Bavencio

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.

Bavencio can cause serious side effects, including:

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

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

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

• feeling tired
• infusion-related reaction 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

These are not all the possible side effects of Bavencio. Ask your healthcare provider or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Premedication

• Premedicate patients with an antihistamine and with acetaminophen prior to the first 4 infusions of Bavencio. Premedication should be administered for subsequent Bavencio doses based upon clinical judgment and presence/severity of prior infusion reactions.

Recommended Dosage For MCC

• 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 UC

• 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 RCC

• The recommended dose of Bavencio is 800 mg 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.
• When axitinib is used in combination with Bavencio, dose escalation of axitinib above the initial 5 mg dose may be considered at intervals of two weeks or longer.
• Review the Full Prescribing Information for axitinib prior to initiation.

Dose Modifications

• Recommended dose modifications of Bavencio for adverse reactions are provided in Table 1.
• Detailed information regarding clinical and laboratory monitoring guidelines for early detection of adverse reactions of Bavencio and recommended management (immunosuppressant treatment guidelines) are described in the prescription labeling.

Table 1: Recommended Dose Modifications of Bavencio for Adverse Reactions

In patients with RCC being treated with Bavencio in combination with axitinib:

• If ALT or AST ≥ 3 times ULN but < 5 times ULN or total bilirubin ≥ 1.5 times ULN but < 3 times ULN, withhold both Bavencio and axitinib until these adverse reactions recover to Grades 0-1. If persistent (greater than 5 days), consider corticosteroid therapy [initial dose of 0.5 to 1 mg/kg/day] prednisone or equivalent followed by a taper. Consider rechallenge with a single drug or sequential rechallenge with both drugs after recovery. Dose reduce per the axitinib Full Prescribing Information if rechallenging with axitinib.
• If ALT or AST ≥ 5 times ULN or > 3 times ULN with concurrent total bilirubin ≥ 2 times ULN or total bilirubin ≥ 3 times ULN, permanently discontinue both Bavencio and axitinib and consider corticosteroid therapy [initial dose 1 to 2 mg/kg/day prednisone or equivalent followed by a taper].

When Bavencio is administered in combination with axitinib, review the axitinib Full Prescribing Information for recommended dose modifications for axitinib.

Currently there is no information available on Bavencio drug interactions.

• 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.
• There is no information regarding the presence of avelumab in human milk, the effects on the breastfed infant, or the effects on milk production.
• Since many drugs including antibodies are excreted in human milk, advise a lactating woman not to breastfeed during treatment and for at least one month after the last dose of Bavencio due to the potential for serious adverse reactions in breastfed infants.