LUCENTIS Prefilled Syringe


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LUCENTIS Prefilled Syringe 0.5 mg: 0.5 mg NDC Code 50242-080-03

LUCENTIS Prefilled Syringe 0.5 mg

NDC Code 50242-080-03

Indicated for patients with: 

  • Myopic choroidal neovascularization (mCNV)

Preparation: Step-By-Step Instructions

See how LUCENTIS Prefilled Syringe works1

Administration Preparation

1

PREPARE

  • Make sure that your pack contains a sterile prefilled syringe in a sealed tray
  • Peel the lid off the syringe tray and, using aseptic technique, remove the syringe

2

INSPECT SYRINGE

  • LUCENTIS should be colorless to pale yellow
  • Do not use the prefilled syringe if:
    • The syringe cap is detached from the Luer lock
    • The syringe is damaged
    • Particulates, cloudiness, or discoloration are visible

 

SNAP


3

REMOVE SYRINGE CAP

  • Snap off (do not turn or twist) the syringe cap (see Figure 1)

 

Snap off (do not turn or twist) the syringe cap

Figure 1

ATTACH


4

ATTACH NEEDLE

  • Attach a 30G x ½-inch sterile injection needle firmly onto the syringe by screwing it tightly onto the Luer lock (see Figure 2)
  • Carefully remove the needle cap by pulling it straight off

Note: Do not wipe the needle at any time.

 

 Attach a 30G x ½-inch sterile injection needle firmly onto the syringe by screwing it tightly onto the Luer lock

Figure 2

TAP


5

DISLODGE AIR BUBBLES

 

  • Hold the syringe with the needle pointing up
  • If there are any air bubbles, gently tap the syringe with your finger until the bubbles rise to the top (see Figure 3)

 

 

If there are any air bubbles, gently tap the syringe with your finger until the bubbles rise to the top

Figure 3

6

EXPEL AIR AND ADJUST DRUG DOSE

  • Hold the syringe at eye level, and carefully push the plunger rod until the edge below the dome of the rubber stopper is aligned with the 0.05 mL dose mark (see Figure 4)

Note: The plunger rod is not attached to the rubber stopper—this is to prevent air from being drawn into the syringe.

 

Hold the syringe at eye level, and carefully push the plunger rod until the edge below the dome of the rubber stopper is aligned with the 0.05 mL dose mark

Figure 4

7

INJECT

  • The injection procedure should be carried out under aseptic conditions
  • Insert the needle into the injection site
  • Inject slowly until the rubber stopper reaches the bottom of the syringe to deliver the volume of 0.05 mL
  • After injection, do not recap the needle or detach it from the syringe. Dispose of the used syringe together with the needle in a sharps disposal container, or in accordance with local requirements

 

INDICATIONS
Myopic choroidal neovascularization (mCNV)

LUCENTIS® (ranibizumab injection) is indicated for the treatment of patients with myopic choroidal neovascularization (mCNV).

Wet age-related macular degeneration (wAMD)

LUCENTIS® (ranibizumab injection) is indicated for the treatment of patients with neovascular (wet) age-related macular degeneration (wAMD).

Diabetic retinopathy (DR)

LUCENTIS® (ranibizumab injection) is indicated for the treatment of patients with diabetic retinopathy (DR).

Diabetic macular edema (DME)

LUCENTIS® (ranibizumab injection) is indicated for the treatment of patients with diabetic macular edema (DME).

Macular edema following retinal vein occlusion (RVO)

LUCENTIS® (ranibizumab injection) is indicated for the treatment of patients with macular edema following retinal vein occlusion (RVO).

CONTRAINDICATIONS

LUCENTIS is contraindicated in patients with ocular or periocular infections or known hypersensitivity to ranibizumab or any of the excipients in LUCENTIS. Hypersensitivity reactions may manifest as severe intraocular inflammation.

WARNINGS AND PRECAUTIONS

Intravitreal injections, including those with LUCENTIS, have been associated with endophthalmitis, retinal detachment, and iatrogenic traumatic cataract. Proper aseptic injection technique should always be utilized when administering LUCENTIS. Patients should be monitored following the injection to permit early treatment, should an infection occur.

Increases in intraocular pressure (IOP) have been noted both pre-injection and post-injection (at 60 minutes) with LUCENTIS. Monitor intraocular pressure prior to and following intravitreal injection with LUCENTIS and manage appropriately.

Although there was a low rate of arterial thromboembolic events (ATEs) observed in the LUCENTIS clinical trials, there is a potential risk of ATEs following intravitreal use of VEGF inhibitors. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause).

Neovascular (wet) age-related macular degeneration

The ATE rate in the 3 controlled neovascular AMD studies during the first year was 1.9% (17 of 874) in the combined group of patients treated with 0.3 mg or 0.5 mg LUCENTIS compared with 1.1% (5 of 441) in patients from the control arms. In the second year of Studies AMD-1 and AMD-2, the ATE rate was 2.6% (19 of 721) in the combined group of LUCENTIS-treated patients compared with 2.9% (10 of 344) in patients from the control arms. In Study AMD-4, the ATE rates observed in the study during the first year were similar to rates observed in Studies AMD-1, AMD-2, and AMD-3.

In a pooled analysis of 2-year controlled studies (AMD-1, AMD-2, and a study of LUCENTIS used adjunctively with verteporfin photodynamic therapy), the stroke rate (including both ischemic and hemorrhagic stroke) was 2.7% (13 of 484) in patients treated with 0.5 mg LUCENTIS compared to 1.1% (5 of 435) in patients in the control arms (odds ratio 2.2 [95% confidence interval (0.8-7.1)]).

Macular edema following retinal vein occlusion

The ATE rate in the 2 controlled RVO studies during the first 6 months was 0.8% in both the LUCENTIS and control arms of the studies (4 of 525 in the combined group of patients treated with 0.3 mg or 0.5 mg LUCENTIS and 2 of 260 in the control arms). The stroke rate was 0.2% (1 of 525) in the combined group of LUCENTIS-treated patients compared to 0.4% (1 of 260) in the control arms.

Diabetic macular edema and Diabetic Retinopathy

In a pooled analysis of Studies DME-1 and DME-2, the ATE rate at 2 years was 7.2% (18 of 250) with 0.5 mg LUCENTIS, 5.6% (14 of 250) with 0.3 mg LUCENTIS, and 5.2% (13 of 250) with control. The stroke rate at 2 years was 3.2% (8 of 250) with 0.5 mg LUCENTIS, 1.2% (3 of 250) with 0.3 mg LUCENTIS, and 1.6% (4 of 250) with control. At 3 years, the ATE rate was 10.4% (26 of 249) with 0.5 mg LUCENTIS and 10.8% (27 of 250) with 0.3 mg LUCENTIS; the stroke rate was 4.8% (12 of 249) with 0.5 mg LUCENTIS and 2.0% (5 of 250) with 0.3 mg LUCENTIS.

Fatal events occurred more frequently in patients with DME and DR at baseline treated monthly with LUCENTIS compared with control. A pooled analysis of Studies D-1 and D-2, showed that fatalities in the first 2 years occurred in 4.4% (11 of 250) of patients treated with 0.5 mg LUCENTIS, in 2.8% (7 of 250) of patients treated with 0.3 mg LUCENTIS, and in 1.2% (3 of 250) of control patients. Over 3 years, fatalities occurred in 6.4% (16 of 249) of patients treated with 0.5 mg LUCENTIS and in 4.4% (11 of 250) of patients treated with 0.3 mg LUCENTIS. Although the rate of fatal events was low and included causes of death typical of patients with advanced diabetic complications, a potential relationship between these events and intravitreal use of VEGF inhibitors cannot be excluded.

ADVERSE EVENTS

Serious adverse events related to the injection procedure that occurred in <0.1% of intravitreal injections included endophthalmitis, rhegmatogenous retinal detachment, and iatrogenic traumatic cataract.

In the LUCENTIS Phase III clinical trials, the most common ocular side effects included conjunctival hemorrhage, eye pain, vitreous floaters, and increased intraocular pressure. The most common non-ocular side effects included nasopharyngitis, anemia, nausea, and cough.

As with all therapeutic proteins, there is the potential for an immune response in patients treated with LUCENTIS. The clinical significance of immunoreactivity to LUCENTIS is unclear at this time.

FOR ADDITIONAL SAFETY INFORMATION, PLEASE SEE LUCENTIS FULL PRESCRIBING INFORMATION.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

    • LUCENTIS [package insert]. South San Francisco, CA: Genentech, Inc; 2018.

      LUCENTIS [package insert]. South San Francisco, CA: Genentech, Inc; 2018.

    • Data on file. South San Francisco, CA: Genentech, Inc.

      Data on file. South San Francisco, CA: Genentech, Inc.