Lutsentis - instructions for use, analogs, reviews and release forms (injections in ampoules for intraocular or intravitreal injections in solution) of a drug for the treatment of retinal vein occlusion in adults, children and pregnancy. Composition

In this article, you can read the instructions for using the drug Lucentis. Presented are reviews of visitors to the site - consumers of this medication, as well as opinions of doctors of specialists on the use of Lucentis in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Lucentis in the presence of existing structural analogues.Use to treat occlusion of retinal veins of the eye, reduce visual acuity in adults, children, as well as during pregnancy and lactation. Composition of the preparation.

Lucentis - a drug for the treatment of exudative hemorrhagic form of age-related macular degeneration (AMD), an inhibitor of growth factors of newly formed vessels.

Ranibizumab (the active substance of the drug Lucentis) selectively binds to the isoforms of the endothelial vascular growth factor, VEGF-A (VEGF110, VEGF121, VEGF165), and prevents the interaction of VEGF-A with its receptors on the surface of endothelial cells (VEGR1 and VEGR2), resulting in suppression neovascularization and proliferation of blood vessels. By suppressing the growth of newly formed choroid vessels into the retina, ranibizumab stops the progression of the exudative hemorrhagic form of AMD and macular edema in diabetes mellitus and retinal vein occlusion (thrombosis).

With the use of Lucentis for 24 months in patients with AMD with a minimal classical and hidden subfoveal choroidal neovascularization (CNV), in most cases (90%) the risk of visual acuity reduction (OD) was reduced significantly (loss less than 15 letters on the ETDRS visual acuity scale or 3 lines according to the Snellen table), in 1/3 patients (33%) there was an improvement in OZ by 15 letters or more on the ETDRS scale (p less than 0.01).In patients with injection imitations, the loss of less than 15 letters on the ETDRS scale (3 lines according to the Snellen table) and improvement of the OZ by more than 15 letters on the ETDRS scale was noted in 53% and 4% of cases, respectively.

In the majority of patients (90%) suffering from AMD with predominantly classical subfoveal CNV, during the course of treatment with ranibizumab for 24 months the frequency of development of pronounced decrease in vision (by more than 3 lines) decreased, in 1/3 patients (41% (more than 3 lines). In the group of patients receiving photodynamic therapy with verteporfinom (wDDT), a decrease in the risk of O3 decrease (by more than 3 lines) and improvement of OZ (more than 3 lines) was observed in 64% and 6%, respectively.

In patients with a decrease in OC associated with diabetic macular edema (DMO), the change in OC after 12 months of therapy compared with baseline was +6.8 letters against ranibizumab monotherapy, +6.4 letters - with Lucentis combined with laser coagulation (LC) and 0.9 letters - only with LC (p less than 0.0001). Improvement of OZ by more than 15 letters on the ETDRS scale was noted in 22.6%, 22.9% and 8.2% of patients receiving only ranibizumab, the drug in combination with LC and only LC, respectively (p less than 0.0001).When both therapies were administered within one day, ranibizumab was administered at least 30 minutes after LC.

When ranibizumab was used for 12 months (if necessary in combination with LC) in patients with a decrease in OC associated with DMO, the average change in OZ compared to baseline was +10.3 letters compared to -1.4 letters when imitating injection. Improvement of OZ by more than 10 and 15 letters on the ETDRS scale was noted in 60.8% and 32.4% of patients receiving ranibizumab compared with 18.4% and 10.2% when imitating injection (p less than 0.0001).

The discontinuation of the drug administration was possible with the achievement of stable indicators of OZ at 3 consecutive examinations. If it was necessary to resume treatment with ranibizumab, at least 2 consecutive monthly injections of the drug were carried out.

With the application of Lucentis, there was a pronounced persistent decrease in the thickness of the central zone of the retina, measured by optical coherence tomography. After 12 months of ranibizumab therapy, the thickness of the retina in the central zone decreased by 194 μm compared to 48 μm when imitating the injection.

The safety profile of the drug in patients with DME was similar to that in the treatment of a wet form of AMD.

