What is a Patient Information Leaflet and why is it useful?

The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.

Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: EU/1/13/819/002.


JETREA 0.375 mg/0.3 mL solution for injection

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 (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: www.mhra.gov.uk/yellowcard

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.

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

S.A. Alcon-Couvreur N.V.
Rijksweg 14
B-2870 Puurs
Belgium

Oxurion NV
Gaston Geenslaan 1
B-3001 Leuven
Belgium

This leaflet was last revised in 09/2020

Other sources of information

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