Macugen (pegaptanib) – Package leaflet - S01LA03

Updated on site: 08-Oct-2017

Medication nameMacugen
ATC CodeS01LA03
ManufacturerPharmaSwiss Ceska Republika s.r.o

Package Leaflet: Information for the patient

Macugen 0.3 mg solution for injection


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 Factor165 (VEGF165).

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 know before you are given Macugen

You must not be given Macugen:

If you are allergic to pegaptanib or any of the other ingredients of this medicine (listed in section 6). If you have an active or suspected infection in or around the eye.

Warnings and precautions

Talk to your doctor before you are given Macugen.

Occasionally, an infection or bleeding in the eye can occur after Macugen injection (in the next two weeks). It is important to identify and treat these types of conditions as soon as possible. Please tell your doctor immediately if you notice any of the following symptoms: eye pain or increased discomfort, worsening eye redness, blurred or decreased vision, increased sensitivity to light, increased number of small particles in your vision. If your doctor cannot be reached for any reason, an alternate doctor should be contacted immediately.

In some patients the pressure inside the treated eye may increase for a short period directly after the injection. Your doctor may monitor this after each injection.

Soon after the injection serious allergic reactions may occur. The symptoms you might experience and the instruction what to do in such cases are described in section 4 of this leaflet.

Children and adolescents

Macugen should not be used in children and adolescents under 18 years old.

Other medicines and Macugen

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before Macugen treatment.

There is no experience of using Macugen in pregnant women. Macugen should not be used during pregnancy unless the potential benefit outweighs the potential risk to the unborn child. If you are pregnant discuss this with your doctor before treatment with Macugen.

Macugen is not recommended during breastfeeding as it is not known whether Macugen passes into human milk. Ask your doctor or pharmacist for advice before starting Macugen treatment.

Driving and using machines

You may experience temporary visual blurring after receiving Macugen. If you are affected, do not drive or use machines until this resolves.

Important information about some of the ingredients of Macugen

This medicine contains less than 1 mmol sodium (23 mg) per 90 microlitre dose, i.e. essentially ‘sodium-free’ (see section 6).

3.How you will be given Macugen

All injections of Macugen will be administered by your doctor.

Macugen is administered as a single injection (0.3 mg) into your eye at intervals of 6 weeks (i.e.

9 times per year). The injection is given into the vitreous of the eye, which is the jelly-like substance inside the eye. Your doctor will monitor your condition and recommend how long you should be treated with Macugen.

Before the treatment is given your doctor may ask you to use antibiotic eye drops, or to wash your eyes carefully. Your doctor will also give you some local anaesthetic (numbing medicine). This will reduce or prevent any pain you might have with the injection.

Please do not forget to tell your doctor if you are known to be allergic to any substance.

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 have been given more Macugen than you should have

In the case excess Macugen volume is injected, serious increase in intraocular pressure may occur. Whenever you’ll experience vision disturbances, eye discomfort/pain, eye redness or nausea and vomiting, immediately refer to your doctor and tell about your symptoms.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Cases of serious allergic reaction, including anaphylactic reaction and angioedema of which symptoms are described below, 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 or diarrhoea. Frequency of these side effects cannot be estimated from the data available.

Uncommonly, an infection in the internal portion of the eye can occur after two weeks following Macugen treatment. The symptoms you might experience are described in section 2 of this leaflet ("Warnings and precautions"). Please read section 2. It tells you what to do if you have any of these symptoms.

Other possible side effects are as follows:

Very common (may affect more than 1 in 10 people)

These side effects are most probably caused by the injection procedure rather than the medicine, and include:

eye inflammation

eye pain

increased pressure inside the eye

small marks on the eye surface (punctate keratitis)

small particles or spots in your vision (vitreous floaters or opacities).