In patients with a decrease in OC caused by edema of the macula due to occlusion of the branches of the retinal veins, the change in OZ after 12 months of therapy compared with the initial value was +18.3 letters against ranibizumab therapy in combination with LC, +12.1 letters - with ranibizumab therapy after 6 months of use simulation of injection in combination with LC. Improvement of OZ by more than 15 letters on the ETDRS scale was noted in 60.3 and 43.9% of patients who received ranibizumab or ranibizumab after applying the imitation injection. When both therapies were administered within one day, ranibizumab was administered at least 30 minutes after LC.

In patients with a decrease in OC caused by edema of the macula due to occlusion of the central retinal vein (CVV), the change in OC after 12 months of therapy compared with baseline was +13.9 letters against ranibizumab monotherapy, +7.3 letters for ranibizumab therapy after 6 months of imitation injections. Improvement of OZ by more than 15 letters on the ETDRS scale was noted in 50.8 and 33.1% of patients who received ranibizumab or ranibizumab after the imitation injection.

In the application of Lucentis in both cases, there was a pronounced persistent decrease in the thickness of the central zone of the retina.

In patients with a decrease in OC caused by CNV caused by pathological myopia, the change in OC after 1-3 months of therapy compared with baseline was +10.5 letters against ranibizumab therapy, depending on the achievement of the criteria for stabilizing OZ, +10.6 letters - with ranibizumab therapy in dependence on the activity of the disease; the change in OZ after 6 months of therapy compared with the initial value was +11.9 letters and +11.7 letters, respectively; in 12 months - +12.8 and +12.5 letters respectively.

When assessing the dynamics of the mean changes of the OZ from the initial value within 12 months, a rapid achievement of the results was recorded, while the maximum improvement was achieved already by 2 months. Improvement of OS remained throughout the 12-month period.

It should be noted that in patients who underwent condition monitoring and treatment on the basis of disease activity criteria, the number of injections during the 12-month period was, on average, one less than in patients receiving therapy, depending on the achievement of the criteria for stabilizing OZ. Immediately after the suspension of therapy, no adverse effect on OZ was found.

After the resumption of therapy, recovery of the lost OZ was observed within one month.

There was a decrease in the proportion of patients with subretinal fluid, intraurethral edema and / or intra-retinal cysts compared with baseline, and an overall improvement in the overall NEI-VFQ-25 questionnaire was noted.

Composition

Ranibizumab + auxiliary substances.

Pharmacokinetics

When Lucentis was administered to the vitreous body (once a month), patients with a neovascular form of CMax of ranibizumab in blood plasma were low and insufficient to inhibit the biological activity of VEGF-A by 50% (11-27 ng / ml according to cell proliferation studies). When the drug was administered to the vitreous humor in the dose range from 0.05 to 1.0 mg C max, ranibizumab in plasma was proportional to its dose.

Based on the results of the pharmacokinetic analysis and taking into account the removal of ranibizumab from the blood plasma, the average half-life (when applied at a dose of 0.5 mg) from the vitreous humus was about 9 days on average.

When Lucentis is injected into the vitreous body (once a month), C max ranibizumab in the blood plasma is reached within 24 hours after the injection and is in the range of 0.79-2.90 ng / ml. Cmin ranibizumab in the blood plasma is in the range 0.07-0.49 ng / ml. The concentration of ranibizumab in serum is approximately 90,000 times lower than that in the vitreous.

Indications

• treatment of neovascular (wet) forms of age-related macular degeneration in adults;
• treatment of visual acuity reduction due to diabetic edema of the macula as a monotherapy or in combination with laser coagulation in patients who had previously undergone laser coagulation;
• treatment of visual acuity reduction due to macular edema caused by retinal vein occlusion (the central vein of the retina or its branches);
• treatment of visual acuity reduction caused by choroidal neovascularization caused by pathological myopia.

Forms of release

Solution for intraocular administration (injections in ampoules for intraocular or intravitreal injections (IVB or IVI)).

Instructions for use and usage diagram

Lutsentis is used only in the form of injections into the vitreous.

