Macugen Official FDA information, side effects and uses.
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`Macugen
`
`Generic Name: pegaptanib sodium
`
`Dosage Form: injection, solution
`Macugen®
`
`(pegaptanib sodium injection)
`
`DESCRIPTION
`
`Macugen® (pegaptanib sodium injection) is a sterile, aqueous solution containing pegaptanib sodium for
`intravitreous injection. Macugen is supplied in a single-dose, pre-filled syringe and is formulated as a
`
`3.47 mg/mL solution, measured as the free acid form of the oligonucleotide. The active ingredient is 0.3 mg of
`the free acid form of the oligonucleotide without polyethylene glycol, in a nominal volume of 90 uL. This dose
`
`is equivalent to 1.6 mg of pegaptanib sodium (pegylated oligonucleotide) or 0.32 mg when expressed as the
`sodium salt form of the oligonucleotide moiety. The product is a sterile, clear, preservative-free solution
`
`containing sodium chloride, monobasic sodium phosphate monohydrate, dibasic sodium phosphate
`
`heptahydrate, hydrochloric acid, and/or sodium hydroxide to adjust the pH and water for injection.
`
`Pegaptanib sodium is a covalent conjugate of an oligonucleotide of twenty-eight nucleotides in length that
`
`terminates in a pentylamino linker, to which two 20-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:
`
` Dosing lite
`
`{Actual air bubble fennationlmay vary-j
`Where R is
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`Regeneron Exhibit 1009.001
`
`

