Balversa Patient Counseling Information

Advise the patient to read the patient labeling (Patient Information).
FGFR Genetic Alterations: Advise patients that evidence of a susceptible FGFR3 or FGFR2 mutation or gene fusion within the tumor specimen is necessary to identify patients for whom treatment is indicated [see Patient Selection under Dosage & Administration].
Ocular Disorders: Advise patients to contact their healthcare provider if they experience any visual changes [see Ocular Disorders under Precautions]. In order to prevent or treat dry eyes, advise patients to use artificial tear substitutes, hydrating or lubricating eye gels or ointments frequently, at least every 2 hours during waking hours [see Dose Modifications for Adverse Reactions under Dosage & Administration].
Skin, Mucous or Nail Disorders: Advise patients to contact their healthcare provider if they experience progressive or intolerable skin, mucous or nail disorders [see Clinical Trials Experience under Adverse Reactions].
Hyperphosphatemia and Soft Tissue Mineralization: Inform patients that BALVERSA may cause hyperphosphatemia and soft tissue mineralization. Advise patients to immediately inform their healthcare provider of painful skin lesions or any symptoms related to acute change in phosphate levels such as muscle cramps, numbness, or tingling around the mouth [see Hyperphosphatemia and Soft Tissue Mineralization under Precautions].
Advise patients that their healthcare provider will assess their serum phosphate level between 14 and 21 days of initiating treatment and will adjust the dose if needed [see Hyperphosphatemia and Soft Tissue Mineralization under Precautions]. Advise patients to restrict phosphate intake to 600-800 mg daily. During this initial phosphate-assessment period, advise patients to avoid concomitant use with agents that can alter serum phosphate levels. Advise patients that, after the initial phosphate assessment period, monthly phosphate level monitoring for hyperphosphatemia should be performed during treatment with BALVERSA [see Effect of Other Drugs on BALVERSA under Interactions].
Drug Interactions: Advise patients to inform their healthcare providers of all concomitant medications, including prescription medicines, over-the-counter drugs, and herbal products [see Effect of Other Drugs on BALVERSA and Effect of BALVERSA on Other Drugs under Interactions].
Dosing Instructions: Instruct patients to swallow the tablets whole once daily with or without food. If vomiting occurs any time after taking BALVERSA, advise patients to take the next dose the next day. [See Recommended Dosage and Schedule under Dosage & Administration.]
Missed Dose: If a dose is missed, advise patients to take the missed dose as soon as possible. Resume the regular daily dose schedule for BALVERSA the next day. Extra tablets should not be taken to make up for the missed dose [see Recommended Dosage and Schedule under Dosage & Administration].
Embryo-Fetal Toxicity: Advise pregnant women and females of reproductive potential of the potential risk to the fetus. Advise females to inform their healthcare providers of a known or suspected pregnancy [see Embryo-Fetal Toxicity under Precautions; Pregnancy under Use in Pregnancy & Lactation].
Advise female patients of reproductive potential to use effective contraception during treatment and for one month after the last dose of BALVERSA. Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for one month after the last dose of BALVERSA [see Females and Males of Reproductive Potential under Use in Pregnancy & Lactation].
Lactation: Advise females not to breastfeed during treatment with BALVERSA and for one month after the last dose [see Lactation under Use in Pregnancy & Lactation].