Balversa (Erdafitinib) – Complete Product Information

Balversa (erdafitinib) represents a breakthrough in precision cancer medicine as a selective pan-FGFR (fibroblast growth factor receptor) kinase inhibitor specifically designed for treating advanced urothelial carcinoma. The medication targets cancer cells with specific genetic mutations in the FGFR2 or FGFR3 genes, which drive tumor growth and progression in approximately 15-20% of patients with bladder cancer.

Erdafitinib’s mechanism of action involves binding to and inhibiting the kinase activity of FGFR1, FGFR2, FGFR3, and FGFR4 receptors. By blocking these receptors, the medication prevents the signaling pathways that tell cancer cells to grow, divide, and spread throughout the body. This targeted approach allows the medication to specifically attack cancer cells while potentially causing fewer side effects than traditional chemotherapy.

The medication is available in three dosage strengths: 3mg (yellow tablets), 4mg (orange tablets), and 5mg (brown tablets), allowing for precise dose adjustments based on individual patient response and tolerability. Each tablet is film-coated and designed for once-daily oral administration, providing patients with convenient treatment that can be managed at home.

Clinical Effectiveness and Disease Control: Clinical studies demonstrate that erdafitinib achieves meaningful tumor responses in patients with FGFR-altered urothelial carcinoma who have progressed on platinum-based chemotherapy. The medication typically shows response rates of 30-40% in appropriately selected patients, with some achieving complete remission of their cancer.

For patients with cancer conditions, Balversa offers the advantage of targeted therapy that specifically addresses the underlying genetic drivers of their disease. Unlike traditional chemotherapy that affects all rapidly dividing cells, erdafitinib selectively targets cancer cells with FGFR alterations, potentially improving both effectiveness and tolerability.

Biomarker Testing and Patient Selection: Before starting Balversa, patients must undergo genetic testing to confirm the presence of FGFR2 or FGFR3 alterations in their tumor tissue. This testing is typically performed through comprehensive genomic profiling or specific FGFR testing panels. Only patients with confirmed FGFR alterations are candidates for erdafitinib therapy, as these genetic changes predict response to the medication.

The importance of proper biomarker testing cannot be overstated, as patients without FGFR alterations are unlikely to benefit from erdafitinib therapy and may experience unnecessary side effects. Oncologists work closely with pathologists and molecular testing laboratories to ensure accurate and timely genetic analysis.

Treatment Monitoring and Management: Patients receiving Balversa require comprehensive monitoring throughout treatment, including regular blood tests to monitor phosphate levels, kidney function, liver function, and blood counts. Eye examinations are particularly important, as erdafitinib can cause serious ocular side effects including retinal pigment epithelial detachment and corneal disorders.

Phosphate level monitoring is critical, as hyperphosphatemia (elevated blood phosphate) is a common and potentially serious side effect that may require dose modifications or treatment interruption. Doctors typically check phosphate levels on days 14 and 21 after starting treatment, then monthly thereafter.

Important Safety Considerations: Balversa can cause serious side effects that require immediate medical attention, including severe eye problems, hyperphosphatemia, and kidney dysfunction. The medication is contraindicated in pregnancy due to potential harm to the developing fetus, and both male and female patients must use effective contraception during treatment and for one month after the last dose.

Patients must be counseled about the importance of adherence to dosing schedules, regular monitoring appointments, and immediate reporting of concerning symptoms such as vision changes, severe fatigue, or signs of infection.

For patients managing complex cancer conditions, coordination with specialized oncologists or urologic oncologists is essential. Those using multiple targeted therapy medications need careful monitoring for drug interactions and cumulative toxicities. Patients exploring affordable cancer treatment options should work with qualified oncologists to ensure proper genetic testing, treatment selection, and ongoing monitoring for both therapeutic effectiveness and potential complications, as cancer medications require specialized expertise and should never be managed without appropriate oncologic oversight and comprehensive supportive care.

