Israel - English - Ministry of Health

j-c health care ltd - erdafitinib - film coated tablets - erdafitinib 3 mg - erdafitinib - balversa is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (muc), that has:- susceptible fgfr3 or fgfr2 genetiic 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.

Israel - English - Ministry of Health

j-c health care ltd - erdafitinib - film coated tablets - erdafitinib 4 mg - erdafitinib - balversa is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (muc), that has:- susceptible fgfr3 or fgfr2 genetiic 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.

Israel - English - Ministry of Health

j-c health care ltd - erdafitinib - film coated tablets - erdafitinib 5 mg - erdafitinib - balversa is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (muc), that has:- susceptible fgfr3 or fgfr2 genetiic 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.

United States - English - NLM (National Library of Medicine)

janssen products lp - erdafitinib (unii: 890e37nhmv) (erdafitinib - unii:890e37nhmv) - balversa is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (muc) with susceptible fgfr3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy. select patients for therapy based on an fda-approved companion diagnostic for balversa [see dosage and administration (2.1)and clinical studies (14.1)] . limitations of use balversa is not recommended for the treatment of patients who are eligible for and have not received prior pd-1 or pd-l1 inhibitor therapy [see clinical studies (14.1)] . none. risk summary based on the mechanism of action and findings in animal reproduction studies, balversa can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data on balversa use in pregnant women to inform a drug-associated risk. oral administration of erdafitinib to pregnant rats during organogenesis caused malformations and embryo-fetal death at maternal exposures that were less than the human exposures at the maximum recommended human dose based on auc (see data ). advise pregnant women and females of reproductive potential of the potential risk to the fetus. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. data animal data in an embryo-fetal toxicity study, erdafitinib was orally administered to pregnant rats during the period of organogenesis. doses ≥4 mg/kg/day (at total maternal exposures <0.1% of total human exposures at the maximum recommended human dose based on auc) produced embryo-fetal death, major blood vessel malformations and other vascular anomalies, limb malformations (ectrodactyly, absent or misshapen long bones), an increased incidence of skeletal anomalies in multiple bones (vertebrae, sternebrae, ribs), and decreased fetal weight. risk summary there are no data on the presence of erdafitinib in human milk, or the effects of erdafitinib on the breastfed child, or on milk production. because of the potential for serious adverse reactions from erdafitinib in a breastfed child, advise lactating women not to breastfeed during treatment with balversa and for one month following the last dose. balversa can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . pregnancy testing verify pregnancy status in females of reproductive potential prior to initiating treatment with balversa. contraception females advise females of reproductive potential to use effective contraception during treatment with balversa and for one month after the last dose. males advise male patients with female partners of reproductive potential to use effective contraception during treatment with balversa and for one month after the last dose. infertility females based on findings from animal studies, balversa may impair fertility in females of reproductive potential [see nonclinical toxicology (13.1)] . safety and effectiveness of balversa in pediatric patients have not been established. in 4 and 13-week repeat-dose toxicology studies in rats and dogs, toxicities in bone and teeth were observed at an exposure less than the human exposure (auc) at the maximum recommended human dose. chondroid dysplasia/metaplasia were reported in multiple bones in both species, and tooth abnormalities included abnormal/irregular denting in rats and dogs and discoloration and degeneration of odontoblasts in rats. of the 479 patients treated with balversa in clinical studies, 40% of patients were less than 65 years old, 40% of patients were 65 years to 74 years old, and 20% were 75 years old and over. patients 65 years of age and older treated with balversa experienced a higher incidence of adverse reactions requiring treatment discontinuation than younger patients. in clinical trials, the incidence of treatment discontinuations of balversa due to adverse reactions was 10% in patients younger than 65 years, 20% in patients ages 65–74 years, and 35% in patients 75 years or older. no overall difference in efficacy was observed between these patients and younger patients [see clinical studies (14.1)]. cyp2c9*3/*3 genotype: erdafitinib plasma concentrations are predicted to be higher in patients with the cyp2c9*3/*3 genotype. monitor for increased adverse reactions in patients who are known or suspected to have cyp2c9*3/*3 genotype [see pharmacogenomics (12.5)] .

Canada - English - Health Canada

janssen inc - erdafitinib - tablet - 3mg - erdafitinib 3mg - antineoplastic agents

Canada - English - Health Canada

janssen inc - erdafitinib - tablet - 4mg - erdafitinib 4mg - antineoplastic agents

Canada - English - Health Canada

janssen inc - erdafitinib - tablet - 5mg - erdafitinib 5mg - antineoplastic agents

Canada - English - Health Canada

janssen inc - erdafitinib - tablet - 4mg - erdafitinib 4mg - antineoplastic agents

Singapore - English - HSA (Health Sciences Authority)

johnson & johnson international (singapore) pte ltd - erdafitinib - tablet, film coated - erdafitinib 3.00 mg

Singapore - English - HSA (Health Sciences Authority)

johnson & johnson international (singapore) pte ltd - erdafitinib - tablet, film coated - erdafitinib 4.00 mg