Balversa (erdafitinib)

Balversa is a prescription medicine used to treat adults with bladder cancer (urothelial cancer) that has spread or cannot be removed by surgery:

• which has a certain type of abnormal “FGFR” gene, and
• who have tried at least one other chemotherapy medicine that contains platinum, and it did not work or is no longer working.

Balversa may cause serious side effects, including:

• Eye problems. Eye problems are common with Balversa but can also be serious. Eye problems include dry or inflamed eyes, inflamed cornea (front part of the eye) and disorders of the retina, an internal part of the eye.
• Tell your healthcare provider right away if you develop blurred vision, loss of vision or other visual changes.
• You should use artificial tear substitutes, hydrating or lubricating eye gels or ointments at least every 2 hours during waking hours to help prevent dry eyes.
• During treatment with Balversa, your healthcare provider will send you to see an eye specialist.
• High phosphate levels in the blood (hyperphosphatemia). Hyperphosphatemia is common with Balversa but can also be serious.
• Your healthcare provider will check your blood phosphate level between 14 and 21 days after starting treatment with Balversa, and then monthly, and may change your dose if needed.

The most common side effects of Balversa include:

• mouth sores
• feeling tired
• change in kidney function
• diarrhea
• dry mouth
• nails separate from the bed or poor formation of the nail
• change in liver function
• low salt (sodium) levels
• decreased appetite
• change in sense of taste
• low red blood cells (anemia)
• dry skin
• dry eyes
• hair loss
• redness, swelling, peeling or tenderness, mainly on the hands or feet ('hand-foot syndrome')
• constipation
• stomach (abdominal) pain
• nausea
• muscle pain

Tell your healthcare provider right away if you develop any nail or skin problems including nails separating from the nail bed, nail pain, nail bleeding, breaking of the nails, color or texture changes in your nails, infected skin around the nail, an itchy skin rash, dry skin, or cracks in the skin.

Balversa may affect fertility in females who are able to become pregnant. Talk to your healthcare provider if this is a concern for you.

These are not all possible side effects of Balversa. For more information, ask your healthcare provider or pharmacist.

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

Patient Selection

• Select patients for the treatment of locally advanced or metastatic urothelial carcinoma with Balversa based on the presence of susceptible FGFR genetic alterations in tumor specimens as detected by an FDA-approved companion diagnostic.
• Information on FDA-approved tests for the detection of FGFR genetic alterations in urothelial cancer is available at: http://www.fda.gov/CompanionDiagnostics.

Recommended Dosage And Schedule

• The recommended starting dose of Balversa is 8 mg (two 4 mg tablets) orally once daily, with a dose increase to 9 mg (three 3 mg tablets) once daily based on serum phosphate (PO4) levels and tolerability at 14 to 21 days.
• Swallow tablets whole with or without food. If vomiting occurs any time after taking Balversa, the next dose should be taken the next day. Treatment should continue until disease progression or unacceptable toxicity occurs.
• If a dose of Balversa is missed, it can be taken as soon as possible on the same day.
• Resume the regular daily dose schedule for Balversa the next day. Extra tablets should not be taken to make up for the missed dose.

Dose Increase Based On Serum Phosphate Levels

• Assess serum phosphate levels 14 to 21 days after initiating treatment.
• Increase the dose of Balversa to 9 mg once daily if serum phosphate level is < 5.5 mg/dL and there are no ocular disorders or Grade 2 or greater adverse reactions.
• Monitor phosphate levels monthly for hyperphosphatemia.

Dose Modifications For Adverse Reactions

The recommended dose modifications for adverse reactions are listed in Table 1.

Table 1: Balversa Dose Reduction Schedule

Table 2 summarizes recommendations for dose interruption, reduction, or discontinuation of Balversa in the management of specific adverse reactions.

Table 2: Dose Modifications for Adverse Reactions

Effect Of Other Drugs On Balversa

Table 5 summarizes drug interactions that affect the exposure of Balversa or serum phosphate level and their clinical management.

Table 5: Drug Interactions that Affect Balversa

Effect Of Balversa On Other Drugs

Table 6 summarizes the effect of Balversa on other drugs and their clinical management.

Table 6: Balversa Drug Interactions that Affect Other Drugs

• Based on the mechanism of action and findings in animal reproduction studies, Balversa can cause fetal harm when administered to a pregnant woman.
• There are no available data on Balversa use in pregnant women to inform a drug-associated risk.
• There are no data on the presence of erdafitinib in human milk, or the effects of erdafitinib on the breastfed child, or on milk production.
• Because of the potential for serious adverse reactions from erdafitinib in a breastfed child, advise lactating women not to breastfeed during treatment with Balversa and for one month following the last dose.