Brand	Balversa Brand
Form	4mg 56 Tablets

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Balversa can cause various side effects ranging from common manageable effects to serious complications requiring immediate medical attention. Most side effects are related to the medication's mechanism of action on FGFR pathways throughout the body.

Very Common Side Effects (≥20% of patients):

Stomatitis: Mouth sores, ulcers, and inflammation of oral tissues
Fatigue: Persistent tiredness and lack of energy
Diarrhea: Loose or frequent bowel movements
Dry mouth: Reduced saliva production and oral dryness
Kidney dysfunction: Changes in kidney function and creatinine levels
Onycholysis: Nail separation from nail bed or poor nail formation
Liver function changes: Elevated liver enzymes
Low sodium levels: Hyponatremia requiring monitoring
Poor appetite: Decreased interest in food and eating
Taste changes (dysgeusia): Altered or metallic taste sensations
Low red blood cells (anemia): Reduced oxygen-carrying capacity
Dry skin: Skin dryness and potential cracking
Dry eyes: Reduced tear production and eye discomfort
Hair loss (alopecia): Thinning or loss of hair

Common Side Effects (10-20% of patients):

Hand-foot syndrome: Redness, swelling, peeling, or tenderness mainly on hands and feet
Constipation: Difficulty with bowel movements
Abdominal pain: Stomach discomfort or cramping
Nausea: Feeling of sickness or upset stomach
Muscle pain: General muscle aches and discomfort
Vomiting: Actual throwing up or retching
Fever (pyrexia): Elevated body temperature
Nail discoloration: Changes in nail color or appearance
Increased lacrimation: Excessive tearing from eyes
Lower pharyngeal pain: Throat discomfort
Difficulty breathing (dyspnea): Shortness of breath
Blood in urine (hematuria): Pink, red, or dark-colored urine
Joint pain: Discomfort in joints
Weight loss: Unintentional reduction in body weight

Serious Ocular (Eye) Side Effects:

Retinal pigment epithelial detachment: Separation of retinal layers
Corneal disorders: Damage or inflammation of the cornea
Blurred vision: Difficulty seeing clearly
Vision loss: Partial or complete loss of sight
Conjunctivitis: Inflammation of the eye's outer membrane
Dry eye syndrome: Severe reduction in tear production
Corneal inflammation: Swelling and irritation of corneal tissue
Visual disturbances: Changes in visual perception

Critical Metabolic Side Effects:

Hyperphosphatemia: Dangerously elevated blood phosphate levels
Kidney dysfunction: Reduced kidney function and elevated creatinine
Electrolyte imbalances: Abnormal sodium, potassium, calcium, or magnesium levels
Liver toxicity: Elevated liver enzymes indicating liver stress
Hyperglycemia: Elevated blood sugar levels

Hematologic (Blood) Side Effects:

Anemia: Low red blood cell count causing fatigue
Thrombocytopenia: Low platelet count increasing bleeding risk
Leukopenia: Low white blood cell count increasing infection risk
Neutropenia: Low neutrophil count compromising immune function

Infectious Complications:

Paronychia: Infection around fingernails or toenails
Urinary tract infections: Bacterial infections of urinary system
Opportunistic infections: Infections due to compromised immune system
Skin infections: Secondary bacterial infections of damaged skin

Dermatologic (Skin) Side Effects:

Severe skin rash: Widespread red, itchy, or painful skin eruption
Skin cracking: Deep fissures in skin, especially hands and feet
Nail problems: Bleeding, breaking, texture changes, or inflammation around nails
Photosensitivity: Increased sensitivity to sunlight
Skin hyperpigmentation: Darkening of skin areas

Reproductive and Fertility Effects:

Female fertility impairment: Potential effects on reproductive function
Pregnancy complications: Risk of birth defects and pregnancy loss
Hormonal disruptions: Changes in reproductive hormone levels

Laboratory Abnormalities:

