Lucentis 10 mg/ml solucion inyectable en jeringa precargada

Prospecto:information for the patient

LUCENTIS 10mg/ml injectable solution in pre-filled syringe

ranibizumab

Read this prospectus carefully beforeyou receive this medication, because it contains important information for you.

-Keep this prospectus, as you may need to read it again.

-If you have any questions, consult your doctor.

-Ifyou experienceadverse effects, consult your doctor,evenifthey do not appearin this prospectus. See section4.

1.What is LUCENTIS and for what it is used

2.What you need to knowbefore receiving LUCENTIS

3.How to administer LUCENTIS

4.Possible adverse effects

5.Storage of LUCENTIS

6.Contents of the package and additional information

What is Lucentis

Luentis is a solution that is injected into the eye. Lucentis belongs to a group of medications called anti-neovascular agents. It contains the active ingredient called ranibizumab.

What is Lucentis used for

Luentis is used in adults to treat several eye diseases that cause vision impairment.

These diseases are the result of a retinal injury (the light-sensitive layer at the back of the eye) caused by:

-The growth of abnormal blood vessels that leak fluid. This is seen in diseases such as age-related macular degeneration (AMD) and proliferative diabetic retinopathy (PDR, a disease caused by diabetes). It can also be associated with choroidal neovascularization (CNV) due to pathological myopia (PM), angioid streaks, central serous chorioretinopathy or inflammatory CNV.

-Macular edema (swelling of the center of the retina). The cause of this swelling can be diabetes (a disease known as diabetic macular edema (DME)) or a blockage of the retinal veins (a disease known as retinal vein occlusion (RVO)).

How Lucentis works

Luentis recognizes and specifically binds to a protein called human vascular endothelial growth factor A (VEGF-A) present in the eyes. In excess, VEGF-A causes the growth of abnormal blood vessels and swelling in the eye that can cause vision impairment in diseases such as AMD, DME, PDR, RVO, PM and CNV. By binding to VEGF-A, Lucentis can prevent it from acting and prevent said abnormal growth and swelling.

In these diseases, Lucentis can help stabilize and, in many cases, improve vision.

Do not administer Lucentis

-If you are allergic to ranibizumab or any of the other components of this medication (listed in section 6).

-If you have an infection in the eye or around it.

-If you have severe eye pain or inflammation (intraocular inflammation) in the eye.

Warnings and precautions

Consult your doctor before receiving Lucentis

-Luentis is administered by injection into the eye. Occasionally, after treatment with Lucentis, an infection in the inner part of the eye, pain, or redness (inflammation), retinal detachment or tear, or clouding of the lens (cataract) may occur. It is essential to identify and treat such an infection or retinal detachment as soon as possible. Inform your doctor immediately if you notice signs such as eye pain or increased eye discomfort, worsening redness in the eye, blurry vision or decreased vision, an increase in small spots in your vision, or increased sensitivity to light.

-In some patients, the pressure in the eye may increase temporarily after the injection. Your doctor may monitor your eye pressure after each injection, as you may not be aware of it.

-Inform your doctor if you have had eye diseases or received eye treatment previously, or if you have had a stroke or had transient signs of a stroke (weakness or paralysis of a limb or face, difficulty speaking or understanding). This information will be taken into consideration to evaluate if Lucentis is the appropriate treatment for you.

For more detailed information on possible side effects that may occur during treatment with Lucentis, see section 4 (“Possible side effects”).

Children and adolescents (under 18 years)

Luentis is not recommended for use in children and adolescents, as it has not been established in these age groups.

Other medications and Lucentis

Inform your doctor if you are using, have used recently, or may need to use any other medication.

Pregnancy and breastfeeding

-Women who may become pregnant should use an effective contraceptive method during treatment and for at least three months after the last Lucentis injection.

-There is no experience with the use of Lucentis in pregnant women. Lucentis should not be used during pregnancy unless the potential benefit outweighs the potential risk to the fetus. If you are pregnant, think you may be pregnant, or plan to become pregnant, consult your doctor before treatment with Lucentis.

-Small amounts of Lucentis may pass into breast milk, so it is not recommended to use Lucentis during breastfeeding. Consult your doctor or pharmacist before treatment with Lucentis.

Driving and operating machinery

After treatment with Lucentis, you may experience temporary blurred vision. If this occurs, do not drive or operate machinery until this symptom disappears.

Lucentis is administered by the ophthalmologist in the form of a single injection into the eye under local anesthesia.The usual dose of a single injection is 0.05ml (which contains 0.5mg of active ingredient). The preloaded syringe contains more quantity than the recommended dose of 0.5mg. The extractable volume will not be administered in its entirety. The excess volume must be expelled before the injection. If the entire volume of the preloaded syringe is injected, it may lead to an overdose.

