Prospecto:Information for the Patient

Erivedge150Hard Capsules

vismodegib

Erivedge may cause severe congenital defects. It may cause the baby's death before birth or shortly after birth. Do not become pregnant while taking this medication. You must follow the contraceptive advice described in this prospectus.

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

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospectus. See section 4.

1.What is Erivedge and for what it is used

2.What you need to know before starting to take Erivedge

3.How to take Erivedge

4.Possible adverse effects

5.Storage of Erivedge

6.Contents of the package and additional information

What is Erivedge

Erivedge is a cancer medication 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 (known as metastatic basal cell carcinoma)
• Has spread to nearby areas (known as 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 these damaged cells into cancerous ones, starting to grow and divide. Erivedge is a cancer medication that acts 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.

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

Read carefully and follow the patient leaflet instructions given to you by your doctor.

Do not take Erivedge

• if you areallergicto vismodegib or any of the other components of this medication (listed in section 6).
• if you arepregnant, think you might be, or are planning to become pregnant during treatment or within 24 months after the last dose of this medication. This is because Erivedge can harm or kill the fetus.
• if you arebreastfeedingor plan to breastfeed during treatment or within 24 months after 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 theErivedge Pregnancy Prevention Program.
• if you are taking St. John's Wort (Hypericum perforatum): a plant-based medication used for depression (see “Taking Erivedge with other medications”).

More information on the above issues can be found in the sections “Pregnancy”, “Breastfeeding”, “Fertility” and “Contraception in men and women”.

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

Warnings and precautions

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

• Do not donate blood at any time during treatment or within 24 months after the last dose of this medication.
• If you are a man, do not donate semen at any time during treatment or within 2 months after the last dose.
• Severe skin reactions associated with Erivedge treatment have been reported. If you notice any of the symptoms described in section 4, stop taking Erivedge and see your doctor immediately.
• Do not give this medication to anyone else. You should return any 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 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 Erivedge treatment. Animal studies with this medication have shown problems with tooth and bone growth.

Other medications and Erivedge

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This also includes over-the-counter medications, vitamins, and herbal supplements.

Some medications may affect the way Erivedge works, or make it more likely to have side effects. Erivedge may also affect the way other medications work.

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 conditions, and especially
• St. John's Wort (Hypericum perforatum), a plant-based medication used for depression, as you should not take it with Erivedge

Pregnancy

Do not take Erivedge if you are pregnant, think you might be, or are planning to become pregnant during treatment or within 24 months after the last dose of this medication.

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

Erivedge can cause severe congenital defects. It can also cause fetal death. 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 within 24 months after the last dose of this medication. It is unknown if Erivedge passes into breast milk and can harm your baby.

Fertility

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

Contraception: for women and men

Forwomen taking Erivedge

Before starting treatment, consult your doctor if you can become pregnant. Even if you have stopped having menstrual periods, it is essential 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 methods of contraception, a highly effective method and a barrier method (please see examples below)
• You need to continue with contraceptive measures for 24 months after the last dose because Erivedge may remain in your body for up to 24 months after the last dose

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

Use a highly effective method, such as:

• injectable contraception
• intrauterine device (IUD)
• surgical sterilization

You should also use a barrier method, such as:

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

Your doctor will ensure 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 should inform your doctor immediately during treatment or within 24 months after your last dose of medication if:

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

Formen taking Erivedge

Erivedge may pass into semen. Always use a condom (preferably with spermicide), even after a vasectomy, when having sex with a woman. Do this during treatment and for 2 months after the last dose of this medication.

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

Driving and operating machinery

It is unlikely that Erivedge will affect your ability to drive or use tools or machinery. 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; it is essentially “sodium-free”.

Follow exactly the administration instructions for Erivedge as indicated by your doctor. If in doubt, consult again with your doctor or pharmacist.

Medication Taking

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 missed dose, but instead continue with the next scheduled dose.

If You Interrupt Treatment with Erivedge

Do not stop treatment with this medication without first consulting your doctor, 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.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Erivedge may cause severe congenital defects. It may also lead to the death of your baby before birth or shortly after birth. Do not become pregnant while taking this medicine (see section 2 “Do not take Erivedge” and “Pregnancy”, “Breastfeeding” and “Fertility”).

Other side effects are presented in order of severity and frequency

If any of the following side effects become severe, inform your doctor or pharmacist.

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

• loss of menstruation in fertile women
• loss of appetite and weight loss
• feeling of fatigue
• muscle spasms
• diarrhea
• hair loss (alopecia)
• eruption
• a change in the taste of things or total loss of taste
• constipation
• nausea or feeling of wanting to vomit
• stomach discomfort or indigestion
• joint pain
• general pain 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)
• dehydration
• muscle pain, in tendons, ligaments, or bones
• stomach pain
• loss of taste
• abnormal hair growth
• loss of eyelashes (madarosis)
• changes in blood tests, including elevated liver function tests or elevated creatine phosphokinase (a protein mainly from muscle)

Unknown frequency

• interruption of bone growth (premature epiphyseal fusion)
• premature puberty (precocious puberty)
• liver damage
• severe skin reactions:
• • round, red spots 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 inflamed lymph nodes (DRESS syndrome or drug hypersensitivity syndrome)
  • widespread, scaly, reddish rash with bumps under the skin and blisters accompanied by fever at the start of treatment (acute generalized pustular psoriasis).

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

• Keep this medication out of the sight and reach of children.
• Do not use this medication after the expiration date that appears on the bottle and on the packaging after CAD. The expiration date is the last day of the month indicated.
• Do not store at a temperature above 30°C.
• Keep the bottle perfectly closed to protect it from moisture.
• Medicines should not be thrown down the drains or into the sewer.
• When the treatment is finished, return all unused capsules. These measures will prevent misuse and help protect the environment. Ask your doctor or pharmacist where to return the medication.

Composition of Erivedge

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

Appearance of Erivedge and contents of the package

The capsules have a pink opaque body with the inscription “150mg” and a gray cap with the inscription “VISMO” in edible black ink. The available packaging is a child-resistant screw-top bottle containing 28 capsules. Each package contains a bottle.

Marketing Authorization Holder

Roche Registration GmbH

Emil-Barell-Strasse 1

79639 Grenzach-Wyhlen

Germany

Responsible Person

Roche Pharma AG

Emil‑Barell‑Strasse 1

D‑79639 Grenzach‑Wyhlen

Germany

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Last update of this leaflet:

Other sources of information

The detailed information on this medicine 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 part of the Erivedge Pregnancy Prevention Program, all patients will receive a patient leaflet.

Please consult this document for more information.