The contents of 1 bottle of Lucentis should be used for only 1 intravitreal injection. Enter ranibizumab (in aseptic conditions) should only an ophthalmologist who has experience of performing intravitreal injections.

Between the introduction of two doses of the drug should be observed interval of at least 1 month.

The recommended dose of Lucentis is 0.5 mg (0.05 ml) once a month as an intravitreal injection.

During the treatment, the patient undergoes monthly visual acuity control.

Treatment of a wet form of age-related macular degeneration in adults

Injections of Lucentis are performed on a monthly basis and continue until a maximum stable OC is detected on 3 consecutive monthly visits with Lucasence.

Treatment with Lucentis is resumed in case of a decrease in OZ by 1 or more lines (more than 5 letters) due to AMD; OZ is determined during monitoring. Treatment continues until a stable OZ is reached, also on 3 consecutive monthly visits.

Treatment for reduced visual acuity due to diabetic edema of the macula

Injections of Lucentis are performed on a monthly basis and continue until a maximum stable OC is detected on 3 consecutive monthly visits with Lucasence.

Treatment with Lucentis is resumed in the event of a decrease in visual acuity due to DMO; OZ is determined during monitoring.Treatment continues until a stable OZ is reached, also on 3 consecutive monthly visits. Therapy with Lucentis can be combined with the use of LC in patients with DMO (including in patients with previous LC). In the appointment of both methods of therapy for one day, the drug Lucentis should be administered after at least 30 minutes after the LC.

Treatment for reducing visual acuity caused by edema of the macula due to retinal vein occlusion (the central vein of the retina or its branches)

Injections of Lucentis are performed on a monthly basis and continue until the maximum OZ is reached, determined on 3 consecutive monthly visits against the background of the introduction of Lucentis.

Treatment with Lucentis is resumed in the form of monthly injections in the event of a decrease in OC due to OVS; OZ is determined by monthly monitoring; The treatment is continued until a stable visual acuity is achieved on 3 consecutive monthly visits. Therapy with Lucentis can be combined with the use of LK. With the appointment of both methods of therapy for one day, Lucentis should be administered at least 30 minutes after the LC.Lutsentis can also be used in patients with a previous LC.

Treatment of visual acuity reduction caused by choroidal neovascularization caused by pathological myopia

Treatment with Lucentis begins with a single injection. When identifying signs of disease activity, determined by periodic monitoring of the condition, which may include clinical examination, optical coherence tomography (OCT) or fluorescent angiography (FA), it is recommended to resume treatment with Lucentis.

In most cases, 1 or 2 injections of Lucentis in the first year of therapy are required. However, in some cases, more frequent use of the drug may be required. In this regard, during the first 2 months, it is recommended to monitor the condition on a monthly basis and then at least once every 3 months during the first year of treatment with Lucentis. In the future, the frequency of control is determined by the attending physician.

The use of the drug in patients with impaired liver function has not been studied. Given the low concentration of the drug Lucentis in blood plasma,Do not change the dosage regimen.

Patients with impaired renal function do not need a dose adjustment.

Patients of the elderly (65 years and older) do not need a dose adjustment.

Rules of drug administration

Before the administration of Lucentis, the quality of dissolution and the color of the solution should be checked. The drug can not be used when changing the color of the solution and the appearance of insoluble visible particles.

Injection of the drug into the vitreous humor should be performed under aseptic conditions, including the treatment of the hands of medical personnel, the use of sterile gloves, napkins, the eyelid (or its analog) and, if necessary, tools for paracentesis.

Before the introduction of the drug, it is necessary to conduct appropriate disinfection of the skin of the eyelids and the eye area, conjunctival anesthesia and antimicrobial therapy with a wide spectrum of action. Antimicrobials should be instilled in the conjunctival sac 3 times a day for 3 days before and after the administration of the drug.

Lucentis should be injected into the vitreous for 3.5-4 mm posterior to the limbus, avoiding the horizontal meridian and directing the needle to the center of the eyeball. The volume of the injected drug is 0.05 ml.The next injection of the drug is carried out in the other half of the sclera.

