Macugen

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

pegaptanib

Available from:

PharmaSwiss Ceska Republika s.r.o

ATC code:

S01LA03

INN (International Name):

pegaptanib

Therapeutic group:

Ophthalmologicals

Therapeutic area:

Wet Macular Degeneration

Therapeutic indications:

Macugen is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD).

Product summary:

Revision: 15

Authorization status:

Withdrawn

Authorization date:

2006-01-31

Patient Information leaflet

22
B. PACKAGE LEAFLET
Medicinal product no longer authorised
23
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MACUGEN 0.3 MG SOLUTION FOR INJECTION
Pegaptanib
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START YOUR TREATMENT
WITH THIS MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Macugen is and what it is used for
2.
What you need to know before you are given Macugen
3.
How you will be given Macugen
4.
Possible side effects
5.
How to store Macugen
6.
Contents of the pack and other information
1.
WHAT MACUGEN IS AND WHAT IT IS USED FOR
Macugen is a solution which is injected into the eye. Pegaptanib, the
active substance of this medicine,
inhibits the activity of the factor involved in the abnormal formation
of new blood vessels in the eye,
known as Vascular Endothelial Growth Factor
165
(VEGF
165
).
Macugen is used for the treatment of the wet form of age-related
macular degeneration (AMD). This
disease leads to vision loss resulting from damage to the central part
of the retina (called the macula),
at the back of the eye. The macula enables the eye to provide the fine
central vision that is needed for
activities such as driving a car, reading fine print and other similar
tasks.
In the wet form of AMD, abnormal blood vessels grow under the retina
and macula. These new blood
vessels may bleed and leak fluid, causing the macula to bulge or lift
up, thus distorting or destroying
central vision. Under these circumstances vision loss may be rapid and
severe. Macugen works by
inhibiting the growth of these abnormal blood vessels and by stemming
the bleeding and leakage. The
medicine is used for the treatment of all types of abnormal blood
vessels growth in adult AMD
patients.
2.
WHAT YOU NEED TO

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Macugen 0.3 mg solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One pre-filled syringe provides a usable amount to deliver a single
dose of 90 microlitres containing
pegaptanib sodium, corresponding to 0.3 mg of the free acid form of
the oligonucleotide.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection).
The solution is clear and colourless.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Macugen is indicated for the treatment of neovascular (wet)
age-related macular degeneration (AMD)
in adults (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Macugen should only be administered by ophthalmologists experienced in
intravitreal injections.
Posology
The patient’s medical history for hypersensitivity reactions should
be carefully evaluated prior to
performing the intravitreal procedure (see section 4.4).
The recommended dose is 0.3 mg pegaptanib, equivalent to 90
microliters, administered once every
six weeks (9 injections per year) by intravitreal injection into the
affected eye.
Following the injection, transient increases in intraocular pressure
were seen in Macugen treated
patients. Therefore, the perfusion of the optic nerve head and
intraocular pressure should be
monitored. Moreover patients should be closely monitored for vitreous
haemorrhage and
endophthalmitis in the two weeks following the injection. Patients
should be instructed to report any
symptoms suggestive of these conditions without delay (see section
4.4).
After 2 consecutive injections of Macugen, if a patient does not
demonstrate a treatment benefit (loss
of less than 15 letters of visual acuity) at the 12-week visit,
consideration should be given to stopping
or withholding Macugen therapy.
Special populations
_Elderly _
No special considerations are needed.
_Hepatic impairment _
Macugen has not been studied in patients with hepatic impa