XIMLUCI Solution for injection Ref.[50507] Active ingredients: Ranibizumab

Ximluci must be administered by a qualified ophthalmologist experienced in intravitreal injections.

Posology

Adults

The recommended dose for Ximluci in adults is 0.5 mg given as a single intravitreal injection. This corresponds to an injection volume of 0.05 mL. The interval between two doses injected into the same eye should be at least four weeks.

Treatment in adults is initiated with one injection per month until maximum visual acuity is achieved and/or there are no signs of disease activity i.e. no change in visual acuity and in other signs and symptoms of the disease under continued treatment. In patients with wet AMD, DME, PDR and RVO, initially, three or more consecutive, monthly injections may be needed.

Thereafter, monitoring and treatment intervals should be determined by the physician and should be based on disease activity, as assessed by visual acuity and/or anatomical parameters.

If, in the physician’s opinion, visual and anatomic parameters indicate that the patient is not benefiting from continued treatment, Ximluci should be discontinued.

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

If patients are being treated according to a treat-and-extend regimen, once maximum visual acuity is achieved and/or there are no signs of disease activity, the treatment intervals can be extended stepwise until signs of disease activity or visual impairment recur. The treatment interval should be extended by no more than two weeks at a time for wet AMD and may be extended by up to one month at a time for DME. For PDR and RVO, treatment intervals may also be gradually extended, however there are insufficient data to conclude on the length of these intervals. If disease activity recurs, the treatment interval should be shortened accordingly.

The treatment of visual impairment due to CNV should be determined individually per patient based on disease activity. Some patients may only need one injection during the first 12 months; others may need more frequent treatment, including a monthly injection. For CNV secondary to pathologic myopia (PM), many patients may only need one or two injections during the first year (see section 5.1).

Ximluci and laser photocoagulation in DME and in macular oedema secondary to BRVO

There is some experience of ranibizumab administered concomitantly with laser photocoagulation (see section 5.1). When given on the same day, Ximluci should be administered at least 30 minutes after laser photocoagulation. Ximluci can be administered in patients who have received previous laser photocoagulation.

Ximluci and verteporfin photodynamic therapy in CNV secondary to PM

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

Special populations

Elderly

No dose adjustment is required in the elderly. There is limited experience in patients older than 75 years with DME.

Renal impairment

Dose adjustment is not needed in patients with renal impairment (see section 5.2).

Hepatic impairment

Ranibizumab has not been studied in patients with hepatic impairment. However, no special considerations are needed in this population.

Paediatric population

The safety and efficacy of Ximluci in children and adolescents below 18 years of age have not been established. Available data in adolescent patients aged 12 to 17 years with visual impairment due to CNV are described in section 5.1 but no recommendation on a posology can be made.

Method of administration

Single-use vial for intravitreal use only.

Since the volume contained in the vial (0.23 mL) is greater than the recommended dose (0.05 mL for adults), a portion of the volume contained in the vial must be discarded prior to administration.

Ximluci should be inspected visually for particulate matter and discolouration prior to administration.

The injection procedure should be carried out under aseptic conditions, which includes the use of surgical hand disinfection, sterile gloves, a sterile drape and a sterile eyelid speculum (or equivalent) and the availability of sterile paracentesis (if required). The patient’s medical history for hypersensitivity reactions should be carefully evaluated prior to performing the intravitreal procedure (see section 4.4). Adequate anaesthesia and a broad-spectrum topical microbicide to disinfect the periocular skin, eyelid and ocular surface should be administered prior to the injection, in accordance with local practice.

Adults

In adults, the injection needle should be inserted 3.5-4.0 mm posterior to the limbus into the vitreous cavity, avoiding the horizontal meridian and aiming towards the centre of the globe. The injection volume of 0.05 mL is then delivered; a different scleral site should be used for subsequent injections.

For instructions on preparation of the medicinal product before administration, see section 6.6.

Cases of accidental overdose have been reported from the clinical studies in wet AMD and postmarketing data. Adverse reactions associated with these reported cases were intraocular pressure increased, transient blindness, reduced visual acuity, corneal oedema, corneal pain, and eye pain. If an overdose occurs, intraocular pressure should be monitored and treated, if deemed necessary by the attending physician.

3 years.

Store in a refrigerator (2°C–8°C).

Do not freeze.

Keep the vial in the outer carton in order to protect from light.

Prior to use, the unopened vial may be kept at room temperature (25 °C) for up to 48 hours.

Vial-only pack: One vial (type I glass) with a stopper (bromobutyl rubber) containing 0.23 mL sterile solution.

Vial + filter needle pack: One vial (type I glass) with a stopper (bromobutyl rubber) containing 0.23 mL sterile solution and one sterile, blunt 5 µm filter needle (18G x 1½″, 1.2 mm x 40 mm).

Not all pack sizes may be marketed.

Vial-only pack:

The vial is for single use only. After injection any unused product must be discarded. Any vial showing signs of damage or tampering must not be used. The sterility cannot be guaranteed unless the packaging seal remains intact.

For preparation and intravitreal injection the following medical devices for single use are needed:

• a sterile 5 µm filter needle (18G x 1½″, 1.2 mm x 40 mm)
• a 1 mL sterile syringe (including a 0.05 mL mark) and an injection needle (30G x ½″, 0.3 mm x 13 mm)

These medical devices are not included within this pack.

Vial + filter needle pack:

The vial and filter needle are for single use only. Re-use may lead to infection or other illness/injury. All components are sterile. Any component with packaging showing signs of damage or tampering must not be used. The sterility cannot be guaranteed unless the component packaging seal remains intact.

For preparation and intravitreal injection the following medical devices for single use are needed:

• a sterile 5 µm filter needle (18G x 1½″, 1.2 mm x 40 mm, provided)
• a 1 mL sterile syringe (including a 0.05 mL mark, not included within this pack) and an injection needle (30G x ½″, 0.3 mm x 13 mm, not included within this pack)

To prepare Ximluci for intravitreal administration to adults, please adhere to the following instructions:

1. Before withdrawal, remove the vial cap and clean the vial septum (e.g. with 70% alcohol swab).

2. Assemble a 5 µm filter needle (18G x 1½″, 1.2 mm x 40 mm) onto a 1 mL syringe using aseptic technique. Push the blunt filter needle into the centre of the vial stopper until the needle touches the bottom edge of the vial.

3. Withdraw all the liquid from the vial, keeping the vial in an upright position, slightly inclined to ease complete withdrawal.

4. Ensure that the plunger rod is drawn sufficiently back when emptying the vial in order to completely empty the filter needle.

5. Leave the blunt filter needle in the vial and disconnect the syringe from the blunt filter needle. The filter needle should be discarded after withdrawal of the vial contents and should not be used for the intravitreal injection.

6. Aseptically and firmly assemble an injection needle (30G x ½″, 0.3 mm x 13 mm) onto the syringe.

7. Carefully remove the cap from the injection needle without disconnecting the injection needle from the syringe. Note: Grip at the hub of the injection needle while removing the cap.

8. Carefully expel the air along with the excess solution and adjust the dose to the 0.05 mL mark on the syringe. The syringe is ready for injection.

Note: Do not wipe the injection needle. Do not pull back on the plunger.

After injection, do not recap the needle or detach it from the syringe. Dispose of the used syringe together with the needle in a sharps disposal container or in accordance with local requirements.