Lucentis
Lucentis: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. Drug interactions
- 12. Analogs
- 13. Terms and conditions of storage
- 14. Terms of dispensing from pharmacies
- 15. Reviews
- 16. Price in pharmacies
Latin name: Lucentis
ATX code: S01LA04
Active ingredient: ranibizumab (ranibizumab)
Manufacturer: NOVARTIS PHARMA, AG (Switzerland), NOVARTIS PHARMA STEIN, AG (Switzerland)
Description and photo update: 15.06.2018
Prices in pharmacies: from 47 420 rubles.
Buy
Lucentis is an ophthalmic preparation.
Release form and composition
Dosage form of Lucentis - solution for intraocular administration: slightly opalescent or transparent, colorless (in 0.23 ml vials with a needle equipped with a filter for extracting the drug from the vial, a syringe and injection needle included, in a cardboard box 1 set; in blisters 1 pre-filled syringe with 0.165 ml of solution, 1 blister in a cardboard box).
Composition of 1 ml solution:
- active substance: ranibizumab - 0.01 g;
- auxiliary components: water for injection - up to 1 ml; polysorbate 20 - 0.000 1 g; histidine - 0.000321 g; histidine hydrochloride monohydrate - 0.001 662 g; a, a-trehalose dihydrate - 0.1 g
Pharmacological properties
Pharmacodynamics
Ranibizumab, by selectively binding to isoforms of vascular endothelial growth factor VEGF-A (VEGF110, VEGF121, VEGF165) and preventing the interaction of VEGF-A with its receptors on the surface of endothelial cells (VEGR1 and VEGR2), inhibits proliferation and neovascularization. With retinal vein occlusion and diabetes mellitus, the substance, through suppression of the growth of newly formed vessels of the choroid into the retina, stops the progression of exudative hemorrhagic form of macular edema and age-related macular degeneration (AMD).
In 90% of cases, when ranibizumab was used for 2 years for the treatment of AMD with minimally expressed classical and latent subfoveal choroidal neovascularization (CNV), a significant decrease in the risk of reduced visual acuity was observed (loss of no more than 15 letters on the ETDRS scale or 3 lines on the Snellen table) … In 33% of cases, there was an improvement in visual acuity on the ETDRS scale by 15 letters or more. When simulating injections, 53% and 4% of cases, respectively, lost less than 15 letters and improved visual acuity by more than 15 letters on the ETDRS scale.
In 90% of patients with AMD with predominantly classical subfoveal CNV, using the drug for 2 years, there was a decrease in the incidence of pronounced decrease in vision by more than 3 lines; 41% of patients showed improvement in visual acuity by more than 3 lines.
The risk of decreased visual acuity (more than 3 lines) in the group of patients receiving photodynamic treatment with verteporfin decreased in 64% and 6% of cases, respectively.
According to the NEI-VFQ questionnaire (assessment of quality of life), after 1 year of therapy with ranibizumab for AMD with minimally expressed classical and latent subfoveal CNV, on average, visual acuity compared with the initial value improved by +10.4 and +7 letters, respectively. A decrease in this indicator by 4.7 letters was observed in the sham injection control group. In cases of ranibizumab therapy for AMD with minimally expressed classical and latent subfoveal CNV, improvement in visual acuity persisted for 2 years.
When treating Lucentis for 1 year in patients with AMD with predominantly classical subfoveal CNV, the average change in visual acuity near and far in comparison with the initial value ranged from +9.1 and +9.3 letters, respectively. The average change in visual acuity near and far in the control group of patients receiving photodynamic treatment with verteporfin compared to the initial value was +3.7 and +1.7 letters. The indicator of disability associated with vision in patients receiving the drug increased by +8.9 points, and in patients receiving imitation injections - by +1.4 points.
With a decrease in visual acuity associated with diabetic macular edema, its change after one year of treatment in comparison with the initial value was:
- monotherapy with ranibizumab: +6.8 letters;
- combined use of ranibizumab with laser coagulation: +6.4 letters;
- laser coagulation: +0.9 letters.
Visual acuity of more than 15 letters on the ETDRS scale improved with ranibizumab monotherapy / combined use of ranibizumab with laser coagulation / laser coagulation in 22.6 / 22.9 / 8.2% of patients, respectively. When using two methods of treatment for 1 day, ranibizumab was administered after half an hour (minimum) after laser coagulation.
In cases of using ranibizumab for 1 year (if necessary, together with laser coagulation) with a decrease in visual acuity associated with diabetic edema of the macula, the average change in visual acuity compared to the initial value was +10.3 letters compared to −1.4 letters when simulating an injection.
