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Treatment Name: Avelumab (Bavencio®)

Avelumab (Bavencio®) is an Immunotherapy Regimen for Merkel Cell Carcinoma (MCC)

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.

Schedule

  • 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.

Side Effects

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.

Side effect videos Side Effect Videos
Fatigue Fatigue AnemiaAnemiaDiarrheaDiarrheaNausea and VomitingNausea and VomitingConstipationConstipationPainPain

Monitoring

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.

ChemoExperts Tips

  • 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:

  • Avelumab

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.

Emotional Wellness

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®)

Individual Drug Label Information

Avelumab (Bavencio®)

  • Is an intravenous (I.V.) infusion
  • Is a clear to slightly yellow solution
  • Doses may need to be delayed or adjusted due to: lung, liver, colon/gastrointestinal tract, thyroid, adrenal glands, pancreas, kidney, or other treatment-related problems
  • Inflammation of the lungs is rare, but serious if it occurs. Call your doctor immediately if you notice change in breathing, worsening cough, or chest pain as immediate treatment may be necessary
  • Liver inflammation may occur and is usually found through blood tests and may not cause any symptoms early in treatment. Avelumab therapy may need to be put on hold if this occurs, or steroid treatment may be started to help the liver recover. It may be possible to restart treatment if the liver fully recovers. Signs of liver problems may include yellowing of eyes or skin, pain on right side of abdomen, or easy bruising or bleeding
  • Intestine (colon) inflammation is relatively common and often causes diarrhea, with or without abdominal pain. Avelumab therapy may need to be put on hold if this occurs, or steroid treatment may be started to help the intestines recover. It may be possible to restart treatment if the intestines recover
  • Avelumab may cause fetal harm in a pregnant woman. Females of childbearing potential should use effective contraception during treatment and for one month after finishing treatment. Breastfeeding infants while on this drug is not advised.
General side effects from avelumab (Bavencio®)
  • Fatigue
  • Low lymphocyte white blood cells [lymphopenia]
  • Low red blood cells [anemia]
  • Muscle pain
  • Low blood platelets [thrombocytopenia]
  • Diarrhea
  • Infusion-related reactions
  • Nausea
  • Rash
  • Decreased appetite
  • Swelling of arms and legs [peripheral edema]
  • Cough
  • Constipation
  • Abdominal pain
  • Joint pain
  • Decreased weight
  • Dizziness
  • High blood pressure
  • Vomiting
  • Shortness of breath
  • Headache
  • Itching
  • Low white blood cells [neutropenia] 
  • Click on the avelumab (Bavencio®) package insert below for all reported side effects and possible drug interactions

Side Effect Videos
Nausea and VomitingNausea and VomitingDiarrheaDiarrheaFatigue Fatigue ConstipationConstipationPainPainAnemiaAnemia

See DailyMed package insert.

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References

Kaufman HL, Russell J, Hamid O, et al. Avelumab in patients with chemotherapy-refractory metastatic Merkel cell carcinoma: a multicentre, single-group, open-label, phase 2 trial. Lancet Oncol. 2016;17:1374-1385.

Created: September 18, 2017 Updated: September 18, 2017

What is Merkel Cell Carcinoma (MCC)?

A rare and very aggressive skin cancer that most often occurs on sun exposed areas such as the head, neck, arms, legs or trunk. Known causes of MCC include the Merkel cell polyomavirus (MCV). Roughly 80% of MCC tumors are infected with the Merkel cell polyomavirus. People with a weakened immune system and/or extensive sun damage are at higher risk of developing MCC. The stage of MCC can vary at diagnosis and throughout treatment.

The stage at diagnosis is the best predictor if the cancer will return. Stages of MCC include 0, IA, IB, IIA, IIB, IIC, IIIA, IIIB, and IV. The effectiveness of the treatment may depend upon the stage at diagnosis. MCC usually involves multiple therapy types such as radiation, surgery, and systemic (intravenous and/or oral) medications.

What does Cure mean?

The word “cure” means there are no cancer cells left in the body and cancer will never come back. Depending on the cancer type and stage, this may be the true goal of therapy. However, it is very difficult to prove all cancer cells are gone. Even though images, like X-rays and MRI’s, and blood tests may not show any signs of cancer, there can be a small amount of cancer cells still left in the body. Because of this, the word “remission” is used more often. This means there are no signs or symptoms of cancer. Patients in remission are followed closely for any signs of cancer returning. Sometimes, more chemotherapy may be given while in remission to prevent the cancer from coming back.

Doctors usually do not consider a patient “cured” until the chance of cancer returning is extremely low. If cancer does return, it usually happens within 5 years of having a remission. Because of this, doctors do not consider a patient cured unless the cancer has not come back within 5 years of remission. The five-year cutoff does not apply to all cancers.

Common avelumab (Bavencio®) starting dose

  • Avelumab 10 mg/kg intravenous (I.V.) infusion over 60 minutes on Day 1 of a 14-day Cycle
  • Premedications are recommended for the first four cycles: acetaminophen (Tylenol) + antihistamine (diphenhydramine or hydroxyzine)

What is a CBC?

A Complete Blood Count (CBC) is a frequently ordered blood test that tells clinicians the status of your: 1) White blood cell count, 2) Hemoglobin, and 3) Platelet count at the time the test was taken.

Common uses:
1) White blood cell count (WBC): is used to determine infection risk, or response to chemotherapy. Certain chemotherapy agents may harm our good infection-fighting cells. Sometimes chemotherapy may need to be delayed to allow these cells to recover.

2) Hemoglobin: is used to determine if someone is anemic. Anytime the hemoglobin is below 12 g/dL, the person is said to be anemic. Red blood cell transfusions, and sometimes iron can be given to restore the hemoglobin level, but anemia treatment should always aim at treating the underlying cause or condition.

3) Platelet count: is used to determine if the risk of bleeding is increased or if a platelet transfusion is required to prevent bleeding. Certain medications that increase bleeding risk, such as: aspirin, certain chemotherapy agents, and blood thinners, may need to be stopped temporarily until the platelet count is within a safe range.

What is a CMP?

A Comprehensive Metabolic Panel (CMP) is a frequently ordered blood test that tells clinicians the status of your: 1) Electrolytes & Acid/Base status2) Kidney function, 3) Liver function, 4) Blood sugar, and 5) Calcium at the time the test was taken. It is commonly used to monitor liver and kidney function when beginning new medications such as chemotherapy. A total of 14 tests are run simultaneously and are shown below.

Electrolytes & Acid/Base status:
1) Sodium, 2) Potassium, 3) Carbon dioxide, 4) Chloride

Kidney Function:
5) BUN (blood urea nitrogen), 6) Serum creatinine (Scr)

Liver Function:
7) AST, 8) ALT, 9) Total bilirubin, 10) Alk Phos, 11) Albumin, 12) Total protein

Blood sugar:
13) Serum glucose

Calcium:
14) Serum calcium