Accentrix

One mL contains Ranibizumab 10 mg.

Vial: Each vial contains Ranibizumab 2.3 mg in 0.23 mL solution.

Pre-filled Syringe: One pre-filled syringe contains 0.165 mL, equivalent to 1.65 mg Accentrix. The extractable volume of one pre-filled syringe is 0.1 mL. This provides a usable amount to deliver a single dose of 0.05 mL containing 0.5 mg Accentrix.

Accentrix is a humanized monoclonal antibody fragment produced by Escherichia coli cells by recombinant DNA technology.

Excipients/Inactive Ingredients: L-histidine hydrochloride, monohydrate, L-histidine, trehalose dihydrate, polysorbate 20, water for injection.

treatment of neovascular (wet) form of age-related macular degeneration in adults,

treatment of visual acuity decline associated with diabetic macular edema as monotherapy or in combination with LC in patients who have previously had LC,

treatment of visual acuity loss caused by macular edema due to retinal vein occlusion (CVS or its branches),

treatment of visual acuity loss caused by choroidal neovascularization caused by pathological myopia.

Intravitreal.

The drug Lucentis is used only in the form of injections into the vitreous body.

The contents of one bottle of Lucentis should be used for only one intravitreal injection. Only an ophthalmologist with experience in performing intravitreal injections should administer ranibizumab (under aseptic conditions). Between the introduction of two doses of the drug, an interval of at least 1 month should be observed.

The recommended dose of Lucentis is 0.5 mg (0.05 ml) once a month in the form of an injection into the vitreous body.

During treatment with the drug, a monthly monitoring of the OZ is carried out.

Treatment of wet AMD

Injections of the drug Lucentis are performed monthly and continue until the maximum stable OZ is reached, determined on three consecutive monthly visits against the background of the administration of the drug Lucentis.

Treatment with Lucentis is resumed in the case of a decrease in the OS by 1 or more lines (≥5 letters) associated with AMD, determined during monitoring, and continues until a stable OS is achieved, also on three consecutive monthly visits.

Treatment of DMO-related reduced OZ

Injections of the drug Lucentis are performed monthly and continue until the maximum stable OZ is reached, determined on three consecutive monthly visits against the background of the administration of the drug Lucentis.

Treatment with Lucentis is resumed in the case of a decrease in the DMO-related OZ determined during monitoring, and continues until a stable OZ is achieved, also on three consecutive monthly visits.

Therapy with Lucentis can be combined with the use of LC in patients with DMO (including in patients with previous use of LC). When both methods of therapy are prescribed for one day, the drug Lucentis should be administered at least 30 minutes after LC.

Treatment of reduced OS caused by macular edema due to OVA (CVS or its branches)

Injections of the drug Lucentis are performed monthly and continue until the maximum OZ is reached, determined on three consecutive monthly visits against the background of the administration of the drug Lucentis.

Treatment with Lucentis is resumed in the form of monthly injections in the case of a decrease in the OZ associated with OAT, determined by monthly monitoring, and continues until a stable OZ is achieved on three consecutive monthly visits. Therapy with Lucentis can be combined with the use of LC in patients. When both methods of therapy are prescribed for one day, the drug Lucentis should be administered at least 30 minutes after LC. Lucentis can also be used in patients with previous use of LC.

Treatment of a decrease in HP caused by CNV due to PM

Treatment with Lucentis begins with a single injection. If signs of disease activity are detected during periodic monitoring of the condition, which may include a 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 the drug Lucentis are required during the 1st year of therapy. 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 monthly and then-at least once every 3 months during the 1st year of treatment with Lucentis. In the future, the frequency of monitoring is set by the attending physician.

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

The injection of the drug into the vitreous body should be carried out under aseptic conditions, including the treatment of the hands of medical professionals, the use of sterile gloves, wipes, an expander (or its equivalent), and, if necessary, instruments for paracentesis.

Before the administration of the drug, it is necessary to carry out appropriate disinfection of the skin of the eyelids and the area around the eyes, conjunctival anesthesia and broad-spectrum antimicrobial therapy. Antimicrobials should be instilled in the conjunctival sac 3 times a day for 3 days before and after administration of the drug.

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

Since IOP may temporarily increase within 60 minutes after the injection of Lucentis, IOP, optic disc perfusion should be monitored and appropriate treatment should be applied if necessary. There were also cases of a steady increase in IOP after injection of the drug Lucentis.

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

Special patient groups

Impaired liver function. The use of the drug in patients with impaired liver function has not been studied. Given the low concentration of the drug Lucentis in the blood plasma, no change in the dosage regimen of the drug is required.

Impaired renal function. Patients with impaired renal function do not need to adjust the dose of the drug.

