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Balversa is a brand name for Erdafitinib. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Balversa as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC), harbouring susceptible FGFR3 genetic alterations who have previously received at least one line of therapy containing a PD-1 or PD-L1 inhibitor in the unresectable or metastatic treatment…
Verbatim from this product's EMA label. Tap a section to expand.
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.
8. Method of administration Balversa is for oral use. The tablets should be swallowed whole with or without food at about the same time each day. 5). 1. 4 Special warnings and precautions for use Ocular disorders Prior to initiating Balversa, a baseline ophthalmological exam including an Amsler grid test, fundoscopy, visual acuity and, if available, an optical coherence tomography (OCT) should be performed.
8). 8%). 1%). 8). 8). All patients should receive dry eye prophylaxis or treatment with ocular demulcents (for example artificial tear substitutes, hydrating or lubricating eye gels or ointment) at least every 2 hours during waking hours.
Severe treatment-related dry eye should be evaluated by an ophthalmologist. 2). If any abnormality is observed, follow the management guidelines in Table 3. Ophthalmological examination should include assessment of visual acuity, slit lamp examination, fundoscopy, and optical coherence tomography.
Close monitoring including clinical ophthalmological examinations should be performed in patients who have restarted Balversa after an ocular adverse event. When CSR occurs Balversa should be withheld and permanently discontinued if it does not resolve within 4 weeks or if Grade 4 in severity.
2, Eye disorder management). Hyperphosphataemia Balversa can cause hyperphosphataemia. Prolonged hyperphosphataemia can lead to soft tissue mineralisation, cutaneous calcinosis, non-uraemic calciphylaxis, hypocalcaemia, anaemia, secondary hyperparathyroidism, muscle cramps, seizure activity, QT interval prolongation and arrhythmias.
Hyperphosphataemia was reported early during Balversa treatment, with most events occurring within the first 3-4 months and Grade 3 events occurring within the first month. Monitor for hyperphosphataemia throughout treatment. 2). Supplementation with vitamin D in patients receiving erdafitinib is not recommended due to potential contribution to increased serum phosphate and calcium levels.
4 Nail, skin, and mucosal changes Nail, skin, and mucosal changes have been observed with Balversa. Treatment with Balversa should be discontinued or modified based on erdafitinib-related toxicity as described in Table 4.
Table 4:
Recommended dose modifications for nail, skin and mucosal adverse reactions with use of Balversa Severity of adverse reaction Balversa Nail disorder Balversa dose management Grade 1 Continue Balversa at current dose. Grade 2 Withhold Balversa with reassessment in 1-2 weeks.
If first occurrence and it resolves to ≤Grade 1 or baseline within 2 weeks, restart at same dose. If recurrent event or takes >2 weeks to resolve to ≤Grade 1 or baseline, then restart at next lower dose. Grade 3 Withhold Balversa, with reassessment in 1-2 weeks.
When resolves to ≤Grade 1 or baseline, restart at next lower dose. Grade 4 Discontinue Balversa. Dry skin and skin toxicity Grade 1 Continue Balversa at current dose. Grade 2 Continue Balversa at current dose. Grade 3 Withhold Balversa (for up to 28 days), with weekly reassessments of clinical condition.
When resolves to ≤Grade 1 or baseline, restart at next lower dose. Grade 4 Discontinue Balversa. Oral mucositis Grade 1 Continue Balversa at current dose. Grade 2 Withhold Balversa if the subject has other concomitant erdafitinib related Grade 2 adverse reactions.
Withhold Balversa if the subject was already on symptom management for more than a week. If Balversa is withheld, reassess in 1-2 weeks. If this is the first occurrence of toxicity and resolves to ≤Grade 1 or baseline within 2 weeks, restart at same dose.
If recurrent event or takes >2 weeks to resolve to ≤Grade 1 or baseline, then restart at next lower dose. Grade 3 Withhold Balversa, with reassessments of clinical condition in 1-2 weeks. When resolves to ≤Grade 1 or baseline, restart at next lower dose.
1.
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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 […]
0 mg/dL. 2). , haloperidol and thioridazine). Hypophosphataemia Hypophosphataemia can occur during treatment with Balversa. Serum phosphate level should be monitored during erdafitinib treatment and erdafitinib treatment breaks. If the serum phosphate level falls below normal, phosphate-lowering therapy and dietary phosphate restrictions (if applicable) should be discontinued.
Severe hypophosphataemia may present with confusion, seizures, focal neurologic findings, heart failure, respiratory failure, muscle weakness, rhabdomyolysis, and 8 haemolytic anaemia. 2. 0% of patients. 8). Patients should be monitored for signs and symptoms of nail toxicities.
Patients should be advised on preventative treatment such as good hygiene practices, over-the-counter nail strengthener as needed and monitor for signs of infection. Treatment with Balversa should be discontinued or modified based on erdafitinib-related toxicity as described in Table 4.
8). Patients should be monitored and provided supportive care such as avoiding unnecessary exposure to sunlight and excessive use of soap and bathing. Patients should use moisturisers regularly and avoid […]
Grade 4 Discontinue Balversa. 6 Dry mouth Grade 1 Continue Balversa at current dose. Grade 2 Continue Balversa at current dose. Grade 3 Withhold Balversa (for up to 28 days), with weekly reassessments of clinical condition. When resolved to ≤Grade 1 or baseline, restart at next lower dose.
Table 5:
Recommended dose modifications for other adverse reactions with use of Balversa Other adverse reactionsa Grade 3 Withhold Balversa until toxicity resolves to Grade 1 or baseline, then may resume Balversa at the next lower dose. Grade 4 Permanently discontinue.
0). 2). There are no data on the use of Balversa in patients with severe renal impairment. 2). 2). Limited data are available on the use of Balversa in patients with severe hepatic impairment. 2). 2). Limited data are available in patients older than 85 years old.
Paediatric population There is no relevant use of erdafitinib in the paediatric population for the treatment of urothelial carcinoma. The safety and efficacy of erdafitinib in paediatric patients (< 18 years of age) have not been established.
8. Method of administration Balversa is for oral use. The tablets should be swallowed whole with or without food at about the same time each day. 5). 1. 4 Special warnings and precautions for use Ocular disorders Prior to initiating Balversa, a baseline ophthalmological exam including an Amsler grid test, fundoscopy, visual acuity and, if available, an optical coherence tomography (OCT) should be performed.
8). 8%). 1%). 8). 8). All patients should receive dry eye prophylaxis or treatment with ocular demulcents (for example artificial tear substitutes, hydrating or lubricating eye gels or ointment) at least every 2 hours during waking hours.
Severe treatment-related dry eye should be evaluated by an ophthalmologist. 2). If any abnormality is observed, follow the management guidelines in Table 3. Ophthalmological examination should include assessment of visual acuity, slit lamp examination, […]