Rimmyrah 10 mg/ml solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Rimmyrah 10 mg/ml solution for injection

ranibizumab

This medicinal product is subject to additional monitoring, which will allow quicker identification of new safety information. You can help by reporting any side effects you may experience. Information on how to report side effects is provided at the end of section 4.

Read all of this leaflet carefully before you are given this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor.
• If you experience any side effects, consult your doctor, even if they are not listed in this leaflet. See section 4.

Contents of this leaflet

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

1. What Rimmyrah is and what it is used for

What Rimmyrah is

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

What Rimmyrah is used for

Rimmyrah 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 diseases such as age-related macular degeneration (AMD) and proliferative diabetic retinopathy (PDR, a disease caused by diabetes). It may also be associated with choroidal neovascularisation (CNV) due to pathological myopia (PM), angioid streaks, central serous chorioretinopathy, or inflammatory CNV.
• Macular oedema (swelling of the centre of the retina). The cause of this swelling may be diabetes (a condition known as diabetic macular oedema (DME)) or blockage of the retinal veins (a disease known as retinal vein occlusion (RVO)).

How Rimmyrah works

Rimmyrah specifically recognizes and binds to a protein called human vascular endothelial growth factor A (VEGF-A) present in the eyes. 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, Rimmyrah prevents it from acting and thereby inhibits this abnormal growth and swelling.

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

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

Do not be given Rimmyrah

• 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 your eye.
• If you have eye pain or redness (severe intraocular inflammation) in the eye.

Warnings and precautions

Talk to your doctor before you are given Rimmyrah

• Rimmyrah is administered by injection into the eye. Occasionally, after treatment with Rimmyrah, 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 early as possible. Immediately inform your doctor if you notice signs such as eye pain or increased eye discomfort, worsening redness in the eye, blurred vision or decreased vision, an increase in the number of small floating spots in your vision, or increased sensitivity to light.
• In some patients, eye pressure may increase for a short period of time 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 a stroke (weakness or paralysis of a limb or face, difficulty speaking or understanding). This information will be considered when evaluating whether Rimmyrah is the appropriate treatment for you.

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

Children and adolescents (under 18 years of age)

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

Other medicines and Rimmyrah

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 injection of Rimmyrah.
• There is no experience with the use of Rimmyrah in pregnant women. Rimmyrah 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 Rimmyrah.
• Small amounts of ranibizumab may pass into breast milk; therefore, the use of Rimmyrah during breastfeeding is not recommended. Consult your doctor or pharmacist before treatment with Rimmyrah.

Driving and using machines

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

3. How Rimmyrah is administered

Rimmyrah 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 ranibizumab). The interval between two doses given 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 wash 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 a monthly injection of Rimmyrah. Your doctor will monitor the disease in your eye and, depending on how you respond to treatment, will decide whether you need further treatment and when it should be given.

Detailed instructions for use are provided at the end of the leaflet.

Elderly patients (aged 65 years and older)

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

Before stopping treatment with Rimmyrah

If you are considering stopping treatment with Rimmyrah, please 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 Rimmyrah.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

The following are the most serious adverse effects:

Frequent serious adverse effects (may affect up to 1 in 10 people):

• 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 adverse effects (may affect up to 1 in 100 people):

• 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 eye redness, blurred vision or decreased vision, an increase in the number of small floating spots in your vision, or increased sensitivity to light.

Contact your doctor immediately if you experience any of these adverse effects.

The following are the most commonly reported adverse effects:

Very common adverse effects (may affect more than 1 in 10 people)

Ocular adverse effects include:

• Eye inflammation,
• Bleeding in 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,
• Redness or itching of the eye,
• Increased eye pressure.

Non-ocular adverse effects include:

• Sore throat,
• Nasal congestion,
• Runny nose,
• Headache,
• Joint pain.

The following are other adverse effects that may occur after treatment with Rimmyrah:

Common adverse effects (may affect up to 1 in 10 people)

Ocular adverse effects include:

• Decreased visual sharpness,
• Swelling of 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,
• Pain in the eyelid.

Non-ocular adverse 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 adverse effects (may affect up to 1 in 100 people)

Ocular adverse 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 adverse effects

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

5. Storage of Rimmyrah

• 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 CAD and on the label of the vial 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 unopened vial may be stored at room temperature (25°C) for up to 24 hours.
• Keep the vial in the outer packaging to protect it from light.
• Do not use any container that is damaged.

