JETREA 0.375 MG / 0.3 ML SOLUTION FOR INJECTION - patient leaflet, side effects, dosage

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.

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.

• – 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

• – colour vision changes

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

• – decreased vision which may be severe – inflammation of the eye

• – visual disturbances – flashes of light in the eye

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

of view – irritation on the surface of the eye

• – blurred vision – dry eye

• – bleeding inside the eye – a feeling of having something in the eye

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

• – distorted vision – eye discomfort

• – swelling of the surface of the eye – sensitivity to light

• – swelling of the eyelid – 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 (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom

Yellow Card Scheme

Website: or search for MHRA Yellow Card in the Google Play or Apple App Store

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.

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.

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.

Other sources of information

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

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.

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.