervous system: Headache, dizziness
Respiratory: Cough, difficulty in breathing
Cardiovascular: Increased blood pressure, heartbeat abnormalities, lightheadedness when getting up suddenly from lying or sitting position
Skin: Rashes and itching
Musculoskeletal: Arthralgia and muscle pain
Kidney: Nephritis, renal dysfunction
Immune-reactions: Inflammation of the heart, lung, colon, liver, endocrine organs, diabetes, muscle, brain, blood vessels, psoriasis, arthritis, skin reactions
Others: vision problems, reduced appetite, reduced weight, loss of weight
Patients should be advised to report to an emergency center in case of serious immune-mediated adverse reactions or infusion-related reactions.
Breastfeeding mothers must be informed not to breastfeed during avelumab therapy and also until 1 month after the final dose of avelumab.
All prescription and non-prescription drugs including herbal supplements should be taken only after the approval of the treating physician during the therapy.
While administering avelumab injection a separate intravenous line should be used.
The avelumab injection must be protected from light.
The diluted solution of avelumab with sodium chloride should be stored at room temperature (15°C to 25°C) but not more than 4 hours after dilution, or in a refrigerator from 2°C to 8°C for up to 24 hours. If refrigerated, the diluted solution should be allowed to come to the room temperature before intravenous administration.
The diluted solution should not be shaken or frozen.
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