Lucentis 10 mg/ml solution for injection in pre-filled syringe

Patient Information Leaflet

Introduction

Patient Information Leaflet

Lucentis 10 mg/ml solution for injection in a pre-filled syringe

ranibizumab

Read this entire 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 questions, ask your doctor.
• If you experience any side effects, talk to your doctor, even if it is a side effect not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Lucentis is and what it is used for
2. What you need to know before you are given Lucentis
3. How Lucentis is given
4. Possible side effects
5. How to store Lucentis
6. Contents of the pack and other information

1. What Lucentis is and what it is used for

What Lucentis is

Lucentis is a solution that is injected into the eye. Lucentis belongs to a group of medicines known as anti-neovascularization agents. It contains the active substance called ranibizumab.

What Lucentis is used for

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

These diseases result from damage to the retina (the light-sensitive layer at the back of the eye) caused by:

• The growth of abnormal blood vessels that leak fluid. This occurs in conditions such as age-related macular degeneration (AMD) and proliferative diabetic retinopathy (PDR, a disease caused by diabetes). It may also be associated with choroidal neovascularization (CNV) due to pathological myopia (PM), angioid streaks, central serous chorioretinopathy, or inflammatory CNV.
• Macular edema (swelling in the center of the retina). The cause of this swelling may be diabetes (a condition known as diabetic macular edema (DME)) or blockage of the retinal veins (a condition known as retinal vein occlusion (RVO)).

How Lucentis works

Lucentis specifically recognizes and 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, which can lead to vision impairment in conditions such as AMD, DME, PDR, RVO, PM, and CNV. By binding to VEGF-A, Lucentis can block its activity and prevent such abnormal growth and swelling.

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

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

Do not use Lucentis

• If you are allergic to ranibizumab or to any of the other ingredients of this medicine (listed in section 6).
• If you have an infection in or around the eye.
• If you have pain or redness (severe intraocular inflammation) in the eye.

Warnings and precautions

Talk to your doctor before you are given Lucentis

• Lucentis is administered by injection into the eye. Occasionally, after treatment with Lucentis, an infection inside the eye, eye pain or redness (inflammation), detachment or tear of one of the layers at the back of the eye (retinal detachment or tear and detachment or tear of the retinal pigment epithelium), or clouding of the lens (cataract) may occur. It is important to identify and treat such infection or retinal detachment as soon as possible. Immediately inform your doctor if you notice signs such as eye pain or increased discomfort in the eye, worsening redness of the eye, blurred vision or decreased vision, an increase in the number of small spots in your vision, or increased sensitivity to light.
• In some patients, eye pressure may increase temporarily after the injection. You may not notice this, so your doctor may monitor your eye pressure after each injection.
• Inform your doctor if you have had eye diseases or previous eye treatments, or if you have had a stroke or transient signs of stroke (such as weakness or paralysis of a limb or face, difficulty speaking or understanding). This information will be considered when evaluating whether Lucentis is the appropriate treatment for you.

For more detailed information about adverse effects that could occur during treatment with Lucentis, see section 4 (“Possible side effects”).

Children and adolescents (under 18 years of age)

The use of Lucentis is not recommended in children and adolescents, as it has not been established in these age groups.

Other medicines and Lucentis

Tell your doctor if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy and breastfeeding

• Women who could become pregnant must use an effective method of contraception 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 might be pregnant, or plan to become pregnant, consult your doctor before treatment with Lucentis.
• Small amounts of Lucentis may pass into breast milk; therefore, the use of Lucentis during breastfeeding is not recommended. Consult your doctor or pharmacist before treatment with Lucentis.

Driving and using machines

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

3. How Lucentis is administered

Lucentis is administered by an ophthalmologist as a single injection into the eye under local anaesthesia. The usual dose for one injection is 0.05 ml (containing 0.5 mg of active substance). The pre-filled syringe contains more than the recommended dose of 0.5 mg. The extractable volume will not be administered in full. The excess volume must be expelled before injection. If the entire volume of the pre-filled syringe is injected, it may result in an overdose.

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

To prevent infection, your doctor will carefully clean your eye before the injection. Your doctor will also administer a local anaesthetic to reduce or prevent any pain you might feel during the injection.

Treatment starts with one monthly Lucentis injection. Your doctor will monitor your eye disease and, depending on your response to treatment, will decide whether you need further treatment and when you should receive it.

Detailed instructions for use are provided at the end of the leaflet in the section “How to prepare and administer Lucentis”.

Elderly patients (65 years of age and older)

Lucentis may be used in patients aged 65 years or older, and no dose adjustment is required.

Before stopping Lucentis treatment

If you are considering stopping treatment with Lucentis, attend your next scheduled appointment and discuss this with your doctor beforehand. Your doctor will advise you and decide for how long you should continue treatment with Lucentis.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.

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

The following are the most serious side effects:

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

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

Symptoms you may experience include eye pain or increased discomfort, worsening redness in the eye, blurred vision or decreased vision, an increasing number of small spots in your vision, or increased sensitivity to light. Contact your doctor immediately if you experience any of these side effects.

The following are the most commonly reported side effects:

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

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

Non-ocular side effects include: Sore throat, nasal congestion, runny nose, headache, and joint pain.

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

Common side effects

Ocular side effects include: Decreased sharpness of vision, swelling in a part of the eye (uvea, cornea), corneal inflammation (front part of the eye), small marks on the eye surface, 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, eyelid pain.

Non-ocular 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, hives, itching, and skin redness.

Uncommon side effects

Ocular 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.