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`Macugen Official FDA information, side effects and uses.
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`2 of 11
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`Dosing the and top edge of 3'“ iibaliglneud
`
`and n is approximately 450.
`
`The chemical name for pegaptanib sodium is as follows: RNA, ((2' - deoxy - 2' - fluoro)C - Gm - Gm - A - A -
`(2' - deoxy - 2' - fluoro)U - (2' - deoxy - 2' - fluoro)C - Am - Gm - (2' - deoxy - 2' - fluoro)U - Gm - Am - Am - (2'
`
`- deoxy - 2' - fluoro)U - Gm - (2' - deoxy - 2' - fluoro)C - (2' - deoxy - 2' - fluoro)U - (2' - deoxy - 2' - fluoro)U -
`Am - (2' - deoxy - 2' - fluoro)U - Am - (2' - deoxy - 2' - fluoro)C - Am - (2' - deoxy - 2' - fluoro)U - (2' - deoxy - 2'
`
`- fluoro)C - (2' - deoxy - 2' - fluoro)C - Gm - (3'—>3') - dT), 5'-ester with d,d' - [4,12 - dioxo - 6 - [[[5 -
`(phosphoonoxy)pentyl]amino]carbonyl] - 3,13 - dioxa - 5,11 - diaza - 1,15 - pentadecanediyl]bis[w -
`
`methoxypoly(oxy - 1,2 - ethanediyl)], sodium salt.
`
`The molecular formula for pegaptanib sodium is C294H342F13N107Na280188P28[C2H40]n (where n is
`
`approximately 900) and the molecular weight is approximately 50 kilodaltons.
`
`Macugen is formulated to have an osmolality of 280-360 mOsm/Kg, and a pH of 6-7.
`
`CLINICAL PHARMACOLOGY
`
`Mechanism of Action
`
`Pegaptanib is a selective vascular endothelial growth factor (VEGF) antagonist. 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. Under in vitro testing conditions, pegaptanib binds
`to the major pathological VEGF isoform, extracellular VEGF165, thereby inhibiting VEGF165 binding to its
`
`VEGF receptors. The inhibition of VEGF164, the rodent counterpart of human VEGF165, was effective at
`suppressing pathological neovascularization.
`
`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.
`
`In humans, a mean maximum plasma concentration of about 80 ng/mL occurs within 1 to 4 days after a 3 mg
`
`monocular dose (10 times the recommended dose). The mean area underthe plasma concentration-time
`curve (AUC) is about 25 ug-hr/mL at this dose.
`
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`Macugen Official FDA information, side effects and uses.
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`Distribution/Metabolism/Excretion
`
`Twenty-four hours after intravitreous administration of a radiolabeled dose of pegaptanib to both eyes of
`rabbits, radioactivity was mainly distributed in vitreous fluid, retina, and aqueous fluid. 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. ln rabbits, the component
`
`nucleotide, 2'-fluorouridine is found in plasma and urine after single radiolabeled pegaptanib intravenous and
`
`intravitreous doses. ln rabbits, pegaptanib is eliminated as parent drug and metabolites primarily in the urine.
`
`Based on preclinical data, pegaptanib is metabolized by endo- and exonucleases.
`
`In humans, after a 3 mg monocular dose (10 times the recommended dose), the average (:t standard
`
`deviation) apparent plasma half-life of pegaptanib is 10 (:4) days.
`
`Special Populations
`
`Plasma concentrations do not appearto be affected by age or gender, but have not been studied in patients
`under the age of 50.
`
`Renal Insufficiency
`
`Dose adjustment for patients with renal impairment is not needed when administering the 0.3 mg dose.
`
`Following a single 3 mg dose (10 times the recommended dose), in patients with severe (N=7), moderate
`(N=18), and mild (N=10) renal impairment, the mean (CV%) pegaptanib AUC values were 37.8 (17%), 26.7
`
`(31%), and 23.6 (21%) ug-hr/mL, respectively. The corresponding Cmax values were 96.8 (23%), 81.6
`
`(29.2%), and 66.5 (47%) ng/mL, respectively.
`
`In patients with renal impairment, following administration of 3 mg pegaptanib doses every 6 weeks, the last
`detectable pegaptanib concentrations in plasma after the fourth dose were highly variable (ranging from
`
`8 ng/mL to 66 ng/mL) and the variability was more pronounced in patients with severe renal impairment.
`
`Hemodialysis
`
`Macugen has not been studied in patients requiring hemodialysis.
`
`Hepatic Impairment
`
`Macugen has not been studied in patients with hepatic impairment.
`
`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 0.3 mg,
`1 mg or 3 mg Macugen administered as intravitreous injections every 6 weeks for 48 weeks. A total of
`
`approximately 1200 patients were enrolled with 892 patients receiving Macugen and 298 receiving a sham
`
`injection. The median age of the patients was 77 years. Patients received a mean 8.5 treatments out of a
`possible 9 total treatments across all treatment arms. Patients were re-randomized between treatment and no
`
`treatment during the second year. Patients who continued treatment in year 2 received a mean of
`16 treatments out of a possible total 17 overall.
`
`The two trials enrolled patients with neovascular AMD characteristics including classic, occult, and mixed
`lesions of up to 12 disc areas and baseline visual acuity in the study eye between 20/40 and 20/320. The
`
`primary efficacy endpoint was the proportion of patients losing less than 15 letters of visual acuity, from
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`Macugen Official FDA information, side effects and uses.
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`baseline up to 54 week assessment. Verteporfin photodynamic therapy (PDT) usage was permitted at the
`
`discretion of the investigators in patients with predominantly classic lesions.
`
`The groups treated with Macugen 0.3 mg exhibited a statistically significant result in both trials for the primary
`
`efficacy endpoint at 1 year: Study EOP1003, Macugen 73% vs. Sham 60%; Study EOP1004, Macugen 67%
`vs. Sham 53%. Concomitant use of PDT overall was low. More sham treated patients (75/296) received PDT
`
`than Macugen 0.3 mg treated patients (58/294).
`
`On average, Macugen 0.3 mg treated patients and sham treated patients continued to experience vision loss.
`
`However, the rate of vision decline in the Macugen treated group was slower than the rate in the patients who
`received sham treatment. See Figure 1.
`
`Figure 1
`
`
`
`At the end of the first year (week 54), approximately 1050 of the original 1200 patients were re-randomized to
`either continue the same treatment or to discontinue treatment through week 102. See Figure 2.
`
`Macugen was less effective during the second year than during the first year. The percentage of patients
`losing less than 15 letters from baseline to week 102 was: Study EOP1003, Macugen 38/67 (57%); Sham
`
`30/54 (56%); Study EOP1004, Macugen 40/66 (61%); Sham 18/53 (34%).
`
`Figure 2
`
`‘0‘
`
`Wmifigflmgfif
`
`“‘10“an
`
`Dose levels above 0.3 mg did not demonstrate any additional benefit.
`
`The safety or efficacy of Macugen beyond 2 years has not been demonstrated.
`
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`
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`

