Posology : מינונים

4.2    Posology and method of administration

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

Posology

Adults
The recommended dose for Lucentis 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, Lucentis 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 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).

Lucentis and laser photocoagulation in DME and in macular oedema secondary to BRVO There is some experience of Lucentis administered concomitantly with laser photocoagulation (see section 5.1). When given on the same day, Lucentis should be administered at least 30 minutes after laser photocoagulation. Lucentis can be administered in patients who have received previous laser photocoagulation.

Lucentis and verteporfin photodynamic therapy in CNV secondary to PM
There is no experience of concomitant administration of Lucentis and verteporfin.

Preterm infants
The recommended dose for Lucentis in preterm infants is 0.2 mg given as an intravitreal injection. This corresponds to an injection volume of 0.02 ml. In preterm infants treatment of ROP is initiated with a single injection per eye and may be given bilaterally on the same day. In total, up to three injections per eye may be administered within six months of treatment initiation if there are signs of disease activity.
Most patients (78%) in the 24-week RAINBOW clinical study received one injection per eye.
Patients who were treated with 0.2 mg in this clinical study did not require additional treatment in the subsequent long-term extension study which followed the patients up to five years of age (see section 5.1). The administration of more than three injections per eye has not been studied. The interval between two doses injected into the same eye should be at least four weeks.

Special populations

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

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

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

Paediatric population
Lucentis is not indicated for use in children and adolescents.

Method of administration
Pre-filled syringe
Single-use pre-filled syringe for intravitreal use only.
The pre-filled syringe contains more than the recommended dose of 0.5 mg. The extractable volume of the pre-filled syringe (0.1 ml) is not to be used in total. The excess volume should be expelled prior to injection. Injecting the entire volume of the pre-filled syringe could result in overdose. To expel the air bubble along with the excess medicinal product, slowly push the plunger until the edge below the dome of the rubber stopper is aligned with the black dosing line on the syringe (equivalent to 0.05 ml, i.e., 0.5 mg ranibizumab).

Vial
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 and 0.02 ml for preterm infants), a portion of the volume contained in the vial must be discarded prior to administration.
Use of more than one injection from a vial can lead to product contamination and subsequent ocular infection.

Pre-filled syringe and Vial
Lucentis should be inspected visually for particulate matter and discoloration 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.

For information on preparation of Lucentis, see section 6.6.

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.
Each pre-filled syringe should only be used for the treatment of a single eye.

Paediatric population
In preterm infants, the injection needle should be inserted into the eye 1.0 to 2.0 mm posterior to the limbus, with the needle pointing towards the optic nerve. The injection volume of 0.02 ml is then delivered.