Patient Medication Information: uses, side effects, how to take - Macugen
ABOUT THIS MEDICATION
What the medication is used for:
MACUGEN is an ophthalmic product, which means it is for eye treatment only. It is a solution for injection contained within a glass syringe. Your eye doctor will administer the injection.
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 driving a car, reading fine print and other similar tasks.
What it does:
In the wet form of AMD, abnormal blood vessels (known as choroidal neovascularization, or CNV) 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. MACUGEN is used for the treatment of subfoveal CNV in AMD patients.
When it should not be used:
If you are hypersensitive (allergic) to pegaptanib sodium or any of the other ingredients of MACUGEN (see list of other ingredients under MACUGEN 0.3 mg).
What the medicinal ingredient is:
The active substance is pegaptanib sodium. Each syringe contains 0.3 mg of pegaptanib sodium.
What the important nonmedicinal ingredients are:
The other ingredients are sodium chloride, sodium phosphate monobasic monohydrate, sodium phosphate dibasic heptahydrate, sodium hydroxide, hydrochloric acid and water for injections.
What dosage forms it comes in:
MACUGEN is a solution for injection contained within a glass syringe.
Staked needle syringe: Each box of MACUGEN contains one syringe (with a pre-fitted needle) inside a sealed pouch. A plastic plunger and a snap-on flange, that are used by your doctor when injecting the medicine, are contained within a separate pouch inside the box.
Luer Lock syringe: Each pack contains a pouch in a carton, containing a 1 ml pre-filled syringe, Type I glass, sealed with a plastic plunger stopper and a pre-attached plunger rod, held by a plastic clip. The syringe has a pre-attached plastic luer lock adaptor and the tip is sealed with a tip cap. The pack is supplied without a needle.
The syringe will be used once and then thrown away.
WARNINGS AND PRECAUTIONS
BEFORE MACUGEN is used, tell your doctor if:
- You have an eye infection in or around the eye.
- You suffer from liver or kidney problems (reduced function) or if you have to undergo haemodialysis treatment, because MACUGEN has not been studied in patients with these problems.
You are pregnant or breastfeeding. There is no experience of using MACUGEN in pregnant or breast-feeding women. Discuss with your doctor if you are pregnant or planning to become pregnant or breast-feed.
- You are taking or have recently taken any other medicines - including nonprescription (OTC [over-the-counter), or natural health products.
PROPER USE OF THIS MEDICATION
How the injection of MACUGEN is administered:
All injections of MACUGEN will be administered by your eye doctor.
Before the treatment is given your eye doctor may ask you to use antibiotic eye drops, or to wash your eyes carefully. Please follow these instructions carefully.
Before the injection, your eye doctor will give you some local anaesthetic (numbing medication). After that you should not feel the injection, which is a simple and rapid procedure. The injection is given into the vitreous of the eye, which is the jelly-like substance inside the eye.
MACUGEN is administered as a single injection into your eye at intervals of 6 weeks (ie. 9 times per year). Your eye doctor will schedule follow-up appointments to monitor your condition and will decide on the duration of treatment.
Read all of this leaflet carefully before your treatment with MACUGEN begins.
- Keep this leaflet. You may need to read it again.
- If you have further questions, please ask your doctor or your pharmacist.
- This medicine has been prescribed for you and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.
After each injection you might be asked to use antibiotic eye drops (or another type of antibiotic treatment) to guard against eye infection.
If you forget to attend an appointment:
Contact the hospital or clinic as soon as possible to re-schedule your appointment.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Like all medicines, MACUGEN can have side effects. During clinical trials, the following side effects were recorded in the treated eye, most probably caused by the injection procedure (rather than by MACUGEN).
Side effects associated with the eye:
- eye infection
- increased or decreased intraocular pressure (pressure inside the eye)
- risk of a lasting increased pressure inside the eye after repeated injection in the eye
- inflammation, irritation, discomfort, periorbital bleeding,
- conjunctival swelling, inflammation or haemorrhage (bloodshot eye),
- small particles in the field of vision (vitreous floaters or opacities)
- pupillary enlargement, eye strain
- bleeding, displacement or tear of the retina
- bleeding or displacement of the vitreous
- macular degeneration
- decreased vision
- cataract (clouding of the lens)
- eye movement disorder or disorder of the surface of the eye (cornea)
- increased sensitivity to light or appearance of flashing lights
- eyelid irritation, swelling, inflammation or drooping
- discharge, tear formation or dry eye
- lack of blood circulation to the retina
If you suffer any of the above, consult your (eye) doctor promptly.
If your eye doctor is not accessible for any reason, an alternate should be contacted immediately especially if you experience the following symptoms: increased eye discomfort, bloodshot eye, decreased vision, increased sensitivity to light or vitreous floaters.
Other side effects:
- headache
- nasal discharge
In some rare cases, serious allergic reaction has been reported soon after the injection. Please seek immediate medical help if you experience any of the following soon after the injection: sudden onset of breathing difficulty or wheezing, swollen mouth, face, hands or feet, itching skin, fainting, rapid pulse, stomach cramps, nausea, vomiting and diarrhoea.
Driving and using machines: You may experience temporary visual blurring after receiving MACUGEN. If you are affected you should not drive or use machines until this resolves.
If these or other side effects not mentioned in this leaflet are bothersome, please consult your eye doctor or pharmacist.
HOW TO STORE IT
Keep MACUGEN out of the reach and sight of children.
MACUGEN should be stored at 2 C-8 C (in a refrigerator).
Do not freeze.
Store in the original box. Do not use after the expiry date on the box.
REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways: --------------------------------------------------------------------------
Canada Vigilance Program Health Canada Postal Locator 0701D Ottawa, Ontario K1A 0K9 Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect. NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice. |
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found at:
http://www.pfizer.ca or by contacting the sponsor, Pfizer Canada Inc., at 1-800-463-6001 (Medical Information).
Last revised: September 25 2013
TM (OSI) Eyetech, Inc.,
Pfizer Canada Inc., licensee
© Pfizer Canada Inc., 2013