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United Kingdom
Drug details for : MACUGEN
| Drug class description : | Other Ophthalmologicals |
| Generic Name : | Pegaptanib Sodium, Oligonucleotide, Microlitres |
| Drug description : | 0.3 mg solution for injection The solution is clear and colourless. |
| Presentation : | A single dose pre-filled syringe delivers 1.65 mg pegaptanib sodium, corresponding to 0.3 mg of the free acid form of the oligonucleotide, in a nominal volume of 90 microlitres. |
| Indications : | Macugen is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD). |
| Adult Dosage : | FOR INTRAVITREAL USE ONLY. Treatment with Macugen is for intravitreal injection only and should be administered by ophthalmologists experienced in intravitreal injections. Macugen 0.3 mg should be administered once every six weeks (9 injections per year) by intravitreal injection into the affected eye. Macugen should be inspected visually for particulate matter and discoloration prior to administration. The injection procedure should be carried out under aseptic conditions, which includes the use of surgical hand disinfection, sterile gloves, a sterile drape and a sterile eyelid speculum (or equivalent) and the availability of sterile paracentesis (if required). The patient's medical history for hypersensitivity reactions should be carefully evaluated prior to performing the intravitreal procedure (See Special Precautions). Adequate anaesthesia and a broad-spectrum topical microbicide should be administered prior to the injection. Following the injection, transient increases in intraocular pressure were seen in Macugen treated patients. Therefore, the perfusion of the optic nerve head and intraocular pressure should be monitored. Moreover patients should be closely monitored for endophthalmitis in the two weeks following the injection. Patients should be instructed to report any symptoms suggestive of endophthalmitis without delay (See Special Precautions). Specific patient groups: Hepatic impairment: Macugen has not been studied in patients with hepatic impairment. However, no special considerations are needed in this population Renal insufficiency: Macugen has not been adequately studied in patients with creatinine clearance < 20 ml/min. No special considerations are needed in patients with creatinine clearance above 20 ml/min. |
| Child Dosage : | Macugen has not been studied in patients below the age of 18 years. Use in children and adolescents is therefore not recommended. |
| Elderly Dosage : | No special considerations are needed. |
| Contra Indications : | Active or suspected ocular or periocular infection. Known hypersensitivity to the active substance or to any of the excipients. |
| Special Precautions : | As expected with intravitreal injections, transient increases in intraocular pressure may be seen. Therefore, the perfusion of the optic nerve head should be verified and elevation of intraocular pressure should be managed appropriately post injection. Immediate (on the day of injection) and delayed intravitreous haemorrhages may occur following pegaptanib injections. Intravitreal injection procedures are associated with a risk of endophthalmitis; in Macugen clinical trials, the incidence of endophthalmitis was 0.1% per injection. Cases of anaphylaxis/anaphylactoid reactions, including angioedema, have been observed within several hours after the pegaptanib intravitreal administration procedure in the post-marketing experience. A direct relationship to Macugen or any of the various medications administered as part of the injection preparation procedure, or to other factors has not been established in these cases. |
| Interactions : | Drug interaction studies have not been conducted with Macugen. Pegaptanib is metabolised by nucleases and therefore cytochrome P450 mediated drug interactions are unlikely. Two early clinical studies conducted in patients who received Macugen alone and in combination with PDT (photodynamic therapy) revealed no apparent difference in the plasma pharmacokinetics of pegaptanib. Pegaptanib has not been studied in pregnant women. Animal studies are insufficient, but have shown reproductive toxicity at high systemic exposure levels. The potential risk to humans is unknown. The systemic exposure to pegaptanib is expected to be very low after ocular administration. Nevertheless, Macugen should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the foetus. It is not known whether Macugen is excreted in human milk. Macugen is not recommended during breast-feeding. |