`Macugen Official FDA information, side effects and uses.
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`INDICATIONS AND USAGE
`
`Macugen is indicated for the treatment of neovascular (wet) age-related macular degeneration.
`
`CONTRAINDICATIONS
`
`Macugen is contraindicated in patients with ocular or periocular infections.
`
`Macugen is contraindicated in patients with known hypersensitivity to pegaptanib sodium or any other
`
`excipient in this product.
`
`WARNINGS
`
`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).
`
`Increases in intraocular pressure have been seen within 30 minutes of injection with Macugen. Therefore,
`intraocular pressure as well as the perfusion of the optic nerve head should be monitored and managed
`
`appropriately.
`
`PRECAUTIONS
`
`General
`
`FOR OPHTHALMIC INTRAVITREAL INJECTION ONLY.
`
`Rare cases of anaphylaxis/anaphylactoid reactions, including angioedema, have been reported in the post-
`marketing experience following the Macugen intravitreal administration procedure (see ADVERSE EVENTS
`
`and DOSAGE AND ADMINISTRATION).
`
`Information for Patients
`
`In the days following Macugen administration, patients are at risk forthe 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.
`
`Drug Interactions
`
`Drug interaction studies have not been conducted with Macugen. Pegaptanib is metabolized by nucleases
`
`and is generally not affected by the cytochrome P450 system.
`
`Two early clinical studies conducted in patients who received Macugen alone and in combination with PDT
`
`revealed no apparent difference in the plasma pharmacokinetics of pegaptanib.
`
`Carcinogenesis, Mutagenesis, Impairment of Fertility
`
`Carcinogenicity studies with pegaptanib have not been conducted.
`
`Pegaptanib and its monomer component nucleotides (2'-MA, 2'-MG, 2'-FU, 2'-FC) were evaluated for
`
`genotoxicity in a battery of in vitro and in vivo assay systems. Pegaptanib, 2'-O-methyladenosine (2'-MA), and
`2'-O-methylguanosine (2'-MG) were negative in all assay systems evaluated. 2'-fluorouridine (2'-FU) and 2'-
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`Macugen Official FDA information, side effects and uses.
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`fluorocytidine (2'-FC) were nonclastogenic and were negative in all S. typhimurium tester strains, but
`
`produced a non-dose related increase in revertant frequency in a single E. coli tester strain. Pegaptanib, 2'-
`FU, and 2'-FC tested negative in cell transformation assays.
`
`No data are available to evaluate male orfemale mating orfertility indices.
`
`Pregnancy
`
`Teratogenic Effects: Pregnancy Category B.
`
`Pegaptanib produced no maternal toxicity and no evidence of teratogenicity or fetal mortality in mice at
`
`intravenous doses of up to 40 mg/kg/day (about 7,000 times the recommended human monocular ophthalmic
`dose of 0.3 mg/eye). Pegaptanib crosses the placenta in mice.
`
`There are no studies in pregnant women. The potential risk to humans is unknown. Macugen should be used
`during pregnancy only if the potential benefit to the motherjustifies the potential risk to the fetus.
`
`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 studied.
`
`Geriatric Use
`
`Approximately 94% (834/892) of the patients treated with Macugen were 2 65 years of age and
`
`approximately 62% (553/892) were 2 75 years of age. No difference in treatment effect or systemic exposure
`was seen with increasing age.
`
`ADVERSE EVENTS
`
`Serious adverse events related to the injection procedure occurring in < 1% of intravitreous injections
`included endophthalmitis (see WARNINGS), retinal detachment, and iatrogenic traumatic cataract.
`
`The most frequently reported adverse events in patients treated with Macugen 0.3 mg for up to two years
`were anterior chamber inflammation, blurred vision, cataract, conjunctival hemorrhage, corneal edema, eye
`
`discharge, eye irritation, eye pain, hypertension, increased intraocular pressure (IOP), ocular discomfort,
`punctate keratitis, reduced visual acuity, visual disturbance, vitreous floaters, and vitreous opacities. These
`
`events occurred in approximately 10-40% of patients.
`
`The following events were reported in 6—10% of patients receiving Macugen 0.3 mg therapy:
`
`Ocular: blepharitis, conjunctivitis, photopsia, vitreous disorder.
`
`Non-Ocular: bronchitis, diarrhea, dizziness, headache, nausea, urinary tract infection.
`
`The following events were reported in 1-5% of patients receiving Macugen 0.3 mg therapy:
`
`Ocular: allergic conjunctivitis, conjunctival edema, corneal abrasion, corneal deposits, corneal epithelium
`disorder, endophthalmitis, eye inflammation, eye swelling, eyelid irritation, meibomianitis, mydriasis,
`
`periorbital hematoma, retinal edema, vitreous hemorrhage.
`
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`

