Universal reference book for medicines
Product name: LUCENTIS ®

Active substance: ranibizumab

Type: The drug used for age-related macular degeneration.
Monoclonal antibodies to the endothelial growth factor A (VEGF-A)
Manufacturer: NOVARTIS PHARMA (Switzerland) manufactured by NOVARTIS PHARMA STEIN (Switzerland)
Composition, form of production and packaging
The solution for intraocular administration is
clear or slightly opalescent, colorless.

1 ml of 1 fl.

ranibizumab * 10 mg 2.3 mg

Excipients:?,? - trehalose dihydrate - 100 mg / 23 mg, L-histidine hydrochloride monohydrate - 1.66 mg / 382 μg, L-histidine 320 μg / 74 μg, polysorbate 20-100 μg / 23 μg, water q / and up to 1 ml / 0.23 ml.

* ranibizumab is a fragment of a humanized antibody to the endothelial growth factor A (VEGF-A) and is expressed by a recombinant strain of Escherichia coli.

0.23 ml - bottles of colorless glass (1) complete with a needle, equipped with a filter, a syringe and a needle d / and - a pack of cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2016.

PHARMACHOLOGIC EFFECT

Ranibizumab selectively binds with isoforms of endothelial vascular growth factor, VEGF-A (VEGF 110 , VEGF 121 , VEGF 165 ), and prevents the interaction of VEGF-A with its receptors on the surface of endothelial cells (VEGR 1 and VEGR 2 ), resulting in suppression of neovascularization and vascular proliferation.
By suppressing the growth of newly formed choroid vessels into the retina, ranibizumab stops the progression of the exudative hemorrhagic form of age-related macular degeneration (AMD) or pathological myopia (PM) and macular edema in diabetes mellitus and retinal vein occlusion (thrombosis).
With the use of ranibizumab for 24 months in patients with AMD with minimal classical and concealed subfoveal choroidal neovascularization ( CNV), in most cases (90%) the risk of reducing visual acuity (OZ) was significantly decreased (loss of less than 15 letters on the OST ETDRS or 3 lines according to the Snellen table), in one third of patients (33%) there was an improvement in O3 by 15 letters or more on the ETDRS scale (p <0.01).
In patients with injection imitations, the loss of less than 15 letters on the ETDRS scale (3 rows according to 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%), with AMD with predominantly classical subfoveal CNV, during the treatment with ranibizumab for 24 months, the incidence of marked decrease in vision (by more than 3 rows) decreased, in one third of patients (41%) there was an improvement in OE (more than on 3 lines).
In the group of patients receiving photodynamic therapy with verteporphin (wDDT), a decrease in the risk of visual acuity reduction (by more than 3 lines) and improvement of OZ (more than 3 lines) were observed in 64 and 6% cases, respectively.
According to the questionnaire for assessing the quality of life of NEI-VFQ (National Eye Institute Visual Function Questionnaire) after 12 months of ranibizumab in patients with AMD with a minimal classical and subfoveal CNV, the mean improvement in OC near and far from baseline was + 10.4 and + 7.0 letters respectively (p <0.01).
In the control group, in patients with imitating injections of the drug, the mean change in OC near and far from baseline was -2.6 and -5.9 letters (p <0.01). In patients receiving ranibizumab, the indicator of vision-related capacity increased by +6.8 letters, and in patients receiving imitation injection, this indicator decreased by 4.7 letters (p <0.01). When ranibizumab was used in patients with AMD with a minimal pronounced classical and subfoveal CNV, the improvement of the OSremained for 24 months.
In the majority of patients with AMD with predominantly classical subfoveal CNV on the background of drug treatment for 12 months, the average change in OC near and far from baseline was +9.1 and + 9.3 letters, respectively (p <0.01).
In the control group, the average change in OZ near and far in comparison with the baseline value was +3.7 and +1.7 letters (p <0.01) in patients receiving wFDT. In patients receiving ranibizumab, the capacity of the visually impaired by +8.9 increased, and in patients receiving imitation injection, this index improved by 1.4 (p <0.01).
In patients with reduced OZ,
(P <0.0001), +6.4 letters - with a combination of ranibizumab with laser coagulation (PK) (p = 0.0001), with a combination of ranibizumab and laser coagulation (P = 0.0004) and 0.9 letters - only with LC. Improvement of OZ by more than 15 letters on the ETDRS scale was noted in 22.69% (p = 0.0032), 22.9% (p = 0.0021) and 8.2% of patients receiving only ranibizumab, the drug in combination with LC and only LC, respectively. In the application of both methods of therapy for one day, ranibizumab was administered at least 30 minutes after LC. In a similar study conducted with the participation of a population of Asian patients, results comparable to the European patient population were obtained.
With the use of ranibizumab for 12 months (with the possibility of combination with LC from the 3rd month of therapy) in patients with a decrease in OC associated with DMO, the average change in OZ compared to the baseline was +10.3 letters compared to -1.4 letters when imitated injections (p <0.0001).
Improvement of OZ by more than 10 and 15 letters on the ETDRS scale was noted respectively in 60.8% and 32.4% (p = 0.0043) of patients receiving ranibizumab as compared with 18.4% (p <0.0001) and 10.2% when imitating injection.
The discontinuation of the drug administration was possible when stable PI values ​​were achieved in three consecutive examinations.
If necessary to resume treatment with ranibizumab, at least 2 consecutive monthly injections of the drug were carried out.
When ranibizumab was used, a pronounced steady decrease in the thickness of the central zone of the retina, measured by optical coherence tomography, was observed.
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 decreased O3 associated with DMO, three treatment regimens were studied: ranibizumab 0.5 mg in combination with LC, in the treatment and prolongation (TE) regime; monotherapy with ranibizumab 0.5 mg in the regime of "treatment and prolongation"; and ranibizumab monotherapy with 0.5 mg in "as needed" (prorenata (PRN)). The average change in the maximally corrected OZ (ICEH) at 24 months was 8.3; 6.5; 8.1 in patients treated with ranibizumab in combination with LC, ranibizumab in the "treatment and extension" mode, and ranibizumab in "as needed" mode, respectively.
Average change in OZ?
by 15 letters to 24 months were observed in 25.6%, 28.0%, 30.8% of patients receiving ranibizumab in combination with LK, ranibizumab in the "treatment and extension" mode and ranibizumab in "as needed" mode, respectively.
In patients with a decrease in OC caused by edema of the macula due to occlusion of retinal vein branches (OVC), the change in OZ after 12 months of therapy compared with baseline was +18.3 letters against ranibizumab therapy in combination with LC, +12.1 letters - with ranibizumab therapy after 6 months of imitation injection application 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 receiving ranibizumab or ranibizumab after applying the imitation injection. When both methods of therapy were used for 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 - with 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 receiving ranibizumab or ranibizumab after simulating injection.

