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 * Important Safety Information|
 * Prescribing Information|
 * Medication Guide|
 * For Patients
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DERMATOLOGY

ONCOLOGY

Safety & Tolerability
 * Safety Profile
 * Lab Abnormalities
 * Tips for Managing ARs

Pharmacokinetic Profile
 * The ODOMZO Effect
 * Why the Molecule Matters

Patient Cases
 * Barbara: Lesion Near Eye
 * Henrietta: Lesion on Lip
 * David: Lesions on Groin
 * Alex: Lesion Near Ear
 * Jerry: Lesions on Scalp

BOLT Trial - mRECIST
 * Trial Design Criteria
 * mRECIST Criteria

Efficacy
 * Lesion Reduction
 * Long-Term Results

Dosing
 * Dosage & Administration
 * Dosing Guidance
 * Monitoring

Access & Resources
 * ODOMZO CARE
 * Access & Co-pay
 * Resources

Contact a Rep








ODOMZO® IS WIDELY COVERED ACROSS MEDICARE AND COMMERCIAL PLANS

There are 2 options for your patients to receive ODOMZO:

Specialty Pharmacy (SP)

 * Processes patient and prescription details via a prescription enrollment form
 * Verifies patient’s insurance benefits and determines whether a prior
   authorization is required
 * Coordinates payment and follow-up to ensure patient received ODOMZO


SOME OF THE PREFERRED SPS THAT YOU CAN WORK WITH TO ACCESS ODOMZO:

SPs

Accredo Specialty Pharmacy

Alliance Walgreens

CVS Specialty Customer Care

Optum Specialty Pharmacy (formerly known as Briova)

Senderra Rx

Phone

[888-608-9010]

[855-244-2555]

[800-237-2767]

[855-427-4682]

[855-460-7928]



Supporting Patient Access to ODOMZO® (sonidegib)


Download a PDF

Sun Pharmaceutical Industries, Inc. cannot guarantee insurance coverage or
reimbursement. Coverage or reimbursement may vary significantly by payer, plan,
patient, and setting of care. It is the sole responsibility of the health care
provider to ensure the accuracy of all statements made in seeking coverage and
reimbursement for an individual patient.

Download our authorization and appeals kit

Download a PDF

Additional resources to download

Sample PA request letter for ODOMZO®
Sample letter of appeal for ODOMZO®
Sample letter of medical necessity
for ODOMZO®
Sample formulary exception
requestion letter
for ODOMZO®



CO-PAY PROGRAM FOR ELIGIBLE COMMERCIALLY INSURED PATIENTS


PATIENTS CAN ACTIVATE THIS CARD BY CALLING
1-877-ODOMZO-1 (1-877-636-6961) OR VISITING WWW.ACTIVATETHECARD.COM/7436

 * Patients who are members of health plans (often termed “maximizer” plans)
   that claim to reduce their patients’ out-of-pocket costs will have a reduced
   maximum program benefit of $6,000 per calendar year. Out-of-pocket costs may
   be co-pay, co-insurance, or deductible. Limitations apply. See full terms and
   conditions below. This offer is not valid under Medicare, Medicaid, or any
   other federal or state program. We reserve the right to rescind, revoke, or
   amend this program without notice

To participate in the ODOMZO® (sonidegib) Co-Pay Program ("Program"), you must
present this card, along with a valid prescription for ODOMZO, to your
pharmacist. Patients with commercial health insurance who qualify to participate
can pay as little as $10 per month for ODOMZO. Enrollment is subject to the
Eligibility Rules and Terms and Conditions, stated below. If you have any
questions regarding Eligibility, the Terms and Conditions, or to discontinue
participation, please call 1-877-ODOMZO-1 (1-877-636-6961) (8:00 AM-8:00 PM EST,
Monday-Friday).

Eligibility Rules

 * To participate in this Program, you must have commercial health insurance and
   be a resident of the United States, Puerto Rico, Guam, or the Virgin Islands
 * Patients who are members of health plans (often termed "maximizer" plans)
   that claim to reduce their patients' out-of-pocket costs may have a reduced
   maximum program benefit of $6,000 per calendar year. Out-of-pocket costs may
   be co-pay, co-insurance, or deductible
 * The following patients are ineligible for this Program:
   * Patients covered under Medicaid (including Medicaid patients enrolled in a
     Medicaid Managed Care Plan or a qualified health plan purchased through a
     health insurance exchange marketplace established by a state government or
     the federal government)
   * Patients covered by Medicare or a Medicare Part D or Medicare Advantage
     plan (regardless of whether a specific prescription is covered)
   * Patients covered by TRICARE, CHAMPUS, Puerto Rico Government Health
     Insurance Plan or any other state or federal medical or pharmaceutical
     benefit program or pharmaceutical assistance program
   * Patients who are members of health plans that claim to eliminate their
     out-of-pocket costs are not eligible for cost support. If you are a member
     of one of these plans, please call 1-877-264-2440
   * Patients with no insurance

Terms and Conditions

 * You agree not to seek any reimbursement for all or any part of the co-pay
   assistance received through the Program. By using this card, you are
   certifying that you understand the Eligibility Rules and Terms and
   Conditions, that you have responded truthfully to questions when activating
   the card, and that you will disclose and report your receipt of any Program
   benefits to your insurer, health plan, or any third party that pays or
   reimburses you for the cost of medications, if required
 * This offer may be rescinded, revoked, or cancelled at any time, without
   further notice, and the rules may be amended at any time, without further
   notice

Disclosures

 * This Program is not insurance
 * The Program is void where prohibited by law, taxed, or restricted. Any
   benefit provided is not transferable and cannot be combined with any other
   program, free trial, discount, prescription savings card, or other offer. No
   purchase, other than for an ODOMZO prescription, is required to participate
 * Personal data that you provide to the Program may be collected, analyzed, and
   shared with the program sponsor for market research and other lawful purposes
   but only in aggregated and de-identified form



If your patient needs financial assistance


ODOMZO PATIENT ASSISTANCE PROGRAM (PAP)


SUN PHARMA IS COMMITTED TO HELPING ELIGIBLE PATIENTS OBTAIN ODOMZO

Patients who are underinsured or uninsured may be eligible to receive free
medication.* To get your patients started on ODOMZO, you will first need to
attempt all available authorizations to obtain an approval. You will then submit
documentation of an authorization or denial with the application.

*Income documentation is required. Subject to terms and conditions. Available to
US, Guam, Virgin Islands, or Puerto Rico residents only.

For additional information, please call: 1-844-5-ODOMZO (1-844-563-6696)



Foundations that provide financial support to patients who are taking ODOMZO:


PAN FOUNDATION

www.panfoundation.org

1-866-316-7263


HEALTHWELL FOUNDATION

www.healthwellfoundation.org

800-675-8416


PATIENT ADVOCATE FOUNDATION (PAF) COPAY RELIEF

www.patientadvocate.org/connect-with-services/copay-relief/

866-512-3861


PATIENT ADVOCATE FOUNDATION
(PAF)

www.patientadvocate.org

800-532-5274



EXPAND +
COLLAPSE -


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.

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 * Privacy Policy |
 * Site Map |
 * Contact Us |
 * Accessibility Statement

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.

 

LINK TO THIRD-PARTY SITE

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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.

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LINK TO THIRD-PARTY SITE

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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.

Stay on this page Leave this page


 * Terms of Use|
 * Privacy Policy|
 * Site Map|
 * Contact Us|
 * Accessibility Statement

ODOMZO and ODOMZO CARE are trademarks 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-0490 8/24



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