Eylia: does it have SUS? Understand how to use according to the package insert

Since 2011, Bayer’s drug Eylia has been approved in the United States. In Brazil, ANVISA approved and registered the drug in 2012, facilitating the treatment of some conditions related to vision loss.

Among the conditions that can be treated is age-related macular degeneration (AMD), the biggest cause of vision loss after 65 years of age.

In addition, its use can be indicated for other conditions, such as damage to vision related to retinal vein occlusion or, still, processes resulting from diabetic macular edema .


What is Eylia?

Eylia is one of the trade names of the active substance aflibercept, marketed by the pharmaceutical industry Bayer.

The drug is indicated for the treatment of some vision changes, such as age-related macular degeneration (AMD) or visual impairment due to myopic choroidal neovascularization (myopic NVC).

Its application is by means of an intravitreal injection, that is, applied to the vitreous (internal and posterior region of the eye). Its action causes the blocking of the activity of agents called Vascular Endothelial Growth Factor A (VEGF-A) and the Placental Growth Factor (PLGF).

In general, what occurs is the impediment of the formation of new vessels in the retina, reducing the edema and bleeding, common in AMD disease. The applications need to be continuous, improving the quality of life and recovering the vision of patients.

Although it looks quite uncomfortable and painful, as a rule, intraocular injection does not cause major pain or discomfort. It is a quick procedure and, currently, it is the main way to treat some diseases related to vision, returning it with quality to the person.

Indication: What is the medicine Eylia Bayer for?

According to the package insert, Eylia, from the manufacturer Bayer, can be indicated to treat some changes or diseases related to vision, which are:

Neovascular age-related macular degeneration (AMD)

Age-related macular degeneration (AMD) generates progressive lesions in the macula, which is a central part of the retina (transparent part, located in the back of the eye). This causes damage to vision, leading to a reduction in vision.

There are two types, which are dry and wet AMD, in which the first is less severe and more frequent. But only the second type, wet AMD, also called neovascular or exudative, can be treated with Eylia.

They are the conditions in which new abnormal blood vessels develop in the retina and sclera, causing blood and fluids to leak (due to the leak, the region becomes wet, characterizing the type of AMD).

This is the most severe picture of the disease, usually related to permanent vision damage.

Central retinal vein occlusion (OVCR) or retinal vein branch occlusion (ORVR)

The retina is a tissue with great vascularity, that is, many blood vessels, located at the back of the eye. Eylia is indicated to treat Visual impairment due to macular edema secondary to retinal vein occlusion, more specifically in cases of OVCR (occlusion of the final part of the central vein) or ORVR (occlusion of some venous branch).

The conditions are the result of the obstruction due to a clot that forms at the site, which may be at the end of the central vein (OVCR) or in some venous branch that drains blood from the retina (ORVR).

In these cases, if there is occlusion, the blood that irrigates the retina cannot be drained, following the normal flow. In this way, leakage (that is, leakage) begins to occur within the retina. This generates swelling and edema that cause damage to vision.

In general, it is a disease that mostly affects older people, between 60 and 70 years old. In addition to the age group, other conditions can favor the occurrence of obstruction, such as glaucoma , diabetes and blood clotting problems.

Visual impairment due to diabetic macular edema (EMD)

Eylia can be indicated for the treatment of diabetic macular edema (EMD), a condition resulting from diabetic retinopathy. The latter is characterized by the accumulation of fluid in the vessels of the eyes. Initially, there are no changes in vision, but the blood vessels in the eyes accumulate fluid and become swollen.

New vessels may also appear, which are more fragile. High blood sugar levels ( hyperglycemia ) are the main cause for the appearance of edema, as it leads to increased retinal vascular permeability.

That is, gradually, the fluids seep out of the vessels and begin to accumulate near the retina and macula. This condition is diabetic macular edema, which results in image distortion, blurred vision and even blindness.

Visual impairment due to myopic choroidal neovascularization (myopic NVC)

The choroid is a layer located in the middle part of the eyes, between the sclera and the retina. It is a very thin membrane, but very vascularized, because it is the spider veins in this region that supply the cells of the retina and sclera with necessary nutrients and oxygen.

Eylia is indicated for patients with choroidal neovascularization, that is, the appearance of new and irregular blood vessels in the choroid. The condition can lead to edema and loss of vision.

What is intravitreal injection for?

Intravitreal injection consists of an injection into the vitreous region, which is gelatinous and viscous, and which occupies the central part of the eyeball. The administration of medications in this location is indicated to treat a series of problems related to vision.

It is a very effective treatment to contain neovascularization, that is, the emergence of new blood vessels, which are generally more fragile and can more easily allow the leakage of blood and fluids to other tissues of the eyes.

The procedure is simple, despite being invasive and, for many people, looking uncomfortable.

There is the application of local anesthesia, causing only a slight discomfort at the time of application. The process is fast and there is no need for hospitalization or long hours of observation.

What is the mechanism of action of the active substance Aflibercept?

The active substance Aflibercept, as the package insert indicates, acts as a soluble receptor-bait that binds VEGF-A and placental growth factor (PLGF). It has a greater affinity than natural receptors and, therefore, can inhibit the binding and activation of these cognate VEGF receptors.

Thus, its action is to inhibit the formation of new pathological vessels (neovascularization), stabilize or even recover vision in cases of problems related to the high presence of vascular endothelial growth factors (VEGF).

Growth factors (VEGF) play an important role in maintaining the correct functioning of the body, in several processes. For example, in the formation and vascular development of fetuses, bone growth, ovulation, in addition to tissue repair when injuries occur.

However, these growth factors, when they are altered, also trigger serious alterations or pathologies.

For this reason, the chemicals developed for the treatment of some diseases related to neovascularization are called anti-VEGF, as they prevent the Growth Factor from binding to cell membrane receptors.

This then blocks the action of forming new vessels and, consequently, damage after vision.

These components are elevated in vision pathologies, such as age-related macular degeneration.

How does the package insert indicate using Eylia?

The frequency and dosage of application of Eylia should be prescribed by ophthalmology professionals, taking into account the diagnosis of each patient.

In general, the package insert advises that the drug should be administered in injections containing a volume of 0.050mL (which is equivalent to 2mg of aflibercept). The time between each new application must be designated by specialists, as well as the need for monitoring, maintenance or change of dosage.

The application of intravitreal injection must be done in appropriate places, respecting the hygiene and asepsis protocols. Administration should only be carried out by trained persons with experience in administering injections of this type.

With each new application, the package insert guides you to avoid repeating the location of the last administration, always aiming at the center of the eyeball.

What are the side effects?

As with any other treatment, the use of Eylia can trigger undesirable effects related to the active substance or the application. Some of them, although uncommon (occur, on average, once every 1900 administrations of the drug), can be serious and include:

  • Blindness;
  • Infection or inflammation inside the eye (endophthalmitis);
  • Detachment;
  • Tearing or bleeding from the retina (light-sensitive layer at the back of the eye);
  • Cataract (lenticular opacification);
  • Vitreous hemorrhage (bleeding in the eye);
  • Vitreous detachment;
  • Increased intraocular pressure (inside the eye).

Very common adverse effects

Very common adverse reactions are those that occur in more than 1 person in 10. They include:

  • Deterioration of vision;
  • Red eyes caused by bleeding from small blood vessels in the outermost layers of the eye (subconjunctival hemorrhage);
  • Pain in the eye.

