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See Full Prescribing Information
ODOMZO®
For your patients with locally
advanced basal cell carcinoma (laBCC)
Save on the only HHI contracted
with ION: ODOMZO® – evaluated
using the most stringent criteria1,2
Explore the deal
For your patients with locally
advanced basal cell carcinoma (laBCC)
Save on the only HHI contracted
with ION: ODOMZO® – evaluated
using the most stringent criteria1,2
Explore the deal
The BOLT trial* used the mRECIST criteria to study
ODOMZO, setting a new standard for laBCC treatment.1,2
Complete response measurements:
Using mRECIST criteria1
• ≥2 negative biopsies
• Complete disappearance
of target lesions per
photography and MRI
 
Using previous
BCC RECIST-like criteria2-4
• ≥1 negative biopsy
• Partial response or
stable disease allowed
BCC=basal cell carcinoma; BOLT=Basal cell carcinoma Outcomes with LDE225 Treatment. LDE
was the investigative term for sonidegib; HHI=hedgehog pathway inhibitor; mRECIST=modified
Response Evaluation Criteria In Solid Tumors; MRI=magnetic resonance imaging.
* About the BOLT trial: a multicenter (58 centers, 12 countries), randomized, double-blind,
phase II study evaluating once-daily dosing of ODOMZO in 194 patients with laBCC. Patients
were randomized 1:2 to the 200 mg or 800 mg dose.1,4
ODOMZO should not be used during pregnancy.
Please see Boxed WARNING below.
The BOLT trial* used the mRECIST criteria to study
ODOMZO, setting a new standard for laBCC treatment.1,2
Complete response measurements:
Using mRECIST criteria1
  • ≥2 negative biopsies
  • Complete disappearance
    of target lesions per
    photography and MRI
Using previous
BCC RECIST-like criteria2-4
  • ≥1 negative biopsy
  • Partial response or
    stable disease allowed
BCC=basal cell carcinoma; BOLT=Basal cell carcinoma Outcomes with LDE225 Treatment. LDE was the investigative term for sonidegib; HHI=hedgehog pathway inhibitor; mRECIST=modified Response Evaluation Criteria In Solid Tumors; MRI=magnetic resonance imaging.
* About the BOLT trial: a multicenter (58 centers, 12 countries), randomized, double-blind, phase II study evaluating once-daily dosing of ODOMZO in 194 patients with laBCC. Patients were randomized 1:2 to the 200 mg or 800 mg dose.1,4
ODOMZO should not be used during pregnancy.
Please see Boxed WARNING below.
Sonidegib (ODOMZO®) is recommended by the
National Comprehensive Cancer Network® (NCCN®)
as NCCN Category 2A under other recommended
regimens for laBCC5,†
† NCCN makes no warranties of any kind whatsoever regarding their content, use or application
and disclaims any responsibility for their application or use in any way.
Sonidegib (ODOMZO®) is recommended by the National Comprehensive Cancer Network® (NCCN®) as NCCN Category 2A under other recommended regimens for laBCC5,†
† NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.
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-FATAL 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. 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; 125.e1-125.e5. 3. Erivedge® (vismodegib) capsule Prescribing Information. Genentech, Inc. March 2023. 4. 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. 5. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Basal Cell Skin Cancer V.3.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed May 20, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org.
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-FATAL 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. 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; 125.e1-125.e5. 3. Erivedge® (vismodegib) capsule Prescribing Information. Genentech, Inc. March 2023. 4. 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. 5. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Basal Cell Skin Cancer V.3.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed May 20, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org.
Contact  |  Privacy Policy
Sun Pharmaceutical Industries, Inc.
2 Independence Way
Princeton, NJ 08540
ODOMZO is a registered trademark of Sun
Pharmaceutical Industries Limited. All other trademarks are the property of their
respective owners.
© 2024 Sun Pharmaceutical Industries, Inc.
All rights reserved.
PM-US-ODZ-0685 6/24
Sun Pharmaceuticals Inc. logo
Contact  |  Privacy Policy
Sun Pharmaceutical Industries, Inc.
2 Independence Way
Princeton, NJ 08540
ODOMZO is a registered trademark of Sun
Pharmaceutical Industries Limited. All other
trademarks are the property of their
respective owners.
© 2024 Sun Pharmaceutical Industries, Inc.
All rights reserved.
PM-US-ODZ-0685 6/24
Sun Pharmaceuticals Inc. logo