ERIVEDGE

Main information

  • Trade name:
  • ERIVEDGE vismodegib 150 mg hard capsule bottle
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ERIVEDGE vismodegib 150 mg hard capsule bottle
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 214475
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

214475

ERIVEDGE vismodegib 150 mg hard capsule bottle

ARTG entry for

Medicine Registered

Sponsor

Roche Products Pty Ltd

Postal Address

PO Box 255,DEE WHY, NSW, 2099

Australia

ARTG Start Date

3/12/2013

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. ERIVEDGE vismodegib 150 mg hard capsule bottle

Product Type

Single Medicine Product

Effective date

30/06/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

ERIVEDGE is indicated for the treatment of adult patients with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma where

surgery and/or radiation therapy are not appropriate.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Bottle

HDPE

36 Months

Store below 30

degrees Celsius

Child resistant closure

Keep Container

Tightly Closed/Airtight

Pack Size/Poison information

Pack Size

Poison Schedule

28 capsules

(S4) Prescription Only Medicine

Components

1. ERIVEDGE vismodegib 150 mg hard capsule blister pack

Dosage Form

Capsule, hard

Route of Administration

Oral

Visual Identification

Hard gelatin capsule, with a pink opaque body with 150mg printed in black

ink and a grey opaque cap with VISMO printed in black ink.

Active Ingredients

Vismodegib

150 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 19.10.2017 at 08:58:39 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet

ERIVEDGE

®

pronounced "EH-rih-vedge"

vismodegib

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about ERIVEDGE

capsules.

It does not contain all the available

information. It does not take the

place of talking to your pharmacist or

doctor.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you taking ERIVEDGE

against the benefits they expect it

will have for you.

If you have any concerns about

taking this medicine, ask your

pharmacist or doctor.

Keep this leaflet with the medicine.

You may need to read it again.

What ERIVEDGE is

used for

ERIVEDGE contains the active

ingredient vismodegib.

ERIVEDGE belongs to a group of

medicines called anti-neoplastic (or

anti-cancer) agents.

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) or

has spread to surrounding areas

(called "locally advanced" basal

cell carcinoma) and your doctor

has decided that treatment with

surgery or radiation is not

appropriate.

Surgery and radiation treatment may

not be appropriate because;

surgery will change the shape of a

body part (cause deformity)

with surgery, you may lose the

use of a body part such as an eye

or ear

the cancer has returned after

previous surgeries and further

surgery isn't likely to be

successful

radiation was previously

unsuccessful or you are not

suitable for radiation.

ERIVEDGE works by controlling a

key protein involved in this type of

cancer. ERIVEDGE may slow or

stop the cancer cells from growing,

or may kill them. As a result, your

skin cancer may shrink.

Research undertaken in the

development of ERIVEDGE utilised

cell lines derived from human

embryos.

Ask your doctor if you have any

questions about why this medicine

has been prescribed for you.

Your doctor may have given it for

another reason.

This medicine is not addictive.

This medicine is available only with

a doctor's prescription.

Before you take it

When you must not take it

Do not take ERIVEDGE if:

1.

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 the medicine.

You must not take this medicine

if you are pregnant or plan to

become pregnant.

ERIVEDGE may affect your

developing baby if you take it

during pregnancy. ERIVEDGE

may cause your baby to die

before it is born (stillborn) or

cause your baby to have severe

birth defects.

2.

you are a woman who is able to

have children but you are

unable or unwilling to use two

acceptable forms of birth

control (contraception) during

the course of treatment or

during the 24 months after your

final dose of the medicine.

Women able to have children

need to use two acceptable forms

of contraception so that a

pregnancy does not happen

during treatment and for 24

months after the final dose.

3.

you are breast-feeding or

intend to breast-feed in the

future

The active ingredient in

ERIVEDGE may pass into breast

milk and there is a possibility that

your baby may suffer serious

growth defects.

You must not breast-feed while

taking ERIVEDGE and for 24

months after the last dose.

4.

the package is torn or shows

signs of tampering

ERIVEDGE 170301

If the package is damaged, return

it to your pharmacist for disposal.

5.

the expiry date (EXP) printed

on the pack has passed.

If you take this medicine after the

expiry date has passed, it may not

work as well.

If you are not sure whether you

should start taking this medicine,

talk to your doctor.

Before you start to take it

Tell your doctor if:

1.

you plan to donate blood or

blood products during

treatment with ERIVEDGE or

you plan to do so in the future.

If a pregnant woman receives

your donated blood, the baby may

develop birth defects.

You must not donate blood

while taking ERIVEDGE and

for 24 months after your final

dose.

2.

you plan to donate sperm

during treatment with

ERIVEDGE or you plan to do

so in the future.

If a woman receives your donated

sperm, the baby may develop

birth defects.

You must not donate sperm

while taking ERIVEDGE and

for 2 months after your final

dose.

3.

you are allergic (hypersensitive)

to vismodegib or any of the

ingredients listed at the end of

this leaflet or allergic to any

other medicines, foods,

preservatives or dyes.

Some of the symptoms of an

allergic reaction may include:

shortness of breath

wheezing or difficulty breathing

swelling of the face, lips, tongue

or other parts of the body

rash, itching or hives on the skin.

If you have not told your doctor

about any of the above, tell him or

her before you start taking

ERIVEDGE.

Use in Children

ERIVEDGE should not be used in

children and adolescents. The safety

and effectiveness in people younger

than 18 years old have not been

established. Premature fusion of the

growth plates has been reported in

paediatric patients exposed to

ERIVEDGE. In some cases, fusion

progressed after drug

discontinuation.

Taking other medicines

Tell your doctor if you are taking

any other medicines, including any

that you have bought without a

prescription from a pharmacy,

supermarket or health food shop.

Tell your pharmacist or doctor if

you are taking antibiotics or any

herbal medicines (such as St.

John's wort), because they can

make female birth control

(contraception) less effective.

Some medicines may be affected by

ERIVEDGE, or may affect how well

it works. Your doctor will advise you

about this. Your doctor or pharmacist

has more information on medicines

to be careful with or avoid while

taking ERIVEDGE.

Ask your doctor or pharmacist if

you are not sure about any

medicine you are taking.

Fertility preservation

If you are a female patient and

want to have children after

treatment with ERIVEDGE, talk

to your doctor about fertility

preservation.

It is not known whether ERIVEDGE

causes infertility. In clinical trials,

some female patients no longer

experienced their menstrual period

after starting treatment.

How to take it

Follow all directions given to you

by your doctor or pharmacist

carefully.

They may differ from the

information contained in this leaflet.

How much to take

The recommended dose of

ERIVEDGE is one capsule once a

day.

How to take it

Swallow the capsules whole with a

full glass of water.

Do not crush, open or chew the

capsule.

ERIVEDGE can be taken with or

without food.

When to take it

Take ERIVEDGE at about the

same time each day.

Taking it at the same time each day

will have the best effect. It will also

help you remember when to take it.

How long to take it

Continue taking ERIVEDGE for

as long as your doctor tells you.

How long you will be treated with

ERIVEDGE depends on how you are

responding to treatment. Your doctor

will discuss this with you.

If you forget to take it

If you forget to take ERIVEDGE,

do not to take the missed capsule

but resume with the next scheduled

dose.

Do not take a double dose to make

up for the dose you missed.

If you are not sure what to do, ask

your doctor or pharmacist.

If you have trouble remembering

your dose, ask your pharmacist for

some hints.

ERIVEDGE 170301

If you take too much

(overdose)

Immediately telephone your doctor

or the Poisons Information Centre

(Australia - telephone 13 11 26;

New Zealand - telephone 0800 764

766 or 0800 POISON) for advice,

or go to Accident and Emergency

at the nearest hospital, if you think

that you or anyone else may have

taken too much ERIVEDGE. Do

this even if there are no signs of

discomfort or poisoning.

