Macugen

Macugen should only be administered by ophthalmologists experienced in intravitreal injections. 4). 3 mg pegaptanib, equivalent to 90 microliters, administered once every six weeks (9 injections per year) by intravitreal injection into the affected eye.

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 vitreous haemorrhage and endophthalmitis in the two weeks following the injection.

4). After 2 consecutive injections of Macugen, if a patient does not demonstrate a treatment benefit (loss of less than 15 letters of visual acuity) at the 12-week visit, consideration should be given to stopping or withholding Macugen therapy.

Special populations Elderly No special considerations are needed. Hepatic impairment Macugen has not been studied in patients with hepatic impairment. 2)Medicinal product no longer authorised 3 Renal impairment Macugen has not been adequately studied in patients with severe renal impairment.

2). Paediatric population The safety and efficacy of Macugen in children under 18 years has not yet been established. No data are available. Method of administration For intravitreal injection use only. 6). 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).

Adequate anaesthesia and a broad-spectrum topical microbicide should be administered prior to the injection. The pre-filled syringe is supplied with an excess product volume. 9). 6 for instructions to expel the excess volume before injection.

Summary of the safety profile The majority of adverse reactions reported following administration of Macugen are related to the intravitreal injection procedure. In clinical trials the most frequently reported ocular adverse reactions following injection of Macugen are: anterior chamber inflammation, eye pain, increased intraocular pressure, punctate keratitis,Medicinal product no longer authorised 5 vitreous floaters and vitreous opacities.

Less frequently reported serious ocular adverse reactions included endophthalmitis, retinal haemorrhage, vitreous haemorrhage and retinal detachment. 3 mg treatment group. The adverse reactions are listed by system organ class and frequency: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), and not known (cannot be estimated from the available data).

Reports from post-marketing experience are included in italics. 4). Cases of serious increase in intraocular pressure have been reported when the excess volume in the pre-filled syringe was not expelled before injection. Sustained small increases in intraocular pressure (IOP) have also been reported after repeated intravitreal dosing in a post marketing observational study.

0003). No statistical difference was found in the incidence of increased IOP between patients with a history of increased IOP or glaucoma versus patients without. Product-class-related adverse reactions In the clinical trial, the overall frequency of non-ocular haemorrhages, an adverse event potentially related to systemic VEGF (vascular endothelial growth factor) inhibition, was slightly increased in intravitreal VEGF inhibitor-treated patients.

However, there was no consistent pattern among the different haemorrhages. Arterial thromboembolic events (ATEs) are adverse events potentially related to systemic VEGF inhibition. Medicinal product no longer authorised 7 A few cases of arterial thromboembolic events were observed in the pegaptanib clinical trials in patients with AMD, DME, and there were no major differences between the groups treated with pegaptanib compared to control.

2). Increased intraocular pressure 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.

8). 2). Hypersensitivity reactions 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 treatments administered as part of the injection preparation procedure, or to other factors has not been established in these cases. Systemic effectsMedicinal product no longer authorised 4 Systemic adverse events including non-ocular haemorrhages and arterial thromboembolic events have been reported following intravitreal injection of VEGF inhibitors and there is a theoretical risk that these may relate to VEGF inhibition.

There are limited data on safety in patients with prior history of stroke or transient ischaemic attacks. 8, heading ‘Product-class-related adverse reactions’). 6). e. essentially ‘sodium-free’.

1. Active or suspected ocular or periocular infection.