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Nodular BCC on superior central malar cheek1

Tim, a 56-year-old objective responder treated with Erivedge in clinical practice

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

Right superior central malar cheek: Nodular BCC

Baseline Baseline basal cell carcinoma lesion on malar cheek of patient treated with Erivedge
Week 47 Basal cell carcinoma lesion on malar cheek after 47 weeks of treatment with Erivedge
Baseline basal cell carcinoma lesion on malar cheek of patient treated with Erivedge
Baseline
Week 5
Week 26
Week 47

Patient details

Tim’s history of BCC

  • Tim was initially diagnosed with locally advanced BCC on June 29, 2015
  • He had no prior treatment for advanced BCC

Reasons why Tim was eligible for treatment with Erivedge

  • Tim was not a candidate for surgery because of anticipated substantial morbidity and/or deformity
  • He was not a candidate for radiotherapy because of the location of the tumor and anticipated side effects

Factors that contributed to this physician’s eligibility assessment

  • The location of the lesion involved the right lower eyelid, which would make surgical reconstruction difficult and extensive
  • Radiation was not appropriate due to tumor location and risk of side effects

Other patient considerations

  • No access to radiation treatment center within 50 miles of home

Treatment

  • Tim started treatment with Erivedge in July 2015 and was treated over a period of 10.8 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 June 2016, he decided to discontinue Erivedge

Clinical outcome

  • Tim experienced an objective response, as assessed by the treating physician
  • A sampling biopsy in June 2016 showed evidence of residual BCC

Treatment-related adverse reactions

  • Tim experienced muscle spasms, alopecia, dysgeusia, weight loss, nausea, diarrhea, decreased appetite, constipation, and arthralgias
  • He had 5 treatment interruptions for 1 to 4 weeks to manage intolerable adverse reactions (4 of which were instances of muscle spasms)
    • Per Erivedge USPI, withhold Erivedge for up to 8 weeks for intolerable adverse reactions until improvement or resolution5

Tim was treated by George Monks, MD
Tulsa Dermatology Clinic, Inc
Tulsa, OK

NEXT: All Cheek 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.

    • Data on file. Genentech, Inc.

      Data on file. Genentech, Inc.

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