You may need urgent medical

attention.

Keep telephone numbers for these

places handy.

While you are taking it

Things you must do

If you are about to be started on

any new medicine, remind your

doctor and pharmacist that you

are taking ERIVEDGE.

Tell all doctors, dentists, and

pharmacists who treat you that

you are taking this medicine.

If you are going to have surgery,

tell the surgeon or anaesthetist that

you are taking this medicine.

Both men and women who are able

to have children need to take

precautions so that a pregnant

woman is not exposed to

ERIVEDGE. You need to do this

for 24 months after stopping

treatment if you are a woman and

for 2 months after stopping

treatment if you are a man.

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.

Talk to your doctor immediately if

you have unprotected sex or if you

think your contraception has

failed.

Women taking ERIVEDGE

Women who are able to have

children will need to show a

negative pregnancy test

(conducted under medical

supervision) before starting

treatment with ERIVEDGE.

You should then have a

medically-supervised

pregnancy test each month

during treatment.

Women who are able to get

pregnant must use two forms of

acceptable contraception (a

barrier and a non-barrier

form). This applies during

treatment and for 24 months

after your final dose.

Use one non-barrier form of

contraception from this list:

combination hormonal

contraceptives e.g. Yasmin, Yaz,

Levlen or vaginal ring e.g.

Nuvaring

progestogen-only oral

contraceptives e.g. Microlut,

Provera

subcutaneous hormonal implant

e.g. Jadelle, Implanon NXT,

Implanon

birth control patch

birth control injections e.g. Depo-

Provera

tubal sterilisation

vasectomy (surgery performed on

male partner)

intrauterine device (IUD e.g.

Copper TT38 Slimline,

Multiload-Cu375, Mirena).

In addition, use one barrier

form of contraception from this

list:

any male condom (with

spermicide, if available)

diaphragm (with spermicide, if

available).

Talk to your doctor straight away

if you become pregnant or think

that you may be pregnant.

If you have stopped menstruating

during the course of treatment you

must still use 2 forms of acceptable

contraception during treatment

and for 24 months after your last

dose.

Men taking ERIVEDGE

Always use a condom (with

spermicide, if available), when you

have sex during treatment and for

2 months after your final dose of

ERIVEDGE.

A vasectomy does not give enough

protection without a condom.

Talk to your doctor straight away

if your partner becomes pregnant

or thinks she is pregnant while you

are taking ERIVEDGE.

Do not donate sperm while taking

ERIVEDGE and for 2 months

after your final dose.

Talk to your doctor about the best

contraception for you.

Tell your doctor if, for any reason,

you have not taken ERIVEDGE

exactly as prescribed.

Otherwise, your doctor may think

that it was not effective and change

your treatment unnecessarily.

Tell your doctor if you feel

ERIVEDGE is not helping your

condition.

Be sure to keep all of your

appointments with your doctor so

that your progress can be checked.

Things you must not do

Do not stop taking ERIVEDGE or

change the dose without first

checking with your doctor.

Do not let yourself run out of

medicine over the weekend or on

holidays.

Do not take any other medicines

whether they require a

prescription or not without first

telling your doctor or consulting a

pharmacist.

Do not give ERIVEDGE to anyone

else even if they have the same

condition as you.

ERIVEDGE 170301

Things to be careful of

Be careful driving or operating

machinery until you know how

ERIVEDGE affects you.

It is not known if ERIVEDGE affects

your ability to drive or operate

machinery.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are taking

ERIVEDGE.

This medicine helps most people

with advanced basal cell carcinoma

but it may have unwanted side

effects.

All medicines can have side effects.

Sometimes they are serious, most of

the time they are not. You may need

medical attention if you get some of

the side effects.

Do not be alarmed by the following

lists of possible side effects. You

may not experience any of them.

Ask your doctor to answer any

questions you may have.