When ranibizumab was used in both cases, a pronounced permanent decrease in the thickness of the central zone of the retina was observed.

In patients with a decrease in OC caused by CNV caused by pathological myopia (PM), the change in OZ in 1-3 months of therapy, compared with baseline, was +10.5 letters against ranibizumab therapy, depending on the achievement of the OZ stabilization criteria, +10.6 letters - for therapy ranibizumab, depending 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.
The proportion of patients with an increase in OZ of 10 letters or more, or reaching a value of 84 letters, was higher with ranibizumab compared with WDVD.
After 3 months of therapy, an increase in OZ of 10 letters or more (or reaching an OZ of 84 letters) compared with the baseline was observed in 61.9% of patients on the background of ranibizumab therapy, depending on the achievement of criteria for stabilizing OZ and in 65.5% of patients treated with ranibizumab in dependence from the activity of the disease; in 6 months - in 71.4% and 64.7% of patients, respectively; in 12 months - in 69.5% and 69.0% of patients, respectively. The increase in OZ by 10 letters or more (or the achievement of OZ-84 letters) in the group of PDPH after 3 months of therapy was observed only in 27.3% of patients.
After 3 months of therapy, an increase in OZ of 15 letters or more (or the achievement of OZ-84 letters) compared with baseline was observed in 38.1% of patients on the background of ranibizumab therapy, depending on the achievement of criteria for stabilizing OZ and in 43.1% of patients with ranibizumab therapy in dependence from the activity of the disease;
in 6 months - in 46.7% and 44.8% of patients, respectively; in 12 months - 53.3% and 51.7% of patients, respectively. The increase in OZ by 15 letters or more (or the achievement of OZ-84 letters) in the group of PDPH after 3 months of therapy was observed only in 14.5% of patients.
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, intra-retinal edema and / or intra-retinal cysts compared to baseline, and an overall improvement in the overall NEI-VFQ-25 questionnaire was noted.

