Erdafitinib
Composition: Erdanib-4: Each film coated tablet contains Erdafitinib INN 4.00 mg.
Indications: It is indicated for the treatment of adult patients with locally advanced or metastatic Urothelial Carcinoma (mUC), that has-
· Susceptible FGFR3 or FGFR2 genetic alterations, and
· Progressed during or following at least one line of prior platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.
Dosage & Administration: The recommended starting dose of Erdafitinib is 8 mg (two 4 mg tablets) orally once daily, with a dose increase to 9 mg (three 3 mg tablets) once daily based on serum phosphate (PO4) levels and tolerability at 14 to 21 days. Whole tablets should be swallowed with or without food. If vomiting occurs any time after taking Erdafitinib, the next dose should be taken the next day. Treatment should be continued until disease progression or unacceptable toxicity occurs. If a dose is missed, it can be taken as soon as possible on the same day. The regular daily dose schedule for Erdafitinib should be resumed the next day. Extra tablets should not be taken to make up for the missed dose. Or, as directed by the registered physicians.
Dose Modification:
|
Dose |
1st Dose Reduction |
2nd Dose Reduction |
3nd Dose Reduction |
4nd Dose Reduction |
5nd Dose Reduction |
|
9mg (three 3mg tablets) |
8mg (two 4mg tablets) |
6mg (two 3mg tablets) |
5mg (one 5mg tablet) |
4mg (one 4mg tablet) |
Stop |
|
8mg (two 4mg tablets) |
6mg (two 3mg tablets) |
5mg (one 5mg tablet) |
4mg (one 4mg tablet) |
Stop |
|
Use in Pregnancy and Lactation: Erdafitinib can cause fetal harm when administered to a pregnant woman. Pregnancy testing is recommended for females of reproductive potential prior to initiating treatment with Erdafitinib. Advise pregnant women and females of reproductive potential of the potential risk to the fetus. Males and females of reproductive potential are advised to use effective contraception during treatment with Erdafitinib and for one month after the last dose. Based on findings from animal studies, Erdafitinib may impair fertility in females of reproductive potential.
Lactation: Because of the potential for serious adverse reactions from Erdafitinib in a breastfed child, lactating women should not to breastfeed during treatment with Erdafitinib and for one month following the last dose.
Packaging:
Erdanib-4: Each box contains 60 tablets in a container.
