What is Balversa, and how does it work?
- which has a certain type of abnormal “FGFR” gene, and
- who have tried at least one other chemotherapy medicine that contains platinum, and it did not work or is no longer working.
What are the side effects of Balversa?
Balversa may cause serious side effects, including:
- Eye problems. Eye problems are common with Balversa but can also be serious. Eye problems include dry or inflamed eyes, inflamed cornea (front part of the eye) and disorders of the retina, an internal part of the eye.
- Tell your healthcare provider right away if you develop blurred vision, loss of vision or other visual changes.
- You should use artificial tear substitutes, hydrating or lubricating eye gels or ointments at least every 2 hours during waking hours to help prevent dry eyes.
- During treatment with Balversa, your healthcare provider will send you to see an eye specialist.
- High phosphate levels in the blood (hyperphosphatemia). Hyperphosphatemia is common with Balversa but can also be serious.
- Your healthcare provider will check your blood phosphate level between 14 and 21 days after starting treatment with Balversa, and then monthly, and may change your dose if needed.
The most common side effects of Balversa include:
- mouth sores
- feeling tired
- change in kidney function
- dry mouth
- nails separate from the bed or poor formation of the nail
- change in liver function
- low salt (sodium) levels
- decreased appetite
- change in sense of taste
- low red blood cells (anemia)
- dry skin
- dry eyes
- hair loss
- redness, swelling, peeling or tenderness, mainly on the hands or feet ('hand-foot syndrome')
- stomach (abdominal) pain
- muscle pain
Tell your healthcare provider right away if you develop any nail or skin problems including nails separating from the nail bed, nail pain, nail bleeding, breaking of the nails, color or texture changes in your nails, infected skin around the nail, an itchy skin rash, dry skin, or cracks in the skin.
These are not all possible side effects of Balversa. For more information, ask your healthcare provider or pharmacist.
Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is the dosage for Balversa?
- Select patients for the treatment of locally advanced or metastatic urothelial carcinoma with Balversa based on the presence of susceptible FGFR genetic alterations in tumor specimens as detected by an FDA-approved companion diagnostic.
- Information on FDA-approved tests for the detection of FGFR genetic alterations in urothelial cancer is available at: http://www.fda.gov/CompanionDiagnostics.
Recommended Dosage And Schedule
- The recommended starting dose of Balversa is 8 mg (two 4 mg tablets) orally once daily, with a dose increase to 9 mg (three 3 mg tablets) once daily based on serum phosphate (PO4) levels and tolerability at 14 to 21 days.
- Swallow tablets whole with or without food. If vomiting occurs any time after taking Balversa, the next dose should be taken the next day. Treatment should continue until disease progression or unacceptable toxicity occurs.
- If a dose of Balversa is missed, it can be taken as soon as possible on the same day.
- Resume the regular daily dose schedule for Balversa the next day. Extra tablets should not be taken to make up for the missed dose.
Dose Increase Based On Serum Phosphate Levels
- Assess serum phosphate levels 14 to 21 days after initiating treatment.
- Increase the dose of Balversa to 9 mg once daily if serum phosphate level is < 5.5 mg/dL and there are no ocular disorders or Grade 2 or greater adverse reactions.
- Monitor phosphate levels monthly for hyperphosphatemia.
Dose Modifications For Adverse Reactions
The recommended dose modifications for adverse reactions are listed in Table 1.
Table 1: Balversa Dose Reduction ScheduleDose1st dose reduction2nd dose reduction3rd dose reduction4th dose reduction5th dose reduction9 mg → (three 3 mg tablets)8 mg (two 4 mg tablets)6 mg (two 3 mg tablets)5 mg (one 5 mg tablet)4 mg (one 4 mg tablet)Stop8 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 of Balversa in the management of specific adverse reactions.
Table 2: Dose Modifications for Adverse ReactionsAdverse ReactionBalversa Dose ModificationHyperphosphatemiaIn all patients, restrict phosphate intake to 600-800 mg daily. If serum phosphate is above 7.0 mg/dL, consider adding an oral phosphate binder 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 hypercalcemiaWithhold 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 onlyWithhold 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 baselineWithhold 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 baselineWithhold 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 eyePermanently discontinue.Other Adverse Reactions*Grade 3Withhold Balversa until resolves to Grade 1 or baseline, then may resume dose level lower.Grade 4Permanently discontinue.* Dose adjustment graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAEv4.03).
What drugs interact with Balversa?
