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You are here: Home / Our Medicines / Erivedge

Erivedge

Erivedge is a hedgehog pathway inhibitor for adults with advanced basal cell carcinoma.

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Please review the Data Sheet before prescribing.

About Erivedge

Erivedge, also known as vismodegib, is a targeted treatment for adults with advanced basal cell carcinoma (aBCC).1

Erivedge is a Prescription Medicine, available as a 150 mg oral capsule.1

For information on dosage and administration of Erivedge, please refer to the Data Sheet on the Medsafe website here.1

Medsafe registered indication 1

Erivedge is indicated for the treatment of adult patients with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma where surgery and/or radiation therapy are not appropriate.

Erivedge’s Mechanisms of Action

Erivedge is a first-in-class inhibitor of the hedgehog signalling pathway.2 More than 90% of all BCCs have abnormal hedgehog pathway signalling.3

Hedgehog pathway signalling through the smoothened transmembrane protein (SMO) leads to the activation and nuclear localisation of GLI transcription factors and induction of Hedgehog target genes. Many of these genes are involved in proliferation, survival, and differentiation. Erivedge binds to and inhibits SMO thereby preventing Hedgehog signal transduction.3

Hedgehog Pathway Signalling

Erivedge works systemically to target hedgehog pathway signalling.1,4 For a short video explaining Erivedge’s mode of action, click the image below.


Erivedge’s Funding Status

Erivedge is not funded by PHARMAC and patients need to pay for it.

We provide a Cost Share Programme to assist with the cost of Erivedge for New Zealand adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma where surgery and/or radiation therapy are not appropriate.

If your patient has private health insurance, it may be worthwhile they check their policy regarding cancer treatments like Erivedge.

For more information please refer to the Cost Share Programme section below.

References

1. Erivedge® (vismodegib) Data Sheet. Available here.

2. Sekulic A, Migden MR, Oro AE, et al. Efficacy and safety of vismodegib in advanced basal-cell carcinoma. N Engl J Med 2012;366:2171-2179.

3. Epstein EH. Basal cell carcinomas: attack of the hedgehog. Nat Rev Cancer 2008;8:743-754.

4. Low JA, de Sauvage FJ. Clinical experience with hedgehog pathway inhibitors. J Clin Oncol 2010;28:5321-5326.

The Erivedge Cost Share Programme assists with the cost of Erivedge for New Zealand adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma where surgery and/or radiation therapy are not appropriate.1

For information on the Cost Share Programme, please contact us here.

Reference

1. Erivedge® (vismodegib) Data Sheet. Available here.

Key Efficacy & Safety Information

The ERIVANCE BCC pivotal study was a single arm study of 104 patients with locally advanced or metastatic BCC. Patients were treated with 150 mg Erivedge daily.1,2 The primary endpoint was objective response rate (ORR) and the primary analysis was conducted 9 months after the last patient enrolled.

The ERIVANCE study found that Erivedge reduced or controlled lesions in more than 80% of patients with locally advanced BCC. Further, Erivedge effectively reduced or controlled lesions in more than 90% of patients with metastatic BCC (mBCC) by Independent Review Facility (IRF).1,2,3

54% of patients with laBCC had no residual basal cell carcinoma in sampling biopsies of target lesions at 24 weeks of treatment.1

Figure 1. Overall Disease Control Rate in laBCC.

Figure 1

Figure 2. Overall Disease Control Rate in mBCC.

Figure 2

At the 30 month ERIVANCE update, the median duration of response (mDOR) more than tripled in laBCC patients compared to the primary analysis.4

Figure 3. mDOR at the 30 month update.

Figure 3

Safety

For full safety information, please refer to the Erivedge Data Sheet available here.3

Contraindications3

Erivedge is contraindicated in:

  • Pregnant women
  • Women of childbearing potential, unless using two reliable methods of contraception are being used during treatment and for 24 months after the last dose
  • Nursing mothers during the course of the treatment and for 24 months after the last dose

Warnings for use3

Erivedge exposure during pregnancy may cause embryo-foetal death or severe birth defects. This can result either from Erivedge administration to a pregnant woman, or through her exposure to semen from a male patient taking Erivedge. Patients should not donate blood or blood products while taking Erivedge and for 24 months after the final dose.

Erivedge may impair fertility. Amenorrhea has been observed in women of child-bearing potential.

Premature fusion of the epiphyses has been reported in paediatric patients exposed to Erivedge.

For a full discussion of the Erivedge contraindications, warnings and precautions, read the Erivedge Data Sheet, available here.3

In order to help avoid embryonic and foetal exposure to Erivedge, the Erivedge Pregnancy Prevention Programme educational materials are provided to reinforce these risks and to outline contraceptive measures patients must follow. We strongly recommend that you read the 'Erivedge® (vismodegib): Important Safety Information For Healthcare Professionals About the Risk of Embryo-foetal Death and Severe Birth Defects fact sheet' before prescribing Erivedge.

We also strongly recommend that your patients read the ‘Important Safety Information for All Patients on the Risks of ERIVEDGE® (vismodegib) in Pregnancy and Breastfeeding’ before taking the medicine.

Report any pregnancies to Roche Drug Safety immediately:

  • email nz.drugsafety@roche.com
  • call 0800 276243
  • Adverse Effects: (very common only; see Data Sheet for full list)

  • GI disorder: nausea; diarrhoea; constipation; vomiting; dyspepsia.
  • General disorder: fatigue.
  • Investigations: weight decreased.
  • Metabolism/nutrition disorder: decreased appetite.
  • Musculoskeletal/CT disorders: muscle spasms; arthralgia; pain in extremity.
  • Nervous system disorder: dysgeusia; ageusia.
  • Skin/SC disorder: alopecia.

Please contact the Roche team for further information on the efficacy and/or safety of our products.

References

1 Sekulic A, Migden MR, Oro AE, et al. Efficacy and safety of vismodegib in advanced basal-cell carcinoma. N

Engl J Med. 2012;366:2171-2179.

2 Sekulic A, Migden MR, Basset-Seguin N, et al. Long-term safety and efficacy of vismodegib in patients with advanced basal cell carcinoma: Final update (30-month) of the pivotal ERIVANCE BCC study. J Clin Oncol 2014; 32:5s (suppl; abstr 9013)

3 Erivedge® (vismodegib) Data Sheet. Available here.

4 Sekulic et al. Poster #9013, ASCO 2014

Resources

In order to help avoid embryonic and foetal exposure to Erivedge, the Erivedge Pregnancy Prevention Programme educational materials are provided to reinforce these risks and to outline contraceptive measures patients must follow.

We strongly recommend that you read the ‘Erivedge® (vismodegib): Important Safety Information For Healthcare Professionals About the Risk of Embryo-foetal Death and Severe Birth Defects fact sheet’ before prescribing Erivedge. Click the image below to download.

We also strongly recommend that your patients read the ‘Important Safety Information for All Patients on the Risks of ERIVEDGE® (vismodegib) in Pregnancy and Breastfeeding’ before taking the medicine. Click the image below to download.