PHARMACOKINETICS

When ranibizumab was administered to the vitreous body (once a month), the maximum concentration of ranibizumab (C max ) in plasma was low and insufficient to inhibit the biological activity of VEGF-A by 50% (11-27 ng / ml according to data studies of cell proliferation in vitro).
When ranibizumab was administered to the vitreous humor in the dose range from 0.05 to 1.0 mg C max in blood plasma was proportional to its dose.
Based on the results of the pharmacokinetic analysis and taking into account the removal of ranibizumab from blood plasma, the average half-life of ranibizumab (0.5 mg dose) from the vitreous humus averaged about 9 days.

When ranibizumab is administered to the vitreous body (once a month), the concentration of ranibizumab in the blood plasma reaches its maximum value within 24 hours after the injection and is in the range of 0.79-2.90 ng / ml.
The minimum concentration of ranibizumab in the blood plasma is in the range 0.07-0.49 ng / ml. The concentration of ranibizumab in the blood plasma is approximately 90,000 times lower than that in the vitreous.
Patients with impaired renal function

Patients with renal dysfunction did not undergo special pharmacokinetic studies using ranibizumab.
In 68% (136 of 200) patients with AMD included in the pharmacokinetic analysis, there were violations of the kidney function (46.5% - mild, 20% - moderate severity and 1.5% - severe). In 48.2% (253 of 525) patients with retinal vein occlusion (SVC), there were impaired renal function (36.4% - mild, 9.5% - moderate severity, and 2.3% - severe). Against the backdrop of drug treatment in patients with impaired renal function, there was a minimal decrease in clearance of ranibizumab, which was not clinically significant.
Patients with impaired hepatic function

In patients with impaired liver function, special pharmacokinetic studies on the use of ranibizumab have not been conducted.

INDICATIONS

- treatment of neovascular (wet) forms of age-related macular degeneration in adults;

- treatment of visual acuity reduction with diabetic edema of the macula;

- treatment of visual acuity reduction due to edema of the macula caused by retinal vein occlusion (central vein of the retina or its branches);

- treatment of visual acuity reduction caused by choroidal neovascularization caused by pathological myopia.

DOSING MODE

The drug Lucentis ® is used only in the form of injections into the vitreous.
The contents of one vial of Lucentis ® should be used for only one intravitreal injection.
Ranibizumab should be administered only by an ophthalmologist who has experience in performing intravitreal injections, using aseptic rules.

Before carrying out the procedure, it is necessary to collect allergological anamnesis.

