150 mg hard capsules 
vismodegib

Erivedge can cause serious malformations. This can lead to the baby dying before birth or shortly after birth. You must not become pregnant while taking this medicine. You must follow the advice on the use of contraceptives described in this leaflet.

Read all of this leaflet carefully before you start taking this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In 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 packaging and other information 

1. What Erivedge is and what it is used for


What Erivedge is

Erivedge is a 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 cancer:

  • has spread to other parts of the body (called “metastatic” basal cell carcinoma )
  • has spread to surrounding areas (called “locally advanced” basal cell carcinoma ) and your doctor decides that treatment with surgery or radiation is not appropriate.

How Erivedge works

Basal cell carcinoma develops when DNA in normal skin cells is damaged, and the body cannot repair the damage. This damage can change the way certain proteins in these cells work and the damaged cells become cancerous and begin to grow and divide. Erivedge is a cancer drug that works by controlling one of the major proteins involved in basal cell carcinoma. This can slow down or stop the growth of the cancer cells, or can kill them. As a result, your skin cancer may shrink.

2. What you need to know before taking Erivedge

Read the specific instructions given to you by your doctor, especially about the effect of Erivedge on the fetus.

Read carefully and follow the instructions in the patient brochure that you received from 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 treatment or for 24 months after your last dose of the medicine. This is because Erivedge can harm or cause your fetus to die.
  • if you are breast-feeding or plan to breast-feed during treatment and for 24 months after your last dose of the medicine. This is because it is not known if Erivedge can pass into breast milk and harm your baby.
  • if you may be pregnant but are unable or unwilling to take the necessary pregnancy avoidance measures listed in the Erivedge Pregnancy Prevention Program ;
  • if you are also taking St. John’s wort (Hypericum perforatum ) – an herbal medicine used for mild depression (see “Other medicines and Erivedge”).

More information on the above topics can be found in the sections “Pregnancy, breast-feeding and fertility” and “Contraceptives 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 cautions

Talk to your doctor or pharmacist before taking Erivedge if you have any questions about the information in this section:

  • You should not donate blood at any time during treatment and within 24 months after the last dose of this medicine.
  • If you are a man, do not donate semen at any time during treatment or within 2 months after the last dose.
  • Serious skin reactions have been reported 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. Return unused capsules after treatment. Talk to your doctor or pharmacist about where to return the capsules.

Children and young people

The use of Erivedge in children and adolescents under 18 years of age is not recommended. This is because it is not known if it is safe and effective in people in this age group. Erivedge can cause the skeleton to stop growing and lead to premature puberty (before the age of 8 in girls and before the age of 9 in boys). This can happen even after stopping treatment with Erivedge. Problems with tooth growth and bone growth have been seen in animal studies with this drug.

Other drugs and Erivedge

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This also includes over-the-counter medicines, vitamins, and herbal medicines.

Some medicines may affect the way Erivedge works, or make you more likely to get side effects. Erivedge may also affect the way some other medicines work. 
Tell your doctor in particular if you are taking any of the following medicines:

  • rifampicin, – used against bacterial infections,
  • carbamazepine, phenytoin – used for epilepsy ,
  • ezetimibe and statins, such as – atorvastatin, fluvastatin, pravastatin, rosuvastatin, simvastatin – are used for high cholesterol,
  • bosentan , glibenclamide, repaglinide, valsartan,
  • topotecan – used to treat certain types of cancer,
  • sulfasalazine – used against certain types of inflammatory diseases, and in particular,
  • St. John’s wort (Hypericum perforatum) – a natural remedy used for mild depression, as you may not use it with Erivedge.

Pregnancy, breastfeeding, and fertility

Pregnancy 
Do not take Erivedge if you are pregnant, think you may be pregnant or are planning to have a baby during treatment, or for 24 months after your last dose of this medicine.

You must stop treatment and contact your doctor immediately if: you have missed or think you have missed a period, or if you have unusual menstrual bleeding, or if you suspect you may be pregnant. If you become pregnant during treatment with Erivedge, you must stop treatment and contact your doctor immediately.