Common (may affect up to 1 in 10 people)

Other common eye side effects reported to be possibly caused by the medicine or by the injection procedure include:

blurred vision

visual disturbance

eye discomfort

decreased vision

increased sensitivity to light, appearance of flashing lights

bleeding that occurs around the eye (periorbital bleeding)

bloodshot eye (conjunctival haemorrhage)

disorder of the jelly portion inside the eye (vitreous disorder), such as displacement or tear (vitreous detachment)

clouding of the lens (cataract)

disorder of the surface of the eye (cornea)

swelling or inflammation of the eyelid, swelling of the area on the inside of the eyelid or the outer surface of the eye (conjunctiva)

eye inflammation, tears, inflammation of the conjunctiva (conjunctivitis), dryness, eye discharge, eye irritation, itching of the eye, eye redness or enlargement of the pupil

Other common non-visual side effects reported to be possibly caused by the medicine or by the injection procedure include:


nasal discharge.

Uncommon (may affect up to 1 in 100 people)

Uncommon eye side effects reported to be possibly caused by the medicine or by the injection procedure include:

inflammation of your eye or of the outer surface of the eye

bleeding in the eye or the internal portion of the eye (vitreous)

eye strain

inflammation of the central part of the surface of the eye (keratitis)

small deposits on the eye or on the surface of the eye (cornea), deposits in the back of the eye,

itching of the eyelids

disturbance in your eye’s reaction to the light (pupillary reflex impaired)

small erosion on the central part of the surface of the eye (cornea)

drooping eyelid

scar inside the eye (retinal scar)

small lump on your eyelid due to inflammation (chalazion)

decreased pressure inside the eye

injection site reaction, injection site vesicles

displacement or tear of a layer in the back of the eye (retina)

disorder of the pupil, of the coloured part of the eye (iris)

retinal artery occlusion

eversion of the eyelid, eye movement disorder, eyelid irritation

blood in your eye, discoloured eye, deposit eye

inflammation of the eye (iritis)

optic nerve cupping

deformation of the pupil

occlusion of the vein at the back of the eye

discharge of inner jelly of the eye

Uncommon non-visual side effects reported to be possibly caused by the medicine or by the injection procedure include:

nightmare, depression, deafness, vertigo

palpitations, high blood pressure, dilatation of the aorta (the main blood vessel)

inflammation of the higher respiratory tract, vomiting, indigestion

irritation and inflammation of the skin, hair colour changes, rash, itching,

night sweats, back pain, tiredness, shivering, tenderness, chest pain, sudden fever and flu-like symptoms (generalised aches and pains)

elevation of the liver enzymes, abrasion.

There is a small risk of a slight lasting increased pressure inside the eye after repeated injection in the eye.

Reporting of side effects

If you get any side effects, talk to your doctor , pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5.How to store Macugen

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2ºC - 8ºC).

Do not freeze.

The medicine must be discarded if kept at room temperature for more than two weeks.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Macugen contains

-The active substance is pegaptanib. Each single dose pre-filled syringe delivers a dose of 0.3 mg pegaptanib in 90 microlitres.

-The other ingredients are sodium chloride, monobasic sodium phosphate monohydrate, dibasic sodium phosphate heptahydrate, sodium hydroxide and hydrochloric acid (for pH adjustment) and water for injections. For additional information regarding sodium content of Macugen, see section 2.

What Macugen looks like and contents of the pack

Macugen solution for injection is supplied in a single dose pack.

Each pack contains a pouch in a carton, containing a pre-filled syringe, Type I glass, filled with 0.25- 0.27 ml of solution, sealed with an elastomeric plunger stopper and a pre-attached plunger rod, held by a plastic clip. The syringe has a pre-attached polycarbonate plastic luer lock adaptor and the tip is sealed with an elastomeric tip cap.

The pack is supplied without a needle.

Marketing Authorisation Holder:


PharmaSwiss Česká republika s.r.o.

