OZURDEX dexamethasone 700 microgram intravitreal implant

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

dexamethasone, Quantity: 700 microgram

Available from:

Abbvie Pty Ltd

INN (International Name):

Dexamethasone

Pharmaceutical form:

Implant

Composition:

Excipient Ingredients: polyglactin

Administration route:

Intravitreal-Within The Vitreous Cavity Of The Eye

Units in package:

1 intravitreal implant

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

OZURDEX is indicated for the treatment of:,- Diabetic macular oedema (DME),- Macular oedema due to Branch Retinal Vein Occlusion (BRVO) or Central Retinal Vein Occlusion (CRVO).,- Non-infectious uveitis affecting the posterior segment of the eye. OZURDEX is indicated for the treatment of diabetic macular oedema (DME).

Product summary:

Visual Identification: Rod-shaped, solid implant in a single use applicator; Container Type: Dispenser Pack; Container Material: Other plastic laminate/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2015-06-04

Patient Information leaflet

OZURDEX
®
(dexamethasone) 700 µg intravitreal implant CMI V3.0 PI v5.0
1
OZURDEX
®
(DEXAMETHASONE) 700 ΜG INTRAVITREAL IMPLANT
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about OZURDEX
®
. 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 receiving
OZURDEX
®
against the benefits
they expect it will have for you.
If you have any concerns about
using this medicine, ask your doctor
or pharmacist.
KEEP THIS LEAFLET. You may need
to read it again.
WHAT OZURDEX
® IS USED FOR
OZURDEX
®
is contained within a
small implant injected into the back
of the eye by your doctor using a
specially designed applicator.
OZURDEX
®
is used to treat adult
patients with Diabetic Macular
Oedema (DME), which is a swelling
of the light-sensitive layer at the
back of the eye called the macula.
DME is a condition that affects
some people with diabetes.
OZURDEX
®
is used to treat vision
loss caused by a blockage of veins
in the eye. This blockage leads to a
build up of fluid causing swelling in
the area of the retina (the light-
sensitive layer at the back of the
eye) called the macula. The
swelling may lead to damage to the
macula which affects your central
vision which is used for tasks like
reading.
OZURDEX
®
is also used to treat
adult patients with Uveitis, which is
an inflammation affecting the
choroid (the layer of blood vessels
and connective tissue between the
white of the eye and retina at the
back of the eye). Uveitis is a
chronic disease with a high risk of
permanent vision loss.
The active ingredient in OZURDEX
®
is dexamethasone.
Dexamethasone belongs to a group
of medicines called corticosteroids.
OZURDEX
®
works by reducing the
swelling which helps to lessen or
prevent more damage to the
macula.
BEFORE YOU USE OZURDEX
®
_WHEN YOU MUST NOT USE IT _
Do not use OZURDEX
®
if:

you have an allergy to
dexamethasone o

Summary of Product characteristics

OZURDEX
®
Intravitreal implant PI v5.0 CCDS v7.0-8.0-9.0
1
AUSTRALIAN PRODUCT INFORMATION – OZURDEX
®
(DEXAMETHASONE) INTRAVITREAL IMPLANT
1
NAME OF THE MEDICINE
Dexamethasone
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
OZURDEX
®
is a biodegradable intravitreal implant containing 700 μg
dexamethasone in a
solid polymer drug delivery system (DDS).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Intravitreal implant
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
OZURDEX
®
is indicated for the treatment of:

Diabetic macular oedema (DME)
.

Macular oedema due to Branch Retinal Vein Occlusion (BRVO) or Central
Retinal
Vein Occlusion (CRVO).

Non-infectious uveitis affecting the posterior segment of the eye.
4.2
DOSE AND METHOD OF ADMINISTRATION
The safety and efficacy of OZURDEX
®
administered to both eyes on the same day has not
been studied; and is not recommended.
OZURDEX
®
must be administered by a qualified ophthalmologist, experienced in
intravitreal
insertions.
Treatment with OZURDEX
®
for diabetic macular oedema, macular oedema following BRVO
or CRVO, and non-infectious uveitis affecting the posterior segment of
the eye is 700 µg per
eye (entire contents of a single-use OZURDEX
®
device).
If, in the physician’s opinion, visual and anatomic parameters
indicate that the patient is not
benefitting from continued treatment, OZURDEX
®
should be discontinued.
OZURDEX
®
Intravitreal implant PI v5.0 CCDS v7.0-8.0-9.0
2
DME
In clinical trials, the majority of retreatments were administered
between 5 and 7 months after
a prior treatment (see
CLINICAL TRIALS
). Patients in the OZURDEX
®
arm of the pivotal
trials received an average of 4 implants over 3 years. The protocol in
the pivotal trials
specified a 6-monthly dosing interval. There is currently no
experience of the efficacy and
safety of repeat administrations in DME beyond 7 implants.
RVO AND UVEITIS
OZURDEX
®
should be used in BRVO or CRVO patients with reduced visual acuity
only
when other