Erivedge

Package leaflet: Information for the patient

Erivedge 150 mg hard capsules

vismodegib
Erivedge can cause severe birth defects. It may result in the death of the unborn child or death shortly after birth.
You must not become pregnant while taking this medicine. You must follow the advice on the use of contraception provided in this leaflet.
Please read this leaflet carefully before taking 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 give it to other people, even if their symptoms are the same as yours, because it may be harmful to them.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Erivedge is and what it is used for
2. What you need to know before taking 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 anticancer medicine that 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:

• 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 Erivedge works
Basal cell carcinoma develops when the DNA of skin cells is damaged and the body cannot repair the damage. This damage can alter the way certain proteins function in these cells. The damaged cells become cancerous and begin to grow and multiply. Erivedge is an anticancer medicine that works by targeting one of the key proteins involved in basal cell carcinoma. This may slow down or stop the growth of cancer cells or kill them, potentially reducing the skin tumour.

2. What you should know before taking Erivedge

Read carefully the specific instructions provided by your doctor, especially regarding the effects of Erivedge on the embryo and fetus.
Read and carefully follow the instructions in the patient leaflet provided by your doctor.
Do not take Erivedge:

• if you are allergic to vismodegib or to any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant, suspect you may be pregnant, or are planning a pregnancy during treatment or within 24 months after taking the last dose of the medicine. Erivedge can cause birth defects or result in the death of the embryo or fetus.
• if you are breastfeeding or planning to breastfeed during treatment or within 24 months after taking the last dose of the medicine, as it is not known whether Erivedge passes into breast milk and could harm the baby.
• if you could become pregnant but are unable or unwilling to comply with the necessary pregnancy prevention measures outlined 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”).

Further information on these topics can be found in the sections “Pregnancy”, “Breastfeeding”, “Fertility”, and “Contraception – for men and women”.
Do not take this medicine if any of the above situations apply to you. 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 any questions about the information in this section:

• 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 during treatment with Erivedge. If you notice any of the symptoms described in section 4, stop treatment with Erivedge immediately and contact a doctor right away.
• Do not give this medicine to anyone else. After treatment ends, return any unused capsules. Speak with your doctor or pharmacist about where to return the capsules.

Children and adolescents
Erivedge is not recommended for use in children and adolescents under 18 years of age, as the safety and efficacy of the medicine in this age group have not been established.
Erivedge may cause cessation of bone growth and may trigger early onset of puberty (before age 8 in girls or age 9 in boys), even after stopping treatment. Animal studies with this medicine have shown adverse effects on bone and tooth development.

Other medicines and Erivedge
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription, vitamins, or herbal supplements.
Some medicines may affect how Erivedge works or increase the likelihood of side effects. Erivedge may in turn affect how other medicines work.
In particular, inform 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 certain types of cancer
• sulfasalazine – used especially for certain inflammatory conditions
• St. John’s wort (Hypericum perforatum) – a herbal medicine used for depression, as you must not take it concurrently with Erivedge

Pregnancy
Do not take Erivedge if you are pregnant, suspect you may be pregnant, or are planning a pregnancy during treatment or within 24 months after taking the last dose of the medicine.
You must stop treatment and inform your doctor immediately if: you miss or think you may have missed a menstrual period, have abnormal menstrual bleeding, or suspect you are pregnant. If you become pregnant during treatment with Erivedge, stop treatment immediately and inform your doctor without delay.
Erivedge can cause severe birth defects. The medicine may also lead to the death of the embryo or fetus. The specific instructions (Erivedge Pregnancy Prevention Programme) provided by your doctor contain detailed information, particularly regarding the potential effects of Erivedge on the embryo and fetus.

Breastfeeding
You must not breastfeed 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 harm the baby.

Fertility
Erivedge may affect a woman’s ability to have children. Some women treated with Erivedge have experienced cessation of menstruation. If this occurs in your case, it is not known whether menstruation will return. Talk to your doctor if you wish to have children in the future.

Contraception – for men and women

For women being treated with Erivedge
Before starting treatment, ask your doctor whether you could become pregnant. Even if your menstrual cycle has stopped, it is essential to ask your doctor whether there is any risk that you could become pregnant.
If you could become pregnant:

• you must take precautions to prevent pregnancy during treatment with Erivedge
• you must use two methods of contraception: one highly effective method and one barrier method (see examples below)
• you must continue using 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 contraceptive method: consult your doctor to determine the two most suitable contraceptive methods for you.

Use a highly effective contraceptive method such as:

• long-acting contraceptive injection
• intrauterine device (“coil” or IUD)
• surgical sterilization

You must also always use a barrier method such as:

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

Your doctor will perform a pregnancy test:

• within 7 days before starting treatment, to confirm you are not already pregnant
• every month during treatment

You must inform your doctor immediately during treatment or within 24 months after taking the last dose of the medicine if:

• you suspect, for any reason, that your contraceptive method has failed
• your menstrual period stops
• you stop using contraceptive methods
• you need to change your contraceptive method

For men taking Erivedge
Erivedge may be present in semen. Always use a condom (with spermicide, if possible) during sexual intercourse with a female partner, even if you have had a vasectomy. The use of a condom is mandatory during treatment and for 2 months after taking the last dose of the medicine.
You must never donate sperm 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 your doctor has diagnosed you with an intolerance to certain sugars, contact them 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 exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
How to take this medicine
The recommended dose is one capsule daily.

