ERIVEDGE 150 mg Hard Capsules

Treść ulotki

1. Erivedge 150 mg hard capsules
   1. What is Erivedge and what is it 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. Package Contents and Other Information

Erivedge 150 mg hard capsules

vismodegib
Erivedge can cause serious birth defects. It can lead to the death of the baby before birth
or shortly after birth. Do not start a pregnancy while taking this medicine. You must

Read this leaflet carefully before you start to take this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• 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 is Erivedge and what is it used for

What is Erivedge
Erivedge is an anti-cancer medicine that contains the active substance vismodegib.

What is Erivedge used for
Erivedge is used to treat adults with a type of skin cancer called basal cell carcinoma
advanced. It is used when the tumor:

• has spread to other parts of the body (called “metastatic” basal cell carcinoma)
• has spread to nearby areas (called “locally advanced” basal cell carcinoma) and the doctor decides that treatment with surgery or radiotherapy is not appropriate How does Erivedge workBasal cell carcinoma develops when the DNA of skin cells is damaged and the body cannot repair the damage. This damage can change the way certain proteins work in these cells. The damaged cells become cancerous and begin to grow and replicate. Erivedge is an anti-cancer medicine that works by controlling one of the key proteins involved in basal cell carcinoma. This can slow down or stop the growth of cancer cells or kill them, leading to a possible reduction of the skin tumor.

2. What you need to know before you take Erivedge

Read the precise instructions provided by your doctor, particularly regarding the effects of Erivedge
on the embryo and the fetus.
Read carefully and follow the instructions in the patient leaflet given to you by your doctor.

Do not take Erivedge:

• if you are allergicto vismodegib or any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant, suspect you are pregnant or are planning to become pregnant during treatment or for 24 months after taking the last dose of the medicine. Erivedge can in fact cause problems or cause the death of the embryo or fetus.
• if you are breast-feedingor are planning to breast-feed with breast milk during treatment or for 24 months after taking the last dose of the medicine, as it is not known whether Erivedge passes into breast milk and could be harmful to the baby.
• if you could become pregnant but are unable or unwilling to adhere to the necessary measures provided for pregnancy prevention, which are outlined in the Erivedge Pregnancy Prevention Programme.
• if you are taking St John's wort (Hypericum perforatum)- a herbal medicine used for depression (see “Other medicines and Erivedge”).

You will find more information on the subject in the sections “Pregnancy”, “Breast-feeding” and
“Fertility” and “Contraception – for men and women“
Do not take the medicine if you fall into any of the cases listed above. If you have any doubts, consult your doctor or
pharmacist before taking Erivedge.

Warnings and precautions
Talk to your doctor or pharmacist before taking Erivedge, if you have questions regarding the
information provided in this paragraph:

• You must never donate blood during treatment and for 24 months after taking the last dose of the medicine.
• If you are a man, you must never donate sperm during treatment and for two months after the last dose.
• Severe skin reactions have been observed in association with treatment with Erivedge. If you notice any of the symptoms illustrated in section 4, stop treatment with Erivedge and consult a doctor immediately.
• Do not give this medicine to anyone else. At the end of treatment, return any unused capsules. Talk to your doctor or pharmacist about where to return the capsules.

Children and adolescents
The use of Erivedge is not recommended in children and adolescents under the age of 18 years, as the
safety and efficacy of the medicine in people belonging to this age group are not known.
Erivedge may cause interruption of bone growth and may lead to early onset of
puberty (before the age of 8 in girls or 9 in boys), even after stopping
administration. Studies in animals given this medicine have
highlighted problems with bone and tooth growth.

Other medicines and Erivedge
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines, including those available without a prescription, vitamins and herbal medicines.
Some medicines can affect the way Erivedge works or make side effects more likely. Erivedge can in turn affect the way other medicines
work.
In particular, tell your doctor if you are taking 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 some types of cancer
• sulfasalazine - used especially for some inflammatory conditions,
• St John's wort (Hypericum perforatum) - a herbal medicine used for depression, as you should not take it at the same time as Erivedge

Pregnancy
Do not take Erivedge if you are pregnant, suspect you are pregnant or are planning to become pregnant
during treatment or for 24 months after taking the last dose of the medicine.
You must stop treatment and inform your doctor immediately if: you have missed or think you have
missed a menstrual period, you have abnormal vaginal bleeding or suspect you are pregnant. If a pregnancy begins during treatment with Erivedge, you must stop
Erivedge can cause serious birth defects. The medicine can also lead to the death
of the embryo or fetus. Specific instructions (Erivedge Pregnancy Prevention Programme)
provided by your doctor contain information, in particular regarding the possible
effects of Erivedge on the embryo and the fetus.

