sonidegib (Odomzo)

  • Pharmacy Author:
    Omudhome Ogbru, PharmD

    Dr. Ogbru received his Doctorate in Pharmacy from the University of the Pacific School of Pharmacy in 1995. He completed a Pharmacy Practice Residency at the University of Arizona/University Medical Center in 1996. He was a Professor of Pharmacy Practice and a Regional Clerkship Coordinator for the University of the Pacific School of Pharmacy from 1996-99.

  • Medical and Pharmacy Editor: Jay W. Marks, MD
    Jay W. Marks, MD

    Jay W. Marks, MD

    Jay W. Marks, MD, is a board-certified internist and gastroenterologist. He graduated from Yale University School of Medicine and trained in internal medicine and gastroenterology at UCLA/Cedars-Sinai Medical Center in Los Angeles.

Cancer 101: Cancer Explained

What is sonidegib, and how does it work (mechanism of action)?

Odomzo (sonidegib) is an oral medication used to treat a type of skin cancer called basal cell carcinoma. Sonidegib is an inhibitor of the hedgehog biological signaling pathway, a pathway that promotes the growth of both normal and cancer cells. Sonidegib binds to and inhibits smoothened, a protein involved in hedgehog signaling. Inhibiting smoothened disrupts cell signaling and growth of cancer cells. Sonidegib was approved by the FDA in July, 2015.

PRESCRIBED FOR: Sonidegib is an oral medication used to treat adults with basal cell carcinoma that has recurred following surgery or radiation treatment. It also is used for treating basal cell carcinoma that cannot be treated with surgery or radiation.

What brand names are available for sonidegib?

Odomzo

Is sonidegib available as a generic drug?

GENERIC AVAILABLE: No

Do I need a prescription for sonidegib?

Yes

What are the side effects of 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.

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What is the dosage for sonidegib?

The recommended dose of sonidegib is 200 mg orally once daily on an empty stomach, at least 1 hour before or 2 hours after a meal. Sonidegib may be taken until the cancer progresses or unacceptable toxicity develops.

Which drugs or supplements interact with sonidegib?

Sonidegib is broken down by a group of liver enzymes known as cytochrome P4503A (CYP3A). Sonidegib should not be combined with drugs that inhibit the activity of these enzymes because enzyme inhibition may result in high blood levels of sonidegib, leading to increased side effects. Examples of such inhibitors include

Similarly, sonidegib should be combined with drugs that induce (increase the activity) of CYP3A enzymes. Strong CYP3A inducers may decrease blood levels of sonidegib causing treatment failure. Examples of CYP3A inducers include

Is sonidegib safe to take if I'm pregnant or breastfeeding?

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

It is not known whether sonidegib is excreted in breast milk. It should not be used while nursing because there is a potential for serious side effects in the breast fed baby. Additionally, women should not breast feed for at least 20 months after the last dose of sonidegib.

What else should I know about sonidegib?

What preparations of sonidegib are available?

Oral capsules: 200 mg

How should I keep sonidegib stored?

Sonidegib capsules should be stored at room temperature between 15 C and 30 C (59 F and 86 F).

REFERENCE: FDA Prescribing Information

Last Editorial Review: 8/24/2015

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Reviewed on 8/24/2015
References
REFERENCE: FDA Prescribing Information

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