Since intraocular pressure (IOP) may temporarily increase during 60 minutes after Lucentis injection, IOP should be monitored, optic nerve perfusion should be performed and, if necessary, appropriate treatment should be used. There were also cases of a steady increase in IOP after the injection of Lucentis.

In one session, the administration of Lucentis is carried out only in one eye.

Side effect

• nasopharyngitis;
• flu;
• anemia;
• anxiety;
• headache;
• stroke;
• intraocular inflammation;
• inflammation of the vitreous body;
• vitreous body detachment;
• retinal hemorrhages;
• visual disturbances;
• Pain in the eyes;
• opacification in the vitreous body;
• increased intraocular pressure;
• conjunctival hemorrhages;
• eye irritation;
• foreign body sensation in the eye;
• lacrimation;
• blepharitis;
• dry eye syndrome;
• redness of the eyes;
• a feeling of itching in the eyes;
• degenerative changes in the retina;
• retinal damage;
• retinal disinsertion;
• rupture of the retina;
• detachment of retinal pigment epithelium;
• rupture of pigment epithelium;
• decreased visual acuity;
• vitreous hemorrhage;
• vitreous damage;
• uveitis, iritis, iridocyclitis;
• cataract, subcapsular cataract;
• opacity of the posterior capsule of the lens;
• point keratitis;
• corneal erosion;
• cell opalescence in the anterior chamber of the eye;
• blurred vision;
• hemorrhage at the injection site, eye hemorrhage;
• conjunctivitis, allergic conjunctivitis;
• discharge from the eyes;
• photopsy;
• photophobia;
• a feeling of discomfort in the eyes;
• swelling of the eyelids;
• painfulness of the eyelids;
• hyperemia of the conjunctiva;
• blindness;
• endophthalmitis;
• hypopion;
• hyphema;
• keratopathy;
• adhesions of the iris;
• deposits in the cornea;
• corneal edema;
• corneal striae;
• pain and irritation at the injection site;
• atypical sensations in the eye and irritation of the eyelids;
• cough;
• nausea;
• rash;
• hives;
• itching;
• arthralgia.

Contraindications

• confirmed or suspected eye infections or infectious processes of periocular localization;
• intraocular inflammation;
• children and adolescents under 18 years of age (efficacy and safety of the drug in this category of patients has not been studied);
• pregnancy;
• lactation period;
• increased sensitivity to ranibizumab or any other component of the drug.

Carefully

Patients with a history of hypersensitivity, in the presence of risk factors for stroke, the drug should be administered only after a thorough assessment of the risk / benefit ratio.

The use of VEGF inhibitors in patients with DME due to retinal vein occlusion (CVD) and CNV caused by pathological myopia, with a history of stroke or transient ischemia of the brain should be carried out with caution because of the risk of developing thromboembolic events. Lucentis should not be used concomitantly with other drugs affecting the endothelial growth factor of the vessels (local or systemic use).

Clinical conditions in which therapy with Lucentis should be stopped and not restarted:

• The decrease of OZ by more than 30 letters in comparison with the last definition;
• intraocular pressure more than 30 mm Hg. p.
• retinal rupture;
• subretinal hemorrhages affecting the central fossa, or lesion area more than 50%;
• condition after intraocular surgery or planned in the next 28 days.

It is necessary to comply with aseptic conditions during injections of Lucentis to prevent the development of complications such as endophthalmitis, retinal rupture, iatrogenic traumatic cataract.

The drug should be used with caution in patients with AMD and the revealed extensive detachment of pigment epithelium, t. they have a higher risk of developing ruptured pigment epithelium.

The drug should be used with caution in patients at risk of developing rheumatogenic retinal detachment. In patients with rheumatogenic retinal detachment or rupture of the macula in stage 3, 4, treatment with Lucentis should be discontinued.

Experience in the use of ranibizumab in patients with OVS in the anamnesis and in patients with ischemic occlusion of the CVC or branches of the CVV is limited. In patients with OVS who have clinical manifestations of irreversible ischemic loss of visual function, the use of the drug is not recommended.