Breast-feeding
Do not breast-feed with breast milk during treatment and for 24 months after taking
the last dose of the medicine. It is not known whether Erivedge passes into breast milk and could cause
problems for the baby.

Fertility
Erivedge may impair a woman's ability to have children. Some women treated with
Erivedge have experienced cessation of their menstrual cycle. If this is also the case for you, it is
not known whether your cycle will return. Talk to your doctor if you want to have children in the future.

Contraception - for men and women
For womentreated with Erivedge
Before starting treatment, ask your doctor if you can become pregnant. Even if your menstrual
cycle has stopped, it is essential to ask your doctor if there is any risk that you could
become pregnant.
If you could become pregnant:

• during treatment with Erivedge you must take precautions to prevent pregnancy
• you must use 2 methods of contraception, a highly effective contraceptive method and a barrier method (see examples below)
• you must continue contraception for 24 months after taking the last dose of the medicine, as Erivedge may remain in the body for up to 24 months after the last dose. Recommended method of contraception: consult your doctor to decide the two best methods of contraception for you.

Use a highly effective contraceptive method, such as:

• long-acting injectable contraception
• intrauterine device (“coil” or IUD)
• surgical sterilization

You should always also use a barrier method such as:

• condom (with spermicide if possible)
• diaphragm (with spermicide if possible)

Your doctor will perform a pregnancy test:

• within a maximum of 7 days before starting treatment, to verify that you are not already pregnant
• every month during treatment You must immediately inform your doctor during treatment or during the 24 months after taking the last dose of the medicine if:
• you suspect, for any reason, that the contraceptive method has not worked
• your menstrual cycle stops
• you stop using the contraceptive methods
• you need to change the contraceptive method

For mentaking Erivedge
Erivedge may pass into semen. Always use a condom (with spermicide if possible) during
sexual intercourse with a female partner, even after a vasectomy. Condom use is mandatory during treatment and for 2 months after taking the last dose
of the medicine.
You must never donate semen during treatment and for 2 months after the last dose of
the medicine.

Driving and using machines
It is unlikely that Erivedge will affect your ability to drive or operate tools or machinery. If you
have any doubts, consult your doctor.

Erivedge contains lactose and sodium
Erivedge contains a type of sugar called lactose. If you have been diagnosed with an
intolerance to certain sugars, contact your doctor before taking this medicine
This medicine contains less than 1 mmol of sodium (23 mg) per capsule, i.e. essentially
‘sodium-free’.

3. How to take Erivedge

Take Erivedge following always exactly the instructions of the doctor. If you have doubts consult the doctor
or the pharmacist.

How to take this medicine
The recommended dose is one capsule a day.

• Swallow the capsule whole with a sip of water.
• Do not break, or open or chew the capsule, to avoid an involuntary exposure to the capsule contents.
• Erivedge can be taken with or without food.

If you take more Erivedge than you should
If you take more Erivedge than you should, inform the doctor.

If you forget to take Erivedge
Do not take a double dose to compensate for the missed dose, but take the next one
at the scheduled time.

If you stop taking Erivedge
Do not stop taking the medicine without first talking to the doctor, as this
could compromise the effectiveness of the treatment.
If you have any doubts about the use of this medicine, ask the doctor or pharmacist.

4. Possible side effects

Like all medicines, Erivedge can cause side effects, although not everybody gets them.
Erivedge can cause serious birth defects. It can also cause the death of the baby before birth or shortly after birth. 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 listed according to their severity and frequency.
If any of these side effects become serious, tell your doctor or pharmacist.

Very common(may affect more than 1 in 10 people):

• absence of menstrual periods in women of childbearing potential
• loss of appetite and weight loss
• feeling tired
• muscle spasm
• diarrhoea
• hair loss (alopecia)
• skin rash
• change in taste or complete loss of taste
• constipation
• vomiting or feeling sick (nausea)
• stomach discomfort or indigestion
• joint pain
• pain (in general) or pain in arms, legs
• itching

Common(may affect up to 1 in 10 people):

• chest, back or flank pain
• lack of energy or weakness (asthenia)
• loss of fluids (dehydration)
• pain in muscles, tendons, ligaments or bones
• stomach pain
• loss of taste
• abnormal hair or hair growth
• eyelash loss (madarosis)
• changes in blood tests, including increased liver function tests or increased levels of creatine phosphokinase (a protein mainly found in muscles) Frequency not known:
• Stopping of bone growth (premature closure of the growth plates)
• Early puberty (precocious puberty)
• Liver injury
• Severe skin reactions:
• target-like macules or reddish circular patches on the trunk, often with a blister in the centre, skin peeling, ulcers of the mouth, throat, nose, genitals and eyes. Skin reactions are often preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis)
• widespread rash, fever and swollen lymph nodes (DRESS syndrome or drug reaction with eosinophilia and systemic symptoms)
• widespread, scaly, red rash with bumps under the skin and blisters, accompanied by fever at the start of treatment (acute generalized pustular exanthematous rash). Reporting of side effectsIf you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Erivedge

