Avelumab

What is Avelumab?

• Avelumab (Bavencio) is a programmed death ligand-1 (PD-L1) blocking antibody used for the treatment of Merkel cell carcinoma, urothelial carcinoma, and renal cell carcinoma.

What are the uses of this medicine?

This medicine used for the: used to treat:

• a type of skin cancer called Merkel cell carcinoma (MCC) in adults and children 12 years of age and older. Bavencio may be used when your skin cancer has spread.
• a type of cancer in the bladder or urinary tract called urothelial carcinoma (UC) when it has spread or cannot be removed by surgery (advanced UC). Bavencio may be used:

1. as maintenance treatment when your cancer has responded or stabilized after you have received platinum-containing chemotherapy as your first treatment.
2. when you have received platinum-containing chemotherapy, and it did not work or is no longer working.

• a type of kidney cancer called renal cell carcinoma (RCC). Bavencio may be used with the medicine axitinib as your first treatment when your kidney cancer has spread or cannot be removed by surgery (advanced RCC).

How does this medicine work?

• Avelumab (av el' ue mab) is a human recombinant monoclonal IgG1 antibody to the programmed cell death receptor ligand-1 (PD-L1) which has distinctive immunomodulatory activity and is used in cancer immunotherapy.
• PD-1 is an important checkpoint molecule that modulates and down regulates T cell responses.
• Antibody binding to the ligand prevents its binding to the programmed cell death receptor which thereby allows for a continued activation and proliferation of T cells.
• The subsequent enhancement of cytotoxic reactivity may play a beneficial role in cancer immunotherapy by breaking immunological tolerance to cancer cell neo-antigens.
• In several multicenter studies, avelumab therapy resulted in objective responses in patients with advanced, metastatic or unresectable malignant neoplasms, and a proportion of patients had a long term remission.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• No clinically important drug interactions have been observed with Bavencio .

Is this medicine FDA approved?

• It was approved for use in the United States in 2017.

How should this medicine be used?

• Premedicate patients with an antihistamine and with acetaminophen prior to the first 4 infusions of Bavencio.

Recommended Dosage for Merkel Cell Carcinoma:

• The recommended dose of Bavencio is 800 mg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity.

Recommended Dosage for Urothelial Carcinoma:

• The recommended dose of Bavencio is 800 mg administered as an intravenous infusion over 60 minutes every 2 weeks until disease progression or unacceptable toxicity.

Recommended Dosage for Renal Cell Carcinoma:

• The recommended dose of Bavencio is 800 mg in combination with axitinib 5 mg orally twice daily administered as an intravenous infusion over 60 minutes every 2 weeks in combination with axitinib 5 mg orally taken twice daily (12 hours apart) with or without food until disease progression or unacceptable toxicity.

Treatment of Advanced Ovarian Cancer after 3 or More Chemotherapies

• The recommended dosage of ZEJULA is 300 mg (three 100-mg capsules) taken orally once daily.

Administration

• Your healthcare provider will give you Bavencio into your vein through an intravenous (IV) line over 60 minutes.
• Bavencio is usually given every 2 weeks.
• Your healthcare provider will give you medicines before the first 4 infusions and then as needed to help reduce infusion reactions.
• Your healthcare provider will decide how many treatments you need.
• Your healthcare provider will do blood tests to check you for certain side effects.
• If you miss an appointment, call your healthcare provider as soon as possible to reschedule your appointment.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 200 mg/10 mL (20 mg/mL) solution in single-dose vial.

This medicine is available in fallowing brand namesː

• Bavencio

What side effects can this medication cause?

The most common side effects of Bavencio in people with MCC include:

• feeling tired
• muscle and bone pain
• diarrhea
• nausea
• infusion-related reactions including chills, fever, and back pain
• rash
• decreased appetite
• swelling in your hands, feet, or ankles

The most common side effects of Bavencio as maintenance treatment in people with UC whose cancer responded or stabilized after platinum-containing chemotherapy as first treatment include:

• feeling tired
• muscle and bone pain
• urinary tract infection
• rash

The most common side effects of Bavencio in people with UC after platinum-containing chemotherapy that did not work, or is no longer working, include:

• feeling tired
• infusion-related reactions including chills, fever, back pain, redness, and shortness of breath
• muscle and bone pain
• nausea
• decreased appetite
• urinary tract infection

The most common side effects of Bavencio when given with axitinib in people with RCC include:

• diarrhea
• feeling tired
• high blood pressure
• muscle and bone pain
• nausea
• mouth sores
• liver problems
• blisters or rash on the palms of your hands and soles of your feet
• hoarseness
• decreased appetite
• low levels of thyroid hormone
• rash
• shortness of breath
• cough
• stomach area (abdomen) pain
• headache

Bavencio can cause serious side effects, including:

• Intestinal problems
• Liver problems
• Hormone gland problems
• Kidney problems
• Skin problems

What special precautions should I follow?

• Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, including the following: immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis, immune-mediated endocrinopathies, immune-mediated nephritis with renal dysfunction, immune-mediated dermatologic adverse reactions, and may result in solid organ transplant rejection.
• Monitor for early identification and management. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment.
• Withhold or permanently discontinue based on severity and type of reaction.
• Bavencio can cause severe or life-threatening infusion-related reactions. Interrupt, slow the rate of infusion, or permanently discontinue Bavencio based on severity of reaction.
• Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/PD-L1 blocking antibody.
• Bavencio in combination with axitinib can cause severe and fatal cardiovascular events. Optimize management of cardiovascular risk factors. Discontinue Bavencio in combination with axitinib for Grade 3-4 events.
• Bavencio can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and use of effective contraception.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Based on its mechanism of action, Bavencio can cause fetal harm when administered to a pregnant woman.
• There are no available data on the use of Bavencio in pregnant women.

Can this medicine be used in children?

• The safety and effectiveness of Bavencio have been established in pediatric patients aged 12 years and older for metastatic MCC.
• Safety and effectiveness of Bavencio have not been established in pediatric patients less than 12 years of age.

What are the active and inactive ingredients in this medicine?

• Active ingredient: avelumab
• Inactive ingredients: D-mannitol, glacial acetic acid, polysorbate 20, sodium hydroxide, and Water for Injection

Who manufactures and distributes this medicine?

• Manufactured by: EMD Serono, Inc. One Technology Place, Rockland, MA 02370 USA
• Marketed by: EMD Serono, Inc. and Pfizer Inc., NY, NY 10017 USA

What should I know about storage and disposal of this medication?

• Store refrigerated at 36°F to 46°F (2°C to 8°C) in original package to protect from light.
• Do not freeze or shake the vial.
• The vial stopper is not made with natural rubber latex.

• Dailymed label info on Avelumab
• FDA Avelumab

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