Drug Detail:Aflibercept ophthalmic (Aflibercept ophthalmic [ a-flib-er-sept-off-thal-mik ])
Drug Class: Anti-angiogenic ophthalmic agents
Usual Adult Dose for Macular Degeneration
2 mg via intravitreal injection every 4 weeks for the first 12 weeks, then 2 mg via intravitreal injection every 8 weeks
- Some patients may need to continue with every 4-week dosing after the first 12 weeks
Comments:
- Patients should be assessed regularly.
- Additional efficacy was not demonstrated for most patients when dosed every 4 weeks compared to every 8 weeks; however, some patients may need monthly dosing.
- After 1 year of effective therapy, patients may be treated with 2 mg via intravitreal injection every 12 weeks, although this regimen is not as effective as the recommended every 8-week dosing regimen.
Use: For the treatment of neovascular (wet) age-related macular degeneration.
Usual Adult Dose for Macular Edema
Macular Edema following Retinal Vein Occlusion (RVO):
2 mg via intravitreal injection every 4 weeks
Diabetic Macular Edema (DME):
2 mg via intravitreal injection every 4 weeks for the first 5 injections (20 weeks), then 2 mg via intravitreal injection every 8 weeks
- Some patients may need to continue with every 4-week dosing after the first 20 weeks
Diabetic Retinopathy (DR):
2 mg via intravitreal injection every 4 weeks for the first 5 injections (20 weeks), then 2 mg via intravitreal injection every 8 weeks
- Some patients may need to continue with every 4-week dosing after the first 20 weeks
Comments:
- Patients should be assessed regularly.
- Additional efficacy was not demonstrated for most patients when dosed every 4 weeks compared to every 8 weeks; however, some patients may need monthly dosing.
Uses: For the treatment of macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy.
Renal Dose Adjustments
No adjustment recommended
Liver Dose Adjustments
No adjustment recommended
Precautions
CONTRAINDICATIONS:
- Hypersensitivity to the active component or any of the ingredients
- Ocular or periocular infections
- Active intraocular inflammation
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
ADMINISTRATION ADVICE:
For ophthalmic intravitreal injection
- This drug should only be administered by a qualified physician
- The procedure should be performed under aseptic conditions to include surgical hand disinfection, sterile gloves, a sterile drape, and a sterile eyelid speculum (or equivalent); adequate anesthesia and a topical broad-spectrum microbicide should be given prior to the injection
Reconstitution/preparation techniques:
- Refer to the manufacturer product information for preparation instructions
- The product should be inspected visually prior to administration; if particulates, cloudiness, or discoloration are visible, the vial should not be used
- Each vial is for the treatment of a single eye
Storage requirements:
- Store in a refrigerator 36F to 46F (2C to 8C); do not freeze
- Protect from light; store in original carton until ready to use
Monitoring:
- Monitor for increased intraocular pressure and perfusion of the optic nerve head
- Monitor for endophthalmitis and retinal detachment (e.g., eye pain, redness of the eye, photophobia, blurring of vision)
Patient advice:
- Patients should be informed that they are at risk of developing endophthalmitis or retinal detachment and they should seek immediate care from an ophthalmologist if their eye becomes red, sensitive to light, painful, or develops a change in vision.
- Patients should be advised not to drive or use machinery until visual function has recovered sufficiently from the procedure and associated eye exams.
- Women of childbearing potential should be advised to use effective contraception prior to the initial dose, during treatment, and for at least 3 months after the last injection.
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