• 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 the carton after “Exp.”. The expiry date refers to the last day of that month.
• Do not store at a temperature above 30°C.
• Keep the bottle tightly closed to protect the medicine from moisture.
• Do not dispose of any medicine in the wastewater or household waste.
• At the end of treatment, you must return all unused capsules. This will prevent misuse of the medicine and help protect the environment. Talk to your pharmacist or doctor about where to return the medicine.

6. Package Contents and Other Information

What Erivedge contains

• The active ingredient is vismodegib. Each hard capsule contains 150 mg of vismodegib.
• The other ingredients are:
• Capsule contents: microcrystalline cellulose, anhydrous lactose, sodium lauryl sulfate, povidone (K29/32), sodium starch glycolate (Type A), talc and magnesium stearate (see section 2 “Erivedge contains lactose and sodium”):
• Capsule shell: red iron oxide (E172), black iron oxide (E172), titanium dioxide and gelatin.
• Printing ink: shellac glaze and black iron oxide (E172).

Description of Erivedge and package contents
The capsules have an opaque pink body imprinted with the inscription “150 mg” and a grey cap imprinted with the inscription “VISMO” in black food ink. They are available in bottles with
a child-resistant safety closure containing 28 capsules. Each pack contains one
bottle.

Marketing Authorisation Holder
Roche Registration GmbH
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany

Manufacturer
Roche Pharma AG
Emil-Barell-Strasse 1
D-79639 Grenzach-Wyhlen
Germany
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
N.V. Roche S.A.
Tél/Tel: +32 (0) 2 525 82 11

Lietuva
UAB “Roche Lietuva”
Tel: +370 5 2546799

България
Рош България ЕООД
Тел: +359 2 818 44 44

Luxembourg/Luxemburg
(Voir/siehe Belgique/Belgien)

Česká republika
Roche s. r. o.
Tel: +420 - 2 20382111

Magyarország
Roche (Magyarország) Kft.
Tel: +36 - 1 279 4500

Danmark
Roche a/s
Tlf: +45 - 36 39 99 99

Malta
(See Ireland)

Deutschland
Roche Pharma AG
Tel: +49 (0) 7624 140

Nederland
Roche Nederland B.V.
Tel: +31 (0) 348 438050

Eesti
Roche Eesti OÜ
Tel: + 372 - 6 177 380

Norge
Roche Norge AS
Tlf: +47 - 22 78 90 00

Ελλάδα
Roche (Hellas) A.E.
Τηλ: +30 210 61 66 100

Österreich
Roche Austria GmbH
Tel: +43 (0) 1 27739

España
Roche Farma S.A.
Tel: +34 - 91 324 81 00

Polska
Roche Polska Sp.z o.o.
Tel: +48 - 22 345 18 88

Portugal
Roche Farmacêutica Química, Lda
Tel: +351 - 21 425 70 00

Hrvatska
Roche d.o.o
Tel: +385 1 4722 333

France
Roche
Tél: +33 (0) 1 47 61 40 00

România
Roche România S.R.L.
Tel: +40 21 206 47 01

Ireland
Roche Products (Ireland) Ltd.
Tel: +353 (0) 1 469 0700

Slovenija
Roche farmacevtska družba d.o.o.
Tel: +386 - 1 360 26 00

Ísland
Roche a/s
c/o Icepharma hf
Sími: +354 540 8000

Slovenská republika
Roche Slovensko, s.r.o.
Tel: +421 - 2 52638201

Suomi/Finland
Roche Oy
Puh/Tel: +358 (0) 10 554 500

Kύπρος
Γ.Α.Σταμ ά τη ς & Σια Λτδ.
Τηλ: +357 - 22 76 62 76

Italia
Roche S.p.A.
Tel: +39 - 039 2471

Sverige
Roche AB
Tel: +46 (0) 8 726 1200

Latvija
Roche Latvija SIA
Tel: +371 - 6 7 039831

United Kingdom (Northern Ireland)
Roche Products (Ireland) Ltd.
Tel: +44 (0) 1707 366000

Other sources of information
More detailed information on this medicinal product is available on the website of the European
Medicines Agency: http://www.ema.europa.eu.
This leaflet is available in all languages of the European Union/European Economic Area on the
website of the European Medicines Agency.
As an integral part of the Erivedge pregnancy prevention plan, all patients will receive a Patient
Booklet
Please refer to this document for further information.