Elevated phosphate levels: Requiring dose modifications
Increased creatinine: Indicating kidney function decline
Decreased albumin: Low protein levels
Elevated liver enzymes: ALT, AST, alkaline phosphatase increases
Decreased magnesium: Low magnesium requiring supplementation
Increased calcium: Elevated calcium levels
Increased potassium: Hyperkalemia requiring monitoring

Drug Interaction Effects:

CYP3A4 inhibitors: Increased erdafitinib levels (fluconazole, itraconazole)
CYP3A4 inducers: Decreased erdafitinib effectiveness (rifampicin)
Acid-reducing medications: Reduced erdafitinib absorption
Phosphate supplements: Worsening hyperphosphatemia
Vitamin D supplements: Enhanced phosphate absorption

Age-Related Considerations:

Elderly patients: Higher risk of kidney and liver toxicity
Reduced drug clearance: Potential for increased side effects
Multiple comorbidities: Interactions with existing medical conditions

Monitoring Requirements:

Phosphate levels: Days 14, 21, then monthly monitoring
Kidney function: Regular creatinine and BUN measurements
Liver function: Periodic liver enzyme testing
Complete blood counts: Monthly hematologic monitoring
Eye examinations: Regular ophthalmologic evaluations
Electrolyte panels: Sodium, potassium, calcium, magnesium monitoring

Emergency Warning Signs:

Sudden vision changes: Blurred vision, vision loss, or eye pain
Severe fatigue: Extreme tiredness interfering with daily activities
Signs of infection: Fever, chills, or unusual infections
Breathing difficulties: Shortness of breath or chest pain
Severe skin reactions: Widespread rash, blistering, or skin breakdown
Dehydration signs: Excessive diarrhea, vomiting, or poor fluid intake

Critical Safety Warning: Eye problems can be serious and potentially permanent. Patients must use artificial tears or lubricating eye gels at least every 2 hours during waking hours and have regular eye examinations throughout treatment. Any vision changes require immediate medical evaluation.

Hyperphosphatemia Management: Elevated phosphate levels are common but can be serious. Patients should avoid phosphate-containing foods, supplements, and medications while on treatment. Regular monitoring allows for dose adjustments before dangerous levels are reached.

Balversa (erdafitinib) has specific FDA and regulatory approvals for treating advanced urothelial carcinoma in carefully selected patients, based on extensive clinical research demonstrating significant anticancer activity in patients with specific genetic alterations:

Primary Indication:

Locally Advanced or Metastatic Urothelial Carcinoma:

Primary bladder cancer: Transitional cell carcinoma originating in the bladder
Upper tract urothelial carcinoma: Cancer of the renal pelvis or ureter
Locally advanced disease: Cancer that has spread beyond the bladder but remains regional
Metastatic disease: Cancer that has spread to distant organs or lymph nodes
Recurrent disease: Cancer that has returned after initial treatment

Required Genetic Alterations:

FGFR2 Gene Alterations:

Point mutations: Specific amino acid changes in FGFR2 protein
Gene fusions: FGFR2 joined with other genes creating fusion proteins
Gene amplifications: Multiple copies of FGFR2 gene
Chromosomal rearrangements: Structural changes affecting FGFR2

FGFR3 Gene Alterations:

Activating mutations: Changes that make FGFR3 protein overactive
Gene fusions: FGFR3 combined with partner genes
Overexpression: Increased production of FGFR3 protein
Splice variants: Alternative forms of FGFR3 protein

Prior Treatment Requirements:

Platinum-Based Chemotherapy:

First-line treatment failure: Disease progression during or after initial platinum therapy
Adjuvant chemotherapy: Progression within 12 months of adjuvant platinum treatment
Neoadjuvant chemotherapy: Progression within 12 months of pre-operative platinum treatment
Metastatic treatment: Progression on platinum-based therapy for advanced disease

Standard Chemotherapy Regimens:

