Jetrea - patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

Package leaflet: Information for the patient

JETREA 0.375 mg/0.3 mL solution for injection

Ocriplasmin

Read all of this leaflet carefully before you are given 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.

• – If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Jetrea is and what it is used for

• 2. What you need to know before you are given Jetrea

• 3. How Jetrea is given

• 4. Possible side effects

• 5. How Jetrea is stored

• 6. Contents of the pack and other information

1. What Jetrea is and what it is used for

Jetrea contains the active substance ocriplasmin.

Jetrea is used to treat adults with an eye disease called vitreomacular traction (VMT), including when it is associated with a small hole in the macula (central part of the light-sensitive layer at the back of the eye).

VMT is caused by traction resulting from a persistent attachment of the vitreous humour (jelly-like material in the back of the eye) to the macula. The macula provides central vision that is needed for everyday tasks such as driving, reading and recognising faces. VMT can cause symptoms such as distorted or decreased vision. When the disease progresses the traction may eventually result in the formation of a hole in the macula (called a macular hole).

Jetrea works by separating the vitreous humour from the macula, and helping to close the macular hole if one is present, which may decrease the symptoms caused by VMT.

2. What you need to know before you are given Jetrea

You must not be given Jetrea

• – if you are allergic to ocriplasmin or any of the other ingredients of this medicine (listed in section 6);

• – if you have (or suspect you may have) an infection in or around your eye.

Warnings and precautions

Talk to your doctor/ophthal­mologist before you are given Jetrea.

Jetrea is given as an injection into the eye. Your doctor/ophthal­mologist will monitor you in case you develop an infection or any complications after the injection. You should contact your doctor/ophthal­mologist immediately if you develop any of the eye symptoms described in section 4, after an injection of Jetrea.

You will not be given Jetrea into both eyes at the same time.

You will not be given Jetrea more than once into the same eye.

Tell your doctor/ophthal­mologist if you have or have had any eye conditions or eye treatments. Your doctor/ophthal­mologist will decide if treatment with Jetrea is right for you.

Children and adolescents

There is no relevant use of Jetrea in children and adolescents below 18 years old. The use of Jetrea is therefore not recommended in this patient group.

Other medicines and Jetrea

Tell your doctor/ophthal­mologist if you are taking, have recently taken or might take any other medicines. Inform your doctor/ophthal­mologist if you have had an injection of a medicine into the eye recently. This information will be taken into account to evaluate if and when Jetrea can be injected into the same eye.

Pregnancy and breast-feeding

There is no experience of using Jetrea in pregnant women or during breast-feeding. Jetrea should not be used during pregnancy or breast-feeding unless your doctor/ophthal­mologist thinks it is clearly necessary. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor/ophthal­mologist for advice before being given this medicine.

Driving and using machines

After Jetrea treatment you may experience some decrease in vision for a limited amount of time. If this happens, do not drive or use any tools or machines until your vision improves.

• 3. How Jetrea is given

Jetrea must be given by a qualified ophthalmologist (eye specialist) who has experience in giving injections into the eye.

Jetrea is given as a single injection into the affected eye. The recommended dose is 0.125 mg.

Your doctor/ophthal­mologist may ask you to use antibiotic eye drops before and after the injection in order to prevent any possible eye infection.

On the day of the injection, your doctor/ophthal­mologist will use antimicrobial eye drops and clean your eye and eyelid carefully to prevent infection. Your doctor/ophthal­mologist will also give you a local anaesthetic to prevent any pain from the injection.

After the injection, your doctor/ophthal­mologist will monitor your vision.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Contact your doctor/ophthal­mologist immediately if you develop any of the following symptoms after injection of Jetrea. Your doctor/ophthal­mologist will monitor you and take corrective measures if needed.

• – A severe decrease in vision has been reported in up to 1 in 10 patients within one week after Jetrea treatment. This is generally reversible and will usually disappear without treatment.

• – Symptoms such as eye pain, worsening eye redness, severely blurred or decreased vision, increased sensitivity to light or increased number of dark floating spots in the field of vision (floaters) are also seen in up to 1 in 10 patients and may be the signs of an infection, bleeding, separation or tear of the retina or an increase in the pressure inside the treated eye.

Symptoms such as fluctuation of vision, double vision, headache, halos around light, nausea and vomiting have been reported in up to 1 in 100 patients and may be the signs of a displacement or wobbling of the lens in the eye from its normal position.

Talk to your doctor/ophthal­mologist if you develop any of the additional side effects listed below:

Very common side effects (may affect more than 1 in 10 patients):

• – dark floating spots in the field of vision (floaters)

• – eye pain

• – bleeding on the surface of the eye

• – colour vision changes

Common side effects (may affect up to 1 in 10 patients):

• – decreased vision which may be severe

• – visual disturbances

• – decreased vision or blind spots in parts of the field of view

• – blurred vision

• – bleeding inside the eye

• – blind spot or blind area in the centre of the vision

• – distorted vision

• – swelling of the surface of the eye

• – swelling of the eyelid

• – inflammation of the eye

• – flashes of light in the eye

• – eye redness

• – irritation on the surface of the eye

• – dry eye

• – a feeling of having something in the eye

• – itching of the eye

• – eye discomfort

• – sensitivity to light

• – increased tear production

Uncommon side effects (may affect up to 1 in 100 patients):

• – transient severe decreased vision

• – difficulty in seeing well at night or in dim light

• – disturbance in your eye’s reaction to the light that may increase your sensitivity to light (pupillary reflex impaired)

• – double vision

• – accumulation of blood in the front part of the eye

• – abnormal constriction of the pupil (black part in the centre of the eye)

• – different sized pupils

• – a scratch or scrape of the cornea (transparent layer that covers the front of the eye)

Some tests and imaging of the back of the eye (retina) have been found to be abnormal after Jetrea administration. Your doctor will be aware of this and will take it into account when monitoring your eye.

