Usual Adult Dose for Macular Degeneration

6 mg/m2 IV over 10 minutes once; this drug is photoactivated by 83 seconds of laser light administration (689 nm) commencing 15 minutes after start of the infusion

A course of therapy is a 2-step process requiring administration of both drug and light. The first step is the IV infusion of this drug. The second step is the activation of the drug with light from a nonthermal diode laser. The physician should reevaluate the patient 3 months after treatment and if choroidal neovascular leakage is detected on fluorescein angiography, therapy may be repeated.

Lesion Size Determination:

• Estimate the greatest linear dimension (GLD) of the lesion (i.e., all classic and occult choroidal neovascularization [CNV], blood and/or blocked fluorescence, and any serous detachments of the retinal pigment epithelium) by fluorescein angiograph and color fundus photography. Fundus cameras with magnification within the range of 2.4X to 2.6X are recommended. The GLD of the lesion on the fluorescein angiogram must be corrected for the magnification of the fundus camera to obtain the GLD of the lesion on the retina.

• Treatment spot size should be 1000 microns larger than the GLD of the lesion on the retina to allow a 500-mcm border and ensure full coverage of the lesion.
• Position the nasal edge of the treatment spot at least 200 microns from the temporal edge of the optic disc, even if this will result in lack of photoactivation of CNV within 200 microns of the optic nerve.

• The controlled trials only allowed treatment of one eye per patient. In patients who present with eligible lesions in both eyes, physicians should evaluate the potential benefits and risks of treating both eyes concurrently. If the patient has already received previous therapy with this drug in one eye with an acceptable safety profile, both eyes can be treated concurrently after a single administration of this drug. The more aggressive lesion should be treated first, at 15 minutes after the start of infusion. Immediately at the end of light application to the first eye, the laser settings should be adjusted to introduce the treatment parameters for the second eye, with the same light dose and intensity as for the first eye, starting no later than 20 minutes from the start of infusion.
• In patients who present for the first time with eligible lesions in both eyes without prior therapy with this drug, only one eye should be treated (the most aggressive lesion) at the first course. One week after the first course, if no significant safety issues are identified, the second eye can be treated using the same treatment regimen after a second infusion of this drug. Approximately 3 months later, both eyes can be evaluated and concurrent treatment following a new infusion of this drug can be started if both lesions still show evidence of leakage.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to the active component or any of the ingredients
• Porphyria

Dialysis

Data not available

Other Comments

General:

• If this drug is spilled, it should be wiped up with a damp cloth.
• Skin and eye contact should be avoided due to the potential for photosensitivity reactions upon exposure to light.
• Use of rubber gloves and eye protection is recommended.
• All materials should be disposed of properly.
• Accidental Exposure: Because of the potential to induce photosensitivity reactions, it is important to avoid contact with the eyes and skin during preparation and administration of this drug. Any exposed person should be protected from bright light.
• Precautions should be taken to prevent extravasation at the injection site. If extravasation occurs, protect the site from light.

• Store this drug at 20C to 25C (68F to 77F).

• Reconstitute each vial with 7 mL of Sterile Water for Injection to provide 7.5 mL containing 2 mg/mL of this drug.
• Protect the reconstituted solution from light and use within 4 hours.
• Inspect the reconstituted vial visually for particulate matter and discoloration prior to administration. Reconstituted drug is an opaque dark green solution.
• This drug may precipitate in saline solutions. Do not use normal saline or other parenteral solutions, except 5% Dextrose for Injection, for dilution of the reconstituted vial. Do not mix this drug in the same solution with other drugs.
• The volume of reconstituted drug required to achieve the desired dose of 6 mg/m2 is withdrawn from the vial and diluted with 5% Dextrose for Injection to a total infusion volume of 30 mL.