Medicine Information

erdafixen

Name: erdafixen
Brand: erdafixen
Rating: 4.5 (117 reviews)

Tablet4 mgKinase Inhibitor, Antineoplastic agentATC: L01XE43

Generic Name

Erdafitinib

Manufacturer

PharmaCorp Oncology

Country

USA

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Price Details

Current market pricing information

Variant	Unit Price	Strip Price
erdafixen 4 mg tablet	৳ 700.00	N/A

Description

Overview of the medicine

Erdafitinib is an oral fibroblast growth factor receptor (FGFR) kinase inhibitor used for the treatment of locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 or FGFR2 genetic alterations.

Uses & Indications

Treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) that has susceptible fibroblast growth factor receptor 3 (FGFR3) or FGFR2 genetic alterations, and who have progressed on or after at least one prior line of systemic therapy.

Dosage

Adults

Initial dose: 8 mg orally once daily for 14-21 days. If serum phosphate levels are <5.5 mg/dL and no unacceptable adverse reactions, dose may be escalated to 9 mg once daily. Continue until disease progression or unacceptable toxicity. It is recommended to perform serum phosphate levels and eye exams as per specific schedule.

Elderly

No specific dosage adjustment based on age is required. Monitor for adverse reactions as with all patients.

Renal_impairment

No dosage adjustment is recommended for patients with mild to moderate renal impairment (creatinine clearance ≥30 mL/min). Erdafitinib has not been studied in patients with severe renal impairment (creatinine clearance <30 mL/min).

How to Take

Take Erdafixen orally once daily, with or without food. Swallow the tablet whole. Do not crush, chew, or split the tablets. If a dose is missed, and it has been more than 12 hours since the scheduled dose, skip the missed dose and resume the next scheduled dose. Do not take two doses at the same time.

Mechanism of Action

Erdafitinib selectively binds to and inhibits the enzymatic activity of FGFR1, FGFR2, FGFR3, and FGFR4, which are involved in various cellular processes including cell proliferation, differentiation, and survival. Inhibition of these receptors can lead to reduced tumor cell growth and survival.

Pharmacokinetics

Onset

Tumor response typically observed over weeks to months, as is common with targeted cancer therapies.

Excretion

Excreted primarily via feces (69%), with approximately 19% excreted renally, mostly as metabolites.

Half life

Approximately 16 hours.

Absorption

Rapidly absorbed after oral administration, with peak plasma concentrations (Cmax) reached approximately 2.5 to 4 hours post-dose. Absolute bioavailability is estimated to be 69%.

Metabolism

Primarily metabolized by CYP2C9 and CYP3A4 enzymes. It is also a substrate of P-glycoprotein (P-gp) and Breast Cancer Resistance Protein (BCRP).

Side Effects

Contraindications

Hypersensitivity to Erdafitinib or any component of the formulation.

Drug Interactions

Moderate CYP3A4 inducers (e.g., efavirenz, bosentan)

Co-administration may decrease erdafitinib exposure. Avoid concomitant use.

Strong CYP2C9 inhibitors (e.g., fluconazole, amiodarone)

Co-administration may increase erdafitinib exposure. Monitor for adverse reactions.

Proton Pump Inhibitors (PPIs) and H2-receptor antagonists

May decrease gastric acidity and affect erdafitinib absorption. Separate administration times or use alternatives if possible.

Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin)

Co-administration may increase erdafitinib exposure. Avoid concomitant use; if unavoidable, reduce erdafitinib dose.

Storage

Store at room temperature (20°C to 25°C), excursions permitted to 15°C to 30°C. Keep in the original container, protected from moisture. Do not freeze.

Overdose

There is no specific antidote for erdafitinib overdose. Management should involve supportive care and symptomatic treatment. Monitor serum phosphate levels and manage hyperphosphatemia as necessary.

Pregnancy & Lactation

Pregnancy Category D. Erdafitinib can cause fetal harm when administered to a pregnant woman. Females of reproductive potential should use effective contraception during treatment and for 1 month after the last dose. It is not known whether erdafitinib or its metabolites are excreted in human milk; due to the potential for serious adverse reactions in breastfed infants, breastfeeding is not recommended during treatment and for 1 month after the last dose.

Frequently Asked Questions

Common questions about this medicine

Pack Sizes

28 tablets per pack56 tablets per pack

Shelf Life

24 months from manufacturing date.

Availability

Specialty pharmacies, Oncology clinics

Approval Status

FDA Approved

Patent Status

Patented

Clinical Trials

Erdafitinib has been studied in several clinical trials, most notably the BLC2001 (NCT02365597) study, which led to its accelerated approval for urothelial carcinoma. Ongoing trials continue to explore its efficacy in other FGFR-driven cancers and in combination therapies.

Lab Monitoring

Serum phosphate levels (weekly for the first 4 weeks, then monthly)
Eye examinations (within 4 weeks of treatment initiation, then every 2 months for the first year, and every 3 months thereafter)
Serum electrolytes (calcium, magnesium, potassium)
Renal function tests

Doctor Notes

Before initiating erdafitinib, confirm the presence of susceptible FGFR3 or FGFR2 genetic alterations in tumor tissue.
Monitor serum phosphate levels weekly for the first 4 weeks, then monthly. Initiate phosphate-lowering therapy if levels exceed 5.5 mg/dL.
Conduct baseline ophthalmological examination within 4 weeks prior to or upon initiation of therapy, and then every 2 months for the first 6 months and every 3 months thereafter.
Patients should be advised about the risk of ocular toxicity and instructed to report any visual changes immediately.

Patient Guidelines

Report any new or worsening visual symptoms (e.g., blurred vision, seeing halos, or reduced central vision) to your doctor immediately.
Maintain good oral hygiene to manage stomatitis.
Stay hydrated by drinking plenty of fluids.
Use moisturizers for dry skin and nail care for nail disorders.

Missed Dose Advice

If a dose is missed by more than 12 hours from the scheduled time, skip the missed dose and take the next scheduled dose at the regular time. Do not take extra tablets to make up for a missed dose.

Driving Precautions

Erdafitinib may cause visual disturbances, fatigue, or dizziness, which could impair your ability to drive or operate machinery. Exercise caution and avoid these activities if you experience such symptoms.

Lifestyle Advice

Use effective contraception during treatment and for 1 month after the last dose, as Erdafitinib can harm an unborn baby.
Avoid prolonged exposure to direct sunlight and use protective clothing and sunscreen, as Erdafitinib may cause photosensitivity.
Limit consumption of high phosphate foods (e.g., dairy products, certain nuts, beans) to help manage hyperphosphatemia.