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

Please see additional Important Safety Information below and Full Prescribing Information.

Not All HHIs Are the Same

Fast absorption for efficient delivery

•	2-4 hours median time-to-peak concentration (Tmax) allows for rapid distribution throughout the body¹
•	~4-month time to steady state after initiation¹

High tissue penetration with targeted activity

•	6x higher steady-state concentration in skin vs plasma²
•	High volume of distribution (~9166 L) with a ~19-fold accumulation at steady state¹

Extended exposure with lasting effects

•	~28-day elimination half-life allows effects to persist through dose modification periods^1,3

A profile that's relevant in laBCC
ODOMZO has been shown to absorb rapidly and maintain extended exposure, with steady state concentration achieved in ~4 months and targeted penetration in skin where laBCCs reside.¹

Learn More About the ODOMZO and ION Partnership

ODOMZO Can Treat Patients Who Do Not Qualify for Surgery or Radiation Therapy^1,4,5

Eligible patients may include those with:

•	Small lesions in problematic areas such as the eyes, nose, ears, lips, and/or face, or large lesions (>2 cm)
•	Multiple lesions or lesions that reoccur
•	laBCC or laBCC with Gorlin syndrome

Result: laBCC Patient Treated With ODOMZO Over Time⁶

At Baseline
Starts ODOMZO 200 mg to treat lesions.

At 6 Months
Ongoing treatment with ODOMZO resulted in tumor reduction.

At 10 Months
Achieved complete tumor response with ODOMZO therapy.

Questions? Request an ODOMZO Rep

*Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) for Basal Cell Skin Cancer V.2.2024. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed September 14, 2023. To view the most recent and complete version of the guideline, go online to NCCN.org. 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.

IMPORTANT SAFETY INFORMATION (CON'T)

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%).

Please see the full Prescribing Information for ODOMZO, including Boxed WARNING.

References: 1. ODOMZO [prescribing information]. Cranbury, NJ: Sun Pharmaceutical Industries, Inc; May 2019. 2. 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. 3. European Medicines Agency. ODOMZO European Public Assessment Report. Amsterdam: The Netherlands: European Medicines Agency; 1995. Accessed September 30, 2022. https://www.ema.europa.eu/documents/overview/odomzo-epar-summary-public_en.pdf 4. Lear JT, Migden MR, Lewis KD, et al. Longterm 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. 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. 6. Data on file. Sun Pharmaceutical Industries, Inc. Princeton, NJ.

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ODOMZO is a registered trademark of Sun Pharmaceutical Industries Limited.
All other trademarks are the property of their respective owners.
© 2023 Sun Pharmaceutical Industries, Inc. All rights reserved.
PM-US-ODZ-0640 11/2023

This content is sponsored by Sun Pharma, and ION Oncology Practice Network has not independently reviewed or verified the information provided by Sun Pharma.

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