The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PLGB 00031/0850.
Erivedge 150 mg hard capsules
Erivedge 150 mg hard capsules
Erivedge may cause severe birth defects. It may lead to the death of a baby before it is born or shortly after being born. You must not become pregnant while taking this medicine. You must follow the contraception advice described in this leaflet.
1. What Erivedge is and what it is used for
2. What you need to know before you take Erivedge
3. How to take Erivedge
4. Possible side effects
5. How to store Erivedge
6. Contents of the pack and other information
Erivedge is an anti-cancer medicine and contains the active substance vismodegib.
Erivedge is used to treat adults with a type of skin cancer called advanced basal cell carcinoma. It is used when the cancer:
Basal cell carcinoma develops when DNA in normal skin cells becomes damaged and the body cannot repair the damage. This damage can change how certain proteins in these cells work and the damaged cells become cancerous and begin to grow and divide. Erivedge is an anti-cancer medicine that works by controlling one of the key proteins involved in basal cell carcinoma. This may slow down or stop the growth of the cancer cells, or may kill them. As a result, your skin cancer may shrink.
Read the specific instructions given to you by your doctor, particularly on the effects of Erivedge on unborn babies.
Read carefully and follow the instructions of the patient brochure given to you by your doctor.
More information on the issues above is found in the sections “Pregnancy, breast-feeding and fertility” and “Contraception – for men and women”.
Do not take this medicine if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Erivedge.
Talk to your doctor or pharmacist before taking Erivedge if you have questions on the information in this section:
The use of Erivedge in children and adolescents under the age of 18 years is not recommended. This is because it is not known if it is safe or effective in this age group. Erivedge can cause bones to stop growing and lead to premature onset of puberty (before age 8 years in girls or age 9 years in boys). This can happen even after stopping Erivedge. Problems with growing teeth and bones were seen in animal studies with this medicine.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This also includes non-prescription medicines, vitamins and herbal medicines.
Some medicines may affect how Erivedge works, or make it more likely that you will have side effects. Erivedge can also affect how some other medicines work.
In particular, tell your doctor if you take any of the following medicines:
Do not take Erivedge if you are pregnant, think you may be pregnant, or are planning to become pregnant during the course of treatment or during the 24 months after your final dose of this medicine.
You must stop treatment and inform your doctor straight away if: you miss or think you have missed a period, or you have unusual menstrual bleeding, or suspect you are pregnant. If you do become pregnant during the treatment with Erivedge, you must stop the treatment and inform your doctor immediately.
Erivedge may cause severe birth defects. It may also lead to the death of the unborn baby. Specific instructions (the Erivedge Pregnancy Prevention Programme), given to you by your doctor contain information particularly on the effects of Erivedge on unborn babies.
Do not breast-feed during your treatment and for 24 months after your final dose of this medicine. It is not known if Erivedge can pass into your breast milk and harm your baby.
Erivedge may affect a woman’s ability to have children. Some women taking Erivedge have stopped having periods. If this happens to you, it is not known if your periods will come back. Talk to your doctor if you wish to have children in the future.
Contraception – for men and women
For women taking Erivedge
Before starting the treatment, ask your doctor if you are able to become pregnant. Even if your periods have stopped, it is essential to ask your doctor if there is any risk that you could become pregnant.
If you are able to become pregnant:
Method of recommended contraception: Talk to your doctor about the best two contraception methods for you.
Use one highly effective method, such as:
You must also use one barrier method, such as:
Your doctor will make sure to test you for pregnancy:
You must tell your doctor immediately during the course of treatment or during the 24 months after your final dose of this medicine if:
For men taking Erivedge
Erivedge can pass into semen. Always use a condom (with spermicide, if available) even after a vasectomy, when you have sex with a female partner. Do this during treatment and for 2 months after your final dose of this medicine.
You should not donate semen at any time during treatment and for 2 months after your final dose of this medicine.
Erivedge is unlikely to affect your ability to drive, use any tools or machines. Talk to your doctor if you are not sure.
Erivedge contains a type of sugar called lactose. If you have been told by your doctor that you have an intolerance to some sugars contact your doctor before taking this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium free’.
Always take Erivedge exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose is one capsule each day.
If you take more Erivedge than you should, talk to your doctor.
Do not take a double dose to make up for a forgotten dose, but resume with the next scheduled dose.
Do not stop taking this medicine without talking to your doctor first as this could make your treatment less effective.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, Erivedge can cause side effects, although not everybody gets them.
Erivedge may cause severe birth defects. It may also lead to the death of a baby before it is born or shortly after being born. You must not become pregnant while taking this medicine (see section 2, “Do not take Erivedge” and “Pregnancy, breast-feeding and fertility”).
Other side effects are presented in order of severity and frequency:
Very common (may affect more than 1 in 10 people):
Common (may affect up to 1 in 10 people):
Frequency not known
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
or search for MHRA Yellow Card in the Google Play or Apple App Store
The capsules have a pink opaque coloured body marked “150 mg” and a grey cap marked "VISMO” in black edible ink. They are available in bottles with a child-resistant closure containing 28 capsules. Each pack contains one bottle.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in January 2022
Other sources of information
As part of the Erivedge Pregnancy Prevention Programme, all patients will receive a:
Please refer to this document for further information.