Erivedge can cause serious malformations. It can also lead to the death of the fetus. Special Instructions (Erivedge Pregnancy Prevention Program),

will be given to you by your doctor with information specifically regarding the Erivedge effect on the fetus.

Breast-feeding 
Do not breastfeed during treatment or for 24 months after your last dose of this medicine.

It is not known if Erivedge can pass into breast milk and harm your baby.

Fertility 
Erivedge can affect a woman’s ability to have children. Menstruation has stopped for some women taking Erivedge. If this happens to you, it is not known if menstruation will return. Consult a doctor if you want to have children later.

Contraceptives – for men and women

For women taking Erivedge 
Before starting treatment, ask your doctor if you may become pregnant. Even if your period has stopped, it is important to ask your doctor if there is a risk that you may become pregnant.

If you can get pregnant:

  • you need to take steps to avoid getting pregnant while taking Erivedge
  • use 2 contraceptive methods, – a highly effective method and a barrier method (see examples below)
  • you need to continue taking contraceptives for 24 months after your last dose of this medicine – as Erivedge may remain in your body for up to 24 months after your last dose.

Recommended contraceptive methods: Talk to your doctor about the best two contraceptive methods for you.

Use a highly efficient method, such as:

  • a depot injection of contraceptives
  • an intrauterine insert (“a coil” or IUD)
  • surgical sterilization.

You must also use a barrier method, such as:

  • a condom (with spermicide, if available)
  • a pessary (with spermicides, if available).

Your doctor will ensure that you undergo pregnancy tests:

  • within a maximum of 7 days before starting treatment – to make sure you are not already pregnant
  • every month during treatment.

You must tell your doctor immediately during treatment or for 24 months after your last dose of this medicine about:

  • you think your contraceptive has not worked for some reason,
  • your period ends,
  • you stop using contraception,
  • you need to change contraceptives.

For men taking Erivedge 
Erivedge can pass to the semen. Always use a condom (with spermicide, if available), even after sterilization (vasectomy), when you have sex with a female partner. Do this during treatment and within 2 months after the last dose of one of these medicines.

You should not donate sperm at any time during treatment or within 2 months after the last dose of this medicine.

Driving and using machines

Erivedge probably does not affect your ability to drive and use tools or machines. Talk to your doctor if you are unsure.

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, ie essentially ‘sodium-free’.

3. How to take Erivedge

Always take Erivedge exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Take this medicine

The recommended dose is one capsule daily.

  • Swallow the capsule whole with a glass of water.
  • To avoid involuntary exposure to the capsule contents, do not crush, open or chew the capsule.
  • 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 continue with the next scheduled dose.

If you stop taking Erivedge

Do not stop taking this medicine without talking to your doctor first as it may make your treatment less effective.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Erivedge can cause side effects, although not everybody gets them.

Erivedge can cause serious malformations. It can also lead to the baby dying 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 presented according to severity and frequency:

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

  • fertile women may miss menstruation,
  • decreased appetite or weight loss,
  • feeling tired,
  • muscle spasms,
  • diarrhea,
  • hair loss ( alopecia ),
  • rash,
  • taste changes or complete loss of taste,
  • constipation,
  • vomiting or nausea,
  • upset stomach or digestive problems,
  • joint pain,
  • pain (general) or pain in your arms, legs
  • itching.

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

  • chest, back or side pain,
  • energy deficiency or weakness ( asthenia ),
  • loss of water ( dehydration ),
  • pain in muscles, tendons, ligaments, bones,
  • magnet
  • loss of taste,
  • abnormal hair growth,
  • eyelashes fall off (madarosis),
  • changes in blood samples which includes increased values ​​in liver samples and increased values ​​for creatine phosphokinase (a protein mainly from the muscles).

No known frequency

  • The skeleton stops growing (early closure of epiphyses)
  • Early puberty
  • Liver damage
  • Severe skin reactions:
    • Reddish target-like spots or round spots often with central blisters on the torso, skin flaking, sores 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 enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
    • A red, scaly, widespread rash with bumps under the skin and blisters accompanied by fever at the start of treatment ( acute generalized exanthematous pustulosis ).