Patients 65 years and older. Patients 65 years and older do not need to adjust the dose of the drug.

hypersensitivity to ranibizumab or any other component of the drug,

confirmed or suspected eye infections or infectious processes of periocular localization,

intraocular inflammation,

pregnancy,

lactation period,

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

With caution: if the patient has one of these diseases, before using the drug, it is necessary to consult a doctor. In patients with a known 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. Use of inhibitors VEGF in patients with diabetic macular edema and macular edema due to OVA and choroidal neovascularization due to pathological myopia, if there is a history of stroke or transient cerebral ischemia, it should be carried out with caution due to the risk of developing thromboembolic events. The drug Lucentis should not be used simultaneously with other drugs that affect endothelial vascular growth factor (local or systemic use).

Clinical conditions in which therapy with Lucentis should be discontinued and should not be resumed:

- reduced visual acuity by ≥30 letters compared to the last definition,

- IOP ≥30 mmHg.,

- the rupture of the retina,

- subretinal hemorrhages affecting the central fossa, or the lesion area ≥50%,

- condition after intraocular surgery or before planned in the next 28 days.

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

Caution should be exercised when using the drug in patients with age-related macular degeneration and revealed extensive detachment of the pigment epithelium, because they have an increased risk of developing ruptures of the pigment epithelium.

The drug should be used with caution in patients at risk of developing regmatogenic retinal detachment. In patients with regmatogenic retinal detachment or macular rupture of the 3rd, 4th stages, treatment with Lucentis should be discontinued.

The experience of using ranibizumab in patients with a history of OVA and in patients with ischemic occlusion of CVS or its branches is limited. In patients with OVD who have clinical manifestations of irreversible ischemic loss of visual function, it is not recommended to use the drug.

Use Accentrix as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Accentrix is given as an injection into the eye at your doctor's office, hospital, or clinic.
• Do not use Accentrix if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
• Accentrix is for injection into the eye only.
• If you miss a dose of Accentrix, contact your doctor right away.

This medication is used to treat certain serious eye conditions (such as age-related macular degeneration, macular edema). It is used to help prevent decreased vision and blindness. Accentrix works by slowing the growth of abnormal new blood vessels in the eye and decreasing leakage from these blood vessels.

How to use Accentrix intravitreal

Read the Patient Information Leaflet if available from your pharmacist before you start receiving Accentrix and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

This medication is given by injection into the affected eye(s) by a health care professional. The affected eye is numbed before each injection. Your eye will be monitored before the injection. After the injection, you will remain in the doctor's office for a while, and your eye will continue to be monitored.

Dosage is based on your medical condition and response to treatment. This medication is usually given once a month or as directed by your doctor.

When treating age-related macular degeneration, if you are not able to have monthly injections after your first few doses, getting injections once every 2 or 3 months may be an option, although not as effective as monthly injections. Consult your doctor for more details.

Use this medication regularly to get the most benefit from it.

Tell your doctor if your condition does not improve or if it worsens.

See also:
What other drugs will affect Accentrix?

No formal interaction studies have been performed.

In clinical trials for treatment of visual impairment due to DME, the outcome with regards to visual acuity or CRT in patients treated with Accentrix was not affected by concomitant treatment with thiazolidinediones.

For the adjunctive use of verteporfin photodynamic therapy (PDT) and Accentrix in wet AMD and PM, see

Pharmacology: Pharmacodynamics: Clinical Studies under Actions.

For the adjunctive use of laser photocoagulation and Accentrix in DME and BRVO, see

Pharmacology: Pharmacodynamics: Clinical Studies under Actions and Dosage & Administration.

Incompatibilities: In the absence of compatibility studies, Accentrix must not be mixed with other medicinal products.

The study of the safety of the drug was conducted in the course of clinical trials in 1315 patients for 2 years. Serious adverse events associated with the drug administration procedure included endophthalmitis, regmatogenic retinal detachment, and cataracts due to iatrogenic trauma.

Other serious eye adverse events observed with Lucentis included intraocular inflammation and increased IOP. The following adverse events (possibly related to the use of the drug) were observed with a frequency of at least 2% in patients receiving Lucentis at a dose of 0.5 mg, compared with the control group (simulated injection or photodynamic therapy).

The frequency of adverse events was estimated as follows: occurring very often (≥1/10), often (≥1/100, <1/10), infrequently (≥1/1000, <1/100), rarely (≥1/10000, <1/1000), very rarely (<1/10000).

Infections and infestations: very often — nasopharyngitis, often-flu, infection of the genitourinary tract (observed only in patients with DMO).

From the hematopoietic system: often-anemia.

Mental disorders: often-anxiety.

From the nervous system: very often — headache, infrequently-stroke.

On the part of the visual organ:

From the respiratory system: often-cough.

From the digestive system: often-nausea.

Dermatological disorders: often-allergic reactions (rash, urticaria, itching, erythema).

From the musculoskeletal system: very often — arthralgia.

If any of the side effects listed in the instructions are aggravated or the patient has noticed any other side effects not listed in the instructions, you should inform your doctor.

Symptoms: in clinical studies and when using the drug in clinical practice, cases of unintentional overdose of the drug were noted. In these cases, an overdose of the drug Lucentis was most often marked by increased IOP and pain in the eye.

Treatment: in the case of an overdose of the drug, it is necessary to monitor the IOP, if necessary, the patient should be under the supervision of a doctor.