MACUGEN PACKAGE INSERT PDF

Dosing Macugen 0. Preparation for Administration Macugen should be inspected visually for particulate matter and discoloration prior to administration. 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.

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Dosing Macugen 0. Preparation for Administration Macugen should be inspected visually for particulate matter and discoloration prior to administration.

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. Remove the syringe from the plastic clip.

Twist off cap. Attach the sterile, single-use administration needle included to the syringe by screwing it into the syringe tip. Remove the plastic needle shield from the needle. 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. Inject the entire contents of the syringe. After expelling air bubble and excess drug 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. Following the injection, patients should be monitored for elevation in intraocular pressure and for endophthalmitis. 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.

The safety and efficacy of Macugen therapy administered to both eyes concurrently have not been studied. Dosage Forms and Strengths Single-use glass syringe pre-filled with 0. Contraindications Macugen is contraindicated in patients with ocular or periocular infections. Hypersensitivity Macugen is contraindicated in patients with known hypersensitivity to pegaptanib sodium or any other excipient in this product. Warnings and Precautions Endophthalmitis Intravitreous injections, including those with Macugen, have been associated with endophthalmitis.

Proper aseptic injection technique should always be utilized when administering Macugen. In addition, patients should be monitored during the week following the injection to permit early treatment, should an infection occur [see Dosage and Administration 2. Therefore, intraocular pressure as well as the perfusion of the optic nerve head should be monitored and managed appropriately [see Dosage and Administration 2.

Clinical Studies Experience The most frequently reported adverse events in patients treated with Macugen 0. Non-Ocular: bronchitis, diarrhea, dizziness, headache, nausea, urinary tract infection. Non-Ocular: arthritis, bone spur, carotid artery occlusion, cerebrovascular accident, chest pain, contact dermatitis, contusion, diabetes mellitus, dyspepsia, hearing loss, pleural effusion, transient ischemic attack, urinary retention, vertigo, vomiting.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure [see Dosage and Administration 2. Pegaptanib crosses the placenta in mice. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers It is not known whether pegaptanib is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Macugen is administered to a nursing woman. Pediatric Use Safety and effectiveness of Macugen in pediatric patients have not been established.

No difference in treatment effect or systemic exposure was seen with increasing age. Macugen is supplied in a single-dose, pre-filled syringe and is formulated as a 3. The active ingredient is 0. This dose is equivalent to 1. Pegaptanib sodium is a covalent conjugate of an oligonucleotide of twenty-eight nucleotides in length that terminates in a pentylamino linker, to which two kilodalton monomethoxy polyethylene glycol PEG units are covalently attached via the two amino groups on a lysine residue.

Pegaptanib sodium is represented by the following structural formula: Where R is and n is approximately VEGF is a secreted protein that selectively binds and activates its receptors located primarily on the surface of vascular endothelial cells. VEGF induces angiogenesis, and increases vascular permeability and inflammation, all of which are thought to contribute to the progression of the neovascular wet form of age-related macular degeneration AMD , a leading cause of blindness.

VEGF has been implicated in blood retinal barrier breakdown and pathological ocular neovascularization. Pegaptanib is an aptamer, a pegylated modified oligonucleotide, which adopts a three-dimensional conformation that enables it to bind to extracellular VEGF.

Pharmacokinetics Absorption In animals, pegaptanib is slowly absorbed into the systemic circulation from the eye after intravitreous administration. The rate of absorption from the eye is the rate limiting step in the disposition of pegaptanib in animals and is likely to be the rate limiting step in humans.

Pegaptanib is metabolized by nucleases and is generally not affected by the cytochrome P system. Two early clinical studies conducted in patients who received Macugen alone and in combination with photodynamic therapy PDT revealed no apparent difference in the plasma pharmacokinetics of pegaptanib. After intravitreous and intravenous administrations of radiolabeled pegaptanib to rabbits, the highest concentrations of radioactivity excluding the eye for the intravitreous dose were obtained in the kidney.

In rabbits, pegaptanib is eliminated as parent drug and metabolites primarily in the urine. Based on preclinical data, pegaptanib is metabolized by endo- and exonucleases.

Special Populations Plasma concentrations do not appear to be affected by age or gender, but have not been studied in patients under the age of Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity studies with pegaptanib have not been conducted.

No data are available to evaluate male or female mating or fertility indices. Clinical Studies Macugen was studied in two controlled, double-masked, and identically designed randomized studies in patients with neovascular AMD. Patients were randomized to receive control sham treatment or 0. Patients received a mean 8.

Patients were re-randomized between treatment and no treatment during the second year. Verteporfin PDT usage was permitted at the discretion of the investigators in patients with predominantly classic lesions.

The groups treated with Macugen 0. Concomitant use of PDT overall was low. On average, Macugen 0. However, the rate of vision decline in the Macugen treated group was slower than the rate in the patients who received sham treatment. Macugen was less effective during the second year than during the first year. A sterile, single-use administration needle is is supplied in a separate pouch.

The foil pouch and needle are packaged together in a carton NDC Do not freeze or shake vigorously. Rx only Patient Counseling Information In the days following Macugen administration, patients are at risk for the development of endophthalmitis.

If the eye becomes red, sensitive to light, painful or develops a change in vision, the patient should seek the immediate care with their ophthalmologist [see Warnings and Precautions 5.

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In the case of pegaptanib, there are no specific foods that you must exclude from your diet when isert this medication. Patient Ratings for Pegaptanib. Especially tell your doctor if you. Pegaptanib Interactions Back to Top. Tell your doctor if you are breastfeeding or plan to breastfeed. However, if inxert is suspected, seek emergency medical attention.

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Grojar This medication ibsert available in an injectable form to be given directly into the eye by a healthcare professional once every six weeks. Ask your doctor or pharmacist for more information. Call your doctor for medical advice about side effects. In animal studies, pregnant animals were given this medication, and the babies did not show any packabe issues related to this medication. No drug interactions have been studied by the manufacturer. After each injection your doctor might prescribe antibiotic eye drops or another type of antibiotic treatment to prevent an eye infection.

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