Some effects (such as flashes, floaters) can also be perceived from the untreated eye in some cases.

Reporting of side effects

If you get any side effects, talk to your doctor/ophthal­mologist. 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. By reporting side effects you can help provide more information on the safety of this medicine.

• 5. How Jetrea is stored

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

Information about storage and the time to use Jetrea once it has been thawed are described in the section intended for healthcare professionals only.

Your ophthalmologis­t/doctor or pharmacist is responsible for storing this medicine and disposing of any unused solution correctly.

6. Contents of the pack and other information

What Jetrea contains

• – The active substance is ocriplasmin. One vial of Jetrea contains 0.375 mg of ocriplasmin in

0.3 mL solution.

• – The other ingredients are sodium chloride (NaCl), mannitol, citric acid, sodium hydroxide (NaOH) (for pH adjustment), hydrochloric acid (HCl) (for pH adjustment) and water for injections.

What Jetrea looks like and contents of the pack

Jetrea is a solution for injection in a vial. The solution is clear and colourless.

Each pack contains one vial.

Marketing Authorisation Holder

Inceptua AB

Gustavslundsv. 143

16751 Bromma

Sweden

Manufacturer

Oxurion NV

Gaston Geenslaan 1

B-3001 Leuven

Belgium

This leaflet was last revised in

Other sources of information

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

The following information is intended for healthcare professionals only:

Jetrea must be administered by a qualified ophthalmologist experienced in intravitreal injections. The diagnosis of vitreomacular traction (VMT) should comprise of a complete clinical picture including patient history, clinical examination and investigation using currently accepted diagnostic tools, such as optical coherence tomography (OCT).

JETREA 0.375 mg/0.3 mL solution for injection is a ‘ready-diluted’ formulation, no further dilution is required. The recommended dose is 0.125 mg in 0.1 mL of the solution administered by intravitreal injection to the affected eye once as a single dose. Each vial should only be used once and for the treatment of a single eye. Treatment with Jetrea in the other eye is not recommended concurrently or within 7 days of the initial injection in order to monitor the post-injection course including the potential for decreased vision in the injected eye. Repeated administration in the same eye is not recommended.

See section 4.4 of the Summary of Product Characteristics for instructions on post-injection monitoring.

Single use vial for intravitreal use only.

Preoperative antibiotic drops may be administered at the discretion of the treating ophthalmologist.

The intravitreal injection procedure should be carried out under controlled aseptic conditions, which include the use of surgical hand disinfection, sterile gloves, a sterile drape, a sterile eyelid speculum (or equivalent) and the availability of sterile paracentesis (if required). The periocular skin, eyelid and ocular surface should be disinfected and adequate anaesthesia and a broad spectrum topical microbiocide should be administered prior to the injection according to standard medical practice.

Only 0.1 mL of the total 0.3 mL solution in the vial should be administered. Any excess volume should be expelled prior to injection in order to deliver a single dose of 0.1 mL containing 0.125 mg ocriplasmin.

The injection needle should be inserted 3.5–4.0 mm posterior to the limbus aiming towards the centre of the vitreous cavity avoiding the horizontal meridian. The injection volume of 0.1 mL is then delivered into the mid-vitreous.

Instructions for use

• 1. Remove the vial from the freezer and allow to thaw at room temperature (takes about 2 minutes).

• 2. Once completely thawed, remove the protective blue polypropylene flip-off cap from the vial (Figure 1).

• 3. Disinfect the top of the vial with an alcohol wipe (Figure 2).

• 4. Visually inspect the vial for particulate matter. Only a clear, colourless solution without visible particles should be used.

• 5. Using aseptic technique, withdraw all of the solution using an appropriate sterile needle (slightly incline the vial to ease withdrawal) (Figure 3 ) and discard the needle after withdrawal of the vial contents. Do not use this needle for the intravitreal injection.

• 6. Replace the needle with an appropriate sterile needle, carefully expel the excess volume from the syringe by slowly depressing the plunger so that the plunger tip aligns with the 0.1 mL line on the syringe (corresponding to 0.125 mg ocriplasmin) (Figure 4).

• 7. Inject 0.1 mL of the solution immediately into the mid-vitreous.

• 8. Discard the vial and any unused portion of the solution after single use.

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

Information about storage

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

Store in a freezer (-20 °C ± 5 °C).

After thawing

The unopened vial in the original carton protected from light may be stored in a refrigerator (2 °C to 8 °C) for up to 1 week. The new in-use expiry date should be calculated and noted on the carton before it is placed in the refrigerator.

Once removed from the freezer or refrigerator, the medicinal product may be kept below 25 °C for up to 8 hours. At the end of this period the product must be used or discarded.

Do not refreeze a vial once it has been thawed.

After opening

From a microbiological point of view, the medicinal product must be used immediately after opening. The vial and any unused portion of the solution must be discarded after single use.

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