Dosage & Administration
Recommended dosage: 200 mg orally once daily taken on an empty stomach, at least 1 hour before or 2 hours after a meal. (
The recommended dosage of ODOMZO is 200 mg taken orally once daily on an empty stomach, at least 1 hour before or 2 hours after a meal, administered until disease progression or unacceptable toxicity
Obtain serum creatine kinase (CK) levels and renal function tests prior to initiating ODOMZO in all patients
If a dose of ODOMZO is missed, resume dosing with the next scheduled dose.
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Odomzo Prescribing Information
- ODOMZO can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. ODOMZO is embryotoxic, fetotoxic, and teratogenic in animals[see
5.1 Embryo-Fetal ToxicityODOMZO can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. In animal reproduction studies, sonidegib was embryotoxic, fetotoxic, and teratogenic at maternal exposures below the recommended human dose of 200 mg
[seeUse in Specific Populations (8.1)].Females of Reproductive PotentialVerify pregnancy status of females of reproductive potential prior to initiating ODOMZO treatment. Advise pregnant women of the potential risk to a fetus. Advise females to use effective contraception during treatment with ODOMZO and for at least 20 months after the last dose
[seeUse in Specific Populations (8.3)].MalesAdvise male patients with female partners to use condoms, even after a vasectomy, during treatment with ODOMZO and for at least 8 months after the last dose to avoid potential drug exposure in pregnant females or females of reproductive potential
[seeUse in Specific Populations (8.3)].Blood DonationAdvise patients not to donate blood or blood products while taking ODOMZO and for at least 20 months after the last dose of ODOMZO, because their blood or blood products might be given to a female of reproductive potential.
and8.1 PregnancyRisk SummaryBased on its mechanism of action and data from animal reproduction studies, ODOMZO can cause fetal harm when administered to a pregnant woman
[seeClinical 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%.
DataAnimal DataDaily 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.
]. - 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[see
5.1 Embryo-Fetal ToxicityODOMZO can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. In animal reproduction studies, sonidegib was embryotoxic, fetotoxic, and teratogenic at maternal exposures below the recommended human dose of 200 mg
[seeUse in Specific Populations (8.1)].Females of Reproductive PotentialVerify pregnancy status of females of reproductive potential prior to initiating ODOMZO treatment. Advise pregnant women of the potential risk to a fetus. Advise females to use effective contraception during treatment with ODOMZO and for at least 20 months after the last dose
[seeUse in Specific Populations (8.3)].MalesAdvise male patients with female partners to use condoms, even after a vasectomy, during treatment with ODOMZO and for at least 8 months after the last dose to avoid potential drug exposure in pregnant females or females of reproductive potential
[seeUse in Specific Populations (8.3)].Blood DonationAdvise patients not to donate blood or blood products while taking ODOMZO and for at least 20 months after the last dose of ODOMZO, because their blood or blood products might be given to a female of reproductive potential.
and8.3 Females and Males of Reproductive PotentialBased on its mechanism of action and animal data, ODOMZO can cause fetal harm when administered to a pregnant woman
[seeUse in Specific Populations (8.1)].Pregnancy TestingVerify the pregnancy status of females of reproductive potential prior to initiating ODOMZO treatment.
ContraceptionFemalesAdvise females of reproductive potential to use effective contraception during treatment with ODOMZO and for at least 20 months after the last dose.
MalesIt 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.
InfertilityBased on findings from animal studies, female fertility may be compromised with ODOMZO
[seeNonclinical Toxicology (13.1)].]. - 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[see
5.1 Embryo-Fetal ToxicityODOMZO can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. In animal reproduction studies, sonidegib was embryotoxic, fetotoxic, and teratogenic at maternal exposures below the recommended human dose of 200 mg
[seeUse in Specific Populations (8.1)].Females of Reproductive PotentialVerify pregnancy status of females of reproductive potential prior to initiating ODOMZO treatment. Advise pregnant women of the potential risk to a fetus. Advise females to use effective contraception during treatment with ODOMZO and for at least 20 months after the last dose
[seeUse in Specific Populations (8.3)].MalesAdvise male patients with female partners to use condoms, even after a vasectomy, during treatment with ODOMZO and for at least 8 months after the last dose to avoid potential drug exposure in pregnant females or females of reproductive potential
[seeUse in Specific Populations (8.3)].Blood DonationAdvise patients not to donate blood or blood products while taking ODOMZO and for at least 20 months after the last dose of ODOMZO, because their blood or blood products might be given to a female of reproductive potential.
and8.3 Females and Males of Reproductive PotentialBased on its mechanism of action and animal data, ODOMZO can cause fetal harm when administered to a pregnant woman
[seeUse in Specific Populations (8.1)].Pregnancy TestingVerify the pregnancy status of females of reproductive potential prior to initiating ODOMZO treatment.
ContraceptionFemalesAdvise females of reproductive potential to use effective contraception during treatment with ODOMZO and for at least 20 months after the last dose.
MalesIt 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.
InfertilityBased on findings from animal studies, female fertility may be compromised with ODOMZO
[seeNonclinical Toxicology (13.1)].].
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.
Recommended dosage: 200 mg orally once daily taken on an empty stomach, at least 1 hour before or 2 hours after a meal. (
The recommended dosage of ODOMZO is 200 mg taken orally once daily on an empty stomach, at least 1 hour before or 2 hours after a meal, administered until disease progression or unacceptable toxicity
Obtain serum creatine kinase (CK) levels and renal function tests prior to initiating ODOMZO in all patients
If a dose of ODOMZO is missed, resume dosing with the next scheduled dose.
Capsules: 200 mg, opaque pink colored with ‘SONIDEGIB 200MG’ printed on the body and ‘NVR’ printed on the cap in black ink (equivalent to 281 mg of diphosphate salt of sonidegib).
- Lactation: Advise not to breastfeed. ()
8.2 LactationNo 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.
None.