Sonidegib

What is Sonidegib?

• Sonidegib (Odomzo) is a hedgehog pathway inhibitor used to treat patients with locally advanced basal cell carcinoma that has recurred following surgery or radiation therapy, or who are not candidates for surgery or radiation therapy.

What are the uses of this medicine?

This medicine is used to treat adults with a type of skin cancer, called basal cell carcinoma, that has come back following surgery or radiation or that cannot be treated with surgery or radiation.

How does this medicine work?

• Sonidegib is an inhibitor of the Hh pathway.
• Sonidegib binds to and inhibits Smoothened, a transmembrane protein involved in Hh signal transduction.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Avoid concomitant administration of Odomzo with strong CYP3A inhibitors(eg: itraconazole, ketoconazole, clarithromycin).
• Avoid concomitant administration of Odomzo with moderate CYP3A inhibitors.
• Avoid concomitant administration of Odomzo with strong and moderate CYP3A inducers (eg: rifampin, carbamazepine, phenytoin, St. John’s wort).

Is this medicine FDA approved?

• It was approved for use in the United States in 2015.

How should this medicine be used?

• Verify the pregnancy status of females of reproductive potential prior to initiating Odomzo.
• Obtain serum creatine kinase (CK) levels and renal function tests prior to initiating Odomzo in all patients.

Recommended Dosage:

• The recommended dosage of Odomzo is 200 mg taken orally once daily on an empty stomach, at least 1 hour before or 2 hours after a meal, administered until disease progression or unacceptable toxicity.

Administration

• Take Odomzo exactly as your healthcare provider tells you.
• Take Odomzo 1 time each day.
• Take Odomzo at least 1 hour before or 2 hours after a meal.
• If you miss a dose, skip the missed dose. Take your next dose as scheduled.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As 200 mg capsules

This medicine is available in fallowing brand namesː

• Odomzo

What side effects can this medication cause?

The most common side effects of this medicine include:

• hair loss
• change in taste
• tiredness
• nausea
• diarrhea
• weight loss
• decreased appetite
• stomach area (abdominal) pain
• headache
• vomiting
• itching

Odomzo can cause serious side effects, including:

• Muscle Problems

What special precautions should I follow?

• Odomzo can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. Advise patients not to donate blood or blood products during treatment with Odomzo and for at least 20 months after the last dose.
• Musculoskeletal adverse reactions, which may be accompanied by serum creatine kinase (CK) elevations, occur with Odomzo. Obtain serum creatine kinase (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 has been reported in pediatric patients exposed to Odomzo.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Based on its mechanism of action and data from animal reproduction studies, Odomzo can cause fetal harm when administered to a pregnant woman .
• There are no available data on the use of Odomzo in pregnant women.

Can this medicine be used in children?

• The safety and effectiveness of Odomzo have not been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

• Active ingredient: sonidegib
• Inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate, poloxamer, and sodium lauryl sulfate. The capsule shell contains gelatin, red iron oxide, and titanium dioxide. The black printing ink contains ammonium hydroxide, black iron oxide, propylene glycol, and shellac.

Who manufactures and distributes this medicine?

• Manufactured for Sun Pharma Global FZE by: Patheon Inc., Mississauga, Ontario L5N 7K9, Canada.
• Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ

What should I know about storage and disposal of this medication?

• Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

• Dailymed label info on Sonidegib
• FDA Sonidegib

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