Indications & Uses
Erdafixen 3 is indicated for:
Pharmacology
Erdafitinib is a kinase inhibitor. In vitro data show that it binds to FGFR1, FGFR2, FGFR3 and FGFR4 and blocks their enzyme activity. It also binds to RET, CSF1R, PDGFRA, PDGFRB, FLT4, KIT and VEGFR2.
In cell lines that carry FGFR genetic alterations (point mutations, amplifications and fusions), erdafitinib inhibits FGFR phosphorylation and signaling, and it lowers cell viability. It shows antitumor activity in FGFR-expressing cell lines and in xenograft models derived from tumor types that include bladder cancer.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Adults start Erdafitinib at 8 mg once daily, taken by mouth as two 4 mg tablets. After 14 to 21 days the dose may go up to 9 mg once daily (three 3 mg tablets), depending on the serum phosphate (PO4) level and how well the person is tolerating the medicine. Treatment continues until the disease progresses or the toxicity becomes unacceptable.
If a dose of Erdafitinib is missed, it can be taken as soon as possible on the same day. The next day, go back to the usual daily schedule. Don't take extra tablets to make up for the missed dose.
Side Effects
The most common side effects of erdafitinib, including abnormal laboratory results, are those seen in 20% or more of people. They are elevated phosphate, stomatitis, fatigue, elevated creatinine, diarrhoea, dry mouth, nail disorder, elevated alanine aminotransferase, elevated alkaline phosphatase, decrease in sodium, decrease in appetite, decrease in albumin, dysgeusia, decrease in hemoglobin, dry skin, elevated aspartate aminotransferase, decrease in magnesium, dry eye, alopecia, palmar-plantar erythrodysesthesia syndrome, constipation, decrease in phosphate, abdominal pain, elevated calcium, nausea, and musculoskeletal pain.
Cautions & Contraindications
Warnings & Precautions
Ocular disorders: Erdafitinib can cause central serous retinopathy/retinal pigment epithelial detachment (CSR/RPED). An ophthalmological examination should be done every month for the first four months of treatment, then every 3 months, and at any time if visual symptoms appear. If CSR/RPED occurs, Erdafitinib should be withheld. It should be stopped permanently if the problem does not resolve within 4 weeks or if it is Grade 4 in severity. Hyperphosphatemia: Phosphate levels should be monitored, and hyperphosphatemia should be managed with dose modifications when required. Embryo-fetal toxicity: Erdafitinib can harm the fetus, so patients should be told about this potential risk and advised to use effective contraception.
Use in Special Populations
Pediatric use: the safety and effectiveness of Erdafitinib in pediatric patients have not been established. Geriatric use: no overall differences in safety or effectiveness were seen between geriatric patients and younger patients. Renal impaired patients: no dose adjustment is recommended for those with mild to moderate renal impairment. Hepatic impaired patients: no dose adjustment is recommended for those with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment, but limited data are available in patients with severe (Child-Pugh C) hepatic impairment. CYP2C9 poor metabolizers, CYP2C9*3/*3 genotype: Erdafitinib plasma concentrations were predicted to be higher in patients with the CYP2C9*3/*3 genotype. Patients who are known or suspected to have the CYP2C9*3/*3 genotype should be monitored for increased adverse reactions.
Storage
Keep Erdafitinib below 30°C, in a cool and dry place. Protect it from light. Always keep it out of the reach of children.
Common questions about Erdafixen 3 3 mg
What is Erdafixen 3 3 mg Tablet?
Erdafixen 3 3 mg Tablet is a medicine that contains Erdafitinib. It is made by Everest Pharmaceuticals Ltd. It belongs to the Cytotoxic Chemotherapy group of medicines.
What is Erdafixen 3 used for?
Erdafixen 3 is used for: Cancer.
What are the side effects of Erdafixen 3?
The most common side effects of erdafitinib, including abnormal laboratory results, are those seen in 20% or more of people. They are elevated phosphate, stomatitis, fatigue, elevated creatinine, diarrhoea, dry mouth, nail disorder, elevated alanine aminotransferase, elevated alkaline phosphatase, decrease in sodium, decrease in appetite, decrease in albumin, dysgeusia, decrease in hemoglobin, dry skin, elevated aspartate aminotransferase, decrease in magnesium, dry eye, alopecia, palmar-plantar erythrodysesthesia syndrome, constipation, decrease in phosphate, abdominal pain, elevated calcium, nausea, and musculoskeletal pain.
How should I store Erdafixen 3?
Keep Erdafitinib below 30°C, in a cool and dry place. Protect it from light.
Do I need a prescription for Erdafixen 3?
Erdafixen 3 is a prescription (Rx) medicine. Take it as your doctor advises.