What is sonidegib? What is sonigegib used for?
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?
No
Do I need a prescription for sonidegib?
Yes
What are the side effects of sonidegib?
The most common side effects of sonidegib include
- hair loss,
- weakness,
- nausea,
- decreased appetite,
- vomiting,
- taste changes,
- diarrhea,
- weight
loss, - stomach pain,
- headache,
- pain,
- muscle pain and spasms, and
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.
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
- ketoconazole (Nizoral),
- itraconazole (Sporanox),
-
voriconazole
(VFEND), - certain HIV medications,
- telithromycin (Ketek), and
- others.
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
- carbamazepine (Tegretol),
- efavirenz (Sustiva),
- modafinil (Provigil),
- phenobarbital (Luminal),
- phenytoin (Dilantin),
- rifampin (Rimactane),
- St. John’s Wort, and
- others.
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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).