In the treatment of advanced basal cell carcinoma… Which patients are eligible for Erivedge?

Images below are of patients from the ERIVANCE pivotal trial.

Consider some of the following important lesion and other clinical factors.


CONSIDER ERIVEDGE IN ADULTS WITH LOCALLY ADVANCED BCC WHO ARE NOT CANDIDATES FOR SURGERY AND RADIATION 13,14*

 

LOCALLY INVASIVE

Tumor extending into underlying tissue, cartilage, bone, or nerve

  • Eyebrow, 46-year-old male
  • Not considered a candidate for surgery or radiation due to substantial morbidity and/or deformity

CURATIVE RESECTION UNLIKELY

Or surgery considered inappropriate

  • Left lateral canthus, 54-year-old male
  • Not considered a candidate for surgery or radiation due to recurrent BCC that was unlikely to be curatively resected

LOCATION OF DISEASE

Surgery or radiation would result in significant disfigurement or loss of function

  • Internal canthus, 69-year-old male
  • Not considered a candidate for surgery or radiation due to lesion location

EXPECTED DEFORMITY OR MORBIDITY

If surgery or radiation were to be performed

  • Cheek, 59-year-old male
  • Not considered a candidate for surgery or radiation due to anticipated substantial morbidity and/or deformity

SOME ADDITIONAL CLINICAL FACTORS TO CONSIDER 2 :

 

  • BCC treatment history
  • Multiple laBCC lesions
  • Medical history, such as comorbidities and concomitant medications
  • Treatment (surgery or radiation) contraindications
  • Gorlin syndrome contraindicated to radiation
  • Performance status (ECOG)

CONSIDER ERIVEDGE IN ADULTS WITH ADVANCED BCC THAT HAS RECURRED FOLLOWING SURGERY AND WHO ARE NOT CANDIDATES FOR RADIATION

NUMBER OF RECURRENCES

Recurrence in the same location after treatment

  • Nose, 79-year-old female
  • Not considered a candidate for surgery or radiation due to anticipated substantial morbidity and/or deformity 

CONSIDER ERIVEDGE IN ADULTS WITH METASTATIC BCC

METASTASIS 2

Metastasis to regional lymph nodes, liver, bone, etc, that is symptomatic

  • Left lung, 56-year-old male
  • Diagnosed with BCC in 1995
  • Metastatic BCC in lungs identified in 2009

*Additional inclusion criterion was size of lesion (≥10 mm in diameter).

BOXED WARNING

Embryo-Fetal Toxicity

  • Erivedge can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. Erivedge is embryotoxic, fetotoxic, and teratogenic in animals. Teratogenic effects included severe midline defects, missing digits, and other irreversible malformations
  • Verify pregnancy status of females of reproductive potential within 7 days prior to initiating Erivedge therapy. Advise females of reproductive potential to use effective contraception during and after Erivedge therapy. Advise males of the potential risk of Erivedge exposure through semen and to use condoms with a pregnant partner or a female partner of reproductive potential. Advise pregnant women of the potential risks to a fetus

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INDICATION

Erivedge® (vismodegib) capsule is indicated for the treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery, and who are not candidates for radiation.

BOXED WARNING AND ADDITIONAL IMPORTANT SAFETY INFORMATION

Embryo-Fetal Toxicity

  • Erivedge can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. Erivedge is embryotoxic, fetotoxic, and teratogenic in animals. Teratogenic effects included severe midline defects, missing digits, and other irreversible malformations
  • Verify pregnancy status of females of reproductive potential within 7 days prior to initiating Erivedge therapy. Advise females of reproductive potential to use effective contraception during and after Erivedge therapy. Advise males of the potential risk of Erivedge exposure through semen and to use condoms with a pregnant partner or a female partner of reproductive potential. Advise pregnant women of the potential risks to a fetus
  • Advise female patients and female partners of male patients to contact their healthcare provider with a known or suspected pregnancy. Report pregnancies to Genentech at (888) 835‑2555

Female Patients

  • Advise females of reproductive potential to use effective contraception during therapy with Erivedge and for 24 months after the final dose

Male Patients

  • Advise males of the potential risk to an embryo or fetus if a female partner of reproductive potential is exposed to Erivedge. Advise male patients to use condoms with a pregnant partner or a female partner of reproductive potential, even after a vasectomy, during therapy and for 3 months after the final dose of Erivedge

Blood Donation

  • Advise patients not to donate blood or blood products while receiving Erivedge and for 24 months after the final dose of Erivedge

Semen Donation

  • Vismodegib is present in semen. It is not known if the amount of vismodegib in semen can cause embryo-fetal harm. Advise male patients not to donate semen during and for 3 months after the final dose of Erivedge

Premature Fusion of the Epiphyses

  • Premature fusion of the epiphyses has been reported in pediatric patients exposed to Erivedge. In some cases, fusion progressed after drug discontinuation

Adverse Reactions

  • The most common adverse reactions (≥10%) were muscle spasms, alopecia, dysgeusia, weight loss, fatigue, nausea, diarrhea, decreased appetite, constipation, arthralgias, vomiting, and ageusia
  • Amenorrhea can occur in females of reproductive potential. Reversibility of amenorrhea is unknown. In clinical trials, a total of 3 of 10 pre-menopausal women developed amenorrhea while receiving Erivedge
  • Treatment-emergent Grade 3 laboratory abnormalities observed in clinical trials were hyponatremia in 6 patients (4%), hypokalemia in 2 patients (1%), and azotemia in 3 patients (2%)
  • Additionally, in a post-approval clinical trial conducted in 1232 patients with locally advanced or metastatic BCC treated with Erivedge, a subset of 29 patients had baseline values for CPK reported. Within the subset of patients, 38% had a shift from baseline, and one of the patients had a Grade 3 value. The prevalence of Grade 3/4 CPK elevation across the entire study population with any CPK measurement was 2.4% (11 out of 453 patients)

Use in Specific Populations

Lactation

  • No data are available regarding the presence of vismodegib in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. Because of the potential for serious adverse reactions in breastfed infants from Erivedge, advise a nursing woman that breastfeeding is not recommended during therapy with Erivedge and for 24 months after the final dose

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

Please see full Prescribing Information, including the BOXED WARNING and the Medication Guide, for a complete discussion of the risks associated with Erivedge.