ablets)
5 mg
(one 5 mg tablet)
4 mg
(one 4 mg
tablet)
Stop
8 mg
(two 4 mg tablets)
6 mg
(two 3 mg
tablets)
5 mg
(one 5 mg tablet)
4 mg
(one 4 mg tablet) Stop
Table 2 summarizes recommendations for dose interruption, reduction, or discontinuation ofBALVERSA in the management of specific adverse reactions.
Table 2: Dose Modifications for Adverse Reactions
Adverse Reaction BALVERSA Dose Modification
Hyperphosphatemia
In all patients, restrict phosphate intake to 600-800 mg daily. If serum phosphate is above 7.0 mg/dL, consider adding an oral phosphatebinder until serum phosphate level returns to < 5.5 mg/dL.
5.6-6.9 mg/dL (1.8-2.3 mmol/L) Continue BALVERSA at current dose.
7.0-9.0 mg/dL (2.3-2.9 mmol/L) Withhold BALVERSA with weekly reassessments until level returns to < 5.5 mg/dL
(or baseline). Then restart BALVERSA at the same dose level. A dose reduction may
be implemented for hyperphosphatemia lasting > 1 week.
> 9.0 mg/dL (> 2.9 mmol/L) Withhold BALVERSA with weekly reassessments until level returns to < 5.5 mg/dL
(or baseline). Then may restart BALVERSA at 1 dose level lower.
> 10.0 mg/dL (> 3.2 mmol/L) or
significant alteration in baseline
renal function or Grade 3
hypercalcemia
Withhold BALVERSA with weekly reassessments until level returns to < 5.5 mg/dL(or baseline). Then may restart BALVERSA at 2 dose levels lower.
Central Serous Retinopathy/Retinal Pigment Epithelial Detachment (CSR/RPED)
Grade 1: Asymptomatic; clinical or
diagnostic observations only
Withhold until resolution. If resolves within 4 weeks, resume at the next lower dose
level. Then, if no recurrence for a month, consider re-escalation. If stable for 2
consecutive eye exams but not resolved, resume at the next lower dose level.
Grade 2: Visual acuity 20/40 or
better or ≤ 3 lines of decreased
vision from baseline
Withhold until resolution. If resolves within 4 weeks, may resume at the next lower
dose level.
Grade 3: Visual acuity worse than
20/40 or > 3 lines of decreased
vision from baseline
Withhold until resolution. If resolves within 4 weeks, may resume two dose levels
lower. If recurs, consider permanent discontinuation.
Grade 4: Visual acuity 20/200 or
worse in affected eye
Permanently discontinue.
Other Adverse Reactions a
Grade 3 Withhold BALVERSA until resolves to Grade 1 or baseline, then may resume dose
level lower.
Grade 4 Permanently discontinue. a Dose adjustment graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAEv4.03).
3 DOSAGE FORMS AND STRENGTHS
Tablets:
•3 mg: Yellow, round biconvex, film-coated, debossed with “3” on one side; and “EF” on theother side.
•4 mg: Orange, round biconvex, film-coated, debossed with “4” on one side; and “EF” on theother side.
•5 mg: Brown, round biconvex, film-coated, debossed with “5” on one side; and “EF” on theother side.
4 CONTRAINDICATIONS
None.
5 WARNINGS AND PRECAUTIONS
5.1 Ocular Disorders
BALVERSA can cause ocular disorders, including central serous retinopathy/retinal pigment epithelialdetachment (CSR/RPED) resulting in visual field defect.
CSR/RPED was reported in 25% of patients treated with BALVERSA, with a median time to first onsetof 50 days. |
