ERIVEDGE 150 mg HARD CAPSULES

Introduction

Leaflet:information for the patient

Erivedge150mg hard capsules

vismodegib

Erivedge can cause serious birth defects. It can cause the death of the baby before or shortly after birth. You should not become pregnant while taking this medication. You must follow the contraceptive advice described in this leaflet.

Read the entire leaflet carefully before starting to take this medication, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Erivedge and what is it used for
2. What you need to know before taking Erivedge
3. How to take Erivedge
4. Possible side effects
5. Storage of Erivedge
6. Package contents and additional information

1. What is Erivedge and what is it used for

What is Erivedge

Erivedge is a medication for the treatment of cancer that contains the active ingredient vismodegib.

What is Erivedge used for

Erivedge is used to treat adults with a type of skin cancer known as 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 your doctor decides that you are not a candidate for surgery or radiation treatment

How Erivedge works

Basal cell carcinoma develops when the DNA of normal skin cells is damaged and the body cannot repair it. This damage can change the way certain proteins work in these cells and turn them into cancer cells, starting to grow and divide. Erivedge is a cancer medication that works by controlling one of the key proteins involved in basal cell carcinoma. This can reduce or stop the growth of cancer cells, or kill them. As a result, your skin cancer may decrease.

2. What you need to know before taking Erivedge

Read the specific instructions your doctor has given you, especially about the effects of Erivedge on the fetus.

Read carefully and follow the instructions in the patient leaflet your doctor has given you.

Do not take Erivedge

• if you are allergicto vismodegib or any of the other components of this medication (listed in section 6).
• if you are pregnant, think you may be pregnant, or plan to become pregnant during treatment or during the 24 months following the last dose of this medication. This is because Erivedge can harm or cause the death of the fetus.
• if you are breastfeedingor plan to breastfeed during treatment or during the 24 months following the last dose of this medication. This is because it is unknown if Erivedge passes into breast milk and can harm your baby.
• if you can become pregnant and cannot or do not want to follow the necessary pregnancy prevention measures mentioned in the Erivedge Pregnancy Prevention Program.
• if you are taking St. John's Wort (Hypericum perforatum): a herbal medicine used for depression (see "Taking Erivedge with other medications").

In the sections "Pregnancy", "Breastfeeding", "Fertility", and "Contraceptive methods in men and women" you can find more information on the above issues.

Do not take this medication if any of the above applies to you. If you have doubts, consult your doctor or pharmacist before taking Erivedge.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Erivedge if you have doubts about the information in this section:

• You must not donate blood at any time during treatment or during the 24 months following the last dose of this medication.
• If you are a man, you must not donate semen at any time during treatment or during 2 months after the last dose.
• Severe skin reactions have been reported with Erivedge treatment. If you notice any of the symptoms described in section 4, stop taking Erivedge and consult your doctor immediately.
• Never give this medication to anyone else. You must return unused capsules at the end of your treatment. Ask your doctor or pharmacist where to return them.

Children and adolescents

Erivedge is not recommended for use in children and adolescents under 18 years of age. This is because it is unknown if it is safe or effective in this age group. Erivedge may prevent bone growth and cause premature puberty (before 8 years in girls or 9 years in boys). This can occur even after stopping treatment with Erivedge. In animal studies with this medication, problems with tooth and bone growth were seen.

Other medications and Erivedge

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication. This also includes non-prescription medications, vitamins, and herbal remedies.

Some medications can affect the functioning of Erivedge or make it more likely that you will have side effects. Erivedge can also affect the functioning of other medications.

In particular, inform your doctor if you are taking any of the following medications:

• 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, which you should not take at the same time as Erivedge

Pregnancy

Do not take Erivedge if you are pregnant, think you may be pregnant, or plan to become pregnant during treatment or during the 24 months following the last dose of this medication.

You must stop treatment and inform your doctor immediately if: you have or think you have had a missed period, or if you have had abnormal menstrual bleeding or suspect you are pregnant. If you become pregnant during treatment with Erivedge, you must stop treatment and inform your doctor immediately.

Erivedge can cause serious birth defects. It can also cause the death of the fetus. Your doctor will give you specific instructions (the Erivedge Pregnancy Prevention Program), especially about the effects of Erivedge on unborn babies.

Breastfeeding

You should not breastfeed your baby during treatment or during the 24 months following the last dose of this medication. It is unknown if Erivedge can pass into breast milk and harm your baby.

Fertility

Erivedge may affect a woman's ability to have children. Some women who have taken Erivedge have stopped having their periods. If this happens to you, it is unknown if you will start having your periods again. Consult your doctor if you want to have children in the future.

