Indication1

Erivedge® (vismodegib) was the first and only EMA-approved Hedgehog pathway inhibitor for the treatment of adults with locally advanced BCC or metastatic BCC that is inappropriate for surgery or radiotherapy.1–3

Specifically, Erivedge® is indicated for the treatment of adult patients with:

  • symptomatic metastatic basal cell carcinoma (mBCC)
  • locally advanced basal cell carcinoma (laBCC) inappropriate for surgery or radiotherapy

Dosing considerations1

  • Erivedge® is conveniently administered as a once-daily capsule with or without food and does not require laboratory monitoring except when indicated (e.g. in the presence of severe renal impairment).1
  • No dose adjustments are required for renal or hepatic insufficiency or for elderly patients1
  • One 150 mg capsule once daily until disease progression or unacceptable toxicity
    • Patients should swallow capsules whole with water; capsules must not be crushed or opened
    • If a dose is missed patients should be instructed not to take the missed dose but resume with the next scheduled dose
    • Treatment interruptions of up to 4 weeks were permitted in clinical trials based on tolerability
  • A pregnancy test should be performed but no other laboratory tests are required before starting Erivedge®. Please refer to: https://www.erivedge-ppp.net
  • Clinically significant interactions are not expected between Erivedge® and pH-elevating agents, CYP450 inhibitors and P-glycoprotein (P-gp) inhibitors. Exposure to Erivedge® may be decreased when administered with CYP inducers

 

 

References

 

1. Erivedge® SPC. June 2022. Available at: https://www.ema.europa.eu/documents/product-information/erivedge-epar-product-information_en.pdf

2. European Medicines Agency. Erivedge. European public assessment report. November 2016. Available at: https://www.ema.europa.eu/documents/overview/erivedge-epar-summary-public_en.pdf

3.Peris K et al. Eur J Cancer 2019;118:10–34. Available at: https://www.ejcancer.com/article/S0959-8049(19)30362-4/pdf