Balversa (Erdafitinib) is a kinase inhibitor used to treat adult patients with locally advanced or metastatic urothelial carcinoma that has susceptible FGFR3/FGFR2 genetic alterations and progressed during or after at least one line of prior platinum-containing chemotherapy including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.
Dosage: The recommended starting dose of Erdafitinib is 8 mg (two 4 mg tablets) orally once a day, with a dose increase to 9 mg (three 3 mg tablets) once a day based on the serum phosphate (PO4) levels and tolerability at 14-21 days. Swallow tablets of Erdafitinib whole either with or without food. If vomiting occurs any time after taking the erdafitinib dose, the next dose should be administered the next day. Treatment should continue until disease progression or unacceptable toxicity occurs. If a dose of erdafitinib is missed, it can be taken as soon as possible on the same day. Resume the regular daily dose schedule for Erdafitinib the next day. Extra pills should not be taken in order to make up for the missed dose.
Side Effects: The most commonly reported balversa side effects include:
- Increased phosphate level
- Mouth sores
- Feeling tired
- Change in kidney function
- Dry mouth
- Dry skin
- Dry eyes
- Hair loss
- Change in liver function
- Low salt (sodium) levels
- Decreased appetite
- Change in sense of taste
- Low red blood cells (anemia)
Warnings and Precautions:
- Monthly ophthalmological assessment should be performed during the first 4 months of therapy and every 3 months afterwards, and urgently at any time for visual symptoms.
- Monitor patients with balversa dose for hyperphosphatemia and follow the dose modification guidelines when required.
- Erdafitinib can cause fetal harm if used by a pregnant woman. Advise females of reproductive potential to consider apt contraception during therapy with Erdafitinib and for 1-month after the last dose.
- Due to the risk for serious adverse events from erdafitinib tablets in a breastfed child, lactating women are advised to avoid breastfeeding during treatment with and for one month following the last dose.
- As per the findings/data from animal studies, the balversa uses may impair fertility in females of reproductive potential.