Contraceptive methods: for women and men

For womentaking Erivedge

Before starting treatment, consult your doctor if you can become pregnant. Even if you have stopped having your periods, it is important to consult your doctor if there is any risk of becoming pregnant.

If you can become pregnant:

• you must take precautions to avoid becoming pregnant while taking Erivedge
• use 2 contraceptive methods, a highly effective method and a barrier method (see examples below)
• you need to continue with contraceptive measures during the 24 months following the last dose because Erivedge can remain in your body for up to 24 months after the last dose

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

Use a highly effective method, such as:

• contraceptive injection
• intrauterine device (IUD)
• surgical sterilization

You must also use a barrier method, such as:

• condom (preferably with spermicide)
• diaphragm (preferably with spermicide)

Your doctor will ensure that you have a pregnancy test:

• within a maximum of 7 days before starting your treatment, to ensure you are not pregnant
• every month during treatment

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

• you think, for any reason, that your contraceptive method has failed
• you have stopped having your periods
• you stop using contraceptive methods
• you need to change your contraceptive method

For mentaking Erivedge

Erivedge can pass into semen. You must always use a condom (preferably with spermicide), even after a vasectomy, when having sexual intercourse with a woman. Do this during treatment and during the 2 months following the last dose of this medication.

You must not donate semen at any time during treatment or during the 2 months following the last dose of this medication.

Driving and using machines

It is unlikely that Erivedge will affect your ability to drive or use tools or machines. Consult your doctor if you are unsure.

Erivedge contains lactose and sodium

The Erivedge capsule contains a type of sugar called lactose. If your doctor has told you that you have an intolerance to certain sugars, consult them before taking this medication.

This medication contains less than 23 mg of sodium (1 mmol) per capsule; this is essentially "sodium-free".

3. How to take Erivedge

Follow exactly the administration instructions of Erivedge indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Taking this medication

The recommended dose is one capsule per day.

• Swallow the capsule whole with a glass of water.
• Do not crush, open, or chew the capsule, to avoid accidental 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, consult 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 treatment with Erivedge

Do not stop treatment with this medication without consulting your doctor first, as it may make your treatment less effective.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

Erivedge can cause serious birth defects. It can also lead to the death of your baby before or shortly after birth. You should not become pregnant while taking this medication (see section 2 "Do not take Erivedge" and "Pregnancy", "Breastfeeding", and "Fertility").

Other side effects are listed in order of severity and frequency

If any of the following side effects become serious, tell your doctor or pharmacist.

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

• loss of menstruation in women of childbearing age
• loss of appetite and weight loss
• feeling tired
• muscle spasms
• diarrhea
• hair loss (alopecia)
• rash
• change in taste or complete loss of taste
• constipation
• nausea or vomiting
• 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 side pain
• lack of energy or weakness (asthenia)
• loss of body water (dehydration)
• muscle, tendon, ligament, or bone pain
• stomach pain
• loss of taste
• abnormal hair growth
• loss of eyelashes (madarosis)
• changes in blood tests, including increased liver function tests or increased creatine phosphokinase (a protein mainly from muscle)

Frequency not known

• Disruption of bone growth (premature epiphyseal closure)
• Premature puberty (precocious puberty)
• Liver damage
• Severe skin reactions:
• • red, rounded, or circular patches on the trunk, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. Skin reactions are usually preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
  • widespread rash, fever, and swollen lymph nodes (DRESS or drug hypersensitivity syndrome)
  • widespread red, scaly rash with bumps under the skin and blisters accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis).

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are side effects not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Erivedge

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date stated on the bottle and packaging after EXP. The expiration date is the last day of the month indicated.
• Do not store above 30°C.
• Keep the bottle tightly closed to protect it from moisture.
• Medications should not be disposed of through wastewater or household waste.
• When you finish treatment, return all unused capsules. These measures will prevent misuse and help protect the environment. Ask your doctor or pharmacist about where to return the medication.

6. Container contents and additional information

Composition of Erivedge

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

Appearance of Erivedge and container contents

The capsules have a pink opaque body with the inscription “150 mg” and a gray cap with the inscription “VISMO” in edible black ink. The available containers are child-resistant screw-cap bottles containing 28 capsules. Each container contains one bottle.

Marketing authorization 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

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Date of the last revision of this prospectus:

Other sources of information

Detailed information about this medication is available on the European Medicines Agency website: http://www.ema.europa.eu.

This prospectus can be found in all languages of the European Union/European Economic Area on the European Medicines Agency website.

As part of the Erivedge Pregnancy Prevention Program, all patients will receive a patient leaflet.

Please consult this document for more information.