• Swallow the capsule whole with a glass of water.
• Do not break, open, or chew the capsule, to avoid unintentional exposure to the capsule contents.
• Erivedge may be taken with or without food.

If you take more Erivedge than you should
If you take more Erivedge than you should, inform your doctor.
If you forget to take Erivedge
Do not take a double dose to make up for the missed dose; instead, take the next dose at the scheduled time.
If you stop taking Erivedge
Do not stop taking this medicine without first talking to your doctor, as this could compromise the effectiveness of the treatment.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, Erivedge may cause side effects, although not everyone experiences them.
Erivedge can cause severe birth defects. It may also cause death of the unborn or newborn baby. You must not become pregnant while taking this medicine (see section 2, "Do not take Erivedge", "Pregnancy", "Breast-feeding", and "Fertility").
Other side effects are listed below in order of severity and frequency.
If any of these side effects become serious, inform your doctor or pharmacist.
Very common (may affect more than 1 in 10 people):

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

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

• chest, back or side pain
• lack of energy or weakness (asthenia)
• fluid loss (dehydration)
• pain in muscles, tendons, ligaments or bones
• stomach pain
• loss of taste
• abnormal hair growth
• loss of eyelashes (madarosis)
• changes in blood tests, including increased liver test values or elevated creatine phosphokinase levels (a protein mainly present in muscles)

Frequency not known :

• Interruption of bone growth (premature closure of epiphyses)
• Early puberty (precocious puberty)
• Liver damage
• Severe skin reactions:
• target-like spots or circular red patches on the trunk, often with central blisters, skin peeling, ulcers in 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 beginning of treatment (generalized exanthematous pustulosis)

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 stated on the vial and on the outer carton after "Exp.". The expiry date refers to the last day of that month.
• Do not store above 30°C.
• Keep the vial tightly closed to protect the medicine from moisture.
• Do not dispose of any medicine via wastewater or household waste.
• At the end of treatment, return all unused capsules. This will prevent misuse of the medicine and help protect the environment. Speak to your pharmacist or doctor about where to return the medicine.

6. Package contents and other information

What Erivedge contains

• The active substance is vismodegib. Each hard capsule contains 150 mg of vismodegib.
• The other components are:
• Capsule contents: microcrystalline cellulose, lactose monohydrate, 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 the appearance of Erivedge and package contents
The capsules have an opaque pink body imprinted with "150 mg" and a grey cap imprinted with "VISMO" in black edible ink. They are available in bottles with child-resistant safety caps containing 28 capsules. Each package 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 about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
N.V. Roche S.A. UAB “Roche Lietuva”
Tél/Tel: +32 (0) 2 525 82 11 Tel: +370 5 2546799

България Luxembourg/Luxemburg
Рош България ЕООД (See/siehe Belgique/Belgien)
Тел: +359 2 818 44 44

Česká republika Magyarország
Roche s. r. o. Roche (Magyarország) Kft.
Tel: +420 - 2 20382111 Tel: +36 - 1 279 4500

Danmark Malta
Roche a/s (See Ireland)
Tlf: +45 - 36 39 99 99

Deutschland Nederland
Roche Pharma AG Roche Nederland B.V.
Tel: +49 (0) 7624 140 Tel: +31 (0) 348 438050

Eesti Norge
Roche Eesti OÜ Roche Norge AS
Tel: + 372 - 6 177 380 Tlf: +47 - 22 78 90 00

Ελλάδα Österreich
Roche (Hellas) A.E. Roche Austria GmbH
Τηλ: +30 210 61 66 100 Tel: +43 (0) 1 27739

España Polska
Roche Farma S.A. Roche Polska Sp.z o.o.
Tel: +34 - 91 324 81 00 Tel: +48 - 22 345 18 88

France Portugal
Roche Roche Farmacêutica Química, Lda
Tél: +33 (0) 1 47 61 40 00 Tel: +351 - 21 425 70 00

Hrvatska România
Roche d.o.o Roche România S.R.L.
Tel: +385 1 4722 333 Tel: +40 21 206 47 01

Ireland Slovenija
Roche Products (Ireland) Ltd. Roche farmacevtska družba d.o.o.
Tel: +353 (0) 1 469 0700 Tel: +386 - 1 360 26 00

Ísland Slovenská republika
Roche a/s Roche Slovensko, s.r.o.
c/o Icepharma hf Tel: +421 - 2 52638201
Sími: +354 540 8000

Italia Suomi/Finland
Roche S.p.A. Roche Oy
Tel: +39 - 039 2471 Puh/Tel: +358 (0) 10 554 500

Κύπρος Sverige
Γ.Α.Σταμάτης & Σια Λτδ. Roche AB
Τηλ: +357 - 22 76 62 76 Tel: +46 (0) 8 726 1200

Latvija United Kingdom (Northern Ireland)
Roche Latvija SIA Roche Products (Ireland) Ltd.
Tel: +371 - 6 7 039831 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 European Medicines Agency website.
As an integral part of the Erivedge Pregnancy Prevention Programme, all patients will receive a Patient Brochure.
Please refer to this document for further information.