page and LUCENTIS full Prescribing Information.
`For Important Safety Information, please see next
`
`Figure 4
`
`accordance with local requirements
`with the needle in a sharps disposal container, or in
`from the syringe. Dispose of the used syringe together
`• After injection, do not recap the needle or detach it
`bottom of the syringe to deliver the volume of 0.05 mL
`• Inject slowly until the rubber stopper reaches the
`• Insert the needle into the injection site
`under aseptic conditions
`• The injection procedure should be carried out
`INJECT
`
`7
`
`drawn into the syringe.
`this is to prevent air from being
`attached to the rubber stopper—
`Note: The plunger rod is not
`
`dose mark (see Figure 4)
`stopper is aligned with the 0.05 mL
`edge below the dome of the rubber
`carefully push the plunger rod until the
`• Hold the syringe at eye level, and
`EXPEL AIR AND ADJUST DRUG DOSE
`
`6
`
`Figure 3
`
`Figure 2
`
`Figure 1
`
`bubble
`
`Air
`
` at any time.
` the needle
` Do not wipe
`
`
`
`
`
`
`
`
`
`
`
` Note:
`
`
`
`bubbles rise to the top (see Figure 3)
`the syringe with your finger until the
`• If there are any air bubbles, gently tap
`pointing up
`• Hold the syringe with the needle
`DISLODGE AIR BUBBLES
`TAP
`
`pulling it straight off
`• Carefully remove the needle cap by
`(see Figure 2)
`screwing it tightly onto the Luer lock
`needle firmly onto the syringe by
`• Attach a 30G x ½-inch sterile injection
`
`5
`
`4ATTACH NEEDLE
`
`ATTACH
`
`the syringe cap (see Figure 1)
`• Snap off (do not turn or twist)
`REMOVE SYRINGE CAP
`SNAP
`
`- Particulates, cloudiness, or discoloration are visible
`- The syringe is damaged
`- The syringe cap is detached from the Luer lock
`
`• Do not use the prefilled syringe if:
`• LUCENTIS should be colorless to pale yellow
`INSPECT SYRINGE
`
`2
`
`technique, remove the syringe
`• Peel the lid off the syringe tray and, using aseptic
`prefilled syringe in a sealed tray
`• Make sure that your pack contains a sterile
`PREPARE
`
`1
`
`3
`
`ADMINISTRATION PREPARATION
`PREFILLED SYRINGE
`
`J:!AN B ZUI\/IAB 11\JJEC~'ON
`LUCENTIS"
`~
`
`Novartis Exhibit 2044.001
`Regeneron v. Novartis, IPR2021-00816
`
`

`

`All rights reserved. M-US-00005586(v1.0) 07/20
`© 2020 Genentech USA, Inc. 1 DNA Way, South San Francisco, CA 94080-4990
`The LUCENTIS logo is a registered trademark of Genentech, Inc.
`
`Genentech
`
`A Member of the Roche Group
`
`Genentech at (888) 835-2555.
`www.fda.gov/medwatch. You may also report side effects to
`You may report side effects to the FDA at (800) FDA-1088 or
`Prescribing Information.
`For additional Safety Information, please see LUCENTIS full
`
`side effects included nasopharyngitis, anemia, nausea, and cough.
`and increased intraocular pressure. The most common non-ocular
`effects included conjunctival hemorrhage, eye pain, vitreous floaters,
` • In the LUCENTIS Phase III clinical trials, the most common ocular side
`
`intravitreal use of VEGF inhibitors cannot be excluded.
`complications, a potential relationship between these events and
`causes of death typical of patients with advanced diabetic
`control. Although the rate of fatal events was low and included
`DR at baseline treated monthly with LUCENTIS compared with
`
` • Fatal events occurred more frequently in patients with DME and
`
`vascular death (including deaths of unknown cause).
`are defined as nonfatal stroke, nonfatal myocardial infarction, or
`risk of ATEs following intravitreal use of VEGF inhibitors. ATEs
`(ATEs) observed in the LUCENTIS clinical trials, there is a potential
` • Although there was a low rate of arterial thromboembolic events
`
`REFERENCE: 1. LUCENTIS [package insert]. South San Francisco, CA: Genentech, Inc; 2018.
`
`injection and post-injection with LUCENTIS.
`
` • Increases in intraocular pressure have been noted both pre-
`
`iatrogenic traumatic cataract.
`been associated with endophthalmitis, retinal detachment, and
`
` • Intravitreal injections, including those with LUCENTIS, have
`
`as severe intraocular inflammation.
`excipients in LUCENTIS. Hypersensitivity reactions may manifest
`infections or known hypersensitivity to ranibizumab or any of the
` • LUCENTIS is contraindicated in patients with ocular or periocular
`IMPORTANT SAFETY INFORMATION
` • Myopic choroidal neovascularization (mCNV)
` • Diabetic retinopathy (DR)
` • Diabetic macular edema (DME)
` • Macular edema following retinal vein occlusion (RVO)
` • Neovascular (wet) age-related macular degeneration (AMD)
`of patients with:
`LUCENTIS® (ranibizumab injection) is indicated for the treatment
`INDICATIONS
`
`IMPORTANT SAFETY INFORMATION
`
`NOTE: The dose must be set to 0.05 mL.
`injection needle should be used (not provided).
`For the intravitreal injection, a 30-gauge x ½-inch sterile
`should be done under aseptic conditions.
`The opening of the sealed tray and all subsequent steps
`is damaged or has been tampered with.
`syringe is sterile. Do not use product if the packaging
`The prefilled syringe is for single-use only. The prefilled
`
`• Do not open sealed tray until time of use
`original carton until time of use
`• Protect LUCENTIS prefilled syringes from light and store in the
`• Do not use beyond the expiration date stamped on the label
`Do not freeze
`• LUCENTIS should be refrigerated at 2°C-8°C (36°F-46°F).
`HOW TO STORE LUCENTIS:
`
`0.05 mL Dose Mark
`
`Luer Lock
`
`ADMINISTRATION INFORMATION.
`FULL PRESCRIBING INFORMATION FOR
`THE PREFILLED SYRINGE. PLEASE SEE THE
`THE INSTRUCTIONS CAREFULLY BEFORE USING
`ACCOMPANYING INSTRUCTIONS. READ ALL
`ADMINISTRATION, PLEASE ADHERE TO THE
`TO PREPARE LUCENTIS FOR INTRAVITREAL
`
`l
`
`Plunger Rod
`
`Finger Grip
`
` Glass Barrel
`
`l l
`
`Rubber Stopper
`
`Syringe Cap
`
`~l l
`l
`
`PREFILLED SYRINGE: ADMINISTRATION PREPARATION
`
`LUCENTIS"
`~
`
`1ANIPIZUMAR \IJET~ CN
`
`DEVICE DESCRIPTION
`
`Novartis Exhibit 2044.002
`Regeneron v. Novartis, IPR2021-00816
`
`