60.8% and 32.4% of patients treated with ranibizumab had improved vision by more than 10 and 15 letters on the ETDRS scale, compared with 18.4% and 10.2% with a sham injection.
When stable indicators of visual acuity were achieved according to the data of three consecutive examinations, it was possible to discontinue the administration of the drug. In cases of the need to resume therapy, 2 (at least) consecutive monthly injections of Lucentis were performed.
During treatment with ranibizumab, a pronounced persistent decrease in the thickness of the central retinal zone was observed, which was measured by optical coherence tomography. The thickness of the retina in the central zone after 1 year of application of the agent decreased by 194 µm in comparison with 48 µm when using a sham injection. In diabetic macular edema, the safety profile of the agent was similar to that of the treatment of wet AMD.
With reduced visual acuity caused by pathological myopia of CNV, after 1–3 months of therapy, visual acuity compared to the initial value was +10.5 letters when using ranibizumab, depending on the achievement of the criteria for stabilizing visual acuity, +10.6 letters - during treatment ranibizumab depending on the activity of the disease; the change in visual acuity after half a year of therapy compared to the initial value was +11.9 letters and +11.7 letters, respectively, and after a year - +12.8 and +12.5 letters, respectively.
When assessing the dynamics of average changes in visual acuity from the initial value over 1 year, a rapid achievement of results was recorded, with the maximum improvement already achieved by 2 months. The improvement in visual acuity persisted throughout the one-year period.
When using ranibizumab in comparison with photodynamic therapy with verteporfin, the proportion of patients with an increase in visual acuity by 10 letters or more, or reached a value of more than 84 letters, was higher. After 3 months from the start of treatment, an increase in visual acuity by 10 letters or more in comparison with the initial value was observed in 61.9% of cases against the background of therapy with ranibizumab, depending on the achievement of the criteria for stabilization of visual acuity and in 65.5% of cases with the use of ranibizumab in depending on the activity of the disease; six months later - respectively in 71.4% and 64.7% of cases; after 1 year - in 69.5% and 69% of cases, respectively. An increase in visual acuity by 10 letters or more in the group of patients receiving photodynamic therapy with verteporfin, after 3 months of treatment, was observed only in 27.3% of cases.
After 3 months of treatment, visual acuity increased by 15 letters or more in comparison with the initial value was observed in 38.1% of patients using ranibizumab, depending on the achievement of the criteria for stabilization of visual acuity, and in 43.1% of patients using ranibizumab, depending on activity diseases; after six months - respectively in 46.7% and 44.8% of patients; after 1 year - respectively in 53.3% and 51.7% of patients. An increase in visual acuity by 15 letters or more in the group of patients receiving photodynamic therapy with verteporfin, after 3 months of treatment, was observed only in 14.5% of cases.
It should be noted that the number of injections per one-year period in patients who were monitored and resumed treatment based on the criteria of disease activity was one less than in patients who received therapy, depending on the achievement of the criteria for stabilizing visual acuity.
There was no negative effect on visual acuity immediately after stopping treatment. Within 1 month after the resumption of treatment, the lost visual acuity was restored.
The proportion of patients with intraretinal cysts, intraretinal edema, or subretinal fluid decreased compared to baseline. There was also an improvement in the overall score on the NEI-VFQ-25 questionnaire.
Pharmacokinetics
C max (maximum plasma concentration) in cases ranibizumab injection of 1 monthly intravitreal with renovascular form AMD was low and insufficient to inhibit the biological activity of VEGF-A at 50%; C max when it was introduced into the vitreous body in the dose range from 0.05 to 1 mg was proportional to the applied dose.
The average half-life of a substance (dose 0.5 mg) from the vitreous body, in accordance with the results of pharmacokinetic analysis and taking into account its elimination from blood plasma, averages approximately 9 days.
The concentration of ranibizumab in blood plasma when it is administered once a month into the vitreous body reaches its maximum value within 1 day after injection and is in the range from 0.79 to 2.9 ng per 1 ml. The minimum concentration in blood plasma varies from 0.07 to 0.49 ng per ml. In the blood serum, the concentration of the substance is approximately 90,000 times lower than that in the vitreous body.
Indications for use
- neovascular (wet) form of age-related macular degeneration (therapy);
- decreased visual acuity associated with diabetic macular edema (monotherapy or combination with laser coagulation in patients who have previously undergone laser coagulation);
- decreased visual acuity caused by macular edema due to retinal vein occlusion (therapy).
Contraindications
Absolute:
- suspected or confirmed eye infections, infectious processes of periocular localization;
- intraocular inflammation;
- the presence of clinical manifestations of irreversible ischemic loss of visual function with retinal vein occlusion;
- age under 18;
- pregnancy;
- period of breastfeeding;
- individual intolerance to the components contained in the preparation.