Application in pregnancy and lactation

The drug is contraindicated for use in pregnancy and lactation (breastfeeding).

The systemic effect of ranibizumab after its intraocular administration is low,but taking into account the mechanism of action of the drug, ranibizumab should be considered as a potentially teratogenic, embryotoxic drug.

Women of childbearing age with the use of the drug Lucentis should use reliable methods of contraception. The interval between the end of Lucentis treatment and conception should not be less than 3 months.

Use in children

Contraindicated in children and adolescents under the age of 18 (efficacy and safety of the drug in this category of patients has not been studied).

Application in elderly patients

Patients aged 65 years and older do not need a dose adjustment.

special instructions

Lentenzis should be treated only by an ophthalmologist who has experience in performing intravitreal injections.

The administration of Lucentis should always be carried out under aseptic conditions. In addition, within 1 week after the injection of the drug, it is necessary to observe the patient in order to identify a possible local infectious process and conduct timely therapy. Patients should be informed of the need to immediately notify the physician of all symptoms,which may indicate the development of endophthalmitis.

The drug has immunogenic properties. In patients with DME, there is a higher risk of systemic exposure to the drug, so it is necessary to remember the higher risk of developing hypersensitivity reactions in this category of patients. Patients should be aware of the signs indicating the development of intraocular inflammation, which may indicate intraocular formation of antibodies to the drug.

With the injection of vitreous VEGF-A inhibitors, the development of arterial thromboembolic complications is possible.

The risk of stroke may be higher if patients have risk factors, including a history of stroke or transient cerebral circulatory disorders.

In patients after the administration of the drug Lucentis, there was a temporary increase (within 60 minutes after the injection) of intraocular pressure (IOP). There have also been cases of a sustained increase in IOP. Against the background of the use of the drug Lucentis, it is recommended to monitor IOP and perfusion of the optic disc.

Lucentis is not recommended to inject simultaneously into both eyes (safety and efficacy of thisintroductions have not been studied). This can lead to an increase in the systemic impact of Lucentis and the risk of side effects.

The experience with Lucentis is limited in patients with DMO due to type 1 diabetes, in patients previously treated with intraocular preparations, in patients with active systemic infections, with proliferative diabetic retinopathy, or in patients with concomitant non-infectious eye diseases, such as retinal detachment , incl. in the area of ​​the macula. Also, there is no experience of using Lucentis in patients with diabetes mellitus with a glycated hemoglobin level of more than 12% and uncontrolled arterial hypertension.

The experience of using the drug Lucentis is limited in patients with pathological myopia, previously unsuccessfully exposed to PDDT. Despite the fact that patients with subfoveal and juxtafoveal localization of the lesion had a similar effect, there is insufficient data for the conclusions regarding the effectiveness of the Lucentis drug in patients with pathological myopia with extrafoveal localization of the lesion.

Impact on the ability to drive vehicles and manage mechanisms

Against the backdrop of using the drug Lucentis, it is possible to develop temporary visual impairments that adversely affect the ability to drive vehicles and work with mechanisms. If such symptoms occur, patients should not drive vehicles or work with mechanisms until the severity of temporary visual disturbances is reduced.

Drug Interactions

The interaction of Lucentis with other drugs has not been studied.

Lucentis should not be mixed with any other medicines or solvents.

There are no data on the use of Lucentis in conjunction with vFDT in patients with decreased OC caused by CNV caused by pathological myopia.

Analogues of the drug Lucentis

Lutsentis does not have structural analogs for the active substance.

Analogues on the curative effect (agents for treating occlusion of the vessels of the retina):

• Agapurin;
• Agapurin retard;
• Bravinton;
• Vazomag;
• Vazonite;
• Vinpoton;
• Vinpocetine;
• Gemase;
• Digofton;
• Idrinol;
• Cavinton;
• Cardion;
• Korsavin;
• Meldonius;
• Parmidin;
• Pentamon;
• Pentoxifylline;
• Preductal;
• Radomine;
• Streptase;
• Teletext;
• Trental;
• Chymotrypsin;
• Emoxibel;
• Emoxipine;
• Endothelon.

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