The interval between two doses applied in the same eye must be at least four weeks. All injections will be administered by an ophthalmologist.

To prevent an infection, before the injection, your doctor will carefully wash your eye. Your doctor will also administer a local anesthetic to reduce or prevent any pain you may feel with the injection.

The treatment begins with a Lucentis injection every month. Your doctor will monitor your eye disease and, depending on how you respond to treatment, will decide if you need or do not need further treatment and when you need to be treated.

At the end of the prospectus in the section "How to prepare and administer Lucentis" detailed use instructions are given.

Patients aged 65years and older)

Lucentis can be used in people 65years of age or older, and no dose adjustment is necessary.

Before interrupting treatment with Lucentis

If you are considering interrupting treatment with Lucentis, attend the next consultation and discuss it with your doctor beforehand. Your doctor will advise you and decide for how long you should be treated with Lucentis.

If you have any other questions about the use of this medication, ask your doctor.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

The side effects associated with the administration of Lucentis are due either to the medicine itself or to the injection procedure, and most of them affect the eye.

The following are the most serious side effects:

Frequent serious side effects(may affect up to 1 in 10patients): Detachment or tear of a layer in the inner part of the eye (retinal detachment), which results inflashes of light with floating particles that progress to transient vision loss or to clouding of the lens (cataract).

Rare serious side effects(may affect up to 1 in 100patients):Blindness, endophthalmitis (infection of the inner part of the eye) with inflammation of the inner part of the eye.

The symptoms you may experience are eye pain or increased discomfort in the eye, if the redness in the eye worsens, blurred vision or decreased vision, an increase in the number of small spots in the vision or increased sensitivity to light.Inform your doctor immediately if you experience any of these side effects.

The following are the most frequently reported side effects:

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

Eye-related side effects include: Inflammation of the eye, bleeding in the back of the eye (retinal hemorrhage), visual disturbances, eye pain, small particles or spots in the vision (floaters), blood in the eye, eye irritation, sensation of having something in the eye, increased tear production, inflammation or infection at the edge of the eyelids, dry eye, redness or itching in the eye, and increased eye pressure.

Non-eye-related side effects include: Sore throat, nasal congestion, nasal discharge, headache, and joint pain.

The following are other side effects that may occur after treatment with Lucentis:

Frequent side effects

Eye-related side effects include: Decreased visual acuity, swelling of a section of the eye (uvea, cornea), inflammation of the cornea (front part of the eye),small marks on the surface of the eye, blurred vision, bleeding at the injection site,bleeding in the eye, eye discharge with itching, redness, and swelling (conjunctivitis), light sensitivity, eye discomfort, eyelid swelling, and eyelid pain.

Non-eye-related side effects include: Urinary tract infection, low red blood cell count (with symptoms such as fatigue, difficulty breathing, dizziness, paleness), anxiety, cough,nausea, allergic reactions such as rash, urticaria, itching, and skin redness.

Rare side effects

Eye-related side effects include: Inflammation and bleeding in the front part of the eye, accumulation of pus in the eye, changes in the central part of the eye surface, pain or irritation at the injection site, abnormal sensation in the eye, eyelid irritation.

Side effect reporting

If you experience any type of side effect, consultyour doctor,even if it is a possible side effect that does not appear in this prospectus.You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medicine.

-Keep this medication out of the sight and reach of children.

• Do not use this medication after the expiration date that appears on the box after CAD and on the pre-filled syringe label after EXP. The expiration date is the last day of the month indicated.

-Store in refrigerator (between 2°C and 8°C). Do not freeze.

-Before use, the sealed tray can be stored at room temperature (25°C) for a maximum of 24hours.

-Store the pre-filled syringe in its tray without opening in the box to protect it from light.

-Do not use any damaged packaging.

Lucentis Composition

-The active ingredient is ranibizumab. Each ml contains 10mg of ranibizumab. A preloaded syringecontains 0.165ml, equivalent to 1.65mg of ranibizumab. This provides a usable amount that provides a single dose of 0.05ml, which contains 0.5mg of ranibizumab.

-The other components areα,α-trehalosa dihydrate; histidine hydrochloride monohydrate; histidine; polisorbate20; water for injection.

Appearance of the product and contents of the package

Lucentis is an injectable solution contained in a preloaded syringe. The preloaded syringe contains 0.165ml of a clear, sterile, colorless to pale yellowish solution.The preloaded syringe contains more than the recommended dose of 0.5mg. The extractable volume will not be administered in its entirety. The excess volume must be expelled before injection. If the entire volume of the preloaded syringe is injected, it may lead to an overdose.