Relative (diseases / conditions in the presence of which the appointment of Lucentis requires caution):
- a known history of hypersensitivity, the presence of risk factors for stroke (a careful assessment of the risk-benefit ratio is required);
- the combined use of VEGF inhibitors for diabetic macular edema and macular edema due to retinal vein occlusion, stroke or transient cerebral ischemia in history (there is a risk of thromboembolic events); other drugs that affect vascular endothelial growth factor;
- a history of retinal vein occlusion;
- ischemic occlusion of the central retinal vein or its branches.
Instructions for the use of Lucentis: method and dosage
A solution (0.05 ml), by means of intravitreal injection, is injected into the vitreous body 3.5–4 mm behind the limbus, directing the needle towards the center of the eyeball and avoiding the horizontal meridian. The next injection is performed in the other half of the sclera. Since a temporary increase in intraocular pressure is possible within 1 hour after the injection of the solution, it is important to control intraocular pressure, perfusion of the optic nerve head and apply appropriate therapy (if necessary). There are reports of a sustained increase in intraocular pressure after the introduction of Lucentis.
One bottle with the drug is designed for only one injection. In one session, the solution is injected into only one eye.
The injection is carried out under aseptic conditions, including the treatment of the hands of medical workers, the use of napkins, sterile gloves, an eyelid dilator or its analogue, paracentesis instruments (if necessary).
Before injection, appropriate disinfection of the eyelid skin and the area around the eyes, anesthesia of the conjunctiva and therapy with a wide range of antimicrobial agents are carried out (they are instilled into the conjunctival sac 3 times a day for 3 days before and after Lucentis application).
The introduction of the drug should be carried out only by an ophthalmologist experienced in intravitreal injections.
It is important to observe an interval of 1 month (minimum) between the introduction of two doses of the drug.
The recommended dose is 0.05 ml (0.000 5 g) of Lucentis once a month.
Before the introduction of the agent, its color and the quality of dissolution are controlled. If the color changes and insoluble visible particles appear, Lucentis cannot be used.
Wet AMD
The introduction of Lucentis is continued until the maximum stable visual acuity is achieved. It is determined during three consecutive monthly visits during the period of drug use.
Visual acuity during treatment with the drug is monitored monthly. The therapy is resumed with a decrease in visual acuity of 1 or more lines associated with AMD, which is determined during monitoring and continues until stable visual acuity is achieved also at three consecutive monthly visits.
Decreased visual acuity associated with DME
The introduction of the drug is carried out monthly and continues until the visual acuity is stable at three consecutive monthly visits during the period of drug therapy.
In patients with diabetic macular edema, Lucentis can be used with laser coagulation, including in patients with previous use of laser coagulation. If both methods of treatment are prescribed for the same day, it is preferable to administer the drug half an hour after laser coagulation.
Decreased visual acuity caused by macular edema due to occlusion of the retinal veins (central retinal vein and its branches)
Lucentis is administered monthly, treatment is continued until the maximum visual acuity is achieved, determined by three consecutive monthly visits during the period of drug therapy.
During treatment with Lucentis, visual acuity is monitored monthly.
If monthly monitoring reveals a decrease in visual acuity due to retinal vein occlusion, the solution is resumed in the form of monthly injections, and continues until visual acuity stabilizes at three consecutive monthly visits.
The drug can be used in combination with laser coagulation. If both methods of treatment are prescribed within one day, Lucentis is administered after half an hour (minimum) after laser coagulation. The drug can be used in patients with previous use of laser coagulation.
Decreased visual acuity caused by CNV due to pathological myopia
Therapy begins with a single injection of the drug. If, while monitoring the patient's condition (including clinical examination, fluorescence angiography and optical coherence tomography), treatment is resumed.
During the first year of treatment, most patients require 1 or 2 injections of the solution. However, some patients may require more frequent use of Lucentis. In such cases, during the first 2 months, the condition is monitored monthly, and then, every three months (at least) during the first year of therapy.
Further, the frequency of monitoring is individually determined by the attending physician.