Reporting of side effects

If you experience any type of side effect, consult your doctor, even if it is a possible side effect not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Lucentis

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

  • Do not use this medicine after the expiry date stated on the carton after "EXP" and on the label of the pre-filled syringe after "EXP". The expiry date refers to the last day of the month indicated.

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

• Before use, the sealed tray may be stored at room temperature (up to 25°C) for a maximum of 24 hours.

• Keep the pre-filled syringe in its unopened tray inside the carton to protect it from light.

• Do not use any container that is damaged.

6. Contents of the pack and other information

Composition of Lucentis

• The active substance is ranibizumab. Each ml contains 10 mg of ranibizumab. A pre-filled syringe contains 0.165 ml, equivalent to 1.65 mg of ranibizumab. This provides a usable amount delivering a single dose of 0.05 ml, containing 0.5 mg of ranibizumab.
• The other components are α,α-trehalose dihydrate; histidine hydrochloride monohydrate; histidine; polysorbate 20; water for injections.

Nature and contents of the container

Lucentis is an injectable solution contained in a pre-filled syringe. The pre-filled syringe contains 0.165 ml of a sterile, clear, aqueous solution, from colourless to pale yellowish-brown. The pre-filled syringe contains a larger volume than the recommended dose of 0.5 mg. The entire extractable volume will not be administered. The excess volume must be expelled before injection. If the entire volume of the pre-filled syringe is injected, it may result in an overdose.

The pack size is one pre-filled syringe, packaged in a sealed carrier tray. The pre-filled syringe is for single use only.

Marketing Authorization Holder

Novartis Europharm Limited
Vista Building
Elm Park, Merrion Road
Dublin 4
Ireland

Manufacturer

Novartis Manufacturing NV
Rijksweg 14
2870 Puurs-Sint-Amands
Belgium

Novartis Pharma GmbH
Sophie-Germain-Strasse 10
90443 Nürnberg
Germany

For further information on this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

Other sources of information

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

This information is intended for healthcare professionals only:

See also section 3, “How Lucentis is administered”.

How to prepare and administer Lucentis

Single-use pre-filled syringe. For intravitreal use only.

Lucentis must be administered by an ophthalmologist experienced in administering intravitreal injections.

For neovascular (wet) age-related macular degeneration (AMD), choroidal neovascularisation (CNV), diabetic retinopathy (DRP), and visual impairment due to macular edema due to retinal vein occlusion (RVO) or due to diabetic macular edema (DME), the recommended dose of Lucentis is 0.5 mg given as a single intravitreal injection. This corresponds to an injection volume of 0.05 ml. The interval between two injections administered into the same eye must be at least four weeks.

Treatment is initiated with monthly injections until maximum visual acuity is achieved 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 neovascular AMD, DME, DRP, and RVO, initially three or more consecutive monthly injections may be required.

Thereafter, monitoring and treatment intervals should be determined according to medical judgment and based on disease activity, assessed by visual acuity and/or anatomical parameters.

Treatment with Lucentis should be discontinued if, according to the physician’s judgment, visual and anatomical parameters indicate that the patient is not benefiting from continued treatment.

Monitoring to determine disease activity may include clinical examination, functional assessment, or imaging techniques (e.g., optical coherence tomography or fluorescein angiography).

If patients are treated according to a treat-and-extend regimen, once maximum visual acuity is achieved and/or there are no signs of disease activity, treatment intervals may be gradually extended until signs of disease activity or visual impairment reappear. In the case of neovascular AMD, treatment intervals should not be extended by more than two weeks at a time; in the case of DME, intervals may be extended by up to one month at a time. For DRP and RVO, treatment intervals may also be gradually extended, although available data are insufficient to determine the duration of these intervals. If disease activity reappears, treatment intervals should be shortened accordingly.

Treatment of visual impairment due to CNV should be individually determined for each patient based on disease activity. Some patients may require only one injection during the first 12 months; others may require more frequent treatment, including monthly injections. In the case of CNV secondary to pathological myopia (PM), many patients may require only one or two injections during the first year.

Lucentis and laser photocoagulation in DME and macular edema secondary to branch retinal vein occlusion (BRVO)

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

Lucentis and photodynamic therapy with verteporfin in CNV secondary to PM

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

Before administration, Lucentis should be inspected visually for particulate matter and discoloration.

The injection procedure must be performed under aseptic conditions, including surgical hand washing, use of sterile gloves, a sterile field, a sterile eyelid speculum (or equivalent), and availability of sterile paracentesis equipment (if needed). Prior to performing the intravitreal injection procedure, the patient’s medical history should be carefully evaluated for hypersensitivity reactions. Prior to injection, appropriate anaesthesia and a broad-spectrum topical microbicide should be administered to disinfect the periocular skin, eyelids, and ocular surface, in accordance with local practice.

The pre-filled syringe is for single use only. The pre-filled syringe is sterile. Do not use the product if the packaging is damaged. The sterility of the pre-filled syringe can only be guaranteed if the tray remains sealed. Do not use the pre-filled syringe if the solution has changed colour, is cloudy, or contains particles.

The pre-filled syringe contains more than the recommended dose of 0.5 mg. The extractable volume from the pre-filled syringe (0.1 ml) should not be administered in full. The excess volume must be expelled prior to injection. Injecting the entire volume of the pre-filled syringe may result in overdose. To expel air bubbles and excess medication, slowly depress the plunger until the lower edge of the dome formed by the rubber stopper aligns with the black dosage line on the syringe (equivalent to 0.05 ml, i.e., 0.5 mg of ranibizumab).

For intravitreal injection, a sterile 30G × ½″ injection needle should be used.

For preparation of Lucentis for intravitreal administration, follow the instructions for use: