Erivedge ® 150 mg Capsules

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. Erivedge contains the active substance vismodegib. 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.

Your doctor will counsel you on the Erivedge Pregnancy Prevention Programme. You and your partner will be required to sign the Verification of Counselling form to acknowledge that you have understood the conditions of use.

Do not take Erivedge

• if you are allergic to vismodegib or any of the other ingredients of 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. This is because Erivedge may harm or cause the death of your unborn baby.
• if you are breastfeeding or plan to breastfeed during the course of treatment or during the 24 months after your final dose of this medicine.
• 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 “Taking other medicines with Erivedge”). More information on the issues above is found in the sections “Pregnancy, breastfeeding and fertility” and “Contraception – for men and women”.

Do not take Erivedge if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking Erivedge.

Take special care with Erivedge

• You should not donate blood at any time during treatment and for 24 months after your final dose of Erivedge.
• If you are male, you should not donate semen at any time during treatment and for 6 months after the final dose.
• Your doctor will check your skin regularly for a type of cancer called “cutaneous squamous cell carcinoma’ (cuSCC). It is not known if cuSCC is related to treatment with Erivedge. Usually this type of lesion appears on sun-damaged skin, remains local and can be cured. Tell your doctor in case you notice any changes in your skin.
• Never give Erivedge 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 unused capsules.

Use in children

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. Problems with growing teeth and bones were seen in animal studies with Erivedge.

Do not share medicines prescribed for you with any other person. Always take Erivedge exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. 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.

Erivedge can cause side effects. Not all side effects reported for Erivedge are included in this leaflet. Should your general health worsen while taking Erivedge, consult your doctor, pharmacist or other healthcare professional for advice. 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 sections “Do not take Erivedge” and “Pregnancy, breastfeeding and fertility”).

Other side effects are presented in order of severity and frequency:

Frequent:

• loss of monthly periods in women of childbearing age,
• loss of appetite and weight loss,
• feeling tired,
• muscle spasm,
• diarrhoea,
• hair loss (alopecia),
• a change in the way things taste or the complete loss of taste,
• constipation,
• vomiting or feeling like you want to vomit (nausea),
• joint pain,
• itchiness.

Less frequent:

• pain (in general) or pain in your arms, legs, chest, back or side,
• lack of energy or weakness (asthenia),
• loss of water from the body (dehydration),
• muscle, tendon, ligament, bone pain,
• stomach pain, upset stomach or indigestion,
• rash,
• loss of taste,
• abnormal hair growth,
• eyelashes falling out (madarosis)
• changes in blood tests, which include increased values in liver tests or decreased values in sodium.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

• Store this medicine out of the 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.

• Store at or below 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 Erivedge.