| Adverse Reactions : | Macugen was administered to 892 patients in controlled studies for one year (total number of injections = 7545, mean number of injections/patient = 8.5) at doses of 0.3, 1.0 and 3.0 mg. All three doses shared a similar safety profile. In the 295 patients who were treated with the recommended dose of 0.3 mg for one year (total number of injections = 2478, mean number of injections/patient = 8.4), 84% of the patients experienced an adverse event attributed by the investigators as being related to the injection procedure, 3% of the patients experienced a Serious Adverse Event potentially related to the injection procedure, and 1% experienced an adverse event potentially related to the injection procedure that led to study treatment discontinuation. Twenty seven percent (27%) of the patients experienced an adverse event attributed by the investigators as being related to the study drug. Two patients (0.7%) experienced Serious Adverse Events potentially related to study drug. One of these patients had an aortic aneurysm; the other had a retinal detachment and retinal haemorrhage, which led to discontinuation of treatment. Serious ocular Adverse Events reported in Macugen treated patients included endophthalmitis (12 cases, 1%), retinal haemorrhage (3 cases, <1%), vitreous haemorrhage (2 cases, <1%) and retinal detachment (4 cases, < 1%). The safety data described below summarise all procedure and drug potentially related adverse events in the 295 patients in the 0.3 mg treatment group. The adverse reactions are listed by system organ class and frequency (very common ( 1/10), common ( 1/100 and <1/10), and uncommon ( 1/1000 and <1/100). Psychiatric disorders uncommon nightmare, depression Nervous system disorders common headache Eye disorders These ocular adverse reactions were considered potentially related to treatment with Macugen (either injection procedure or due to Macugen), and for the most part were considered related to the injection procedure. very common anterior chamber inflammation, eye pain, increased intraocular pressure, punctate keratitis, vitreous floaters and vitreous opacities common abnormal sensation in eye, cataract, conjunctival haemorrhage, conjunctival hyperaemia, conjunctival oedema, conjunctivitis, corneal dystrophy, corneal epithelium defect, corneal epithelium disorder, corneal oedema, dry eye, endophthalmitis, eye discharge, eye inflammation, eye irritation, eye pruritus, eye redness, eye swelling, eyelid oedema, lacrimation increased, macular degeneration, mydriasis, ocular discomfort, ocular hypertension, periorbital haematoma, photophobia, photopsia, retinal haemorrhage, vision blurred, visual acuity reduced, visual disturbance, vitreous detachment, and vitreous disorder uncommon asthenopia, blepharitis, conjunctivitis allergic, corneal deposits, eye haemorrhage, eyelids pruritus, keratitis, vitreous haemorrhage, pupillary reflex impaired, corneal abrasion, retinal exudates, eyelid ptosis, retinal scar, chalazion, corneal erosion, decreased intraocular pressure, injection site reaction, injection site vesicles, retinal detachment, corneal disorder, retinal artery occlusion, retinal tear, ectropion, eye movement disorder, eyelid irritation, hyphaema, pupillary disorder, iris disorder, ocular icterus, anterior uveitis, deposit eye, iritis, optic nerve cupping, pupillary deformity, retinal vein occlusion, and vitreous prolapse Ear and labyrinth disorders: uncommon - deafness, Meniere's disease aggravated, vertigo Cardiac disorders: uncommon - palpitations Vascular disorders: uncommon - hypertension, aortic aneurysm Respiratory, thoracic and mediastinal disorders: common - rhinorrhea, uncommon - nasopharyngitis Gastrointestinal disorders: uncommon - vomiting, dyspepsia Skin and subcutaneous tissue disorders: uncommon - contact dermatitis, eczema, hair colour changes, rash, pruritus, night sweats Musculoskeletal and connective tissue disorders: uncommon - back pain General disorders and administration site conditions: uncommon - fatigue, rigors, tenderness, chest pain, influenza like illness Investigations: uncommon - increased gammaglutamyltransferase activity. Injury, poisoning and procedural complications: uncommon - abrasion. Three hundred seventy four (374) patients received continuous treatment with Macugen for up to 2 years (128 at 0.3 mg, 126 at 1 mg, and 120 at 3 mg). The overall safety data were consistent with the Year 1 safety data, and no new safety signals emerged. In the 128 patients who were treated with the recommended dose of 0.3 mg for up to 2 years (total number of injections in second year = 913, mean number of injections in the second year = 6.9), there was no evidence of increased in frequency of adverse events compared to those seen during the first year. Post-Marketing Experience: Rare cases of anaphylaxis/anaphylactoid reactions, including angioedema, have been reported in patients within several hours after administration of pegaptanib along with various medications administered as part of the injection preparation procedure (See Adult Dosage and Special Precautions). |
| Manufacturer : | Pfizer Ltd |
| Drug Availability : | (POM) |
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