Odomzo (sonidegib)

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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 radiotherapy^[1,2,3]

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 cells^[1].

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 Odomzo^[1].

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, 2015^[3]
• EMA (EU) on August 14, 2015^[1]
• TGA (AUS) on December 19, 2016^[2]

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.

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.

References

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