Tell your doctor if you notice any

of the following and they worry

you:

feeling sick, also called nausea

diarrhoea

constipation

vomiting

indigestion

stomach pain

feeling tired, also called fatigue

unusual weakness

weight loss

decreased appetite

a change in the way things taste

or a loss of taste

symptoms of dehydration, such as

dry or sticky mouth, low or no

urine output, urine looks dark

yellow, no tears or sunken eyes

muscle spasms

pain in your chest, back, side or

extremities (arms and legs)

muscle, tendon, ligament, joint or

bone pain

aching muscles, muscle

tenderness or weakness, not

caused by exercise

hair loss, also called alopecia

loss of eyelashes

abnormal hair growth

loss of menstrual periods.

ERIVEDGE may be associated with

abnormalities in your blood test

results.

The above list includes the more

common side effects of this

medicine.

Tell your doctor immediately or go

to Accident and Emergency at the

nearest hospital if you notice any of

the following:

shortness of breath

difficulty breathing, chest

tightness or wheezing

swelling of the face, lips, tongue

or other parts of the body

rash, itching or hives on the skin.

These are very serious side effects.

You may need urgent medical

attention.

Tell your doctor if you notice

anything that is making you feel

unwell, even if it is not on this list.

This is not a complete list of all

possible side effects. Others may

occur in some people and there may

be some side effects not yet known.

Ask your doctor or pharmacist if

you don't understand anything in

this list.

After using ERIVEDGE

Storage

Keep your capsules in a cool dry

place where the temperature stays

below 30°C.

Keep your capsules in the bottle,

with the cap tightly closed, until it

is time to take them.

If you take the capsules out of the

bottle they may not keep well.

Do not store ERIVEDGE or any

other medicine in the bathroom or

near a sink. Do not leave it on a

window sill or in the car.

Heat and dampness can destroy some

medicines.

Keep it where children cannot

reach it.

A locked cupboard at least one-

and-a-half metres above the

ground is a good place to store

medicines.

Disposal

If your doctor tells you to stop

taking this medicine or the expiry

date has passed, ask your

pharmacist what to do with any

medicine that is left over.

Product description

Availability

ERIVEDGE is available in a bottle of

28 capsules.

What it looks like

ERIVEDGE capsules have a pink

body with "150mg" printed in black

ink and a grey cap with "VISMO"

printed in black ink.

Ingredients

ERIVEDGE contains 150 mg of

vismodegib as the active ingredient.

It also contains the following inactive

ingredients:

cellulose - microcrystalline (460)

lactose

sodium lauryl sulphate

povidone

sodium starch glycollate

talc - purified (553)

magnesium stearate.

ERIVEDGE 170301

The capsule shell contains:

gelatin

titanium dioxide (171)

iron oxide red (CI77491, 172)

iron oxide black (CI77499, 172)

shellac (904).

This medicine does not contain,

sucrose, gluten, tartrazine or any

other azo dyes.

Manufacturer

ERIVEDGE is distributed in

Australia by:

Roche Products Pty Ltd

ABN 70 000 132 865

4 - 10 Inman Road

Dee Why NSW 2099

AUSTRALIA

Medical enquiries: 1800 233 950

Distributed in New Zealand by:

Roche Products (New Zealand)

Limited

PO Box 109113 Newmarket

Auckland 1149

NEW ZEALAND

Medical enquiries: 0800 656 464

Please check with your pharmacist

for the latest Consumer Medicine

Information.

Australian Registration Number:

AUST R 214475

This leaflet was prepared on 1 March

2017.

ERIVEDGE 170301

3-8-2018

Scientific guideline:  Vismodegib hard capsule 150 mg product-specific bioequivalence guidance, adopted

Scientific guideline: Vismodegib hard capsule 150 mg product-specific bioequivalence guidance, adopted

Vismodegib hard capsule 150 mg product-specific bioequivalence guidance

Europe - EFSA - European Food Safety Authority EFSA Journal

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