IMLYGIC talimogene laherparepvec one million PFU/mL injection solution vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

talimogene laherparepvec

Available from:

Amgen Australia Pty Ltd

INN (International Name):

talimogene laherparepvec

Authorization status:

Registered

Patient Information leaflet

IMLYGIC™
(IMM LY JIK)
_talimogene laherparepvec (tal im' oh jeen la her" pa rep' vek)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Imlygic. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using Imlygic against
the benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
USING THIS MEDICINE, ASK YOUR
DOCTOR, NURSE OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT IMLYGIC IS USED
FOR
Imlygic is used to treat a type of skin
cancer called melanoma that has
spread in the skin and/or to the
lymph nodes
Imlygic contains a weakened form of
herpes simplex virus type-1 (HSV-1),
which is commonly called the cold
sore virus. The virus has been altered
to be able to make GM-CSF
(Granulocyte-Macrophage Colony-
Stimulating Factor), a protein which
helps your body's immune system
recognise and destroy tumours.
When Imlygic is injected into
tumours it destroys the melanoma.
Imlygic also helps your immune
system to destroy melanoma
throughout your body.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is available only with
a doctor's prescription.
BEFORE YOU ARE GIVEN
IMLYGIC
_WHEN YOU MUST NOT BE GIVEN_
_IT_
DO NOT HAVE IMLYGIC IF YOU HAVE AN
ALLERGY TO:
•
any medicine containing
talimogene laherparepvec
•
any of the ingredients listed at the
end of this leaflet.
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 .
DO NOT HAVE THIS MEDICINE IF YOU
HAVE A:
•
severely lowered immunity
DO NOT HAVE IMLYGIC AFTER THE
EXPIRY DATE PRINTED ON THE PACK.
DO NOT HAVE IMLYGIC IF THE
PACKAGING IS TORN OR SHOWS S

Summary of Product characteristics

IMLYGIC (TALIMOGENE LAHERPAREPVEC) PRODUCT INFORMATION
PAGE 1 OF 25
20190123 IMLYGIC PRODUCT INFORMATION
AUSTRALIAN PRODUCT INFORMATION – IMLYGIC

(TALIMOGENE LAHERPAREPVEC)
1.
NAME OF THE MEDICINE
talimogene laherparepvec (rmv).
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Talimogene laherparepvec is attenuated herpes simplex virus type-1
(HSV-1) derived by
functional deletion of 2 genes (ICP34.5 and ICP47) and insertion of
coding sequence for
human granulocyte macrophage colony-stimulating factor (GM-CSF) (see
Section 5.1,
Pharmacodynamic properties, Mechanism of action).
Talimogene laherparepvec is produced in vero cells by recombinant DNA
technology.
Each single-use vial contains 1 mL deliverable volume of IMLYGIC at a
nominal
concentration of 1 x 10
6
(1 million) PFU/mL or 1 x 10
8
(100 million) PFU/mL IMLYGIC.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
IMLYGIC is a sterile, preservative free solution for intralesional
injection.
Following thaw the liquid is clear to semi-translucent (10
6
Plaque forming units
(PFU)/mL) or semi-translucent to opaque (10
8
PFU/mL) and may contain white, visible,
variously shaped, virus-containing particles.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
IMLYGIC is indicated as monotherapy for the treatment of melanoma in
patients with
unresectable cutaneous, subcutaneous or nodal lesions after initial
surgery.
4.2
DOSE AND METHOD OF ADMINISTRATION
Dosage (dose and interval)
IMLYGIC is administered by intralesional injection into cutaneous,
subcutaneous, and/or
nodal lesions that are visible, palpable, or detectable by ultrasound
guidance.
IMLYGIC (TALIMOGENE LAHERPAREPVEC) PRODUCT INFORMATION
PAGE 2 OF 25
20190123 IMLYGIC PRODUCT INFORMATION
_Recommended dose and schedule _
THE TOTAL INJECTION VOLUME FOR EACH TREATMENT VISIT SHOULD BE UP TO A
MAXIMUM OF
4 ML. The initial recommended dose is up to a maximum of 4 mL of
IMLYGIC at a
concentration of 10
6
(1 million) PFU/mL. Subsequent doses should be administered up
to 4