Pegaptanib Sodium
Pronouncation: (peg-AP-ta-nib SO-dee-um)Class: Selective vascular endothelial growth factor (VEGF) antagonist
Trade Names:
Macugen
- Injection 0.3 mg
Pharmacology
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Antagonizes effects of VEGF, which are thought to contribute to the progression of neovascular form of age-related macular degeneration.
Pharmacokinetics
Absorption
C max approximately 80 ng/mL and occurs within 1 to 4 days after 3 mg monocular dose (10 × recommended dose). AUC about 25 mcg•hr/mL.
Distribution
Radioactivity was mainly distributed in vitreous fluid, retina, and aqueous fluid 24 hr after intravitreous administration of a radiolabeled dose to both eyes of rabbits.
Metabolism
Following a 3 mg monocular dose (10 × recommended dose) plasma t ½ is about 10 days.
Indications and Usage
Treatment of neovascular (wet) age-related macular degeneration.
Contraindications
Ocular or periocular infections; standard considerations.
Dosage and Administration
AdultsIntravitreous injection 0.3 mg once every 6 wk into eye to be treated.
General Advice
- For intravitreous injection into the eye only. Not for intradermal, subcutaneous, IM, IV, or intra-arterial administration.
- Do not use contents in syringe if solution is cloudy, discolored, or contains particulate matter.
- Administer adequate anesthesia and a broad-spectrum microbicide prior to injection.
Storage/Stability
Store prefilled syringes in refrigerator (36° to 46°F). Do not freeze or shake vigorously.
Drug Interactions
None well documented.
Laboratory Test Interactions
None well documented.
Adverse Reactions
Cardiovascular
Hypertension (10% to 40%); carotid artery occlusion, cerebrovascular accident, transient ischemic attack (1% to 5%).
CNS
Dizziness, headache (6% to 10%); vertigo (1% to 5%).
Dermatologic
Contact dermatitis (1% to 5%).
EENT
Anterior chamber inflammation, blurred vision, cataract, conjunctival hemorrhage, corneal edema, eye discharge, eye irritation, eye pain, increased IOP, ocular discomfort, punctuate keratitis, reduced visual acuity, visual disturbance, vitreous floaters, vitreous opacities (10% to 40%); blepharitis, conjunctivitis, photopsia, vitreous disorder (6% to 10%); allergic conjunctivitis, conjunctival edema, corneal abrasion, corneal deposits, corneal epithelium disorder, endophthalmitis, eye inflammation, eye swelling, eyelid irritation, hearing loss, meibomianitis, mydriasis, periorbital hematoma, retinal edema, vitreous hemorrhage (1% to 5%).
GI
Diarrhea, nausea (6% to 10%); dyspepsia, vomiting (1% to 5%).
Genitourinary
UTI (6% to 10%); urinary retention (1% to 5%).
Metabolic-Nutritional
Diabetes mellitus (1% to 5%).
Musculoskeletal
Arthritis, bone spur (1% to 5%).
Respiratory
Bronchitis (6% to 10%).
Miscellaneous
Chest pain, contusion, pleural effusion (1% to 5%); anaphylaxis/anaphylactoid reactions including angioedema (postmarketing).
Precautions
MonitorFollowing injection, monitor patients for elevations in IOP and for endophthalmitis. |
Pregnancy
Category B .
Lactation
Undetermined.
Children
Safety and efficacy not established.
IOP
Increases in IOP have been seen within 30 min of injection; therefore, monitor IOP and perfusion of the optic nerve head.
Patient Information
- Review administration regimen and importance of returning every 6 wk for additional therapy.
- Advise patient that medication will be prepared and administered by a health care provider in a health care setting.
- Caution patient that there is a risk of developing endophthalmitis for several days following the injection and to immediately seek care from an ophthalmologist if any symptoms consistent with development of endophthalmitis occur (eg, eye becomes red, sensitive to light, or painful; vision changes).
- Advise patient to contact health care provider if experiencing bothersome adverse reactions or any unusual problems.
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