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BAVENCIO- avelumab injection, solution, concentrate


  1. Patient Information
  2. Inform Patients Of The Risk Of Immune-mediated Adverse Reactions Requiring Corticosteroids Or Hormone Replacement Therapy, Including, But Not Limited To:
  3. Bavencio Is A Prescription Medicine Used To Treat:
  4. Before You Receive Bavencio, Tell Your Healthcare Provider About All Of Your Medical Conditions, Including If You:
  5. How Will I Receive Bavencio?
  6. Active Ingredient:
  7. Inactive Ingredients:
  8. Manufactured By:
  9. Marketed By:

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Immune-Mediated Adverse Reactions

Inform Patients Of The Risk Of Immune-mediated Adverse Reactions Requiring Corticosteroids Or Hormone Replacement Therapy, Including, But Not Limited To: 

  • Pneumonitis: Advise patients to contact their healthcare provider immediately for new or worsening cough, chest pain, or shortness of breath[

    BAVENCIO is a medicine that may treat certain cancers by working with your immune system. BAVENCIO can cause your immune system to attack normal organs and tissues and can affect the way they work. These problems can sometimes become serious or life-threatening and can lead to death.

    Call or

Bavencio Is A Prescription Medicine 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). BAVENCIO may be used when your cancer:
    • has spread or cannot be removed by surgery (advanced UC),and
    • you have received chemotherapy that contains platinum, 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).

It is not known if BAVENCIO is safe and effective in children under the age of 12.

Before You Receive Bavencio, Tell Your Healthcare Provider About All Of Your Medical Conditions, Including If You: 

  • have immune system problems such as Crohn's disease or ulcerative colitis
  • have had an organ transplant
  • have lung or breathing problems
  • have liver or kidney problems
  • have diabetes
  • have heart problems or high blood pressure
  • have a high cholesterol level in your blood
  • are pregnant or plan to become pregnant. BAVENCIO can harm your unborn baby. If you are able to become pregnant, you should use an effective method of birth control during your treatment and for at least 1 month after the last dose of BAVENCIO.
  • are breastfeeding or plan to breastfeed. It is not known if BAVENCIO passes into your breast milk. Do not breastfeed during treatment and for at least 1 month after the final dose of BAVENCIO.

Tell your healthcare provider about all the medicines you take,including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How Will I Receive Bavencio? 

  • 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 any appointments, call your healthcare provider as soon as possible to reschedule your appointment.

Active Ingredient: 

avelumab

Inactive Ingredients: 

D-mannitol, glacial acetic acid, polysorbate 20, sodium hydroxide, and Water for Injection

Manufactured By: 

EMD Serono, Inc. One Technology Place, Rockland, MA 02370 USA, U.S. License No. 1773.

Marketed By: 

EMD Serono, Inc. and Pfizer Inc., NY, NY 10017 USA.
BAVENCIO is a trademark of Merck KGaA, Darmstadt, Germany.
For more information, call toll-free 1-844-826-8371 or go to www.bavencio.com.



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