Erivedge

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Vismodegib 150mg;  

Available from:

Roche Products (NZ) Ltd

INN (International Name):

Vismodegib 150 mg

Dosage:

150 mg

Pharmaceutical form:

Capsule

Composition:

Active: Vismodegib 150mg   Excipient: Gelatin Iron oxide black Iron oxide red Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opacode black S-1-17822 Opacode black S-1-17823 Povidone Purified talc Sodium laurilsulfate Sodium starch glycolate Titanium dioxide

Prescription type:

Prescription

Manufactured by:

Siegfried Ltd

Therapeutic indications:

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.

Product summary:

Package - Contents - Shelf Life: Bottle, plastic, HDPE with PP child resistant screw cap - 28 capsules - 36 months from date of manufacture stored at or below 30°C. Keep bottle tightly closed to protect from moisture

Authorization date:

2013-05-27

Patient Information leaflet

Erivedge 220812
1
CONSUMER MEDICINE INFORMATION
ERIVEDGE

_ _
_VISMODEGIB _
150 mg hard capsule
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

Summary of Product characteristics

1
Erivedge 220812
NEW ZEALAND DATA SHEET
ERIVEDGE
®
VISMODEGIB
1.
PRODUCT NAME
Erivedge 150 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains 150 mg of vismodegib.
Excipient with known effect:
Each hard capsule contains 71.5 mg lactose monohydrate per capsule.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Erivedge 150 mg capsules are hard gelatin capsules, with a pink opaque
body with “150mg”
printed in black ink and a grey opaque cap with “VISMO” printed in
black ink.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC 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.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
The recommended daily dose of Erivedge is 150 mg.
MISSED DOSE
If a planned dose of Erivedge is missed, patients should be instructed
not to take the missed
dose but to resume dosing with the next scheduled dose.
SPECIAL POPULATIONS
Elderly Patients
No dose adjustment is required in patients ≥ 65 year years of age
(see section 4.4).
Patients with Renal Impairment
No dose adjustment is required in patients with renal impairment (see
section 5.2).
2
Erivedge 220812
Patients with Hepatic Impairment
No dose adjustment is required in patients with hepatic impairment
(see section 5.2).
Paediatric Patients
The safety and efficacy of Erivedge in children and adolescents (<18
years) have not been
established.
METHOD OF ADMINISTRATION
Erivedge should be taken orally once a day, with or without food.
Capsules must be swallowed
whole with water and must not be opened or crushed under any
circumstances.
Erivedge should be continued until disease progression or until
unacceptable toxicity. In
patients where treatment is discontinued prior to progression,
patients should be monitored for
disease recurrence or worsening of disease.
DOSE MODIFICATIONS
Treatment can be interrupted for up to 8 weeks, t