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`Macugen Official FDA information, side effects and uses.
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`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.
`
`Post-Marketing Experience: Anaphylaxis/anaphylactoid reactions, including angioedema, have been
`identified during postapproval use of Macugen. 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 PRECAUTIONS and DOSAGE AND ADMINISTRATION).
`
`OVERDOSAGE
`
`Doses of Macugen up to 10 times the recommended dosage of 0.3 mg have been studied. No additional
`
`adverse events have been noted but there is decreased efficacy with doses above 1 mg.
`
`DOSAGE AND ADMINISTRATION
`
`Macugen 0.3 mg should be administered once every six weeks by intravitreous injection into the eye to be
`treated.
`
`Macugen should be inspected visually for particulate matter and discoloration priorto 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.
`
`a Twist off cap.
`
`0 Attach the sterile BD® 30G 1/2" Precision Glide® administration needle (included) to the syringe by
`
`screwing it into the syringe tip.
`-- Another sterile administration needle may be used in lieu of the one included. Remove the plastic
`needle shield from the needle.
`
`. Holding the syringe with the needle pointing up, check the syringe for bubbles. Ifthere 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 pre-printed black dosing line (See Fig 2, below).
`
`- Inject the entire contents of the syringe.
`
`PRIOR to Injection
`
`Fig 1. Before expelling air bubble and excess drug
`
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`

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`Macugen Official FDA information, side effects and uses.
`
`Sofll
`
`Figure 1
`
`w
`
`I
`u ‘
`
`9
`
`Mean Tifisual Acuity: Year 1
`
`EOP1003
`
`EOP1004
`
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`c on llll)
`° “Mr"!
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`
`E
`
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`
`
`
`wm
`
`READY for Injection
`
`Fig 2. After expelling air bubble and excess drug
`
`Figure 2
`
`IIII
`
`SE
`
`Ell m Nil
`
`9
`
`E!
`
`a.
`
`Mean Visual Acuity: Year 2
`
`EOP1003
`
`EOP1004
`
`P‘a‘llontTrealmsntm-ar 1]»[Wsr a]
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`¢[0_Smg)—) [03mg]
`0-[SIBI'I'I] -) llism oralnconinuo
`
`ll!
`
`Si
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`Pate ntma inantfiaar 1 1+ [War I]
`fining-r [3.5 mg)
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`
`The patient's medical history for hypersensitivity reactions should be evaluated prior to performing the
`intravitreal procedure (see PRECAUTIONS and ADVERSE EVENTS). Adequate anesthesia and a broad-
`
`spectrum microbicide should be given priorto the injection.
`
`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 biomicroscopy between two and seven
`
`days 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
`
`Macugen (pegaptanib sodium injection) is supplied in a sterile foil pouch as a single-use glass syringe pre-
`
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`
`Regeneron Exhibit 1009.008
`
`