The packaging size is a preloaded syringe, packaged in a sealed tray. The preloaded syringe is for single use only.

Marketing Authorization Holder

Novartis Europharm Limited

Vista Building

Elm Park, Merrion Road

Dublin 4

Ireland

Responsible Person

Novartis Pharma GmbH

Roonstrasse 25

90429 Nuremberg

Germany

Novartis Manufacturing NV

Rijksweg 14

2870 Puurs-Sint-Amands

Belgium

Novartis Pharma GmbH

Sophie-Germain-Strasse 10

90443 Nürnberg

Germany

For more information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last update of this leaflet:

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu

This information is intended solely for healthcare professionals:

See also section 3 “How to administer Lucentis”.

How to prepare and administer Lucentis

Preloaded syringe for single use. Only for intravitreal use.

Lucentis should be administered by an ophthalmologist who has experience in the administration of intravitreal injections.

In the exudative macular degeneration, in the NVC, in the RDP, and in the visual alteration due to EMD or secondary macular edema to OVR, the recommended dose of Lucentis is 0.5mgadministered as a single intravitreal injection. This corresponds to a volume of injection of 0.05ml. The interval between two injections administered in the same eye should be at least four weeks.

The treatment starts with a monthly injection until the maximum visual acuity is reached and/or there are no signs of disease activity, i.e., no change in visual acuity or other signs and symptoms of the disease under continued treatment.In patients with exudative macular degeneration, EMD, RDP, and OVR, initially three or more consecutive injections may be required, administered monthly.

From that moment on, the monitoring and treatment intervals should be determined according to medical judgment and based on the activity of the disease, evaluated by visual acuity and/or anatomical parameters.

The treatment with Lucentis should be discontinued if, under medical judgment, the visual and anatomical parameters indicate that the patient is not benefiting from continued treatment.

The monitoring to determine the activity of the disease may include clinical examination, functional control, or imaging techniques (e.g., optical coherence tomography or fluorescein angiography).

If patients are being treated according to a treat-and-extend regimen, once the maximum visual acuity has been reached and/or there are no signs of disease activity, the treatment intervals can be gradually spaced until signs of disease activity or visual alteration reappear. In the case of exudative macular degeneration, the treatment interval should not be spaced more than two weeks at a time, and in the case of EMD, it can be spaced up to one month at a time. For RDP and OVR, the treatment intervals can also be gradually spaced, but the data available are not sufficient to determine the duration of these intervals. If disease activity reappears, the treatment interval should be shortened accordingly.

The treatment of visual alteration due to NVC should be determined on an individual basis for each patient, based on the activity of the disease. Some patients may only need one injection during the first 12months; others may need more frequent treatment, including a monthly injection. In the case of NVC secondary to pathological myopia (MP), many patients may only need one or two injections during the first year.

Lucentis and laser photocoagulation in EMD and secondary macular edema to ORVR

There is some experience with Lucentis administered concomitantly with laser photocoagulation. When administered on the same day, Lucentis should be administered at least 30minutes after laser photocoagulation. Lucentis can be administered in patients who have received laser photocoagulation previously.

Lucentis and verteporfin photodynamic therapy in NVC secondary to MP

There is no experience with the concomitant administration of Lucentis and verteporfin.

Before administering Lucentis, the absence of particles and discoloration should be visually checked.

The injection procedure should be carried out under aseptic conditions, including surgical hand washing, the use of sterile gloves, a sterile field, a sterile eyelid retractor (or equivalent), and the availability of a sterile paracentesis (if necessary). Before performing the intravitreal injection procedure, the patient's medical history should be thoroughly evaluated for hypersensitivity reactions. Before injection, an adequate anesthesia and a broad-spectrum topical antimicrobial should be administered to disinfect the periocular skin, eyelid, and ocular surface, according to local practice.

The preloaded syringe is for single use only. The preloaded syringe is sterile. Do not use the product if the packaging is damaged. The sterility of the preloaded syringe can only be guaranteed if the tray remains sealed. Do not use the preloaded syringe if the solution has changed color, is turbid, or contains particles.

The preloaded syringe contains more than the recommended dose of 0.5mg. The extractable volume of the preloaded syringe (0.1ml) will not be administered in its entirety. The excess volume should be expelled before injection. If the entire volume of the preloaded syringe is injected, it may lead to an overdose. To expel the air bubbles and excess solution, slowly press the plunger until the lower edge of the dome that forms the tip of the rubber stopper is aligned with the black dosage line on the syringe (equivalent to 0.05ml, i.e., 0.5mg of ranibizumab).

To administer the intravitreal injection, a sterile 30Gx½″injection needle should be used.

To prepare Lucentis for intravitreal administration, follow the usage instructions: