Treatment Name: Avelumab (Bavencio®)
How does avelumab (Bavencio®) work?
Avelumab is designed to enhance your immune system’s ability to target and specifically kill Merkel cell cancer cells. Sometimes cancer cells have the ability to escape discovery from specific cancer-fighting cells in your body known as “T-cells.” Avelumab attaches to Merkel Cell cancer cells which tells the T-cells to kill the cancer.
Goals of therapy:
Avelumab is given to patients with the goal of shrinking tumors, decreasing symptoms, and prolonging survival and is not commonly given with the goal of cure.
- Avelumab intravenous (I.V.) infusion given over one hour (60 minutes) on Day 1
- Pre-medications are used before the first four infusions, then as needed: acetaminophen (Tylenol®) + antihistamine such as diphenhydramine (Benadryl®) or hydroxyzine (Atarax®)
Estimated total infusion time for this treatment:
- Up to two hours for Cycle 1, Day 1; as short as one hour of next cycles if well tolerated
- Infusion times are based on clinical studies, but may vary depending on doctor preference or patient tolerability. Pre-medications and I.V. fluids, such as hydration, may add more time
Avelumab is repeated every 14 days, or two weeks. This is known as one Cycle.
Avelumab is usually given in an outpatient infusion center, allowing the person to go home afterwards. On occasion, it may be given in the hospital if someone is too sick for outpatient care.
Each cycle of avelumab is repeated until the drug no longer works or until unacceptable side effects occur.
Click here for the common avelumab (Bavencio®) starting dose.
In clinical studies, the most commonly reported avelumab (Bavencio®) side effects are shown here:
- Fatigue (50%)
- Low lymphocyte white blood cells [lymphopenia] (49%)
- Low red blood cells [anemia] (35%)
- Muscle pain (32%)
- Low blood platelets [thrombocytopenia, increased bleeding risk] (27%)
- Diarrhea (23%)
- Infusion-related reactions (22%)
- Nausea (22%)
- Rash (22%)
- Decreased appetite (20%)
- Swelling of arms and legs [peripheral edema] (20%)
- Cough (18%)
- Constipation (17%)
- Abdominal pain (16%)
- Joint pain (16%)
- Decreased weight (15%)
- Dizziness (14%)
- High blood pressure (13%)
- Vomiting (13%)
- Shortness of breath (11%)
- Headache (10%)
- Itching (10%)
- Low white blood cells [neutropenia] (6%)
Treatment with avelumab may need to be delayed or discontinued for the following immune system-related reactions:
Lung inflammation (Pneumonitis): Affects roughly 1 out of 100 patients. May lead to shortness of breath, new or worsening cough, or chest pain. Has been reported to occur in as little as three days after treatment. Treatment with steroids is usually continued until breathing returns to normal.
Liver inflammation (Hepatitis): Affects roughly 1 out of 100 patients. May lead to abnormal liver blood tests. Can occur in as little as seven days after treatment. Treatment with steroids is usually continued until the liver-related blood tests return to normal.
Intestine inflammation: (Colitis): Affects roughly 2 out of 100 patients. May lead to diarrhea (loos stools), black or tarry stools, blood in stool, or severe stomach pain, which could lead to hospitalization. Has been reported to occur in as little as two months after treatment. Treatment with steroids is usually continued until diarrhea resolves and bowel movements return to normal.
Adrenal gland, thyroid, or pancreas inflammation: Affects up to 2 out of 100 patients. May lead to rapid heart beat, increased sweating, extreme tiredness, changes in hunger or thirst, weight gain or weight loss, hair loss, changes in mood, constipation, frequent urination, nausea or vomiting, low blood pressure, high blood sugar (diabetes), or stomach pain.
Kidney inflammation: Affects roughly 1 in 1,000 of patients. May lead to blood in urine, swelling in ankles, loss of appetite, or more frequent urination
Other immune system reactions: Affects roughly 1 in 1,000 of patients. May include muscle weakness, joint pain, skin rash, dizziness or fainting, fever or flu-like symptoms, or changes in eyesight.
In the original clinical study, 7% of patients discontinued avelumab due to unacceptable side effects.
How often is monitoring needed?
Labs (blood tests) may be checked before initial treatment, then every two weeks prior to each I.V. infusion of avelumab. Labs often include: Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), liver function tests, plus any others your doctor may order.
How often is imaging needed?
Imaging may be checked before treatment, then every six weeks, then less often if your doctor observes stable disease. Imaging may include: X-rays, computerized tomography (CT) scan, positron emission tomography (PET) scan, or magnetic resonance imaging (MRI).
How might blood test results/imaging affect treatment?
Depending upon the results, your doctor may advise to continue avelumab as planned, reduce the dose of future treatments, delay the next dose until the side effect goes away, or switch to an alternative therapy.
Note: Avelumab may lead to inflammation throughout the body and damage the following organs: lungs, liver, colon/gastrointestinal tract, thyroid, adrenal glands, pancreas, and kidneys. If severe, your doctor may recommend hospitalization and hold further treatment with avelumab until you recover.
- Because avelumab (Bavencio®) enhances your immune system response to cancer, this activation may lead to unintended side effects affecting the following organs: lungs, liver, colon/gastrointestinal tract, thyroid, adrenal glands, pancreas, and kidneys. A corticosteroid (e.g., prednisone or methylprednisolone) may be prescribed by your doctor to decrease symptoms if the immune system attacks healthy tissues during treatment
- Pre-medications are given before the first four infusions: acetaminophen (Tylenol®) and an antihistamine such as diphenhydramine (Benadryl®) or hydroxyzine (Atarax®). These medications will increase the time you spend at the infusion center
- A pharmacist should ALWAYS review your medication list to ensure that drug interactions are prevented or managed appropriately
- Clinical trials may exist for Merkel Cell Carcinoma. Ask your doctor if any studies are currently enrolling in your area. If not, go to clinicaltrials.gov to search for other centers offering study medications.
Patient Assistance & Co-payment Coverage
Patients under the age of 65 years, or those with private insurance plans:
If you have insurance and are looking for patient assistance or copay assistance for Avelumab (Bavencio®), we have provided links that may help.
Visit our Patient Assistance page and click the links to various patient assistance programs for help paying for Avelumab (Bavencio®). Depending upon your income, they may be able to help cover the cost of:
For Branded medications (may be available for generic medications too), check with the manufacturer to determine if a co-pay card is offered and if it could reduce your monthly copay.
- If you are uninsured, check with the manufacturer to determine if you are eligible to receive medication at no cost.
Medicare and Medicaid patients (Patients 65 years or older):
The clinic providing treatment will likely pre-authorize medications and immune therapies such as Avelumab (Bavencio®) and are the best source to help you understand drug cost.
- Ask to speak with a patient assistance technician or financial counselor at the clinic or hospital administering this therapy.
What is Emotional Wellness?
Emotional wellness is having a positive outlook balanced with a realistic understanding of current life events. This requires both an awareness and acceptance of your emotions. It is with this knowledge that you can develop a plan to take the necessary actions to positively impact your life.
Emotional wellness uses an ongoing process to continually reflect on the stressors of life in a constructive manner to move forward and create happiness.
Because emotional wellness is deeply connected with physical, social, and spiritual wellness, pursuing it often becomes particularly difficult in times of major illness. Despite this difficulty, working toward emotional wellness has been connected to improved treatment outcomes and a higher likelihood of achieving goals of therapy.
Learn more about pursuing emotional wellness while receiving treatment with Avelumab (Bavencio®)