Treatment with Balversa should be initiated and supervised by a physician experienced in the use of anticancer therapies. 1) assessed by a CE-marked in vitro diagnostic (IVD) medical device with the corresponding intended purpose. If a CE-marked IVD is not available, an alternative validated test should be used.
Posology The recommended starting dose of Balversa is 8 mg orally once daily. This dose should be maintained and serum phosphate level should be assessed between 14 and 21 days after initiating treatment. 91 mmol/L), and there is no drug-related toxicity.
0 mg/dL or higher follow the relevant dose modifications in Table 2. After day 21 the serum phosphate level should not be used to guide up-titration decision. If vomiting occurs any time after taking Balversa, the next dose should be taken the next day.
Duration of treatment Treatment should continue until disease progression or unacceptable toxicity occurs. Missed dose If a dose of Balversa is missed, it can be taken as soon as possible. The regular daily dose schedule for Balversa should be resumed the next day.
Extra tablets should not be taken to make up for the missed dose. Dose reduction and management of adverse reactions For recommended dose reduction schedule, see Tables 1 to 5. 1). Phosphate concentrations should be assessed prior to the first dose and then monitored monthly.
For elevated phosphate concentrations in patients treated with Balversa dose modification guidelines in Table 2 should be followed. , sevelamer carbonate) should be considered as needed (see Table 2). 75 mmol/L), restrict phosphate intake to 600-800 mg/day.
24 mmol/L) Continue Balversa at current dose. 90 mmol/L) Continue Balversa treatment. 00 mg/dL. 00 mg/dL for a period of 2 months or in the presence of additional adverse events or additional electrolyte disturbances linked to prolonged hyperphosphataemia.
00 mg/dL (weekly testing recommended). 00 mg/dL. Re-start treatment at the same dose level (see Table 1). 00 mg/dL for a period of 1 month or in the presence of additional adverse events or additional electrolyte disturbances linked to prolonged hyperphosphataemia.
00 mg/dL (weekly testing recommended). Re-start treatment at the first reduced dose level (see Table 1). 00 mg/dL is sustained for >2 weeks, Balversa should be discontinued permanently. 4). Significant alteration from baseline renal function or Grade 3 hypocalcaemia due to hyperphosphataemia.
Balversa should be discontinued permanently. Medical management as clinically appropriate. Eye disorder management Treatment with Balversa should be discontinued or modified based on erdafitinib-related toxicity as described in Table 3.
Table 3:
Guideline for management of eye disorders with use of Balversa Severity grading Balversa dose management Grade 1 Asymptomatic or mild symptoms; clinical or diagnostic observations only, or abnormal Amsler grid test. Refer for an ophthalmologic examination (OE).
If an OE cannot be performed within 7 days, withhold Balversa until an OE can be performed. If no evidence of eye toxicity on OE, continue Balversa at same dose level. , CSRa), withhold Balversa until resolution. If reversible in 4 weeks on OE, resume at next lower dose.
Upon restarting Balversa, monitor for recurrence every 1-2 weeks for a month and as clinically appropriate thereafter. Consider dose re-escalation if no recurrence. Grade 2 Moderate; limiting age appropriate instrumental activities of daily living (ADL).
Immediately withhold Balversa and refer for an OE. If there is no evidence of eye toxicity, resume erdafitinib therapy at the next lower dose level upon resolution. If resolved (complete resolution or stabilisation and asymptomatic) within 4 weeks on OE, resume Balversa at the next lower dose level.
Upon restarting Balversa, monitor for recurrence every 1 to 2 weeks for a month and as clinically appropriate thereafter. 5 Grade 3 Severe or medically significant but not immediate sight-threatening; limiting self-care ADL. Immediately withhold Balversa and refer for an OE.
If resolved (complete resolution or stabilisation and asymptomatic) within 4 weeks, then Balversa may be resumed at 2 dose levels lower. Upon […]