`

`Macugen Official FDA information, side effects and uses.
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`9of11
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`filled with 0.3 mg of Macugen® in a nominal 90 uL deliverable volume pack. A sterile packaged BD® single
`
`use 30G x 1/2" Precision Glide® Luer Lok® needle is supplied in a separate pouch. The foil pouch and
`needle are packaged together in a carton.
`
`Storage
`
`Store in the refrigerator at 2° to 8°C (36° to 46°F). Do not freeze or shake vigorously.
`
`Rx only.
`
`BD and Precision Glide Luer Lok® are registered trademarks of Becton Dickinson & CO, Franklin Lakes, New
`Jersey 07417
`
`NDC 68782-001-02
`
`Manufactured by:
`Gilead Sciences, Inc
`650 Cliffside Drive
`
`San Dimas, CA 91773
`
`For:
`
`Eyetech Inc.
`140 East Hanover Avenue
`
`Cedar Knolls, NJ 07927
`
`Revised 08/2008
`
`PRINCIPAL DISPLAY PANEL
`
`NDC 68782-001-02
`
`Rx only
`Macugen®
`
`(pegaptanib sodium injection)
`
`For lntravitreous Injection
`0.3 mg / 90 pL*
`
`
`
`(HOEWIU! wmpgg qiueidufiad]
`
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`
`NDC 65732-00102
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`
`httpz/ /web.archive.org/ web/ 20110307065238/http2// WWW. dmgs.com:80/pro/macugenhtml
`
`Regeneron Exhibit 1009.009
`
`

`

`Macugen Official FDA information, side effects and uses.
`
`10 of 11
`
`Macugen
`pegaptanib sodium injection, solution
`
`Product Information
`
`Product Type
`
`HUMAN PRESCRIPTION
`DRUG
`
`NDC Product Code
`(Source)
`
`68782-001
`
`Route of Administration
`
`INTRAVITREAL
`
`DEA Schedule
`
`Active Ingredient/Active Moiety
`
`Ingredient Name
`
`Basis of Strength
`
`Strength
`
`PEGAPTANIB SODIUM
`(PEGAPTANIB)
`
`PEGAPTANIB
`
`3.47 mg in 1 mL
`
`Inactive Ingredients
`
`Ingredient Name
`
`SODIUM CHLORIDE
`
`SODIUM PHOSPHATE, MONOBASIC,
`MONOHYDRATE
`
`SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
`
`Strength
`
`HYDROCHLORIC ACID
`
`SODIUM HYDROXIDE
`
`WATER
`
`Product Characteristics
`
`Color
`
`Shape
`
`Flavor
`
`Contains
`
`Packaging
`
`#
`
`1
`
`Score
`
`Size
`
`Imprint Code
`
`NDC
`
`68782-001-02
`
`Package
`
`Description
`
`1 SYRINGE In 1
`CARTON
`
`Multilevel
`
`Packaging
`
`contains a SYRINGE
`
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`
`Regeneron Exhibit 1009.010
`
`

`

`Macugen Official FDA information, side effects and uses.
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`11 of 11
`
`1
`
`0.09 mL In 1
`SYRINGE
`
`This package is
`contained within the
`
`CARTON (68782-00
`1-02)
`
`Marketing Information
`
`Marketing Category Application Number Marketing Start Date Marketing End Date
`
`or Monograph
`Citation
`
`NDA
`
`NDAO21756
`
`12/17/2004
`
`Labeler - Eyetech Inc. (828561485)
`
`Establishment
`
`Name
`
`Address
`
`Gilead Sciences, Inc.
`
`Revised: 08/2008
`
`lD/FEl
`
`941715849
`
`Operations
`
`manufacture
`
`Eyetech Inc.
`
`More Macugen resources
`
`Macugen Side Effects (in More Detail)
`Macugen Use in Pregnancy & Breastfeeding
`
`Macugen Drug Interactions
`Macugen Support Group
`
`0 Reviews for Macugen - Add your own review/rating
`
`Macugen Monograph (AHFS DI)
`Macugen Advanced Consumer (Micromedex) - Includes Dosage Information
`
`Macugen MedFacts Consumer Leaflet (Wolters Kluwer)
`
`Macugen Consumer Overview
`
`Compare Macugen with other medications
`
`o Macular Degeneration
`
`httpz/ /web.archive.org/ web/ 20110307065238/http2// WWW. drugs.com:80/pro/macugenhtml
`
`Regeneron Exhibit 1009.011
`
`