Odomzo (sonidegib)

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Odomzo (sonidegib)

Odomzo (sonidegib) is a medication for the treatment of locally advanced basal cell carcinoma (BCC) that cannot be treated with surgery or radiation therapy.

Oncology Skin Cancer
Marketing Authorisation Holder Sun Pharmaceutical Industries Europe B.V.
Mode of Action Hedgehog pathway inhibitor
Administration Oral
Regulatory agency approval European Medical Agency (EMA), European Union, Food and Drug Administration (FDA), USA, Therapeutic Goods Administration (TGA), Australia
Strength 200 milligram
Package 30 Capsules

What is Odomzo (sonidegib) for?

Odomzo (sonidegib) is indicated for the treatment of patients with basal cell carcinoma which is locally advanced and which cannot be treated either by surgery or by radiotherapy1,2,3. 

How does Odomzo (sonidegib) work?

The Hedgehog signalling pathway is a set of processes that control a number of cell activities including cell growth and correct development and differentiation. The active ingredient in Odomzo, sonidegib,  attaches to a protein that controls the Hedgehog signalling pathway. By attaching to this protein, sonidegib blocks the Hedgehog signalling pathway, thereby reducing the growth and spread of cancer cells1.

The most common side effects are muscle spasms, hair loss, taste disturbance, tiredness, nausea, vomiting, muscle and bone pain, belly ache, headache, diarrhoea, weight loss, loss of appetite, and itching. Women who are pregnant or breastfeeding must not take Odomzo1.

Is Odomzo (sonidegib) approved?

Odomzo (sonidegib) was approved for the treatment of adults with locally advanced basal cell carcinoma (BCC) that cannot be treated with surgery or radiation therapy by:

  • FDA (USA) on July 24, 20153
  • EMA (EU) on August 14, 20151
  • TGA (AUS) on December 19, 20162

How do I take Odomzo (sonidegib)?

The standard dosage is:

  • One 200 mg capsule once a day at least 1 hour before and 2 hours after a meal.
Complete information about Odomzo (sonidegib) dosage and administration can be found in the resources section.

Note: Consult your treating doctor for personalised dosing.

Are there any known adverse reactions of Odomzo (sonidegib)?

Common adverse reactions

The most common adverse reactions (incidence ≥10%) listed in the prescribing information include:

  • muscle spasms

  • alopecia

  • dysgeusia

  • fatigue

  • nausea

  • musculoskeletal pain

  • diarrhoea

  • decreased weight and decreased appetite

  • myalgia

  • abdominal pain

  • headache

  • pain

  • vomiting

  • pruritus (itching).

Serious adverse reactions

The serious adverse reactions listed in the prescribing information include: 

  • musculoskeletal adverse reactions

Use in specific populations

As Odomzo (sonidegib) can be fatal for a fetus, pregnancy and breastfeeding is not advised during and for up to 20 months after the last dose.


For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information.

More Information
Working ingredient sonidegib
Shipping method Cold chain (temperature controlled)
Package 30
Therapeutic Area Oncology
Oncology Skin Cancer
Indication Locally advanced basal cell carcinoma (BCC)
Administration Oral
Mode of Action Hedgehog pathway inhibitor
Regulatory agency approval European Medical Agency (EMA), European Union, Food and Drug Administration (FDA), USA, Therapeutic Goods Administration (TGA), Australia
Marketing Authorisation Holder Sun Pharmaceutical Industries Europe B.V.

The approvals of Odomzo (sonidegib) for locally advanced BCC were based on one main study involving 230 patients with basal cell carcinoma which was either locally advanced or metastatic. Patients were started on two different doses of sonidegib: 200 or 800mg once a day. The response on metastatic BCC was less than 20%. However, the medicine resulted effective on patients with locally advanced BCC with a response rate of 56% (95% CI: 43.3, 68.3) on the 200 mg dose, with 5% complete responses, and 45% (95% CI: 43.3, 68.3)4 on the 800 mg dose1. On the 200 mg dosage, the time to tumour response was 4.0 months (95% CI: 3.8, 5.6) and the median duration of response was 26.1 months4.

1. Human Medicines: Odomzo (sonidegib) [PDF]
    EMA, cited May 2015

2. Summary of Product Characteristics [TGA]: Odomzo (sonidegib)
    TGA, Oct. 2017

3. Summary of Product Characteristics [FDA]: Odomzo (sonidegib) [PDF]
    Sun Pharmaceutical Industries, Sep. 2017

4. Summary of Product Characteristics [EMA]: Odomzo (sonidegib) [PDF]
    Sun Pharmaceutical Industries Europe B.V., Mar 2018

Shipping Type Cold Chain
Shipping method Cold chain (temperature controlled)
This content has been reviewed by our medical doctor Jan de Witt.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Medicine information contained herein may be time sensitive. The absence of a warning for a given medicine or combination thereof in no way should be construed to indicate that the medicine or combination is safe, effective or appropriate for any given patient. Always consult your treating physician before starting a course of treatment.