ERIVEDGE vismodegib 150 mg hard capsule bottle
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
24-08-2020
Public Assessment Report
(PAR)
19-10-2017
Active ingredient:
vismodegib, Quantity: 150 mg
Available from:
Roche Products Pty Ltd
INN (International Name):
Vismodegib
Pharmaceutical form:
Capsule, hard
Composition:
Excipient Ingredients: purified talc; iron oxide red; Gelatin; sodium starch glycollate; microcrystalline cellulose; titanium dioxide; iron oxide black; Shellac; lactose monohydrate; povidone; magnesium stearate; sodium lauryl sulfate
Administration route:
Oral
Units in package:
28 capsules
Prescription type:
(S4) Prescription Only Medicine
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.
Product summary:
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.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Authorization status:
Licence status A
Authorization date:
2013-12-03
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
Read the complete document
Summary of Product characteristics
AUSTRALIAN PRODUCT INFORMATION – ERIVEDGE
®
(VISMODEGIB)
Erivedge
200326
1
1.
NAME OF THE MEDICINE
Vismodegib
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Erivedge 150 mg hard capsule
For the full list of excipients, see section 6.1 List of excipients.
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
DOSAGE
The recommended daily dose of Erivedge is 150 mg.
Erivedge should be taken 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.
MISSED DOSE
If a 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 Special
warnings and precautions for use).
Paediatric Patients
The safety and efficacy of Erivedge in children and adolescents (<18
years) have not been
established.
Erivedge 200326
2
Patients with Renal Impairment
No dose adjustment is required in patients with renal impairment (see
section 5.2
Pharmacokinetic properties). Very limited data is available in
patients with severe renal
impairment. Patients with severe renal impairment should be carefully
monitored for adverse
reactions.
Patients with Hepatic Impairment
No dose adjustment is required in patients with hepatic i
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