The recommended dose of Lucentis ® is 0.5 mg, which corresponds to 0.05 ml of the solution, once a month as a vitreous injection.
Between the introduction of the drug in one eye, an interval of at least 1 month should be observed.
Treatment of a moist form of age-related macular degeneration in adults;
reduction in visual acuity associated with diabetic edema of the macula; decrease in visual acuity caused by edema of the macula due to retinal vein occlusion (central vein of the retina or its branches); reduction in visual acuity caused by choroidal neovascularization caused by pathological myopia
Treatment with Lucentis ® begins with one injection per month and continues until the maximum stable O3 is reached or until the signs of disease activity disappear, i.e.
absence of changes in OZ and other signs and symptoms of disease activity on the background of ongoing treatment. Stabilization of the disease is achieved in the absence of improvement of the OZ and / or anatomical parameters of the retina within one month after the last monthly injection.
Patients with a wet form of AMD, DMO and OVC initially require 3 or more consecutive injections of Lucentis ® before stabilizing the disease.
To treat a reduction in visual acuity caused by choroidal neovascularization caused by pathological myopia, many patients may need one or two injections during the first year of treatment, in some other cases the condition may require more frequent use of the drug.
After achieving stabilization of the disease against the background of monthly administration of the drug, the frequency of monitoring the condition and treatment is determined by the doctor depending on the manifestations of disease activity and / or anatomical parameters.
Control of disease activity is performed by evaluating clinical data, functional test data, and special imaging techniques (optical coherence tomography or fluorescent angiography). Evaluation of the effectiveness of treatment can be based on visual acuity or anatomical parameters (disease activity is defined as a decrease in OC and / or deterioration of the anatomical parameters of the retina, the lack of disease activity is defined as the absence of changes in the OT or anatomical parameters of the retina within one month after the last injection).
If, according to the doctor, based on the assessment of OZ and anatomical parameters of the retina, there is no improvement from the treatment, the therapy with Lucentis ® should be discontinued.
With the treatment of a moist form of age-related macular degeneration and pathological myopia, the prevention of a decrease in OD even in the absence of its improvement should be considered positive dynamics, in comparison with the natural course of the disease.
When using the "treatment and prolongation" regime after reaching the maximum OB and / or in the absence of signs of disease activity, a step-by-step increase in the intervals between administration of the drug may be possible until the OZ recedes again or signs of disease activation appear.
Each interval between injections should be increased by no more than 2 weeks in the treatment of a moist form of macular degeneration and no more than 1 month in the treatment of visual acuity reduction associated with diabetic edema of the macula . When treating decline in visual acuity, macular edema caused due to retinal vein occlusion (central retinal vein or its branches) may gradual increase interval, but currently insufficient data to determine the intervals. At intervals of reactivation of the disease should be shortened accordingly.
Therapy with Lucentis ® can be combined with the use of LC patients with DME and patients with SMF (including in patients with previous treatment by LC). In the application of both therapies in one day, the drug Lucentis ® should be administered after a minimum of 30 minutes after the LC.
No experience simultaneous application of the drug Lucentis ®with verteporfin (Vizudin preparation ® ).
Monitoring the patient's condition before and after the procedure would comprise the following steps:
- before the procedure and for 30 minutes after the injection Lucentis ® should monitor intraocular pressure (IOP);
- immediately after the injection should assess perfusion of the optic nerve;
- 2-7 days after the injection should conduct an eye examination using a slit lamp, including fundus examination, for early detection and treatment of possible infection.
Before administration of the drug Lucentis ®should control the quality of dissolution and color of the solution. The drug can not be applied when changing the color of the solution and the appearance of visible insoluble particulate.
Injection of drugs into the vitreous body should be performed under aseptic conditions, including treatment of medical workers hands, the use of sterile gloves, napkins, blepharostat (or analogue thereof). As a precaution, should prepare a sterile set of tools for paracentesis.
Before the introduction of the drug necessary to carry out the proper disinfection of the eyelid skin and eye, the conjunctiva and the instillation of anesthetic drops antimicrobial broad-spectrum.
The drug Lucentis ®to be administered intravitreally at 3.5-4 mm posterior to the limbus, avoiding the horizontal meridian and aiming toward the center of the needle of the eyeball. The injection volume of 0.05 ml. Following the injection should be carried out in the other half of the sclera.
Since a period of 60 min after injection of the drug Lucentis ® IOP can rise temporarily, should control IOP, perfusion of the optic nerve and apply appropriate treatment, if necessary. There have also been cases stable increase in IOP after injection of the drug Lucentis ® .
In one procedure for administering drug Lucentis ® carried out only in one eye.
Patients with impaired liver function