Side effects
Possible adverse reactions (> 10% - very common;> 1% and 0.1% and 0.01% and <0.1% - rarely; <0.01% - very rare):
- infections and invasions: very often - nasopharyngitis; often - flu;
- hematopoietic system: often - anemia;
- psyche: often - anxiety;
- nervous system: very often - headache;
- organ of vision: very often - pain, redness, irritation, itching, a foreign body in the eyes, dry eye syndrome, blepharitis, lacrimation, conjunctival hemorrhages, increased intraocular pressure, opacity in the vitreous humor, visual disturbances, retinal hemorrhages, detachment, vitreous inflammation body, intraocular inflammation; often - conjunctival hyperemia, soreness, eyelid edema, a feeling of discomfort in the eyes, photophobia, photopsia, discharge from the eyes, allergic conjunctivitis, ocular hemorrhages, conjunctivitis, hemorrhage at the injection site, blurred vision, cellular opalescence in the anterior chamber of the eye, erosion keratitis, clouding of the posterior capsule of the lens, subcapsular cataract, iridocyclitis, cataract, iritis, uveitis, vitreous lesion, vitreous hemorrhage,decreased visual acuity, rupture of the pigment epithelium, detachment of the retinal pigment epithelium, retinal ruptures, detachment, damage, degenerative changes in the retina; sometimes - eyelid irritation, atypical sensations in the eye, pain and irritation at the injection site, stretch marks, corneal edema, corneal deposits, iris adhesions, keratopathy, hyphema, hypopyon, endophthalmitis, blindness;
- respiratory system: often - cough;
- digestive system: often - nausea;
- dermatological disorders: often - allergic reactions in the form of itching, urticaria and rash;
- musculoskeletal system: very often - arthralgia.
Overdose
Main symptoms: eye pain, increased intraocular pressure.
Therapy: control of intraocular pressure, medical supervision (if necessary).
special instructions
Within 7 days after the administration of the solution, the patient should be monitored by a doctor to identify a possible local infectious process and provide timely treatment. The patient should immediately inform the doctor about the appearance of symptoms that may indicate the development of endophthalmitis.
Lucentis has an immunogenic effect. Since patients with diabetic macular edema are at increased risk of systemic exposure to the drug, it is important to remember that they are at higher risk of developing hypersensitivity reactions.
Patients should be informed about symptoms indicating the development of intraocular inflammation, which may indicate intraocular formation of antibodies to the agent.
In cases of injections of endothelial growth factor A (VEGF-A) inhibitors into the vitreous body, arterial thromboembolic complications can develop.
With a previous stroke and a history of transient cerebrovascular accident, the risk of stroke increases.
After injection (within 1 hour) of the drug, there is a temporary increase in intraocular pressure. There are reports of a sustained increase in intraocular pressure. In this regard, during the period of use of Lucentis, it is important to monitor intraocular pressure and perfusion of the optic nerve head. The drug should not be injected simultaneously into both eyes, since it is possible to increase the systemic effect of the drug and the risk of side effects.
The experience of using Lucentis is limited in patients with concomitant non-infectious eye diseases such as retinal detachment (in the macular region inclusive), proliferative diabetic retinopathy, active systemic infections, previously treated with intraocular drugs, diabetes mellitus with glycated hemoglobin (HbA1c) levels> 12%, diabetic macular edema due to type 1 diabetes mellitus, uncontrolled arterial hypertension, as well as pathological myopia, previously unsuccessfully exposed to photodynamic therapy with verteporfin.
There are insufficient data to draw conclusions regarding the efficacy of the drug in pathological myopia with extrafoveal localization of the lesion, despite the fact that a similar effect was observed with subfoveal and juxtafoveal localization of the lesion.
It is important for patients of childbearing age to use reliable methods of contraception during treatment.
Influence on the ability to drive vehicles and complex mechanisms
Since the use of Lucentis can serve the development of temporary visual impairments, patients are advised to refrain from driving vehicles and conducting potentially hazardous activities until the severity of these disorders decreases.
Application during pregnancy and lactation
The drug Lucentis is contraindicated for use during pregnancy and lactation.
Pediatric use
According to the instructions, Lucentis is contraindicated in children under the age of 18, since the safety and efficacy of its use in this age group of patients has not been studied.
Drug interactions
There are no data on the interaction of Lucentis with other drugs.
The medicinal product must not be mixed with any other drugs or solvents.
Analogs
There is no information about Lucentis analogues.
Terms and conditions of storage
Store in a place protected from light and moisture, at temperatures up to 8 ° C, do not freeze. Keep out of the reach of children.
Shelf life: solution in vials - 3 years; solution in pre-filled syringes - 2 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Lucentis
According to reviews, Lucentis is an expensive drug that significantly improves vision, increases its sharpness and line accuracy. Among the disadvantages, discomfort inside the eye after injection, which persists for a certain period, is mainly noted.
Price for Lucentis in pharmacies
The approximate price of Lucentis solution for intraocular administration (in 0.23 ml vials) is 48,000 rubles.
Lucentis: prices in online pharmacies
|
Drug name Price Pharmacy |
|
Lucentis 10 mg / ml solution for intraocular administration 0.23 ml 1 pc. RUB 47420 Buy |
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
