Erivedge
vismodegib
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.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What Erivedge is and what it is used for
What you need to know before you take Erivedge
How to take Erivedge
Possible side effects
How to store Erivedge
Contents of the pack and other information
Erivedge is an anti-cancer medicine that 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:
has spread to other parts of the body (called “metastatic” basal cell carcinoma)
has spread to areas nearby (called “locally advanced” basal cell carcinoma) and your doctor decides that treatment with surgery or radiation is inappropriate
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.
if you are allergic to vismodegib or any of the other ingredients of this medicine (listed in section 6).
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. This is because Erivedge may harm or cause the death of your unborn baby.
if you are breast-feeding or plan to breast-feed during the course of treatment or during the 24 months after your final dose of this medicine. This is because it is unknown whether Erivedge can pass into your milk and cause harm to your baby.
if you are able to become pregnant but are unable or unwilling to follow the necessary pregnancy prevention measures that are listed in the Erivedge Pregnancy Prevention Programme.
if you are also taking St John’s wort (Hypericum perforatum) – a herbal medicine used for depression (see “Other medicines and 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.
Talk to your doctor or pharmacist before taking Erivedge if you have questions on the information in this section:
You should not donate blood at any time during treatment and for 24 months after your final dose of this medicine.
If you are male, you should not donate semen at any time during treatment and for 2 months after the final dose.
Serious skin reactions have been reported in association with Erivedge treatment. Stop using Erivedge and seek medical attention immediately if you notice any of the symptoms described in section 4.
Never give this medicine to anyone else. You should return unused capsules at the end of your treatment. Talk to your doctor or pharmacist regarding where to return the capsules.
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:
rifampicin – used for bacterial infections
carbamazepine, phenytoin – used for epilepsy
ezetimibe and statins , such as atorvastatin, fluvastatin, pravastatin, rosuvastatin, simvastatin – used for high cholesterol
bosentan, glibenclamide, repaglinide, valsartan
topotecan – used for certain types of cancer
sulfasalazine – used for certain inflammatory disorders, and especially
St. John’s wort (Hypericum perforatum) – a herbal medicine used for depression, since you must not use it at the same time as Erivedge
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.
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:
you must take precautions so that you do not become pregnant while taking Erivedge
use 2 methods of contraception, one highly effective method and one barrier method (please see the examples below)
you need to continue contraception for 24 months after your final dose of this medicine – because Erivedge may remain in your body for up to 24 months after your final dose
Method of recommended contraception: Talk to your doctor about the best two contraception methods for you.
Use one highly effective method, such as:
a contraceptive depot injection
an intra-uterine device (“the coil” or IUD)
surgical sterilisation
You must also use one barrier method, such as:
a condom (with spermicide, if available)
a diaphragm (with spermicide, if available)
Your doctor will make sure to test you for pregnancy:
within a maximum of 7 days before starting treatment – to make sure that you are not already pregnant
every month during treatment
You must tell your doctor immediately during the course of treatment or during the 24 months after your final dose of this medicine if:
you think your contraception has failed for any reason
your periods stop
you stop using contraception
you need to change contraception
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.
Swallow the capsule whole with a drink of water.
Do not crush, open or chew the capsule, to avoid unintended exposure to the capsule contents.
Erivedge can be taken with or without food.
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”).
If any of these side effects become severe, tell your doctor or pharmacist.
loss of monthly periods in women of childbearing age
loss of appetite and weight loss
feeling tired
muscle spasm
diarrhoea
hair loss (alopecia)
rash
a change in the way things taste or the complete loss of taste
constipation
vomiting or feeling like you want to vomit (nausea)
upset stomach or indigestion
joint pain
pain (in general) or pain in your arms, legs
itchiness
pain in your chest, back or side
lack of energy or weakness (asthenia)
loss of water from the body (dehydration)
muscle, tendon, ligament, bone pain
stomach pain
loss of taste
abnormal hair growth
eyelashes falling out (madarosis)
changes in blood tests, which include increased values in liver tests or increased values in creatine phosphokinase (a protein mainly from muscle)
Bones stop growing (epiphyses premature fusion)
Premature puberty (precocious puberty)
Liver injury
Serious skin reactions:
reddish target-like macules or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. The skin reactions are often preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis)
widespread rash, fever, and enlarged lymph nodes (DRESS-syndrome or drug hypersensitivity syndrome)
red, scaly widespread rash with bumps under the skin and blisters accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis)
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 via the national reporting system
listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the bottle and carton after EXP. The expiry date refers to the last day of that month.
Do not store above 30 °C.
Keep the bottle tightly closed in order to protect from moisture.
Do not throw away any medicines via wastewater or household waste.
At the end of your treatment you should return all unused capsules. This will prevent misuse and help to protect the environment. Talk to your pharmacist or doctor regarding where to return the medicine.
The active substance is vismodegib. Each hard capsule contains 150 mg of vismodegib.
The other ingredients are:
Capsule contents: microcrystalline cellulose, lactose monohydrate, sodium lauril sulfate, povidone (K29/32), sodium starch glycolate (Type A), talc and magnesium stearate (see
section 2 “Erivedge contains lactose and sodium”)
Capsule shell: iron oxide red (E172), iron oxide black (E172), titanium dioxide and gelatine
Printing ink: shellac glaze and iron oxide black (E172)
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.
Roche Registration GmbH
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen Germany
D-79639 Grenzach-Wyhlen Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
N.V. Roche S.A.
Tél/Tel: +32 (0) 2 525 82 11
UAB “Roche Lietuva” Tel: +370 5 2546799
Рош България ЕООД
Тел: +359 2 818 44 44
(Voir/siehe Belgique/Belgien)
Roche s. r. o.
Tel: +420 - 2 20382111
Roche (Magyarország) Kft. Tel: +36 - 1 279 4500
Roche a/s
Tlf: +45 - 36 39 99 99
(See Ireland)
Roche Pharma AG
Tel: +49 (0) 7624 140
Roche Nederland B.V.
Tel: +31 (0) 348 438050
Roche Eesti OÜ
Tel: + 372 - 6 177 380
Roche Norge AS
Tlf: +47 - 22 78 90 00
Roche (Hellas) A.E.
Τηλ: +30 210 61 66 100
Roche Austria GmbH
Tel: +43 (0) 1 27739
Roche Farma S.A.
Tel: +34 - 91 324 81 00
Roche Polska Sp.z o.o.
Tel: +48 - 22 345 18 88
Roche
Tél: +33 (0) 1 47 61 40 00
Roche Farmacêutica Química, Lda Tel: +351 - 21 425 70 00
Roche d.o.o
Tel: +385 1 4722 333
Roche România S.R.L.
Tel: +40 21 206 47 01
Roche Products (Ireland) Ltd. Tel: +353 (0) 1 469 0700
Roche farmacevtska družba d.o.o. Tel: +386 - 1 360 26 00
Roche a/s
c/o Icepharma hf Sími: +354 540 8000
Roche S.p.A.
Tel: +39 - 039 2471
Roche Oy
Puh/Tel: +358 (0) 10 554 500
Γ.Α.Σταμάτης & Σια Λτδ. Τηλ: +357 - 22 76 62 76
Roche AB
Tel: +46 (0) 8 726 1200
Roche Latvija SIA
Tel: +371 - 6 7 039831
Roche Products (Ireland) Ltd.
Tel: +44 (0) 1707 366000
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 Patient Brochure. Please refer to this document for further information.