Macugen - patient leaflet, side effects, dosage

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

In the wet form of AMD, abnormal blood vessels grow under the retina and macula. These new blood

, causing the macula to bulge or lift up, thus distorting or destroying mstances vision loss may be rapid and severe. Macugen works by normal blood vessels and by stemming the bleeding and leakage. The

ent of all types of abnormal blood vessels growth in adult AMD

2. What you need to know before you are given MacugenYou 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 MacugeAll injections of Macugen will be administered by your doctor.Macugen is administered as a single injection (0.3 mg) into you

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)

caused by the medicine or by the injection

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:

• headache
• 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.

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 (2°C – 8°C).

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 informationWhat 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 0.250.27 ml of solution, sealed with an elastomeric plunger stopper and a pre-attached plunger rod, held by a plastic clip. The syringe has a sealed with an elastomeric tip cap.

The pack is supplied without a needle.

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site:

/

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.

The syringe should be checked with the needle pointing u 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.

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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