Country: United States
Language: English
Source: NLM (National Library of Medicine)
SONIDEGIB PHOSPHATE (UNII: W421AI34UW) (SONIDEGIB - UNII:0RLU3VTK5M)
Sun Pharmaceutical Industries, Inc.
SONIDEGIB PHOSPHATE
SONIDEGIB 200 mg
ORAL
PRESCRIPTION DRUG
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.
Each ODOMZO capsule has an opaque pink color with ‘SONIDEGIB 200MG’ printed on the capsule body and ‘NVR’ printed on the cap in black ink. ODOMZO capsules are supplied as follows: Bottle of 30 capsules NDC 47335-303-83 Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
New Drug Application
Sun Pharmaceutical Industries, Inc. ---------- MEDICATION GUIDE ODOMZO® (o-DOM-zo) (sonidegib) capsules What is the most important information I should know about ODOMZO? ODOMZO can cause your baby to die before it is born (be stillborn) or cause your baby to have severe birth defects. For females who can become pregnant: • You should talk to your healthcare provider about the risks of ODOMZO to your unborn child. • Your healthcare provider will do a pregnancy test before you start taking ODOMZO. • In order to avoid pregnancy, you should use birth control during treatment, and for at least 20 months after your final dose of ODOMZO. Talk to your healthcare provider about what birth control method is right for you during this time. • Talk to your healthcare provider right away if you have unprotected sex or if you think your birth control has failed. • Tell your healthcare provider right away if you become pregnant or think that you may be pregnant. For males: • It is not known if ODOMZO is present in semen. Do not donate semen while you are taking ODOMZO and for at least 8 months after your final dose. • You should always use a condom, even if you have had a vasectomy, during sex with female partners who are pregnant or who are able to become pregnant, during treatment with ODOMZO and for at least 8 months after your final dose to protect your female partner from being exposed to ODOMZO. • Tell your healthcare provider right away if your partner becomes pregnant or thinks she is pregnant while you are taking ODOMZO. Exposure to ODOMZO during pregnancy: If you think that you or your female partner may have been exposed to ODOMZO during pregnancy, talk to your healthcare provider right away. If you become pregnant during treatment with ODOMZO, you or your healthcare provider should report your pregnancy to Sun Pharmaceutical Industries, Inc. at 1-800- 406-7984. What is ODOMZO? ODOMZO is a prescription medicine used to treat adults with a type of skin cancer, called basal cell carcinoma, that has com Read the complete document
ODOMZO- SONIDEGIB CAPSULE SUN PHARMACEUTICAL INDUSTRIES, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ODOMZO SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ODOMZO. ODOMZO (SONIDEGIB) CAPSULES, FOR ORAL USE INITIAL U.S. APPROVAL: 2015 WARNING: EMBRYO-FETAL TOXICITY _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ ODOMZO CAN CAUSE EMBRYO-FETAL DEATH OR SEVERE BIRTH DEFECTS WHEN ADMINISTERED TO A PREGNANT WOMAN AND IS EMBRYOTOXIC, FETOTOXIC, AND TERATOGENIC IN ANIMALS. (5.1, 8.1) VERIFY THE PREGNANCY STATUS OF FEMALES OF REPRODUCTIVE POTENTIAL PRIOR TO INITIATING THERAPY. ADVISE FEMALES OF REPRODUCTIVE POTENTIAL TO USE EFFECTIVE CONTRACEPTION DURING TREATMENT WITH ODOMZO AND FOR AT LEAST 20 MONTHS AFTER THE LAST DOSE. (5.1, 8.3) ADVISE MALES OF THE POTENTIAL RISK OF EXPOSURE THROUGH SEMEN AND TO USE CONDOMS WITH A PREGNANT PARTNER OR A FEMALE PARTNER OF REPRODUCTIVE POTENTIAL DURING TREATMENT WITH ODOMZO AND FOR AT LEAST 8 MONTHS AFTER THE LAST DOSE. (5.1, 8.3) INDICATIONS AND USAGE ODOMZO is a hedgehog pathway inhibitor 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. (1) DOSAGE AND ADMINISTRATION Recommended dosage: 200 mg orally once daily taken on an empty stomach, at least 1 hour before or 2 hours after a meal. (2.2) DOSAGE FORMS AND STRENGTHS 200 mg capsules (3) CONTRAINDICATIONS None. (4) WARNINGS AND PRECAUTIONS Embryo-Fetal Toxicity: Advise patients not to donate blood or blood products during treatment with ODOMZO and for at least 20 months after the last dose. (5.1) Musculoskeletal Adverse Reactions: Obtain serum creatine kinase (CK) and creatinine levels prior to initiating therapy, periodically during treatment, and as clinically indicated. Temporary dose interruption or discontinuation of ODOMZO may be required based on the severity o Read the complete document