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

sun pharmaceutical industries, inc. - sonidegib phosphate (unii: w421ai34uw) (sonidegib - unii:0rlu3vtk5m) - sonidegib 200 mg - odomzo (sonidegib) is indicated for the treatment of adult patients with locally advanced basal cell carcinoma (bcc) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy. none. risk summary based on its mechanism of action and data from animal reproduction studies, odomzo can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1) ]. there are no available data on the use of odomzo in pregnant women. in animal reproduction studies, oral administration of sonidegib during organogenesis at doses below the recommended human dose of 200 mg resulted in embryotoxicity, fetotoxicity, and teratogenicity in rabbits (see data). teratogenic effects observed included severe midline defects, missing digits, and other irreversible malformations. advise pregnant women of the potential risk to a fetus. report pregnancies to sun pharmaceutical industries, inc. at 1-800-406-7984. in the u.s. general population, the estimated background risk of major birth defects is 2-4% and of miscarriage in clinically recognized pregnancies is 15-20%. data animal data daily oral administration of sonidegib to pregnant rabbits resulted in abortion, complete resorption of fetuses, or severe malformations at ≥ 5 mg/kg/day (approximately 0.05 times the recommended human dose based on auc). teratogenic effects included vertebral, distal limb and digit malformations, severe craniofacial malformations, and other severe midline defects. skeletal variations were observed when maternal exposure to sonidegib was below the limit of detection. no data are available regarding the presence of sonidegib in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. because of the potential for serious adverse reactions in breastfed infants, advise women not to breastfeed during treatment with odomzo and for 20 months after the last dose. based on its mechanism of action and animal data, odomzo can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1) ] . pregnancy testing verify the pregnancy status of females of reproductive potential prior to initiating odomzo treatment. contraception females advise females of reproductive potential to use effective contraception during treatment with odomzo and for at least 20 months after the last dose. males it is not known if sonidegib is present in semen. advise male patients to use condoms, even after a vasectomy, to avoid potential drug exposure to pregnant partners and female partners of reproductive potential during treatment with odomzo and for at least 8 months after the last dose. advise males not to donate semen during treatment with odomzo and for at least 8 months after the last dose. infertility based on findings from animal studies, female fertility may be compromised with odomzo [see nonclinical toxicology (13.1) ] . the safety and effectiveness of odomzo have not been established in pediatric patients. epiphyseal disorders, including premature fusion of the epiphyses, have been reported in pediatric patients exposed to odomzo in a clinical trial. in some cases, pediatric patients treated with other hh pathway inhibitors have experienced progression of epiphyseal fusion despite discontinuation of the hh pathway inhibitor. juvenile animal data in a 5-week juvenile rat toxicology study, effects of sonidegib were observed in bone, teeth, reproductive tissues, and nerves at doses ≥10 mg/kg/day (approximately 1.2 times the recommended human dose based on auc). bone findings included thinning/closure of bone growth plate, decreased bone length and width, and hyperostosis. findings in teeth included missing or fractured teeth, and atrophy. reproductive tissue toxicity was evidenced by atrophy of testes, ovaries, and uterus, partial development of the prostate gland and seminal vesicles, and inflammation and aspermia of the epididymis. nerve degeneration was also noted. of the 229 patients who received odomzo (79 patients receiving 200 mg daily and 150 patients receiving 800 mg daily) in bolt, 54% were 65 years and older, while 28% were 75 years and older. no overall differences in effectiveness were observed between these patients and younger patients. there was a higher incidence of serious adverse reactions, grade 3 and 4 adverse reactions, and adverse reactions requiring dose interruption or discontinuation in patients ≥65 years compared with younger patients; this was not attributable to an increase in any specific adverse event.

Australia - English - Department of Health (Therapeutic Goods Administration)

sun pharma anz pty ltd - sonidegib phosphate, quantity: 280.8 mg (equivalent: sonidegib, qty 200 mg) - capsule, hard - excipient ingredients: colloidal anhydrous silica; magnesium stearate; purified water; gelatin; lactose monohydrate; titanium dioxide; iron oxide red; sodium lauryl sulfate; poloxamer; crospovidone; butylated hydroxytoluene; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; ethanol absolute; iron oxide black; ethanol; shellac; sulfuric acid - odomzo is indicated for the treatment of adult patients with:,- locally advanced basal cell carcinoma (bcc) who are not amenable to curative surgery or radiation therapy.,- metastatic bcc

Australia - English - Department of Health (Therapeutic Goods Administration)

sun pharma anz pty ltd - sonidegib phosphate, quantity: 280.8 mg (equivalent: sonidegib, qty 200 mg) - capsule, hard - excipient ingredients: colloidal anhydrous silica; magnesium stearate; purified water; gelatin; lactose monohydrate; titanium dioxide; iron oxide red; sodium lauryl sulfate; poloxamer; crospovidone; butylated hydroxytoluene; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; ethanol absolute; iron oxide black; ethanol; shellac; sulfuric acid - odomzo is indicated for the treatment of adult patients with:,- locally advanced basal cell carcinoma (bcc) who are not amenable to curative surgery or radiation therapy.,- metastatic bcc

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

novartis pharmaceuticals corporation - sonidegib phosphate (unii: w421ai34uw) (sonidegib - unii:0rlu3vtk5m) - sonidegib 200 mg

Israel - English - Ministry of Health

taro international ltd, israel - sonidegib as diphosphate - hard capsule - sonidegib as diphosphate 200 mg - sonidegib - odomzo 200 mg is indicated for the treatment of adult patients with locally advanced basal cell carcinoma which cannot be treated with curative surgery or radiation therapy

Israel - English - Ministry of Health

taro international ltd, israel - sonidegib as diphosphate - hard capsule - sonidegib as diphosphate 200 mg - sonidegib - odomzo 200 mg is indicated for the treatment of adult patients with locally advanced basal cell carcinoma which cannot be treated with curative surgery or radiation therapy

Israel - English - Ministry of Health

taro international ltd, israel - sonidegib as diphosphate - hard capsule - sonidegib as diphosphate 200 mg - sonidegib - odomzo 200 mg is indicated for the treatment of adult patients with locally advanced basal cell carcinoma which cannot be treated with curative surgery or radiation therapy

European Union - English - EMA (European Medicines Agency)

sun pharmaceutical industries europe b.v. - sonidegib diphosphate - carcinoma, basal cell - antineoplastic agents - odomzo is indicated for the treatment of adult patients with locally advanced basal cell carcinoma (bcc) who are not amenable to curative surgery or radiation therapy.

Canada - English - Health Canada

sun pharmaceutical industries limited - sonidegib (sonidegib phosphate) - capsule - 200mg - sonidegib (sonidegib phosphate) 200mg - antineoplastic agents

Philippines - English - FDA (Food And Drug Administration)

sun pharmaceutical industries limited.; importer: sun pharma philippines, inc.; distributor: sun pharma philippines, inc. - sonidegib (as phosphate) - capsule - 200 mg