6. Contents of the container and other information

Composition of Rimmyrah

• The active substance is ranibizumab. Each ml contains 10 mg of ranibizumab. Each vial contains 2.3 mg of ranibizumab in 0.23 ml of solution. This provides a sufficient amount to deliver a single dose of 0.05 ml containing 0.5 mg of ranibizumab.
• The other components are trehalose dihydrate, histidine monohydrochloride monohydrate, histidine, polysorbate 20 (E432), water for injections.

Appearance of the product and contents of the container

Rimmyrah is an injectable solution contained in a vial (0.23 ml). The solution is from clear to slightly opalescent, from colourless to brownish, and aqueous.

Two different types of packaging are available:

Vial-only pack

Pack containing one glass vial with ranibizumab, with a chlorobutyl rubber stopper. The vial is for single use.

Vial + filter needle pack

Pack containing one glass vial with ranibizumab, with a chlorobutyl rubber stopper, and one filter needle (18G x 1½ inches, 1.2 mm x 40 mm, 5 micrometers) for withdrawing the solution from the vial. All components are for single use.

Marketing Authorization Holder

QILU PHARMA SPAIN S.L.

Paseo de la Castellana 40, planta 8

28046 Madrid

Spain

Manufacturer

KYMOS, S.L.

Ronda De Can Fatjo 7 B

Parc Tecnologic Del Valles

Cerdanyola Del Valles

Barcelona

08290

Spain

More information about this medicinal product can be requested from the local representative of the marketing authorization holder:

Date of the most recent review of this summary:

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 Rimmyrah is administered”.

Single-use vial. For intravitreal use only.

Rimmyrah must be administered by an ophthalmologist experienced in the administration of intravitreal injections.

For neovascular (wet) age-related macular degeneration (nAMD), for myopic choroidal neovascularization (mCNV), for diabetic macular edema (DME), and for visual impairment due to macular edema secondary to retinal vein occlusion (RVO), the recommended dose of Rimmyrah is 0.5 mg administered 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 should 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 nAMD, DME, diabetic retinopathy (DR), and RVO, three or more consecutive monthly injections may initially 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 Rimmyrah should be discontinued if, in 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 testing, 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 nAMD, treatment intervals should not be extended by more than two weeks at a time; for DME, intervals may be extended by up to one month at a time. For DR 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, the treatment interval should be shortened accordingly.

Treatment of visual impairment due to mCNV 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 mCNV secondary to pathological myopia (PM), many patients may require only one or two injections during the first year.

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

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

Ranibizumab and photodynamic therapy with verteporfin in mCNV secondary to PM

There is no experience with concomitant administration of ranibizumab and verteporfin.

Prior to administration of Rimmyrah, the medicinal product should be visually inspected to ensure absence of particles, discoloration, or other alterations. If particles, discoloration, or other alterations are observed, the vial must be discarded according to local disposal regulations.

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 a sterile paracentesis needle (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 anesthesia and a broad-spectrum topical microbicide should be administered to disinfect the skin of the periocular area, eyelids, and ocular surface, in accordance with local practice.

Vial-only pack

The vial is for single use only. After injection, any unused product remaining must be discarded. Do not use any vial showing signs of damage or tampering. Sterility can only be guaranteed if the container’s seal remains intact.

The following single-use medical devices are required for preparation and intravitreal injection:

• a 5 µm filter needle (18G × 1½ inches, 1.2 mm × 40 mm)
• a sterile 1 ml syringe (with a 0.05 ml mark)
• an injection needle (30G × ½ inch). These medical devices are not included in the Rimmyrah pack.

Vial + filter needle pack

All components are sterile and for single use only. Do not use any component whose packaging shows signs of damage or tampering. Sterility can only be guaranteed if the packaging seal of the components remains intact. Reuse may lead to infection or other illness/injury.

The following single-use medical devices are required for preparation and intravitreal injection:

• a 5 µm filter needle (18G × 1½ inches, 1.2 mm × 40 mm, supplied)
• a sterile 1 ml syringe (with a 0.05 ml mark, not supplied with the Rimmyrah pack)
• an injection needle (30G × ½ inch; not supplied with the Rimmyrah pack)

To prepare Rimmyrah for intravitreal administration in adult patients, follow the instructions below:

Traceability

In order to improve the traceability of biological medicines, the name and batch number of the administered medicine should be clearly recorded.

The injection needle should be inserted 3.5 to 4.0 mm posterior to the limbus into the vitreous cavity, avoiding the horizontal meridian, with the needle directed toward the center of the eyeball. The injection volume of 0.05 mL should then be administered. A different scleral site must be used for subsequent injections.

After injection, do not cover the needle with the closure cap or detach it from the syringe. Dispose of the used syringe together with the needle in a sharps container or according to local regulations.