Pfizer Manufacturing Belgium NV,

Jankovcova 1569/2c

Rijksweg 12

170 00 Praha 7

B-2870 Puurs

Czech Republic


For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:



Bausch & Lomb Pharma nv/sa, Belgium

PharmaSwiss UAB

Tél/Tel: + 32 (0)3 280 82 84

Tel. + 370 5 279 0762



PharmaSwiss EOOD

Bausch & Lomb Pharma nv/sa, Belgium

Тел.: + 359 2 89 52 110

Tél/Tel: + 32 (0)3 280 82 84

Česká republika


PharmaSwiss Česká republika s.r.o.

Valeant Pharma Magyarország Kft.

Tel: + 420 234 719 600

Tel. +36 1 345 5900



Bausch & Lomb Nordic AB

Laboratoire Chauvin, France

Tlf: 80 88 82 68

Tél: + 33 (0)4 67 12 30 30

Tlf (fra udlandet): +46 8 616 95 85




Bausch & Lomb GmbH

Bausch & Lomb Pharma nv/sa, Belgium

Tel: + 49 (0)30 33093 0

Tel: + 32 (0)3 280 82 84




PharmaSwiss Eesti OÜ

Bausch & Lomb Nordic AB

Tel: +372 6 827 400

Tlf: 800 19 841


Fra utlandet Tlf.: +46 8 616 95 85



Pharmaswiss Hellas A.E.

Bausch & Lomb GmbH

Τ λ: +30 210 8108 460

Tel: + 49 (0)30 33093 0



Bausch & Lomb, S.A.

Valeant sp. z o.o. sp. j.

Tel: + 34 91 657 63 00

Tel.: +48 17 865 51 00



Laboratoire Chauvin SAS

Bausch & Lomb, S.A. (Sucursal Portugal)

Tél: + 33 (0)4 67 12 30 30

Tel: + 351 21 424 15 10



PharmaSwiss d.o.o.

Valeant Pharma S.R.L.

Tel: +385 1 6311 833

Tel: +40 374 102 600



Bausch & Lomb UK Ltd.

PharmaSwiss d.o.o.

Tel: +44 (0) 1748 828864

Tel: + 386 1 2364 700


Slovenská republika

Bausch & Lomb UK Ltd.

Valeant Slovakia s.r.o.

Sími frá útlöndum: +44 (0) 1748 828864

Tel: +421 2 3233 4900



Bausch & Lomb-IOM S.p.A.

Bausch & Lomb Nordic AB

Tel: + 39 (0)2 27407300

Puh./Tel: 0800 773 851


Ulkomailta/Från utomlands: +46 8 616 95 85



Kypropharm Ltd.

Bausch & Lomb Nordic AB

Τηλ: + 357 22 43 46 99

Tel: 020 088 3496


Från utomlands: +46 8 616 95 85


United Kingdom

SIA PharmaSwiss Latvia

Bausch & Lomb UK Ltd.

Tel: + 371 67502185

Tel: +44 (0) 1748 828864

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/


The following information is intended for healthcare professionals only:

CAUTION: Since pre-filled syringe contains more medicinal product volume

(250-270 microlitres) than the recommended dose (90 microlitres), a part of the volume contained in the syringe has to be discarded prior to the administration. Follow the instruction below to expel the excess volume before injection.

Figure 1. Before expelling air bubble and excess drug

Dosing line

3rd Rib (top edge)

(Actual air bubble formation may vary)

The syringe should be checked with the needle pointing up for the presence of bubbles. If there are bubbles, the syringe should be gently tapped with a finger until the bubbles rise to the top of the syringe.

SLOWLY depress the plunger to eliminate all the bubbles and to expel the excess drug so that the top edge of the 3rd rib on the plunger stopper aligns with the pre-printed black dosing line (See Figure 2, below). The plunger stopper should not be pulled back.

Figure 2. After expelling air bubble and excess drug

Dosing line and top edge of 3rd rib aligned

At this point, the remaining content of the syringe should be injected.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.


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