Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS 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 control subjects) are conjunctival hemorrhage, eye pain, vitreous floaters, and increased IOP ( 6.2 ).
To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc.
at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Injection Procedure Serious adverse reactions related to the injection procedure have occurred in < 0.1% of intravitreal injections, including endophthalmitis [see Warnings and Precautions ( 5.1 )] , rhegmatogenous retinal detachment, and iatrogenic traumatic cataract.
6.2 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data below reflect exposure to 0.5 mg ranibizumab in 440 patients with neovascular AMD in Studies AMD-1, AMD-2, and AMD-3;
in 259 patients with macular edema following RVO.
The data also reflect exposure to 0.3 mg ranibizumab in 250 patients with DME and DR at baseline [see Clinical Studies ( 14 )] .
Safety data observed in 224 patients with mCNV, as well as Studies AMD-4 and D-3, were consistent with these results.
On average, the rates and types of adverse reactions in patients were not significantly affected by dosing regimen.
5 WARNINGS AND PRECAUTIONS • 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 with control ( 5.4 ).
Like all medications, Cimerli can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: