Eylea HD Dosage

Important Injection Instructions

For ophthalmic intravitreal injection. EYLEA HD must only be administered by a qualified physician.

A 5-micron sterile filter needle (18-gauge × 1½-inch), a 1-mL Luer lock syringe and a 30-gauge × ½-inch sterile injection needle are needed.

EYLEA HD is available packaged as follows:

• Vial Only
• Vial Kit with Injection Components (filter needle, syringe, injection needle)

[see How Supplied/Storage and Handling (16)].

Neovascular (Wet) Age-Related Macular Degeneration (nAMD)

The recommended dose for EYLEA HD is 8 mg (0.07 mL of 114.3 mg/mL solution) administered by intravitreal injection every 4 weeks (approximately every 28 days +/- 7 days) for the first three doses, followed by 8 mg (0.07 mL of 114.3 mg/mL solution) via intravitreal injection once every 8 to 16 weeks, +/- 1 week.

Diabetic Macular Edema (DME)

The recommended dose for EYLEA HD is 8 mg (0.07 mL of 114.3 mg/mL solution) administered by intravitreal injection every 4 weeks (approximately every 28 days +/- 7 days) for the first three doses, followed by 8 mg (0.07 mL of 114.3 mg/mL solution) via intravitreal injection once every 8 to 16 weeks, +/- 1 week.

Diabetic Retinopathy (DR)

The recommended dose for EYLEA HD is 8 mg (0.07 mL of 114.3 mg/mL solution) administered by intravitreal injection every 4 weeks (approximately every 28 days +/- 7 days) for the first three doses, followed by 8 mg (0.07 mL of 114.3 mg/mL solution) via intravitreal injection once every 8 to 12 weeks, +/- 1 week.

Preparation for Administration

The EYLEA HD glass vial is for one-time use in one eye only. Discard unused portion. EYLEA HD does not contain an anti-microbial preservative. Extraction of multiple doses from a single vial may increase the risk of contamination and subsequent infection.

Do not use if the package or its components are expired, damaged, or have been tampered with.

Check the label on the vial to make sure you have the correct aflibercept strength.

Prepare for intravitreal injection with the following medical devices for single use.

• a 5-micron sterile filter needle (18-gauge × 1½-inch)
• a 1-mL sterile Luer lock syringe (with marking to measure 0.07 mL)
• a sterile injection needle (30-gauge × ½-inch)

1.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use the vial if particulates, cloudiness, or discoloration are visible.

2.

Remove the protective plastic cap from the vial (see Figure 1).

Figure 1:

3.

Clean the top of the vial with an alcohol wipe (see Figure 2).

Figure 2:

4.

Use aseptic technique to carry out steps 4 – 11. Remove the 18-gauge × 1½-inch, 5-micron, filter needle and the 1-mL syringe from their packaging. Attach the filter needle to the syringe by twisting it onto the Luer lock syringe tip (see Figure 3).

Figure 3:

5.

Push the filter needle into the center of the vial stopper until the needle is completely inserted into the vial and the tip touches the bottom or bottom edge of the vial.

6.

Withdraw all of the EYLEA HD vial contents into the syringe, keeping the vial in an upright position, slightly inclined to ease complete withdrawal. To deter the introduction of air, ensure the bevel of the filter needle is submerged into the liquid. Continue to tilt the vial during withdrawal keeping the bevel of the filter needle submerged in the liquid (see Figure 4a and Figure 4b).

Figure 4a:	Figure 4b:

7.

Ensure that the plunger rod is drawn sufficiently back when emptying the vial in order to completely empty the filter needle.

8.

Remove the filter needle from the syringe and properly dispose of the filter needle. Note: Filter needle is not to be used for intravitreal injection.

9.

Remove the 30-gauge × ½-inch injection needle from its packaging and attach the injection needle to the syringe by firmly twisting the injection needle onto the Luer lock syringe tip (see Figure 5).

Figure 5:

10.

Holding the syringe with the needle pointing up, check the syringe for bubbles. If there are bubbles, gently tap the syringe with your finger until the bubbles rise to the top (see Figure 6).

Figure 6:

11.

To eliminate all of the bubbles and to expel excess drug, SLOWLY depress the plunger so that the plunger tip aligns with the line that marks 0.07 mL on the syringe (see Figure 7a and Figure 7b).

Figure 7a:	Figure 7b:

Injection Procedure

The intravitreal injection procedure should be carried out under controlled aseptic conditions, which include surgical hand disinfection and the use of sterile gloves, a sterile drape, and a sterile eyelid speculum (or equivalent). Adequate anesthesia and a topical broad–spectrum microbicide should be given prior to the injection.

Immediately following the intravitreal injection, patients should be monitored for elevation in intraocular pressure. Appropriate monitoring may consist of a check for perfusion of the optic nerve head or tonometry. If required, a sterile paracentesis needle should be available.

Following intravitreal injection, patients and/or caregivers should be instructed to report any signs and/or symptoms suggestive of endophthalmitis or retinal detachment (e.g., eye pain, redness of the eye, photophobia, blurring of vision) without delay [see Patient Counseling Information (17)].

Each vial should only be used for the treatment of a single eye. If the contralateral eye requires treatment, a new vial should be used and the sterile field (including a new syringe, gloves, drapes, eyelid speculum, filter and injection needles) should be changed before EYLEA HD is administered to the other eye.

After injection, discard any unused product or waste material in accordance with local regulations.