Reporting of side effects

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 can and carton after EXP. That.
  • The expiration date is the last day of the specified month.
  • Do not store above 30 ° C.
  • Close the jar tightly. Moisture sensitive.
  • Medicines should not be disposed of via wastewater or household waste.
  • After finishing the treatment, return all remaining capsules. These measures are to prevent improper use and to protect the environment. Ask your pharmacist or doctor where you can return the medicine.

6. Contents of the packaging and other information

What Erivedge contains

  • The active substance is vismodegib. Each hard capsule contains 150 mg of vismodegib.
  • Other ingredients are Capsule contents: microcrystalline cellulose, lactose monohydrate, sodium lauryl sulfate, povidone (K29 / 32), sodium starch glycolate (Type A), talc, and magnesium stearate.
  • Capsule shell: red iron oxide (E172), black iron oxide (E172), titanium dioxide, gelatin,
  • Printing ink: shellac and black iron oxide (E172).

What Erivedge looks like and the contents of the pack

The capsules have a pink opaque lower part marked “150 mg” and a gray upper part marked “VISMO” with black edible ink. They are available in jars with a childproof closure containing 28 capsules. Each package contains a jar.

Marketing Authorization Holder and Manufacturer

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 Wahlen

Germany

Contact the representative of the marketing authorization holder to find out more about this medicine:

België / Belgique / Belgien 
N.V. Roche SA 
Tel: +32 (0) 2 525 82 11
Lithuania 
UAB “Roche Lithuania” 
Tel: +370 5 2546799
България 
Рош България ЕООД 
Тел: +359 2 818 44 44
Luxembourg / Luxemburg 
(See / see Belgique / Belgien)
Czech Republic 
Roche sro 
Tel: + 420-2 20382111
Magyarország 
Roche (Magyarország) Kft. 
Tel: + 36-23 446 800
Danmark 
Roche a / s 
Tel: + 45-36 39 99 99
Malta 
(See Ireland)
Germany 
Roche Pharma AG 
Tel: +49 (0) 7624 140
Netherlands 
Roche Netherlands BV 
Tel: +31 (0) 348 438050
Eesti 
Roche Eesti OÜ 
Tel: + 372-6 177 380
Norge 
Roche Norge AS 
Tel: + 47-22 78 90 00
Roλλάδα 
Roche (Hellas) AE 
Τηλ: +30 210 61 66 100
AustriaRoche Austria GmbHTel: +43 (0) 1 27739
Spain 
Roche Farma SA 
Tel: + 34-91 324 81 00
Polska 
Roche Polska Sp.z oo 
Tel: + 48-22 345 18 88
France 
Roche 
Tel: +33 (0) 1 47 61 40 00
Portugal 
Roche Pharmaceutical Pharmacy, Lda 
Tel: + 351-21 425 70 00
Hrvatska 
Roche doo 
Tel: + 385 1 47 22 333
România 
Roche România SRL 
Tel: +40 21 206 47 01
Ireland 
Roche Products (Ireland) Ltd. 
Tel: +353 (0) 1 469 0700
SloveniaRoche pharmaceutical company dooTel: + 386-1 360 26 00
Iceland 
Roche a / s 
c / o Icepharma hf 
Phone: +354 540 8000
Slovak Republic 
Roche Slovensko, sro 
Tel: + 421-2 52638201
Italia 
Roche SpA 
Tel: + 39-039 2471
Suomi / Finland 
Roche Oy 
Puh / Tel: +358 (0) 10 554 500
Γ.Γ.Σταμάτης 
& Λια Λτδ. 
:Ηλ: + 357-22 76 62 76
Sverige 
Roche AB 
Tel: +46 (0) 8 726 1200
Latvija 
Roche Latvija SIA 
Tel: + 371-6 7039831
United Kingdom 
Roche Products Ltd. 
Tel: +44 (0) 1707 366000

Muhammad Nadeem

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