Erdafitinib

[Product Name] Erdafitinib Tablets

[Other Names] Panle / Balversa

[Specification] 4 mg × 56 tablets/box

[Manufacturer] State Pharmaceutical Factory No. 2, Lao People's Democratic Republic

[Indications]

Erdafitinib is primarily indicated for the following conditions:

Bladder Cancer: Erdafitinib may be used to treat metastatic or recurrent bladder cancer, particularly in patients harboring *FGFR2* or *FGFR3* gene alterations.

Urothelial Carcinoma: For patients with advanced or recurrent urothelial carcinoma harboring *FGFR* gene alterations, Erdafitinib may serve as an effective treatment option.

Lung Cancer: Erdafitinib may also be utilized as a first-line treatment option for non-small cell lung cancer (NSCLC) harboring *MET* alterations.

[Dosage and Administration]

The starting dose is 8 mg taken orally once daily, either on an empty stomach or with food. For patients whose serum phosphate levels remain below the target of 5.5 mg/dL between Day 14 and Day 21 of treatment, the dose should be increased to 9 mg once daily; treatment should continue until disease progression or unacceptable toxicity occurs.

If vomiting occurs after taking the medication, do not take a replacement dose; resume the regular dosing schedule at the next scheduled time. If a dose is missed, the missed dose may be taken later on the same day; resume the regular dosing schedule at the next scheduled time.

[Storage]

Store at 20°C to 25°C (68°F to 77°F); excursions are permitted within the range of 15°C to 30°C (59°F to 86°F). [Adverse Reactions]

1. The most common (≥20%) adverse reactions are:

1) Hyperphosphatemia, stomatitis, fatigue, increased creatinine

2) Diarrhea, dry mouth, onycholysis, increased ALT

3) Increased alkaline phosphatase, hyponatremia, decreased appetite, hypoalbuminemia

4) Dysgeusia, decreased hemoglobin, dry skin, increased AST

5) Hypomagnesemia, dry eye, alopecia, Hand-Foot Syndrome

6) Constipation, hypophosphatemia, abdominal pain, hypercalcemia, nausea, and musculoskeletal pain.

2. The most common (>1%) Grade 3 or higher adverse reactions are:

Stomatitis, nail dystrophy, Hand-Foot Syndrome, paronychia, nail disorders, keratitis, onycholysis, and hyperphosphatemia.

[Precautions]

1. Ocular Disorders: Erdafitinib can cause central serous retinopathy or retinal pigment epithelial detachment. Clinical symptoms manifest as blurred vision, visual floaters, or visual fatigue. The incidence rate is 25% (Grade 3: 3%), with a median time to onset of 50 days. Symptoms resolved in 13% of patients; at the clinical data cutoff, 13% of patients were still experiencing the condition. Consequently, 9% of patients required temporary interruption of erdafitinib, 14% required dose reduction, and 3% permanently discontinued erdafitinib.

2. Dry Eye: The incidence rate of dry eye is 28% (Grade 3: 6%). Use ophthalmic lubricants as needed.

3. Perform an ophthalmologic examination—including Optical Coherence Tomography (OCT)—prior to initiating erdafitinib treatment. Conduct follow-up examinations monthly for the first 4 months of treatment, and every 3 months thereafter. If visual symptoms occur, seek immediate medical attention and undergo follow-up examinations every 3 weeks until symptoms resolve.

4. Hyperphosphatemia: Serum phosphate levels exceeded the upper limit of normal in 76% of patients, with a median time to onset of 20 days. 32% of patients required the use of phosphate-lowering agents. If the patient's serum phosphate level exceeds 5.5 mg/dL, adjust the medication dosage regimen according to Tables 1 and 2.

5. Embryo-Fetal Toxicity: Animal studies have demonstrated that erdafitinib causes embryo-fetal toxicity. Patients and their partners should use effective contraception during treatment and for one month after discontinuing the medication.