Cisplatin-based combinations: Cisplatin with gemcitabine or other agents
Carboplatin-based combinations: Carboplatin with gemcitabine for cisplatin-ineligible patients
Multi-drug regimens: MVAC (methotrexate, vinblastine, doxorubicin, cisplatin)
Dose-dense regimens: Accelerated chemotherapy schedules

Diagnostic Requirements:

Biomarker Testing Methods:

Next-generation sequencing: Comprehensive genomic profiling panels
PCR-based assays: Targeted testing for specific FGFR alterations
Immunohistochemistry: Protein expression analysis (supplementary)
Fluorescence in situ hybridization: Gene fusion detection
RNA sequencing: Detection of fusion transcripts

Tissue Requirements:

Primary tumor tissue: Original bladder or urothelial cancer specimens
Metastatic biopsies: Recent tissue from metastatic sites when possible
Archival specimens: Previously collected tumor samples if recent tissue unavailable
Adequate tumor content: Sufficient cancer cells for reliable testing

Dosing and Administration Protocol:

Standard Dosing Regimen:

Starting dose: Typically 8mg once daily
Tablet combinations: Achieved using available 3mg, 4mg, and 5mg tablets
Administration timing: Once daily at approximately the same time
Food requirements: Can be taken with or without food
Duration: Continue until disease progression or unacceptable toxicity

Dose Modifications:

Phosphate level management: Dose reductions for hyperphosphatemia
Toxicity management: Temporary holds or reductions for severe side effects
Organ dysfunction: Adjustments for kidney or liver impairment
Drug interactions: Modifications when used with interacting medications

Patient Selection Criteria:

Ideal Candidates:

Confirmed FGFR alterations: Documented genetic changes by validated testing
Adequate performance status: Ability to tolerate oral targeted therapy
Sufficient organ function: Adequate kidney, liver, and bone marrow function
Disease progression: Documented failure of platinum-based chemotherapy
Life expectancy: Sufficient survival expectation to benefit from treatment

Treatment Goals by Disease Stage:

Locally advanced disease: Disease control and symptom management
Metastatic disease: Tumor shrinkage and progression-free survival
Recurrent disease: Control of disease progression and quality of life
Symptomatic disease: Relief of cancer-related symptoms

Contraindications and Precautions:

Absolute Contraindications:

Hypersensitivity to erdafitinib or any component of the formulation
Pregnancy (Category D - evidence of fetal risk)
Current breastfeeding
Severe kidney dysfunction preventing adequate monitoring
Severe liver dysfunction with inability to metabolize medication

Relative Contraindications and Cautions:

Pre-existing eye conditions: Retinal disorders, severe dry eye syndrome
Hyperphosphatemia: Baseline elevated phosphate levels
Kidney dysfunction: Reduced creatinine clearance
Liver dysfunction: Elevated baseline liver enzymes
Bone marrow suppression: Low blood counts at baseline

What type of cancer does Balversa treat?

Balversa specifically treats locally advanced or metastatic urothelial carcinoma (bladder cancer) that has specific genetic changes in the FGFR2 or FGFR3 genes. The cancer must have progressed during or after at least one line of platinum-containing chemotherapy. Your doctor will need to perform genetic testing on your tumor to determine if you have these specific gene alterations before prescribing Balversa.

How do I know if my cancer has the right genetic changes for Balversa?

Your oncologist will order specialized genetic testing called comprehensive genomic profiling or specific FGFR testing on your tumor tissue. This testing looks for alterations in the FGFR2 and FGFR3 genes that make your cancer likely to respond to erdafitinib. Only patients with confirmed FGFR alterations should receive Balversa, as those without these changes are unlikely to benefit from treatment.

How should I take Balversa?

Take Balversa exactly as prescribed by your doctor, typically once daily with or without food. Swallow the tablet whole - dont crush, break, or chew it. If you miss a dose, take it as soon as possible on the same day, then return to your normal schedule the next day. Never take extra tablets to make up for a missed dose. If you vomit after taking Balversa, dont take another tablet - just take your regular dose the next day.

