NUFYMCO (ranibizumab-leyk) · FORMYCON AG

In patients with neovascular AMD, following monthly intravitreal administration of 0.5 mg ranibizumab, mean (±SD) maximum ranibizumab serum concentrations were 1.7 (± 1.1) ng/mL. These concentrations were below the concentration range of ranibizumab (11 to 27 ng/mL) that was necessary to inhibit the biological activity of VEGF-A by 50%, as measured in an in vitro cellular proliferation assay (based on human umbilical vein endothelial cells (HUVEC)). No significant change from baseline was observ...

Unless otherwise noted, visual acuity was measured at a distance of 4 meters. 14.1 Neovascular (Wet) Age-Related Macular Degeneration (AMD) The safety and efficacy of ranibizumab were assessed in three randomized, double-masked, sham- or active-controlled studies in patients with neovascular AMD. A total of 1323 patients (ranibizumab 879, control 444) were enrolled in the three studies. Studies AMD-1 and AMD-2 In Study AMD-1, patients with minimally classic or occult (without classic) CNV lesions received monthly ranibizumab 0.3 mg or 0.5 mg intravitreal injections or monthly sham injections. ...

The following adverse reactions are discussed in greater detail in other sections of the label: Endophthalmitis and Retinal Detachments [see Warnings and Precautions ( 5.1 )] Increases in Intraocular Pressure [see Warnings and Precautions ( 5.2 )] Thromboembolic Events [see Warnings and Precautions ( 5.3 )] Fatal Events in patients with DME and DR at baseline [see Warnings and Precautions ( 5.4 )] The most common adverse reactions (reported more frequently in ranibizumab-treated subjects than co...

Ocular or periocular infections ( 4.1 ) Hypersensitivity ( 4.2 ) 4.1 Ocular or Periocular Infections NUFYMCO is contraindicated in patients with ocular or periocular infections. 4.2 Hypersensitivity NUFYMCO is contraindicated in patients with known hypersensitivity to ranibizumab products or any of the excipients in NUFYMCO. Hypersensitivity reactions may manifest as severe intraocular inflammatio...

Endophthalmitis and retinal detachments may occur following intravitreal injections. Patients should be monitored following the injection ( 5.1 ). Increases in intraocular pressure (IOP) have been noted both pre- and post‑intravitreal injection ( 5.2 ). There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors ( 5.3 ). Fatal events occurred more frequently in patients with DME and DR at baseline, who were treated monthly with ranibizumab compared w...

7 DRUG INTERACTIONS Drug interaction studies have not been conducted with ranibizumab products. Ranibizumab intravitreal injection has been used adjunctively with PDT. Twelve of 105 (11%) patients with neovascular AMD developed serious intraocular inflammation; in 10 of the 12 patients, this occurred when ranibizumab was administered 7 days (± 2 days) after PDT.