Erdafitinib Instructions

1. Indications

ErdafitinibIndicated for locally advanced or metastatic urothelial carcinoma with fibroblast growth factor receptor-2 (FGFR2) or FGFR3 gene alteration that has progressed during or after at least one cycle of prior platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.

2. Dosage and usage

Before initiatingerdafitinibtreatment, confirm the presence ofFGFRgene alterations in tumor specimens.

The recommended initial dose is 8 mg orally once daily, and if the criteria are met, the dose is increased to 9 mg daily.

If the patient vomits shortly after taking erdafitinib, do not take another dose and wait until the next scheduled dose.

If you miss a dose, Take the missed dose on the same day, Take the next dose at the same time the next day, Do not take two doses in the same day.

Three. Dosage form and strength

Tablets: 3mg, 4mg and 5mg.

4. Contraindications

No

5. Notes

1.Eye diseases: Erdafitinib can cause central serous retinopathy/Retinal pigment epithelial detachment(CSR/RPED). Perform monthly eye exams for visual symptoms during the first four months of treatment, every three months thereafter, and at any time for visual symptoms. Discontinue erdafitinib when CSR/RPED occurs, or permanently if not resolved within 4 weeks or if severity is 4 grade.

2.Hyperphosphatemia:The increase in phosphate levels is the pharmacodynamic effect of erdafitinib. Monitor for hyperphosphatemia and adjust dose if necessary.

3.Embryo-Fetal Toxicity:Can cause fetal harm. Inform patients of potential risks to the fetus and use effective contraception.

6. adverse reactions

Increased phosphate(76%), stomatitis(56%), fatigue(54%), elevated creatinine(52%), diarrhea(47%), elevated alanine aminotransferase(41%), increased alkaline phosphatase(41%), acetonitrile< /span>(41%), decreased sodium(40%), decreased appetite(38%), decreased albumin(37%)< /span>, dysgeusia(37%), decreased hemoglobin(35%), dry skin(34%), aspartate turn Elevated ammonia enzyme(30%), decreased magnesium content(30%), constipation(28%), dry eye syndrome(28 %), palms-plantar red blood cell paresthesia(26%), hair loss(26%), phosphate reduction< /span>(24%), abdominal pain(23%), increased calcium levels(22%), nausea(21%), musculoskeletal pain(20%), thrombocytopenia(19%), leukopenia(17%), blurred vision(17%), paronychia(17%), urinary tract infection(17%), increased potassium(16%), weight loss(16%), fever(14%), vomiting(1 3%), nail discoloration(11%), conjunctivitis(11%), oropharyngeal pain(11%)(11%) span>, hematuria(11%), joint pain(11%), decreased sodium content(16%), etc.

7. drug interactions

ModerateCYP2C9or strongCYP3A4Inhibitors:Consider alternative agents or monitor closely for adverse reactions.

StrongCYP2C9 or CYP3A4 inducers:Avoid concurrent use witherdafitinib.

ModerateCYP2C9or CYP3A4inducers: Increase the erdafitinib dose to 9 mg.

Serum phosphate level altering agents:Avoid coadministration with drugs that may alter serum phosphate levels before the initial dose adjustment period.

CYP3A4Substrates:Avoid co-administration with sensitive CYP3A4 substrates with a narrow therapeutic index.

OCT2Matrix:Consider alternative agents or consider reducing the dose of OCT2Matrix based on tolerability.

P-gpSubstrate:Administer erdafitinib alone at least 6 hours before or after administration of a P-gpsubstrate with a narrow therapeutic index.

eight. Used by specific groups of people

Lactation:It is recommended not to breastfeed.

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