sonidegib (Odomzo®)

ORAL ADMINISTRATION

Indications for Prior Authorization:

  • Basal cell carcinoma, locally advanced
    • Treatment of adult patients with locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy

All of the following must be met as a condition for coverage:

  • Treatment of adult patients with locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy

This Medication is Not Approvable for the following condition(s):

  • Any condition not listed above as an approved indication

Dosing:

Adult

  • Usual dosage: 200 mg orally once daily until disease progression or unacceptable toxicity
  • Dosage adjustment: Withhold treatment for severe or intolerable musculoskeletal toxicity, the first occurrence of serum CK elevations between 2.5 and 10 times upper limit of normal (ULN), or recurrent serum CK elevations between 2.5 and 5 times ULN. May resume therapy at 200 mg once daily upon resolution of toxicity

Pediatric

  • Safety and efficacy have not been established
Renal function impairment
  • Creatinine clearance 30 to 89 mL/minute:   There are no dosage adjustments provided in the manufacturer's labeling; however, mild or moderate impairment had no clinically meaningful effect on sonidegib exposure (compared with patients with normal renal function)
  • Creatinine clearance less than 30 mL/minute:   There are no dosage adjustments provided in the manufacturer's labeling
Hepatic function impairment
  • Mild, moderate, or severe impairment (Child-Pugh classes A, B, C): There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); however, hepatic impairment had no clinically meaningful effect on sonidegib exposure (compared with patients with normal hepatic function)
Approval:

One Year


 

Last review date: July 24, 2016

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