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Infiltrative BCC on ear1

Stanley, a 66-year-old complete responder from the ERIVANCE trial

Learn more about Erivedge: ERIVANCE Trial Design, Erivedge Side Effects & Tips

Left ear: Infiltrative BCC

Baseline Baseline basal cell carcinoma lesion on ear of patient treated with Erivedge
Week 24 Basal cell carcinoma lesion on ear after 24 weeks of treatment with Erivedge
Baseline basal cell carcinoma lesion on ear of patient treated with Erivedge
Baseline
Week 8
Week 16
Week 24

Patient details

Stanley’s history of BCC

  • Stanley was initially diagnosed with BCC in 1999 and subsequently underwent several excisions on the nose

Reasons why Stanley was eligible for treatment with Erivedge

  • Surgery was medically contraindicated because of anticipated substantial morbidity and/or deformity 
  • Radiotherapy was considered contraindicated because of the risk of deformity

Treatment

  • Stanley started treatment with Erivedge in December 2009 and was treated for 8.6 months 
    • In the ERIVANCE trial, the median duration of treatment was 10.2 months (range, 0.7 to 18.7 months), inclusive of locally advanced BCC and metastatic BCC cohorts5
  • In September 2010, treatment was discontinued at his request

Clinical outcome

  • Stanley experienced a complete response, as assessed by independent review
    • Complete response is defined as objective response with no residual BCC on sampling biopsy 
  • The sampling biopsy at Week 24 did not show evidence of residual BCC

Treatment-related adverse reactions

  • Stanley experienced ageusia, alopecia, muscle spasms, and weight loss 
  • He had a treatment interruption for 1 adverse reaction (muscle spasms). He experienced 24 days without treatment* 
    • Per Erivedge USPI, withhold Erivedge for up to 8 weeks for intolerable adverse reactions until improvement or resolution

ERIVANCE patient eligibility is based on study investigator assessment. Case study shows results of treatment in a specific patient and case was last verified at clinical data cutoff. Individual results may vary. This case is for general informational purposes only and is not intended to convey medical advice. You should use your independent medical judgment in the diagnosis and treatment of your patients.

Patient may have had target lesions besides those depicted.

*In ERIVANCE, patients were allowed to interrupt drug treatment for reasons other than managing intolerable adverse reactions.

All Ear Lesion Studies

Indication and Important Safety Information

Indication

Erivedge 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.

Important Safety Information

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 the pregnancy status of females of reproductive potential within 7 days prior to initiating Erivedge. Advise pregnant women of the potential risks to a fetus. Advise females of reproductive potential to use effective contraception during and after Erivedge
  • 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
Warnings and Precautions
 
Embryo-Fetal Toxicity
  • Females of Reproductive Potential: Use contraception during therapy with Erivedge and for 24 months after the final dose
  • Males: Use condoms, even after a vasectomy, to avoid potential drug exposure in pregnant partners and female partners of reproductive potential during and for 3 months after the final dose of Erivedge. Do not donate semen during 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
  • 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
Severe Cutaneous Adverse Reactions
  • Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening or fatal, have been reported during treatment with Erivedge. Permanently discontinue Erivedge in patients with these reactions
Musculoskeletal Adverse Reactions
  • Musculoskeletal adverse reactions, which may be accompanied by serum creatine phosphokinase (CPK) elevations, have occurred with Erivedge and other drugs which inhibit the hedgehog (Hh) pathway. In the pooled safety population in clinical trials of Erivedge, musculoskeletal and connective tissue adverse reactions occurred in 78% of patients treated, with 7% (9/138) reported as Grade 3. The most frequent manifestations of musculoskeletal and connective tissue adverse reactions (all grades) reported were muscle spasms (72%) and arthralgias (16%). In a post-approval clinical trial of 1232 patients, Grade 3 or 4 elevations in serum CPK laboratory values occurred in 2.4% of the 453 patients who had any CPK measurement
  • Obtain baseline serum creatine phosphokinase (CPK) and creatinine levels and as clinically indicated (e.g., if muscle symptoms are reported). Depending on the severity of symptoms, temporary dose interruption or discontinuation may be required for musculoskeletal adverse reactions or serum CPK elevation
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. Erivedge is not indicated for pediatric patients

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, 30% of 10 pre-menopausal women developed amenorrhea while receiving Erivedge
  • Grade 3 laboratory abnormalities observed in clinical trials were hyponatremia (4%), azotemia (2%), and hypokalemia (1%)
  • 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 blood creatine phosphokinase (CPK) reported. Within the subset of patients, 38% had a shift from baseline, including Grade 3 (3%) increased CPK. Grade 3 or 4 increased CPK occurred in 2.4% of the 453 patients across the entire study population with any CPK measurement
  • Adverse reactions identified during post-approval use: drug-induced liver injury, Stevens-Johnson syndrome/toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms

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 child, or the effects of the drug on milk production. Advise women 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, for a complete discussion of the risks associated with Erivedge.

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