Dear Healthcare Professional Letter on the new information aimed at the safe use including the Pregnancy prevention programme for Erivedge 150 mg hard capsules (vismodegib)
03.12.2014
Roche d.o.o. in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and European Medicines agency (EMA) has sent a letter to healthcare professionals on the important safety information with regard to teratogenic effects of Erivedge 150 mg hard capsules (vismodegib) and introduction of the Pregnancy prevention programme for this medicine.
Summary
- Erivedge has teratogenic effects. May cause death of embryo/foetus or severe congenital malformations and may not be used in pregnancy
- The Pregnancy prevention programme when using this medicine has been established. Pregnancy prevention measures during and after the treatment are necessary for women in reproductive age and for men, as Erivedge may be present in sperm
- Erivedge may only be prescribed by or under supervision of a doctor specialist experienced in treating authorised indications.
- The prescribing doctor must ensure:
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- that all patients are completely informed on the risks of teratogenic effects of Erivedge;
- to warn patients that Erivedge must not be given to other individuals and that at the end of treatment unused capsules should be disposed according to local regulations (i.e. return them to pharmacy);
- that all patients, including men and women in reproductive age, obligatory receive a Patient Booklet and Patient reminder where Pregnancy prevention measures that has to carried out are summarised;
- that all patients complete and sign the Confirmation form on Erivedge counselling.
Additional information
Erivedge is indicated for the treatment of adult patients with a symptomatic metastatic basal cell cancer or locally advanced basal cell cancer where surgery or radiotherapy are not feasible.
Evidence suggests that inhibitors of Hedgehog signal pathway, like vismodegib are embryotoxic and/or teratogenic in a number of animal species and may cause severe malformations, including craniofacial anomaly, central line damages and damages of extremities. When used in pregnant women, Erivedge may cause death of embryo/foetus and severe congenital malformations. In the case of pregnancy in women treated with Erivedge, the treatment should be immediately discontinued. Taking account that Erivedge should not be used in pregnancy, a Pregnancy prevention programme has been developed.
Here you may view the Dear Healthcare Professional Letter.
An adequate education material authorised by HALMED is attached to the Dear Healthcare Professional Letter, as well as an additional letter on the error on vial stickers that you may read about here.
We remind healthcare professionals that they should report any adverse reaction, as well as quality defect to HALMED. Patients who have developed any adverse reaction to medicinal product may report it directly to HALMED via form or on-line application, with recommendation regarding any adverse reaction they discover to consult their doctor or pharmacist about the continuation of their therapy.
