Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - erivedge

Document Subject

Generated Narrative: MedicinalProductDefinition mp488e3aaf4c4053ed6d0b296da5f0f508

identifier: http://ema.europa.eu/identifier/EU/1/13/848/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Erivedge 150 mg hard capsules

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-488e3aaf4c4053ed6d0b296da5f0f508

identifier: http://ema.europa.eu/identifier/EU/1/13/848/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - erivedge

Attesters

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

What Erivedge is Erivedge is an anti-cancer 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 areas nearby (called locally advanced basal cell carcinoma) and your doctor decides that treatment with surgery or radiation is inappropriate

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.

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.

Do not take Erivedge

• 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.

Warnings and precautions 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.

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:

• 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

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:

• 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.

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, 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.

Taking this medicine 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 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.

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 If any of these side effects become severe, tell your doctor or pharmacist.

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

• 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

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

• 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)

Frequency not known

• 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)

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 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.

What Erivedge contains

• 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)

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 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 any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien N.V. Roche S.A. T l/Tel: +32 (0) 2 525 82 Lietuva UAB Roche Lietuva
Tel: +370 5 2546

: +359 2 818 44 Luxembourg/Luxemburg (Voir/siehe Belgique/Belgien)

esk republika Roche s. r. o. Tel: +420 - 2 20382Magyarorsz g Roche (Magyarorsz g) Kft. Tel: +36 - 1 279 4Danmark Roche Pharmaceuticals A/S Tlf: +45 - 36 39 99 Malta (See Ireland) Deutschland Roche Pharma AG Tel: +49 (0) 7624 Nederland Roche Nederland B.V. Tel: +31 (0) 348 438Eesti Roche Eesti O
Tel: + 372 - 6 177 Norge Roche Norge AS Tlf: +47 - 22 78 90
Roche (Hellas) A.E.
: +30 210 61 66 sterreich Roche Austria GmbH Tel: +43 (0) 1 27Espa a Roche Farma S.A. Tel: +34 - 91 324 81 Polska Roche Polska Sp.z o.o. Tel: +48 - 22 345 18 France Roche T l: +33 (0) 1 47 61 40 Portugal Roche Farmac utica Qu mica, Lda Tel: +351 - 21 425 70 Hrvatska Roche d.o.o Tel: +385 1 4722 Rom nia Roche Rom nia S.R.L. Tel: +40 21 206 47 Ireland Roche Products (Ireland) Ltd. Tel: +353 (0) 1 469 0Slovenija Roche farmacevtska dru ba d.o.o. Tel: +386 - 1 360 26 sland
Roche Pharmaceuticals A/S c/o Icepharma hf S mi: +354 540 8Slovensk republika
Roche Slovensko, s.r.o. Tel: +421 - 2 52638Italia Roche S.p.A. Tel: +39 - 039 2Suomi/Finland Roche Oy
Puh/Tel: +358 (0) 10 554 K
. . & . : +357 - 22 76 62 Sverige Roche AB Tel: +46 (0) 8 726 1Latvija Roche Latvija SIA Tel: +371 - 6 7 039United Kingdom (Northern Ireland) Roche Products (Ireland) Ltd. Tel: +44 (0) 1707 366This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: