VISMODEGIB CAP,ORAL

Clinical Criteria Summary

AST and ALT > 3 X the upper limit of normal or total bilirubin >1.5 X the upper limit of normal (or >3 X the upper limit of normal for patients with Gilbert disease)
Creatinine clearance <30 mL/min
Patient who is unable to swallow intact capsule
Patients currently receiving systemic therapy for basal cell carcinoma
Patient refuses transfer of care to VA Dermatologist or Oncologist
Pregnancy or lactation

Goals of care and role of Palliative Care consult has been discussed and documented
Diagnosis of metastatic basal cell carcinoma, or locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery, and who are not candidates for radiation or a diagnosis of basal-cell nevus (Gorlin) syndrome
ECOG Performance Status 0-2
Pregnancy must be excluded prior to receiving vismodegib and patient provided contraceptive counseling on potential risk vs benefit of taking vismodegib if patient were to become pregnant; female patients of childbearing potential and men with female partners of childbearing potential are required to use 2 methods of contraception

Recommended dose is one 150mg capsule orally once daily until disease progression or unacceptable toxicity
May be taken with or without food
Capsules should remain whole and not opened or crushed
Caution if given concomitantly with drugs that alter the pH of the upper GI tract

Metastatic disease: Assess radiographically at baseline and then every 2 months
Locally advanced disease: If measurable disease assessed radiographically, assess at baseline and then every 2 months; if not measurable radiographically, assess by physical exam (digital photography) at baseline and every 2 months
Assess renal and hepatic function periodically due to lack of data in safety and effectiveness in patients with either renal or hepatic impairment

Vismodegib may cause fetal death or severe birth defects; both female and male patients should be advised of the risk for fetal death or severe birth defects and the need for contraception during and after treatment
Female patients should use a highly effective form of contraception starting before the first dose and continuing for 7 months after the last dose
Male patients with female partners of childbearing potential should use condoms during vismodegib therapy and for 2 months after the last dose
If pregnancy occurs or exposure occurs, inform of risk to fetus; exposure during pregnancy should be reported to the Genentech Adverse Event Line at 1-888-835-2555
Women exposed to vismodegib during pregnancy can participate in a pharmacovigilance program by contacting Genentech at the same number

Advise patients not to donate blood or blood components during vismodegib therapy and for at least 7 months after the last dose of vismodegib

Drugs that alter the pH of the upper GI tract (e.g., proton pump inhibitors, H2 antagonists, and antacids) may alter the solubility of vismodegib and reduce bioavailability
No formal studies have been conducted to evaluate the effect of gastric pH on systemic exposure of vismodegib; increasing the dose is not likely to compensate for the loss of exposure

Progressive disease (assess every 2 months): an increase in size of 20% or more in externally visible or radiographic dimension, new ulceration, or a new lesion; if multiple measurable lesions, the sum of the longest diameters should be used
Unacceptable toxicity

Download CFU PDF