Lucentis 10 mg/ml solution for injection
Ranibizumab
Read all of this leaflet carefully before you are given this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
In this leaflet:
- 1. What Lucentis is and what it is used for
- 2. Before you use Lucentis
- 3. How to use Lucentis
- 4. Possible side effects
- 5. How to store Lucentis
- 6. Further information
What Lucentis Is And What It Is Used For
Lucentis is given as an injection into the eye by your eye doctor under a local anaesthetic.
It is used to treat damage to the retina (the light-sensitive back part of the eye) when this damage is caused by abnormal blood vessels growing and leaking into the eye. This happens in diseases such as age-related macular degeneration (AMD). Lucentis can help to improve the damaged vision or stop it from getting worse.
The active substance in Lucentis is ranibizumab. Ranibizumab helps to stop the growth and leakage of new blood vessels in the eye, abnormal processes that contribute to the progression of AMD.
Before You Use Lucentis
You must not receive Lucentis
- if you are allergic (hypersensitive) to ranibizumab or any of the other ingredients of Lucentis listed at the end of this leaflet (see section 6).
- if you have an infection in or around your eye.
- if you have pain or redness (severe intraocular inflammation) in your eye.
Take special care with Lucentis
- Lucentis is given as an injection into the eye. Occasionally, an infection in the internal portion of the eye, pain or redness (inflammation), detachment or tear of the layer in the back of the eye (retinal detachment or tear), or clouding of the lens (cataract) may occur after Lucentis treatment. It is important to identify and treat such an infection or retinal detachment as soon as possible. Please tell your doctor immediately if you develop signs such as eye pain or increased discomfort, worsening eye redness, blurred or decreased vision, an increased number of small particles in your vision or increased sensitivity to light.
- In some patients the eye pressure may increase for a short period directly after the injection. This is something you may not notice, therefore your doctor may monitor this after each
injection.
Children and adolescents (below 18 years of age)
The use of Lucentis in children and adolescents has not been studied and is therefore not recommended.
Using other medicines
Please tell your doctor if you are using or have recently used any other medicines, including medicines bought without a prescription.
Pregnancy and breast-feeding
- There is no experience of using Lucentis in pregnant women; therefore the potential risks are unknown. If you are pregnant or planning to become pregnant, please discuss this with your doctor before Lucentis treatment.
- Lucentis is not recommended during breast-feeding because it is not known whether Lucentis passes into human milk. Ask your doctor or pharmacist for advice before Lucentis treatment.
Driving and using machines
After Lucentis treatment you may experience some temporary vision blurring. If this happens, do not drive or use machines until this resolves.
How To Use Lucentis
All Lucentis injections will be administered by your doctor.
Lucentis is administered as a single injection into your eye. The injection is given once a month in the first 3 months. Afterwards, your doctor will monitor your vision on a monthly basis. If your condition is found to be worsening, your doctor will administer Lucentis to your affected eye again. The interval between two doses should not be shorter than 1 month.
Before the injection, your doctor will use antibiotic eye drops and wash your eye carefully to prevent infection. Your doctor will also give you a local anaesthetic to reduce or prevent any pain you might have with the injection.
Before and after each injection your doctor will ask you to use antimicrobial eye drops four times daily for 3 days before and after each injection in order to prevent any possible eye infection.
Older people (age 65 years and over)
Lucentis can be used for people of 65 years of age and over without dose adjustment.
If a dose of Lucentis is missed
Contact your doctor or hospital as soon as possible to re-schedule your appointment.
Before stopping Lucentis treatment
If you are considering stopping Lucentis treatment, please go to your next appointment and discuss this with your doctor. Your doctor will advise you and decide how long you should be treated with Lucentis.
If you have any further questions on the use of this product, ask your doctor.
Possible Side Effects
Like all medicines, Lucentis can cause side effects, although not everybody gets them. Please do not be alarmed by this list of possible side effects. You may not experience any of them.
With administration of Lucentis, there may be some side effects, mostly in the eye and due to the injection procedure. Occasionally an infection in the internal portion of the eye, detachment or tear of the layer in the back of the eye (retinal detachment or tear), or clouding of the lens (cataract) may occur in the two weeks after Lucentis treatment. Other side effects include pain or redness (inflammation) and increased eye pressure. The symptoms you might experience are described in section 2 of this leaflet ("Take special care with Lucentis"). Please read section 2. It tells you what to do if you have any of these symptoms.
Very common side effects (These may affect 10 or more in every 100 patients)
The most common side effects in the eye reported to be possibly caused by the medicinal product or by the injection procedure include: Inflammation of the eye, blurred vision, bleeding in the back of the eye (retinal bleeding), visual disturbances, eye pain, small particles or spots in your vision (floaters), bloodshot eye, eye irritation, a feeling of having something in the eye, increased tear production, inflammation or infection of the eyelid margins, dry eye, redness or itching of the eye. Increased eye pressure has been observed very commonly.
The most common non-visual side effects reported to be possibly caused by the medicinal product or by the injection procedure include: Sore throat, headache and joint pain.
Common side effects (These may affect between 1 and 10 in every 100 patients)
Other common side effects in the eye reported to be possibly caused by the medicinal product or by the injection procedure include: Seeing flashes of light with floaters progressing to a loss of sight, decreased sharpness of vision, swelling of a section of the eye (uvea, cornea), clouding of the lens, small marks on the surface of the eye, bleeding in the eye, discharge from the eye with itching, redness and swelling (conjunctivitis), light sensitivity, eye discomfort, swelling of the eyelid, eyelid pain.
Other common non-visual side effects reported to be possibly caused by the medicinal product or by the injection procedure include: Fatigue, general feeling of being unwell, anxiety, cough, nausea, allergic reactions like rash, itching, skin reddening.
Uncommon side effects (These may affect less than 1 in every 100 patients)
Uncommon side effects in the eye reported to be possibly caused by the medicinal product or by the injection procedure include: Blindness, infection of the eye globe (endophthalmitis), inflammation and bleeding in the front part of the eye, sac of pus on the eye, changes of the central part of the eye surface, pain or irritation at the site of injection, abnormal sensation in the eye, irritation of the eyelid.
If any of the side effects you experience gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
How To Store Lucentis
- Keep Lucentis out of the reach and sight of children.
- Do not use Lucentis after the expiry date which is stated on the carton and vial label after EXP. The expiry date refers to the last day of that month.
- Store in a refrigerator (2°C – 8°C). Do not freeze.
- Keep the vial in the outer carton in order to protect from light.
- Do not use any pack that is damaged.
Further Information
What Lucentis contains
- The active substance in Lucentis is ranibizumab (10 mg/ml). Each ml contains 10 mg ranibizumab.
- The other ingredients are: α,α-trehalose dihydrate; histidine hydrochloride, monohydrate; histidine; polysorbate 20; water for injections.
What Lucentis looks like and contents of the pack
Lucentis is a solution for injection in a vial (0.23 ml). The solution is clear, colourless to pale yellow and aqueous.
Lucentis is supplied as a pack containing one glass vial of ranibizumab with chlorobutyl rubber stopper, one filter needle for withdrawal of the vial contents, one injection needle and one syringe for withdrawal of the vial contents and for intravitreal injection.
Marketing Authorisation Holder
Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last approved in 10/2008.
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