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Balversa is the brand name for erdafitinib and is available as an oral tablet.

Balversa is available as a 3 mg, 4 mg, and 5 mg oral tablet.

• Balversa is a fibroblast growth factor receptor (FGFR) inhibitors and is used to treat bladder cancer with FGFR3 or FGFR2 genetic changes, previously treated with platinum-based chemotherapy

Balversa is a targeted therapy that works by blocking a protein called fibroblast growth factor receptor (FGFR). In normal cells, FGFR helps to control how cells grow. But if there is a change (mutation) in the FGFR gene, it can lead to the development of cancer cells that grow and spread too quickly. So by blocking FGFR from working, Balversa slows down or stops the cancer cells from growing.

• Balversa is typically started at 8 mg by mouth once a day. After 2 to 3 weeks, your provider might raise your dose to 9 mg by mouth once a day if your phosphate lab levels are normal and you don’t experience any serious side effects.

Balversa is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you.

Common side effects of Balversa:

• Mouth irritation or sores
• Feeling tired or weak
• Diarrhea
• Dry mouth
• Nail changes
• Poor appetite
• Changes in taste
• Dry skin
• Constipation
• Dry eyes
• Hair loss
• Redness or irritation to the palms of hands or soles of feet
• Stomach pain
• Nausea

Serious side effects are rare with Balversa. Contact your healthcare provider immediately if you experience any of the following.

• Eye problems: blurred vision, vision changes, vision loss, dry eyes
• High phosphate levels: painful skin lesions, muscle cramps, numbness around the mouth

The following medications may interact with Balversa:

• Moderate CYP2C9 or strong CYP3A4 inhibitors: Consider alternative agents or monitor closely for adverse reactions
• Strong CYP3A4 inducers: Avoid concomitant use with Balversa
• Moderate CYP3A4 inducers: Administer Balversa at a dose of 9 mg
• Serum phosphate level-altering agents: Avoid concomitant use with agents that can alter serum phosphate levels before the initial dose modification period
• P-gp substrates: Separate Balversa administration by at least 6 hours before or after administration of P-gp substrates with narrow therapeutic indices

Janssen Pharmaceuticals

Based on findings from animal studies and its mechanism of action, Balversa can cause fetal harm when administered to a pregnant woman. Women should use effective contraception during treatment with Balversa and for one month after the last dose. Advise male patients with female partners of
reproductive potential to use effective contraception during treatment with Balversa and for one month after the last dose.

• Erdafitinib