ODOMZO® dosage and administration1
Recommended dosing: 200 mg once daily1
ODOMZO should be taken orally once daily on an empty stomach, at least 1 hour before or 2 hours after a meal. Administration should continue until disease progression or unacceptable toxicity.1
1 hour before or 2 hours after
If a dose of ODOMZO is missed, resume dosing with the next scheduled dose1
Verify pregnancy status prior to initiating ODOMZO.1
See what ODOMZO looks like1
NDC:
47335-303-83
Supplied as:
Bottle of 30 capsules
NDC=National Drug Code.
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INDICATION
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.
IMPORTANT SAFETY INFORMATION
WARNING: EMBRYO-FETAL TOXICITY
- ODOMZO can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. ODOMZO is embryotoxic, fetotoxic, and teratogenic in animals
- 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
- 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
WARNINGS AND PRECAUTIONS
Embryo-fetal Toxicity: ODOMZO can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. Females of Reproductive Potential: Verify pregnancy status prior to initiating ODOMZO. Advise females to use effective contraception and not to breastfeed, due to the potential for serious adverse reactions in breastfed infants, during treatment and for at least 20 months after the last dose. Report pregnancies to Sun Pharmaceutical Industries, Inc. at 1-800-406-7984.
Males: Advise males to use condoms, even after a vasectomy, and to not donate semen during treatment and for at least 8 months after the last dose to avoid potential drug exposure in pregnant females or females of reproductive potential.
Blood Donation: Advise patients not to donate blood or blood products while taking ODOMZO, and for at least 20 months after the last dose because their blood or blood products might be given to a female of reproductive potential.
Musculoskeletal Adverse Reactions: Musculoskeletal adverse reactions, which may be accompanied by serum creatine kinase (CK) elevations, occur with ODOMZO and other drugs which inhibit the hedgehog (Hh) pathway. Obtain serum 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 of musculoskeletal adverse reactions.
Premature Fusion of the Epiphyses: ODOMZO is not indicated for use in pediatric patients. Premature fusion of the epiphyses has been reported in pediatric patients exposed to ODOMZO and other Hh pathway inhibitors. In some cases, fusion progressed after discontinuation.
Drug Interactions: Avoid concomitant administration of ODOMZO with strong and moderate CYP3A inhibitors. If a moderate CYP3A inhibitor must be used, administer for less than 14 days and monitor closely for adverse reactions, particularly musculoskeletal. Avoid concomitant administration of ODOMZO with strong and moderate CYP3A inducers.
Geriatric Use: There was a higher incidence of serious adverse events, Grade 3 and 4, and events 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.
Most Common Adverse Reactions: The most common adverse reactions occurring in ≥10% of patients were muscle spasms (54%), alopecia (53%), dysgeusia (46%), fatigue (41%), nausea (39%), musculoskeletal pain (32%), diarrhea (32%), decreased weight (30%), decreased appetite (23%), myalgia (19%), abdominal pain (18%), headache (15%), pain (14%), vomiting (11%), and pruritus (10%).
Click here to see the full Prescribing Information for ODOMZO, including Boxed WARNING.
References: 1. ODOMZO [prescribing information]. Cranbury, NJ: Sun Pharmaceutical Industries, Inc; 08/2023. 2. Data on file. Sun Pharmaceutical Industries, Inc. Princeton, NJ 3. Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0. Published November 27, 2017. US Department of Health and Human Services. Accessed August 14, 2023. https://ctep.cancer.gov/protocoldevelopment/electronic_applications/ctc.htm#ctc_50 4. American Academy of Orthopedic Surgeons. Muscle cramps. Accessed August 8, 2023. https://orthoinfo.aaos.org/en/diseases-conditions/muscle-cramps 5. Cancer fatigue: why it occurs and how to cope. Accessed August 8, 2023. https://www.mayoclinic.org/diseases-conditions/cancer/in-depth/cancer-fatigue/art-20047709 6. Mayo Clinic. Diarrhea. Accessed August 8, 2023. https://www.mayoclinic.org/diseases-conditions/diarrhea/symptoms-causes/syc-20352241 7. Mayo Clinic. Chemotherapy and hair loss: what to expect during treatment. Accessed August 8, 2023. https://www.mayoclinic.org/tests-procedures/chemotherapy/in-depth/hair-loss/art-20046920 8. Mayo Clinic. Eating during cancer treatment: tips to make food tastier. Accessed August 8, 2023. https://www.mayoclinic.org/diseases-conditions/cancer/in-depth/ cancer/art-20047536 9. Mayo Clinic. Chemotherapy nausea and vomiting: prevention is best defense. Accessed August 8, 2023. https://www.mayoclinic.org/tests-procedures/chemotherapy/in-depth/cancer/ art-20047517 10. Gutzmer R, Loquai C, Robert C, et al. Key clinical adverse events in patients with advanced basal cell carcinoma treated with sonidegib or vismodegib: a post hoc analysis. Dermatol Ther (Heidelb). 