Dosing and uses of Lucentis (ranibizumab)
Adult dosage forms and strengths
intravitreal injectable preservative-free solution
- 6mg/mL (0.05mL [0.3mg/vial])
- 10mg/mL (0.05mL [0.5mg/vial])
- 10mg/mL (0.05mL [0.5mg/prefilled syringe])
Neovascular (Wet) Age-related Macular Degeneration
0.5 mg intravitreal qMonth
May give q3month after 3 or 4 monthly injections (if continued monthly dosing not feasible) but is less effective than once monthly dosing
Macular Edema
Indicated for macular edema following retinal vein occlusion
0.5 mg intravitreal injection qMonth x6 months
Diabetic Macular Edema
0.3 mg intravitreally qMonth
Diabetic Retinopathy with DME
Indicated for treatment of diabetic retinopathy in patients with diabetic macular edema (DME)
0.3 mg intravitreally qMonth
Pediatric dosage forms and strengths
Does not apply
Lucentis (ranibizumab) adverse (side) effects
>10%
Conjunctival hemorrhage (43-77%)
Eye pain (17-37%)
Vitreous floaters (3-32%)
Incr IOP (8-24%)
Vitreous detachment (7-22%)
Eye irritation (4-19%)
Intraocular inflammation (5-18%)
Headache (2-15%)
Upper resp tract infection (2-15%)
Retinal disorder (13%)
Blepharitis (3-13%)
Retinal degeneration (1-11%)
1-10%
Conjunctival hyperemia (9%)
Posterior capsule opacification (8%)
Injection site hemorrhage (5%)
Vitreous hemorrhage (4%)
Warnings
Contraindications
Hypersensitivity
Ocular/periocular infections
Cautions
Risk of endophthalmitis or retinal detachment with intravitreous injections
Possibility of IOP increase within 60 min of intravitreal injection
Potential for adverse thromboembolic events (eg, nonfatal stroke, nonfatal MI, vascular death)
Temporary visual disturbances may occur
The incidence of fatal events reported to be higher in diabetic macular edema
Pregnancy and lactation
Pregnancy category: C
Lactation: Unknown if distributed in milk; use caution
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Lucentis (ranibizumab)
Mechanism of action
Humanized monoclonal antibody to VEGF-A, inhibits VEGF-A-induced ocular neovascularization
Pharmacokinetics
Half-Life: 9 days (vitreous)
Peak PlasmaTime: 1 day
Peak Plasma Concentration: 0.3-2.36 ng/mL
Administration
Intravitreal Preparation
Use aseptic technique
Solution should appear colorless to pale yellow Inspect solution; do not use if particulates, cloudiness, or discoloration are visible
Each prefilled syringe or vial should only be used for the treatment of a single eye
If the contralateral eye requires treatment, a new prefilled syringe or vial should be used and the sterile field, syringe, gloves, drapes, eyelid speculum, filter needle (vial only), and injection needles should be changed before administration to the other eye
Single-use viaL
- Use 5-micron, 19-ga filter needle attached to a 1-mL tuberculin syringe to withdraw vial contents
- Discard filter needle; do not use for intravitreal injection
- Replace filter needle with a sterile 30-gauge x 0.5-inch sterile injection needle
- Expell solution until the plunger tip is aligned with the line that marks 0.05 mL on the syringe
Prefilled syringe
- Open the sealed tray
- Snap off (do not turn or twist) the syringe cap
- Firmly attach a 30-gauge x 0.5-inch sterile injection needle to the syringe by screwing it tightly onto the Luer lock
- See complete instructions for syringe preparation in the prescribing information
Intravitreal Administration
Patient preparation and instructions
- Injection procedure should be carried out under aseptic conditions, which include the use of sterile gloves, a sterile drape, and a sterile eyelid speculum (or equivalent)
- Adequate anesthesia and a broad-spectrum microbicide should be given prior to the injection
- Prior to and 30 minutes following the intravitreal injection, patients should be monitored for elevation in intraocular pressure using tonometry
- Monitoring may also consist of a check for perfusion of the optic nerve head immediately after the injection
- Patients should also be monitored for and instructed to report any symptoms suggestive of endophthalmitis without delay following the injection
Injection procedure
- Insert the needle into the injection site
- Inject slowly until rubber stopper reaches the bottom of the syringe to deliver the 0.05 mL volume
- After injection, do not recap the needle or detach it from the syringed; dispose of the used syringe together with the needle in a sharps disposal container or in accordance with local requirements
Storage
Refrigerate at 2-8ºC (36-46ºF)
Do not freeze
Protect from light
Store in original carton until time of use
