Active ingredient
- vismodegib
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original can be viewed in PDF format using the link above.
The text only version may be available from RNIB in large print, Braille or audio CD. For further information call RNIB Medicine Leaflet Line on 0800 198 5000. The product code(s) for this leaflet is: EU/1/13/848/001.
Erivedge 150 mg hard capsules
Package leaflet: Information for the patient
Erivedge 150 mg hard capsules
vismodegib
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.
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
What is 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
1. What Erivedge is and what it is used for
What Erivedge is
Erivedge is an anti-cancer medicine and contains the active substance vismodegib.
What Erivedge is used for
Erivedge is used to treat adults with a type of skin cancer called advanced basal cell carcinoma. It is used when the cancer:
How Erivedge works
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.
2. What you need to know before you take Erivedge
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 and reminder card given to you by your doctor.
Do not take Erivedge
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.
Warnings and precautions
Talk to your doctor or pharmacist before taking Erivedge if you have questions on the information in this section:
Children and adolescents
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.
Other medicines and Erivedge
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:
Pregnancy, breast-feeding and fertility
Pregnancy
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.
Breast-feeding
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.
Fertility
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.
Driving and using machines
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 lactose and sodium
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, i.e. essentially ‘sodium free’.
3. How to take Erivedge
Always take Erivedge exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Taking this medicine
The recommended dose is one capsule each day.
If you take more Erivedge than you should
If you take more Erivedge than you should, talk to your doctor.
If you forget to take Erivedge
Do not take a double dose to make up for a forgotten dose, but resume with the next scheduled dose.
If you stop taking Erivedge
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.
4. Possible side effects
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
Reporting of side effects
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.
Ireland
Malta
United Kingdom
or search for MHRA Yellow Card in the Google Play or Apple App Store
5. How to store Erivedge
6. Contents of the pack and other information
What Erivedge contains
What Erivedge looks like and contents of the pack
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.
Marketing Authorisation Holder
Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in November 2018
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
This leaflet is available in all EU/EEA languages on the European Medicines Agency website.
As part of the Erivedge Pregnancy Prevention Programme, all patients will receive a:
Please refer to these documents for further information.
Hexagon Place, 6 Falcon Way, Shire Park, Welwyn Garden City, Hertfordshire, AL7 1TW
+44 (0)1707 366 000
+44 (0)800 328 1629
+44 (0)800 731 5711
+44 (0)1707 338 297
+44 (0)1707 384555