Why do I need frequent blood tests while taking Balversa?

Balversa can cause elevated phosphate levels in your blood (hyperphosphatemia), which can be serious if not monitored properly. Your doctor will check your phosphate levels on days 14 and 21 after starting treatment, then monthly thereafter. These tests also monitor your kidney function, liver function, and blood counts to ensure the medication is working safely.

What should I do about eye problems while taking Balversa?

Eye problems are common and can be serious with Balversa treatment. Use artificial tears, hydrating eye substitutes, or lubricating eye gels or ointments at least every 2 hours during waking hours to prevent dry eyes. Your doctor will arrange regular eye examinations with an eye specialist throughout treatment. Report any vision changes, eye pain, or visual disturbances immediately.

Can I get pregnant or father children while taking Balversa?

No, Balversa can harm unborn babies and may cause pregnancy loss. Women of childbearing age must have a pregnancy test before starting treatment and use effective birth control during treatment and for one month after the last dose. Men should also use effective birth control during treatment and for one month after the last dose if their partner can become pregnant. The medication may also affect fertility in women of childbearing age.

What foods or supplements should I avoid while taking Balversa?

Avoid phosphate-containing supplements, vitamin D supplements, and phosphate-containing laxatives or enemas, as these can worsen hyperphosphatemia. Also avoid acid-reducing medications like antacids, H2 blockers, and proton pump inhibitors when possible, as they can reduce Balversa absorption. Discuss all medications and supplements with your doctor before starting them.

How long will I need to take Balversa?

You'll typically continue taking Balversa as long as your cancer responds to treatment and you can tolerate the side effects. Your doctor may temporarily stop treatment or reduce your dose if you develop serious side effects, then restart when its safe. Treatment duration varies significantly between patients based on individual response and tolerability.

What should I do if I develop nail or skin problems?

Report any nail or skin problems immediately, including nails separating from the nail bed, nail pain, bleeding, changes in nail color or texture, inflamed skin around nails, itchy skin rash, dry skin, or skin cracks. These effects are common but can become serious if not managed properly. Your doctor may recommend specific skin care measures or adjust your dose.

Can I drink alcohol while taking Balversa?

While theres no specific prohibition against alcohol, Balversa can affect your liver function, and alcohol may worsen this effect. Additionally, alcohol can worsen some side effects like fatigue and nausea. Discuss alcohol consumption with your oncologist, as they may recommend avoiding it during treatment based on your individual situation.

What happens if my phosphate levels get too high?

If your phosphate levels become elevated, your doctor may reduce your Balversa dose, temporarily stop treatment, or prescribe medications to lower phosphate levels. High phosphate levels can cause symptoms like muscle weakness, bone pain, or heart rhythm problems. Following a low-phosphate diet and avoiding phosphate supplements helps prevent dangerous elevations.

How do I manage common side effects like mouth sores and fatigue?

For mouth sores (stomatitis), use gentle oral care with soft toothbrushes, avoid spicy or acidic foods, and ask your doctor about mouth rinses or medications. For fatigue, maintain good nutrition, stay hydrated, get adequate rest, and engage in light exercise as tolerated. Your healthcare team can provide specific recommendations for managing side effects that affect your daily life.

Can I take other medications while on Balversa?

Many medications can interact with Balversa, potentially increasing side effects or reducing effectiveness. Inform your doctor about all medications, including prescriptions, over-the-counter drugs, and supplements. Particularly important are antifungal medications, antibiotics, heart medications, diabetes medications, and acid-reducing drugs. Some interactions require dose adjustments or alternative medications.

Where can I get Balversa safely and affordably?

Balversa requires a prescription and should only be obtained from licensed pharmacies with valid prescriptions. Work with your oncology team and insurance providers to explore coverage options and patient assistance programs. Ensure youre using legitimate sources that provide genuine medications with proper storage and handling, as cancer medications require specialized pharmacy services and should never be obtained from unregulated sources.

Balversa