Usual Adult Dose for Macular Degeneration

0.5 mg via intravitreal injection once a month (approximately 28 days)

Use: Neovascular (wet) age-related macular degeneration (AMD)

Usual Adult Dose for Diabetic Retinopathy

• DME and Diabetic Retinopathy with DME:

0.3 mg via intravitreal injection once a month (approximately 28 days)

• Macular Edema following RVO:

0.5 mg via intravitreal injection once a month (approximately 28 days)

Uses: Diabetic macular edema (DME); diabetic retinopathy with DME; macular edema following retinal vein occlusion (RVO)

Usual Adult Dose for Macular Edema

• DME and Diabetic Retinopathy with DME:

0.3 mg via intravitreal injection once a month (approximately 28 days)

• Macular Edema following RVO:

0.5 mg via intravitreal injection once a month (approximately 28 days)

Uses: Diabetic macular edema (DME); diabetic retinopathy with DME; macular edema following retinal vein occlusion (RVO)

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

Data not available.

Dose Adjustments

Although Not as Effective, the Following Dosing Regimens May Be Used in Patients with Neovascular (Wet) AMD:

• Administer 3 monthly doses followed by less frequent dosing with regular assessment. In the 9 months after 3 initial monthly doses, less frequent dosing with 4 to 5 doses on average is expected to maintain visual acuity while monthly dosing may be expected to result in an additional average 1 to 2 letter gain.

• Administer 1 dose every 3 months after 4 monthly doses with regular assessment. Compared with continued monthly dosing, dosing every 3 months over the next 9 months will lead to an approximate 5-letter (1-line) loss of visual acuity benefit on average.

Precautions

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:

• This drug is for ophthalmic intravitreal injection only.
• Each drug vial only should be used for treatment of a single eye; use of more than one injection from a vial can lead to contamination and subsequent infection.
• Adequate anesthesia and a broad-spectrum microbicide should be given prior to the injection.
• This drug can be administered in patients with DME or macular edema secondary to branch RVO who have received previous laser photocoagulation; it should be given at least 30 minutes after laser photocoagulation when administered on the same day.

Storage Requirements:

• This drug should be refrigerated at 2 to 8 degrees Celsius (36 to 46 Fahrenheit), protected from light, and stored in its original carton until time of use.
• An unopened drug vial may be kept at room temperature (25 degrees Celsius) for up to 24 hours.

Preparation Techniques:

• The manufacturer product information should be consulted on proper drug preparation and injection procedure.

Compatibility:

• This drug should not be mixed with other medicinal products due to the absence of compatibility studies.

General:

• This drug is produced by an Escherichia coli expression system in a nutrient medium containing tetracycline; tetracycline is not detectable in the final product.

Monitoring:

• Intraocular pressure using tonometry (prior to and 30 minutes following injection)
• Perfusion of the optic nerve head (immediately after injection)
• Symptoms of endophthalmitis (following injection)

Patient Advice:

• Seek immediate care from an ophthalmologist if your eye becomes red, painful, sensitive to light, or develops a vision change in vision.
• This drug may cause temporary visual problems; avoid driving and other potentially dangerous activities such as operating machinery until you know how this drug affects you.