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Macugen

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Macugen

Indications
Dosage
How Supplied

INDICATIONS

Macugen is indicated for the treatment of neovascular (wet) age-related macular degeneration.

DOSAGE AND ADMINISTRATION

General Dosing Information

FOR OPHTHALMIC INTRAVITREAL INJECTION ONLY.

Dosing

Macugen 0.3 mg should be administered once every six weeks by intravitreous injection into the eye to be treated.

Preparation for Administration

Macugen should be inspected visually for particulate matter and discoloration prior to administration. If visible particulates are observed and/or the liquid in the syringe is discolored, the syringe must not be used.

Administration of the syringe contents involves assembly of the syringe with the administration needle. The injection procedure should be carried out under controlled aseptic conditions, which includes the use of sterile gloves, a sterile drape, and a sterile eyelid speculum (or equivalent). When ready to assemble syringe and administer injection, carefully peel open pouches, remove contents, and place on sterile field. If upon opening the pouch, the plastic clip is missing or not attached to the syringe, the syringe should not be used.

To avoid compromising the sterility of the product, do not pull back on the plunger.

  1. Remove the syringe from the plastic clip.
  2. Twist off cap.
  3. Attach the sterile BD® 30G ½” Precision Glide® administration needle (included) to the syringe by screwing it into the syringe tip. --Another sterile BD® 30G ½” Precision Glide® administration needle may be used in lieu of the one included. Remove the plastic needle shield from the needle.
  4. Holding the syringe with the needle pointing up, check the syringe for bubbles. If there are bubbles, gently tap the syringe with your finger until the bubbles rise to the top of the syringe. SLOWLY depress the plunger to eliminate all the bubbles and to expel the excess drug so that the top edge of the 3rd rib on the plunger stopper aligns with the preprinted black dosing line (See Figure 2, below).
  5. Inject the entire contents of the syringe.

PRIOR to Injection

Figure1: Before expelling air bubble and excess drug

Before expelling air bubble and excess drug - Illustration

READY for Injection

Figure 2: After expelling air bubble and excess drug

SLOWLY depress the plunger to eliminate all the bubbles - Illustration

Administration

The injection procedure should be carried out under controlled aseptic conditions, which includes the use of sterile gloves, a sterile drape, and a sterile eyelid speculum (or equivalent). Adequate anesthesia and a broad-spectrum microbicide should be given prior to the injection.

The patient's medical history for hypersensitivity reactions should be evaluated prior to performing the intravitreal procedure [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS].

Following the injection, patients should be monitored for elevation in intraocular pressure and for endophthalmitis. Monitoring may consist of a check for perfusion of the optic nerve head immediately after the injection, tonometry within 30 minutes following the injection, and monitoring during the week following the injection. Patients should be instructed to report any symptoms suggestive of endophthalmitis without delay.

No special dosage modification is required for any of the populations that have been studied (i.e. gender, elderly).

The safety and efficacy of Macugen therapy administered to both eyes concurrently have not been studied.

HOW SUPPLIED

Dosage Forms And Strengths

Single-use glass syringe pre-filled with 0.3 mg of Macugen® in a nominal 90 μL solution for intravitreal injection.

Storage And Handling

Macugen (pegaptanib sodium injection) is supplied in a sterile foil pouch as a single-use glass syringe pre-filled with 0.3 mg of Macugen® in a nominal 90 μL deliverable volume pack. A sterile packaged BD® single use 30G x ½” Precision Glide® Luer Lok® needle is supplied in a separate pouch. The foil pouch and needle are packaged together in a carton
(NDC 68782-001-02).

Store in the refrigerator at 2° to 8°C (36° to 46°F). Do not freeze or shake vigorously.

Manufactured by: Gilead Sciences, Inc 650 Cliffside Drive San Dimas, CA 91773. For: Eyetech Inc. 11360 Jog Road, Suite 200 Palm Beach Gardens, Florida 33418.

Last reviewed on RxList: 10/28/2011
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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