Use of the drug in patients with hepatic impairment has not been studied. Given the low concentrations of ranibizumab in plasma, does not require changes in the drug dosing regimen.
Patients with impaired renal function
Patients with impaired renal function is not required dose correction.
Patients aged 65 years and older
patients aged 65 and older do not need dose adjustment.
Instructions for use
vial
unopened vial may be stored at a temperature of 25 ° C for up to 24 hours.
The contents of one vial of drug Lucentis ®It should be used for only a single intravitreal injection. Following the injection of intact drug should be disposed of in accordance with accepted standards.
The vial is sterile. Do not use the vial if damaged packaging. The sterility of the vial can not be guaranteed if packaging is damaged. Do not use the vial if color of the solution changed if the solution is turbid or contains undissolved particles.
To prepare for intravitreal injections require the following disposable medical products:
- The needle is provided with a filter 18G (pore size 5 microns)
- 1 ml capacity syringe
- Needle Injection 30G x 1.2
These medical devices not included in the package containing the bottle only.
The package assembly comprising a needle and a vial equipped with a filter for extracting the contents from the bottle is not within a sterile syringe and a capacity of 1 ml of an injection needle.
Preparation of the solution for intravitreal injection, a preparation should be carried out as follows.
1. should be disinfected before opening the vial with a rubber stopper.
2. aseptically connect the syringe (1 ml capacity) with a needle fitted with a filter (pore size 5 microns). The needle is equipped with a filter, is introduced into the vial through the central portion of the rubber tube (the end of the needle must reach the bottom of the vial).
3. All the contents of the vial in a syringe, keeping the vial in an upright position and tilting it slightly (for complete extraction solution).
4. After extracting the drug from the vial syringe plunger must push back (to the level of 0.8-0.9 mL) to complete the transition from the needle equipped with a filter the solution into the syringe.
5. The needle was then fitted with a filter, is detached from the syringe and leave the vial. After removing the vial from the solution, the needle is provided with a filter disposed of properly.
Caution: a needle equipped with a filter can not be used for the intravitreal injection.
6. aseptically tight syringe connected to a needle for injection (30G x 1.2).
7. Carefully remove the cap from the injection needle (needle must remain attached to the syringe).
Caution: When removing the cap from the needle for the intravitreal injection, it should apply only to the needle cannula.
8. Carefully remove air from the syringe and plunger set at around 0.05 ml. Only then can inject the drug into the vitreous.
Caution: do not touch the needle for injection and push back the piston (after the installation at the level of 0.05 mL).
If after a single injection into the vitreous body in the vial was left intact drug solution, it must be disposed of properly (use solution unacceptable residues).
Pre-filled syringe
unopened package with pre-filled syringe may be stored at a temperature of 25 ° C for up to 24 hours.
The contents of a prefilled syringe preparation Lucentis ®It should be used for only a single intravitreal injection.
Prefilled syringe sterile. Do not use pre-filled syringe with damaged packaging. Sterility is guaranteed only if no damage blister. Do not apply in the case of color change, turbidity or the appearance of inclusions solution / precipitate.
Preparation of drug solution for intravitreal injection should be carried out as follows:
Carefully read the instructions before first use of the drug.
It is necessary to observe the rules of asepsis during drug injections.
Warning: you must install the piston at around 0.05 ml of
Preparation
1. To open the packaging of the syringe, removing from it the foil lid.
2. Carefully remove the pre-filled syringe from the blister aseptically.
Check the syringe
3.
Make sure that:
- the cap for the tip is not disconnected from the tip of the "Luer-Lock";
- a syringe is not damaged;
- drug solution was clear or slightly opalescent, colorless or very slightly colored and does not contain any inclusions.
4. Upon detection of one of the above features must be disposed prefilled syringe and use a new one.
Remove the syringe tip cap
5. Break off (without turning and unscrewing) the syringe tip cap.
6. Remove the syringe tip cap.
Attach the needle
7. Attach injection needle to a pre-filled syringe by screwing tightly to the tip of the "Luer-Lok".
8. Carefully remove the needle protective cap by pulling it along the needle from the syringe.
Caution: do not wipe the injection needle.
Remove air bubbles from the syringe
9. The syringe should hold upright.
10. If you can see air bubbles in the syringe, gently tap the syringe with your finger so any air bubbles up to the top.
Measure dose
11. Holding the syringe at eye level, gently push the piston up until the lower edge of the dome of the rubber stopper stroke equals the line mark 0.05 ml.
Thus, air bubbles are removed and the excess volume of the solution, and the Recommended metered dose - 0.05 ml.
!Attention:rubber stroke limiter and the piston rod is not connected (to prevent the air intake into the syringe).
Intravitreal injection of Run
12. Preparation Lucentis ® should be administered intravitreally at 3.5-4 mm posterior to the limbus, avoiding the horizontal meridian and aiming toward the center of the needle of the eyeball.
13. Slowly introduce a metered dose of the solution (0.05 mL), pushing the piston up until a rubber stopper stroke reaches the bottom of the syringe.
14. It should be an injection of the drug should be made in the other half of the sclera.
15. The unutilized drug solution must be disposed of properly.
SIDE EFFECT

