Ranibizumab
Pronouncation: (RA-ni-BIZ-oo-mab)Class: Selective vascular endothelial growth factor antagonist
Trade Names:
Lucentis
- Ophthalmic injection 10 mg/mL
Pharmacology
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Binds to and inhibits the biologic activity of human vascular endothelial growth factor A (VEGF-A), reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation.
Pharmacokinetics
Absorption
Following monthly intravitreous administration, C max is below the concentration thought necessary to inhibit biological activity of VEGF-A by 50% (0.3 to 2.36 ng/mL).
Indications and Usage
Treatment of neovascular (wet) age-related macular degeneration.
Contraindications
Ocular or periocular infection; hypersensitivity to any component of the product.
Dosage and Administration
AdultsOphthalmic 0.5 mg (0.05 mL) by intravitreous injection once a month.
General Advice
- Withdraw 0.2 mL through a 5-micron 19-gauge filter needle attached to a 1 mL tuberculin syringe.
- Replace filter needle with a 30-gauge × 12-inch needle for intravitreous injection.
- Expel contents until the plunger tip is aligned with the 0.05 mL line mark on the syringe.
- Prior to the injection, give adequate anesthesia and broad-spectrum microbicide.
- Perform the intravitreous injection procedure under aseptic conditions, including use of sterile gloves, sterile drape, and a sterile eyelid speculum.
- Following injection, monitor for elevated IOP and endophthalmitis.
- Instruct patient to report any symptoms suggestive of endophthalmitis without delay.
- Use each vial for the treatment of a single eye.
Storage/Stability
Store under refrigeration at 36° to 46°F. Do not freeze. Protect from light. Store in original carton until use.
Drug Interactions
None well documented.
Laboratory Test Interactions
None well documented.
Adverse Reactions
The ranges represent the minimum and maximum rates across 3 studies.
Cardiovascular
Hypertension/elevated BP (5% to 23%); arterial thromboembolic events (2% to 3%).
CNS
Headache (2% to 15%); dizziness (2% to 8%).
EENT
Conjunctival hemorrhage (43% to 77%); eye pain (17% to 37%); vitreous floaters (3% to 32%); retinal hemorrhage (15% to 26%); increased IOP (8% to 24%); vitreous detachment (7% to 22%); foreign body sensation in eye (6% to 19%); eye irritation (4% to 19%); intraocular inflammation (5% to 18%); blurred/decreased visual acuity (4% to 17%); increased lacrimation (3% to 17%); cataract, nasopharyngitis (5% to 16%); visual disturbance (0% to 14%); blepharitis (3% to 13%); eye pruritus, subretinal fibrosis (0% to 13%); detachment of the retinal pigment epithelium (1% to 11%); ocular hyperemia (5% to 10%); dry eye, maculopathy (3% to 10%); retinal exudates (1% to 9%); conjunctival hyperemia (0% to 9%); ocular discomfort, posterior capsule opacification (0% to 8%); increased IOP (less than 2%).
GI
Nausea (2% to 9%); constipation (3% to 7%).
Genitourinary
UTI (4% to 9%).
Hematologic-Lymphatic
Anemia (3% to 8%).
Musculoskeletal
Arthralgia (3% to 11%); back pain (1% to 10%); arthritis (0% to 8%).
Respiratory
Upper respiratory tract infection (2% to 15%); bronchitis, cough (3% to 10%); sinusitis (2% to 8%).
Miscellaneous
Influenza (2% to 10%); immunoreactivity (0% to 3%).
Precautions
MonitorMonitor IOP and perfusion of the optic nerve following intravitreous injection. |
Pregnancy
Category C .
Lactation
Undetermined.
Children
Safety and efficacy not established.
Endophthalmitis and retinal detachments
May occur.
Increased IOP
May occur within 60 min of intravitreous injection.
Thromboembolic events
Arterial thromboembolic events may occur.
Hepatic or renal function impairment
No studies have been conducted.
Overdosage
Symptoms
Doses as high as 2 mg have been tolerated.
Patient Information
- Advise patient to seek immediate care from an ophthalmologist if the eye becomes red, sensitive to light, or painful, or develops a change in vision.
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