Effect Of Other Drugs On Balversa
Table 5 summarizes drug interactions that affect the exposure of
Balversa or serum phosphate level and their clinical management.
Moderate CYP2C9 or Strong CYP3A4 InhibitorsClinical Impact
Table 5: Drug Interactions that Affect Balversa
Co-administration of Balversa with moderate CYP2C9 or strong CYP3A4
inhibitors increased erdafitinib plasma concentrations.
erdafitinib plasma concentrations may lead to increased drug-related
- Consider alternative therapies that are not moderate CYP2C9 or strong CYP3A4 inhibitors during treatment with
- If co-administration of moderate CYP2C9 or strong
CYP3A4 inhibitor is unavoidable, monitor closely for adverse reactions
and consider dose modifications accordingly. If the moderate CYP2C9 or strong CYP3A4 inhibitor is discontinued, the
Balversa dose may be increased in the absence of drug-related toxicity.
Strong CYP2C9 or CYP3A4 InducersClinical Impact
Co-administration of Balversa with strong inducers of CYP2C9 or CYP3A4 may
decrease erdafitinib plasma concentrations significantly.
- Decreased erdafitinib plasma concentrations may lead to decreased activity.
- Avoid co-administration of strong inducers of CYP2C9 or CYP3A4 with
Moderate CYP2C9 or CYP3A4 InducersClinical Impact
Co-administration of Balversa with moderate inducers of CYP2C9 or CYP3A4 may
decrease erdafitinib plasma concentrations.
- Decreased erdafitinib plasma concentrations may lead to decreased activity.
- If a moderate CYP2C9 or CYP3A4 inducer must be co-administered at the start of
Balversa treatment, administer Balversa dose as recommended (8 mg once daily with potential to increase to 9 mg once daily based on serum phosphate levels on Days 14 to 21 and tolerability).
- If a moderate CYP2C9 or CYP3A4 inducer must be co-administered after the initial dose increase period based on serum phosphate levels and tolerability, increase
Balversa dose up to 9 mg.
- When a moderate inducer of CYP2C9 or CYP3A4 is discontinued, continue
Balversa at the same dose, in the absence of drug-related toxicity.
Serum Phosphate Level-Altering AgentsClinical Impact
Co-administration of Balversa with other serum phosphate level-altering
agents may increase or decrease serum phosphate levels.
- Changes in
serum phosphate levels due to serum phosphate level-altering agents (other
than erdafitinib) may interfere with serum phosphate levels needed for the
determination of initial dose increased based on serum phosphate levels.
Avoid co-administration of serum phosphate level-altering agents with
Balversa before initial dose increase period based on serum phosphate
levels (Days 14 to 21).
Balversa On Other Drugs
Table 6 summarizes the effect of Balversa on other drugs and their clinical management.
Balversa Drug Interactions that Affect Other Drugs
Co-administration of Balversa with CYP3A4 substrates may alter the plasma
concentrations of CYP3A4 substrates.
- Altered plasma concentrations of CYP3A4 substrates may lead to loss of activity or increased toxicity of the CYP3A4 substrates.
- Avoid co-administration of
Balversa with sensitive substrates of CYP3A4 with narrow therapeutic indices.
OCT2 SubstratesClinical Impact
Co-administration of Balversa with OCT2 substrates may increase the plasma
oncentrations of OCT2 substrates.
- Increased plasma concentrations of OCT2 substrates may lead to increased toxicity of the OCT2 substrates.
- Consider alternative therapies that are not OCT2 substrates or consider reducing the dose of OCT2 substrates (e.g., metformin) based on tolerability.
P-glycoprotein (P-gp) SubstratesClinical Impact
Co-administration of Balversa with P-gp substrates may increase the plasma
concentrations of P-gp substrates.
- Increased plasma concentrations of P-gp substrates may lead to increased toxicity of the P-gp substrates.
- If co-administration of
Balversa with P-gp substrates is unavoidable, separate Balversa administration by at least 6 hours before or after administration of P-gp substrates with narrow therapeutic index.
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Is Balversa safe to use while pregnant or breastfeeding?
- Based on the mechanism of action and findings in animal reproduction studies,
Balversa can cause fetal harm when administered to a pregnant woman.
- There are no available data on Balversa use in pregnant women to inform a drug-associated risk.
- There are no data on the presence of erdafitinib in human milk, or the effects of erdafitinib on the breastfed child, or on milk production.
- Because of the potential for serious adverse reactions from erdafitinib in a breastfed child, advise lactating women not to breastfeed during treatment with
Balversa and for one month following the last dose.