2021;11(5):1839-1849. 11. Dummer R, Guminski A, Gutzmer R, et al. The 12-month analysis from Basal Cell Carcinoma Outcomes with LDE225 Treatment (BOLT): a phase II, randomized, double-blind study of sonidegib in patients with advanced basal cell carcinoma. J Am Acad Dermatol. 2016;75(1):113-125. 12. Dummer R, Guminski A, Gutzmer R, et al. Long-term efficacy and safety of sonidegib in patients with advanced basal cell carcinoma: 42-month analysis of the phase II randomized, double-blind BOLT study. Br J Dermatol. 2020;182(6):1369-1378. 13. Lear JT, Migden MR, Lewis KD, et al. Long-term efficacy and safety of sonidegib in patients with locally advanced and metastatic basal cell carcinoma: 30-month analysis of the randomized phase 2 BOLT study. J Eur Acad Dermatol Venereol. 2018;32(3):372-381. 14. Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009;45(2):228-247. 15. Migden MR, Guminski A, Gutzmer R, et al. Treatment with two different doses of sonidegib in patients with locally advanced or metastatic basal cell carcinoma (BOLT): a multicentre, randomised, double-blind phase 2 trial. Lancet Oncol. 2015;16(6):716-728. 16. Sekulic A, Migden MR, Oro AE, et al. Efficacy and safety of vismodegib in advanced basal-cell carcinoma. N Engl J Med. 2012;366(23):2171-2179.
INDICATION
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.
IMPORTANT SAFETY INFORMATION
WARNING: EMBRYO-FETAL TOXICITY
- ODOMZO can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. ODOMZO is embryotoxic, fetotoxic, and teratogenic in animals
- 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
- 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
WARNINGS AND PRECAUTIONS
Embryo-fetal Toxicity: ODOMZO can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. Females of Reproductive Potential: Verify pregnancy status prior to initiating ODOMZO. Advise females to use effective contraception and not to breastfeed, due to the potential for serious adverse reactions in breastfed infants, during treatment and for at least 20 months after the last dose. Report pregnancies to Sun Pharmaceutical Industries, Inc. at 1-800-406-7984 1-800-406-7984.
Males: Advise males to use condoms, even after a vasectomy, and to not donate semen during treatment and for at least 8 months after the last dose to avoid potential drug exposure in pregnant females or females of reproductive potential.
Blood Donation: Advise patients not to donate blood or blood products while taking ODOMZO, and for at least 20 months after the last dose because their blood or blood products might be given to a female of reproductive potential.
Musculoskeletal Adverse Reactions: Musculoskeletal adverse reactions, which may be accompanied by serum creatine kinase (CK) elevations, occur with ODOMZO and other drugs which inhibit the hedgehog Hh pathway. Obtain serum 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 of musculoskeletal adverse reactions.
Premature Fusion of the Epiphyses: ODOMZO is not indicated for use in pediatric patients. Premature fusion of the epiphyses has been reported in pediatric patients exposed to ODOMZO and other (Hh) pathway inhibitors. In some cases, fusion progressed after discontinuation.
Drug Interactions: Avoid concomitant administration of ODOMZO with strong and moderate CYP3A inhibitors. If a moderate CYP3A inhibitor must be used, administer for less than 14 days and monitor closely for adverse reactions, particularly musculoskeletal. Avoid concomitant administration of ODOMZO with strong and moderate CYP3A inducers.
Geriatric Use: There was a higher incidence of serious adverse events, Grade 3 and 4, and events 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.
Most Common Adverse Reactions: The most common adverse reactions occurring in ≥10% of patients were muscle spasms (54%), alopecia (53%), dysgeusia (46%), fatigue (41%), nausea (39%), musculoskeletal pain (32%), diarrhea (32%), decreased weight (30%), decreased appetite (23%), myalgia (19%), abdominal pain (18%), headache (15%), pain (14%), vomiting (11%), and pruritus (10%).
Click here to see the full Prescribing Information for ODOMZO, including Boxed WARNING.
ODOMZO and ODOMZO CARE are trademarks of Sun Pharmaceutical Industries Limited. All other trademarks are the property of their respective owners.
Sun Pharmaceutical Industries, Inc. All rights reserved.
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Link to Third-Party Site
The link you have selected will take you away from odomzo.com, and to an external website. Sun Pharmaceutical Industries, Inc. does not endorse and is not responsible for the content included on, or the way in which information is processed by external websites. Linking to third-party sites is at your own risk. Your use of third-party websites is subject to the terms and conditions and the privacy policies of those individual sites.