Common adverse effects

Common adverse effects are those that can affect between 1 and 10 in every 100 patients. They include:

  • Blurred vision (retinal degeneration);
  • Bleeding in the eye (vitreous hemorrhage);
  • Certain forms of lens opacification (cataract, nuclear cataract, subcapsular cataract, cortical cataract);
  • Injury to the front layer of the eyeball (corneal erosion, corneal abrasion, punctured keratitis);
  • Increased pressure in the eye (increased intraocular pressure);
  • Spots moving in vision (floaters);
  • Detachment of the vitreous (gelatinous substance inside the eye anterior to the retina) resulting in flashes of light with spots moving in the vision;
  • Sensation of cisco in the eyes (sensation of foreign body in the eyes);
  • Increased tear production (increased tearing);
  • Swelling of the eyelid (edema of the eyelid);
  • Bleeding at the injection site (bleeding at the injection site);
  • Decreased clarity of vision (detachment / tearing of the retina);
  • Redness of the eyes (conjunctival hyperemia, ocular hyperemia).

In addition, the package insert indicates that, related only to wet AMD , there may be a decrease in vision clarity due to rupture / detachment of the retinal pigment epithelium.

Is there a contraindication?

The instructions guide that some cases are contraindicated to the use of Eylia, which are:

  • Hypersensitivity to the active substance aflibercept or to any of the excipients present (polysorbate 20, sodium phosphate monobasic monohydrate, sodium phosphate dibasic heptahydrate, sodium chloride, sucrose and water for injections).
  • Active or suspected eye or periocular infection;
  • Severe active intraocular inflammation.

Is Eylia approved by ANVISA?

Yes. Eylia has been registered as a biological medicine with ANVISA since October 2012, in the category of Other medicines with action on the visual apparatus .

Aflibercept has in the SUS?

The Aflibercept-based drug entered the list of substances provided by SUS in November 2019, under the guidance of treatment for cases of diabetic macular edema (EMD).

Published through Ordinance No. 50, of November 5, 2019, in the Federal Official Gazette, the substance can be obtained free of charge by patients who have a medical prescription. However, this is the only dispensation for the medication, and there is no cost for other diagnoses.

If patients have a medical prescription for the use of Aflibercept for the treatment of other health conditions, it is still possible to resort to legal channels.

The judicialization of medicines is an option for those who are unable to afford the medication, and can try to obtain the best and most appropriate treatment through legal means.

Is Eylia part of the ANS role?

The ANS List is a list of mandatory minimum coverage for health plans. To know exactly what each contracted plan should offer, you need to know which category it is.

In general, the ANS listing indicates the coverage of intravitreal implant of controlled-release pharmacological polymer (with usage guidelines), for macular edema in branch and central venous occlusions .

In 2018, ANS also published a note on the assistance of chemotherapy eye treatment with antiangiogenic, establishing some criteria for new health insurance contracts.

If the plan refuses to pay for treatment with Aflibercept, it is possible that patients with a medical prescription will try to obtain the cost of the drug through legal channels.

How to budget Eylia?

People who are going to file a lawsuit to try to pay for the medication through SUS or the health plan can use the service of high cost medication quotation advisory of the Consulta Remedios group.

Just access the link and fill out the form. In a short time, free of charge and personalized, a quote from 3 different pharmacies will be sent, facilitating the organization of the documents necessary for the opening of the process.

Price: How much does Eylia 40mg cost?

Eylia can be consulted in special physical pharmacies or online. The price of Eylia 40mg / mL, box with 1 syringe filled with 0.278ml of solution for intravitreal use + 1 needle is between approximately R $ 2,297 to R $ 4,882.

* Price consulted in January 2020. Prices may change.

A number of conditions and changes in the body are related to age. Although aging is not necessarily synonymous with illness, in this stage of life, people may be more susceptible to diseases and functional impairments, due to the natural fragility of the body.

Age-related macular degeneration is one of these conditions. The picture represents the disease that causes the most blindness in elderly people in developed countries. In Brazil, the disease affects approximately 3 million people, according to the Ministry of Health.

But in addition, other damage to vision can occur due to secondary causes, such as diabetes and hypertension.

For some cases of vision loss, there is treatment such as intravitreal injections, which are done by administering medications directly into the eyes.

Currently, this is one of the most effective methods for the control of conditions, which can improve the vision and the living conditions of patients. The drug Eylia is one of the substances used to treat these conditions.