Summary preparation safety feature
Most adverse events (AEs) registered in the application of the drug, are associated with intravitreal injection procedure.
The most common post-dose were noted: eye pain, eye redness, increased intraocular pressure, inflammation of the vitreous, vitreous detachment, retinal haemorrhage, visual disturbances, vitreous opacities, conjunctival haemorrhage, eye irritation, a feeling of "the body of a foreign" in the eye, lacrimation, blepharitis, a syndrome of "dry" eyes, itching sensation in the eye. The most frequent adverse events not related to the organ of sight, are: headache, nasopharyngitis and arthralgia. More serious, but less common are: endophthalmitis, blindness, retinal detachment, retinal tear and iatrogenic traumatic cataract.
The incidence of AEs was assessed as follows: Emerging "very often" (1/10?) ;"often" (1/100;? <1/10); "infrequently" (1/1000;? <1/100); "rare" (1/10000;? <1/1000); "very rarely" (<1/10000).
Infectious and parasitic diseases: very often - nasopharyngitis; often - flu, urinary tract infection *.
Blood disorders and lymphatic system: often - anemia.
Mental disorders: often - anxiety.
Disorders of the nervous system: very often - headache; rarely - stroke.
Violations by the organ of vision:very often - intraocular inflammation, inflammation of the vitreous, vitreous detachment, retinal haemorrhage, visual disturbances, eye pain, vitreous opacities, increased intraocular pressure, conjunctival haemorrhage, eye irritation, a feeling of "foreign body" in the eye, tearing, blepharitis, syndrome of "dry" eyes, eye redness, itching sensation in the eye; often - degenerative changes of the retina, retinal damage, retinal detachment, retinal tearing, detachment of retinal pigment epithelium, pigment epithelium tear, reduced visual acuity, bleeding into the vitreous, vitreous loss, uveitis, iritis, iridocyclitis, cataracts, subcapsular cataract, blurred rear lens capsule, punctate keratitis, corneal erosion,cell opalescence in the anterior chamber of the eye, blurred vision, hemorrhage at the site of injection, eye hemorrhage, conjunctivitis, allergic conjunctivitis, eye discharge, photopsia, photophobia, eye discomfort, swelling century, soreness century, conjunctival hyperemia; infrequently - blindness, endophthalmitis, hypopyon, hyphema, keratopathy, adhesions of the iris, deposition in the cornea, corneal edema, corneal striae, pain and irritation at the injection site, abnormal sensation and irritation in the eye lids.corneal edema, corneal striae, pain and irritation at the injection site, abnormal sensation and irritation in the eye lids.corneal edema, corneal striae, pain and irritation at the injection site, abnormal sensation and irritation in the eye lids.
Violations of the respiratory system, organs, thoracic and mediastinal disorders: often - cough.
Violations of the digestive system: often - nausea.
Violations of the skin and subcutaneous tissue disorders: often - allergic reactions (rash, urticaria, pruritus, erythema).
Violations by musculoskeletal and connective tissue disorders: very often - arthralgia.
* - was observed only in patients with DME.
Violations of the cardiovascular system:According to a working group of researchers of antiplatelet drugs (1994) there is a link between the development of arterial thromboembolic events (including the deaths due to vascular causes, myocardial infarction, non-fatal, hemorrhagic stroke, non-fatal) and systemic bioavailability of highly active inhibitors of endothelial growth factor. The incidence of thromboembolic complications during the first year of treatment in the group of patients receiving the drug Lucentis ® , was 2.3% compared with 1.3% in the control group. In one study, the figure was 3.0% compared with 3.2% in the control group during the second year of drug treatment.
immunogenicity:As with other therapeutic drugs of protein origin in patients receiving treatment with Lucentis ® , there is risk of immunological reactions. Data reflecting the number of patients using a variety of immunological diagnostic tests antibodies to ranibizumab significantly depend on the specificity and sensitivity of these tests.
In studies of treatment wet age-related macular degeneration in adult incidence of immune responses to drug administration Lucentis ®during the preliminary treatment was 0-3% in all groups. Following monthly administration of the drug for 12-24 months antibodies to ranibizumab were found in about 1-8% of patients with neovascular age-related macular degeneration.
In studies of treatment decrease in visual acuity associated with diabetic macular edema, the incidence of immune responses to drug administration Lucentis ® during the preliminary treatment was 0-2% in all groups. Following monthly administration of the drug for 12 months antibodies to ranibizumab were found in about 2-4% of patients with diabetic macular edema.
In studies of treatment decrease in visual acuity, macular edema caused due to occlusion of retinal vein, the incidence of immune responses to drug administration Lucentis ® during the preliminary treatment was 2.3% in all groups. Following monthly administration of the drug for 12 months antibodies to ranibizumab were found in about 4-5% of patients with macular edema due to retinal vein occlusion.
The clinical relevance of immune reactivity to the drug Lucentis ® at present remains unexplained.
Meta-analysis of the aggregate data security from randomized clinical studies showed an increase in the frequency of infection / inflammation cases wound outside of the eye without formal seriousness criteria, patients with DME receiving ranibizumab 0.5 mg (1.85 / 100 patient / years) compared to those given in the control group (0.27 / 100 patient / years). Relationship with ranibizumab unclear.
CONTRAINDICATIONS

- hypersensitivity to ranibizumab or any other component of the formulation;
- confirmed or suspected infections of the eye or infectious processes periocular localization;
- intraocular inflammation;
- Children up to age 18 years (effectiveness and safety of the drug in these patients has not been studied);
- Pregnancy;

lactation period.

Carefully

Patients with a history of hypersensitivity, the presence of risk factors for stroke, etc.
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