What is Odomzo (sonidegib)?

Odomzo (sonidegib) is a cancer medication used to treat adults with basal cell carcinoma that has recurred following surgery or radiation treatment or that cannot be treated with surgery or radiation. 

Odomzo is an inhibitor of the hedgehog biological signaling pathway, a pathway that promotes the growth of both normal and cancer cells. Odomzo binds to and inhibits smoothened, a protein involved in hedgehog signaling. Inhibiting smoothened disrupts cell signaling and growth of cancer cells. 

Common side effects of Odomzo include:

Women taking Odomzo may experience an absence of menstrual periods (amenorrhea). It is unknown if amenorrhea is permanent. Women who wish to get pregnant in the future should talk to their doctor.

Drug interactions of Odomzo because they may result in high blood levels of Odomzo, leading to increased side effects, include:

The following drugs may decrease blood levels of Odomzo, causing treatment failure:

Use of Odomzo during pregnancy is not recommended because it may cause death and severe birth defects. Female patients who have been exposed to Odomzo during pregnancy should report their pregnancy to Novartis Pharmaceuticals Corporation by calling 1-888-669-6682. 

It is unknown if Odomzo is excreted in breast milk. Breastfeeding is not recommended while using Odomzo and for at least 20 months after the last dose because there is a potential for serious side effects in the breastfed baby. 

What are the important side effects of Odomzo (sonidegib)?

The most common side effects of sonidegib include:

Women taking sonidegib may experience an absence of menstrual periods (amenorrhea). It is not known if amenorrhea is permanent. Women who wish to get pregnant in the future should talk to their doctor for advice.

Odomzo (sonidegib) side effects list for healthcare professionals

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Musculoskeletal Adverse Reactions.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The safety of Odomzo was evaluated in BOLT, a randomized, double-blind, multiple cohort trial in which 229 patients received Odomzo at either 200 mg (n=79) or 800 mg (n=150) daily.

The frequency of common adverse reactions was greater in patients treated with Odomzo 800 mg as compared to 200 mg, including:

The data described below reflect exposure to Odomzo 200 mg daily in 79 patients with locally advanced BCC (laBCC; n=66) or metastatic BCC (mBCC; n=13) enrolled in Study 1. Patients were followed for at least 18 months unless discontinued earlier. The median duration of treatment with Odomzo was 11.0 months (range 1.3 to 33.5 months).

The study population characteristics were:

  • median age of 67 years (range 25 to 92; 59% were ≥65 years),
  • 61% male, and
  • 90% white.

The majority of patients had:

  • prior surgery (75%),
  • radiotherapy (24%),
  • systemic chemotherapy (4%), or
  • topical or photodynamic therapies (18%) for treatment of BCC.

No patient had prior exposure to a Hh pathway inhibitor.

Odomzo was permanently discontinued in 34% of patients or temporarily interrupted in 20% of patients for adverse reactions. Adverse reactions reported in at least two patients that led to discontinuation of the drug were:

  • muscle spasms, and dysgeusia (each 5%),
  • asthenia, increased lipase, and nausea (each 4%),
  • fatigue, decreased appetite, alopecia, and decreased weight (each 3%).

Serious adverse reactions occurred in 18% of patients.

The most common adverse reactions occurring in ≥10% of patients treated with Odomzo 200 mg were:

The key laboratory abnormalities are described in Table 2.

Table 1: Adverse Reactions Occurring in ≥10% of Patients in BOLT

Adverse ReactionOdomzo 200 mg
(N=79)
All Gradesa
%
Grade 3
%
Musculoskeletal and connective tissue
  Muscle spasms543
  Musculoskeletal pain321
  Myalgia190
Skin and subcutaneous tissue
  Alopecia530
  Pruritus100
Nervous system
  Dysgeusia460
  Headache151
General
  Fatigue414
  Pain141
Gastrointestinal
  Nausea391
  Diarrhea321
  Abdominal pain180
  Vomiting111
Investigations
  Decreased weight303
Metabolism and nutrition
  Decreased appetite231
a No Grade 4 adverse reactions were reported.

Table 2: Key Laboratory Abnormalitiesa in BOLT

Laboratory TestOdomzo 200 mg
(N=79)
All Grades
%
Grades 3-4
%
Chemistry
  Increased serum creatinine92b0
  Increased serum creatine kinase (CK)618
  Hyperglycemia514
  Increased lipase4313
  Increased alanine aminotransferase194
  Increased aspartate aminotransferase194
  Increased amylase161
Hematology
  Anemia320
  Lymphopenia283
a Based on worst post-treatment laboratory value regardless of baseline; grading by CTCAE v4.03.
b The serum creatinine level remained within normal range in 76% (60/79) of patients.

Amenorrhea

Amenorrhea lasting for at least 18 months occurred in two of 14 pre-menopausal women treated with Odomzo 200 mg or 800 mg once daily.

What drugs interact with Odomzo (sonidegib)?

Effects Of Other Drugs On Odomzo

Strong And Moderate CYP3A Inhibitors

Avoid concomitant administration of Odomzo with strong CYP3A inhibitors.

Avoid concomitant administration of Odomzo with moderate CYP3A inhibitors. If a moderate CYP3A inhibitor must be used, administer the moderate CYP3A inhibitor for less than 14 days and monitor closely for adverse reactions particularly musculoskeletal adverse reactions.

Strong And Moderate CYP3A Inducers

Avoid concomitant administration of Odomzo with strong and moderate CYP3A inducers.

Summary

Odomzo (sonidegib) is a cancer medication used to treat adults with basal cell carcinoma that has recurred following surgery or radiation treatment or that cannot be treated with surgery or radiation. Common side effects of Odomzo include hair loss, weakness, nausea, decreased appetite, vomiting, taste changes, diarrhea, weight loss, stomach pain, headache, pain, muscle pain and spasms, and itching. Women taking Odomzo may experience an absence of menstrual periods (amenorrhea). Use of Odomzo during pregnancy is not recommended because it may cause death and severe birth defects. It is unknown if Odomzo is excreted in breast milk.

Treatment & Diagnosis

Medications & Supplements

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Medically Reviewed on 5/7/2020
References
FDA Prescribing Information

Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.
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