Drug-Drug:

• Concurrent use of strong CYP3A inhibitors including itraconazole, ketoconazole, nefazodone, posaconazole, or voriconazole ↑ levels/toxicity and should be avoided.
• Concurrent prolonged (> 14 days) use of moderate CYP3A inhibitors including atazanavir, diltiazem or fluconazole ↑ levels/toxicity and should be avoided.
• Concurrent use of strong or moderate CYP3A inducers including carbamazepine, efavirenz, modafinil, phenobarbital, rifabutine or rifampin↓ levels/effectiveness and should be avoided.

Drug-Natural Products:

• Concurrent use of St. John's wort↓ blood levels and may ↓ effectiveness and should be avoided.

• Capsules: 200 mg;

• PO (Adults): 200 mg once daily.

Odomzo

• Binds to and inhibits Smoothened, one of the transmembrane proteins involved in Hedgehog signaled transduction.

• Decreased spread of BCC.

Therapeutic Classification: antineoplastics

Pharmacologic Classification: hedgehog pathway inhibitors

Absorption: <10% absorbed following oral administration.

Distribution: Crosses the placenta.

Protein Binding: >97%.

Metabolism/Excretion: Mostly metabolized in the liver by the CYP3A enzyme system. Mostly eliminated by the hepatic route; 70% excreted in feces (unchanged drug and metabolites); 30% in urine (as unchanged drug).

Half-life: 28 days.

(blood levels)

• Instruct patient to take sonidegib as directed on an empty stomach. If a dose is missed, omit and take next dose at scheduled time. Advise patient to read Patient Information prior to starting therapy and with each Rx refill in case of changes.
• Advise patients to notify health care professional promptly if any new unexplained muscle pain, tenderness or weakness, dark urine, or decreased amount of urine occurs during therapy or persists after discontinuing sonidegib.
• Discuss with patient the possibility of hair loss. Explore methods of coping.
• Rep: Advise patient not to donate blood or blood products while taking and for at least 20 mo after the last dose of sonidegib because blood or blood products might be given to a female of reproductive potential. Advise male patient to avoid donating semen during and for at least 8 mo after final dose.
• Rep: Sonidegib is teratogenic. Caution females with reproductive potential to use effective contraception and avoid breastfeeding during and for at least20 mo after last dose. Advise males with female partners of reproductive potential of potential risk of exposure through semen and to use condoms during and for at least 8 mo after last dose. Advise females who may have been exposed to sonidegib during pregnancy, either directly or through seminal fluid, to contact Sun Pharmaceutical Industries Inc. at 1-800-406-7984.

soe-ni-DEG-ib

NDC Code^*

• 47335- Sun Pharmaceutical Industries, Inc.
  • 47335-303- Odomzo
    • 47335-303-83- 30 CAPSULE in 1 BOTTLE (47335-303-83)