[Efficacy and Safety]

The BLC2001 study was a multicenter, open-label, single-arm Phase 2 clinical trial. A total of 87 patients with urothelial carcinoma were evaluable; the median age was 67 years, 79% were male, 74% were white, 92% had a PS (Performance Status) score of 0–1, and 66% had metastatic disease. 97% of the patients had previously received at least one platinum-containing chemotherapy regimen, while 3 patients had received only neoadjuvant or adjuvant chemotherapy. 24% of the patients had previously received PD-1/L1 immunotherapy. The Complete Response (CR) rate was 2.3%, the Partial Response (PR) rate was 29.9%, the Overall Response Rate (ORR) was 32.2%, and the median Duration of Response (DoR) was 5.4 months.

Enrolled patients all harbored at least one FGFR2 or FGFR3 mutation or fusion, such as FGFR3 mutations (R248C, S249C, G370C, and Y373C), FGFR2 fusions (FGFR2-BICC1 and FGFR2-CASP7), and FGFR3 fusions (FGFR3-TACC3 and FGFR3-BAIAP2L1). For patients with FGFR3 mutations (n=64), the ORR was 40.6%; for those with FGFR3 fusions (n=18), the ORR was 11.1%; and for those with FGFR2 fusions (n=6), the ORR was 0%.

[Manufacturer Introduction]

The National Pharmaceutical Factory No. 2 of the Lao People's Democratic Republic (PHARMACEUTICAL FACTORY NO. 2 / PHARMA 2 VIENTIANE—hereinafter referred to as "Lao Pharma 2") is a state-owned pharmaceutical enterprise in Laos, operating directly under the Ministry of Health of Laos. Lao Pharma 2 was established in the 1970s and has a history spanning over 40 years. It is the largest, most established, and most comprehensive pharmaceutical manufacturing enterprise in Laos.

Laos Pharmaceutical Factory No. 2 provides patients annually with a total of over 160 different types of medicines, including intravenous infusions, injectables, oral tablets, oral capsules, oral syrups, and ointments. Keeping pace with the times and actively engaging in exploration, Laos Pharmaceutical Factory No. 2 continuously introduces advanced foreign technologies and seeks breakthroughs in manufacturing processes and pharmaceutical R&D to ensure that its research, development, and production technologies remain aligned with international standards. Currently, Laos Pharmaceutical Factory No. 2 has obtained ISO 9001:2008 certification for its manufacturing process standards. The mission of Laos Pharmaceutical Factory No. 2 is to provide high-quality, internationally standardized pharmaceutical products and services to an ever-growing number of customers and patients through continuous innovation and active exploration.

**Specifications and Parameters**

**Product Name:** Erdafitinib Tablets 4mg (56 tablets/box)

**Common Name:** Erdafitinib Tablets

**Active Ingredient:** Erdafitinib

**Dosage Form:** Tablets

**Specification:** 4mg (56 tablets/box)

**Manufacturer:** State Pharmaceutical Factory No. 2, Lao People's Democratic Republic

**Indications:** Erdafitinib is primarily indicated for the following conditions:

**Bladder Cancer:** Erdafitinib may be used to treat metastatic or recurrent bladder cancer, particularly in patients harboring *FGFR2* or *FGFR3* gene alterations.

**Urothelial Carcinoma:** For patients with advanced or recurrent urothelial carcinoma harboring *FGFR* gene alterations, Erdafitinib may serve as an effective treatment option.

**Lung Cancer:** Erdafitinib may also be utilized as a first-line treatment option for non-small cell lung cancer (NSCLC) harboring *MET* alterations.

**Dosage and Administration:** The starting dose is 8 mg taken orally once daily, either on an empty stomach or with food. For patients whose serum phosphate levels fall below the target of 5.5 mg/dL between Day 14 and Day 21 of treatment, the dosage should be increased to 9 mg taken orally once daily; treatment should continue at this dose until disease progression occurs or the medication becomes intolerable.

If vomiting occurs after taking the medication, do not take a replacement dose; continue with the next scheduled dose at the regular interval. If a dose is missed, the missed dose may be taken later on the same day; continue with the next scheduled dose at the regular interval.