Cimerli

Warnings and Precautions, Retinal Vasculitis with or without Occlusion                                         06/2024

CIMERLI is indicated for the treatment of patients with:

For ophthalmic intravitreal injection only (

2.1)

• Neovascular (Wet) Age-Related Macular Degeneration (AMD) (
  
  
  2.2):
  
  
  
  
  
  CIMERLI 0.5 mg (0.05 mL) is recommended to be administered by intravitreal injection once a month (approximately 28 days).
  
  
  
  • Although not as effective, patients may be treated with 3 monthly doses followed by less frequent dosing with regular assessment.
    
  • Although not as effective, patients may also be treated with one dose every 3 months after 4 monthly doses. Patients should be assessed regularly.
    
• Macular Edema Following Retinal Vein Occlusion (RVO) (
  
  
  2.3):
  
  
  
  
  
  CIMERLI 0.5 mg (0.05 mL) is recommended to be administered by intravitreal injection once a month (approximately 28 days).
  
  
• Diabetic Macular Edema (DME) and Diabetic Retinopathy (DR) (
  
  
  2.4):
  
  
  
  
  
  CIMERLI 0.3 mg (0.05 mL) is recommended to be administered by intravitreal injection once a month (approximately 28 days).
  
  
• Myopic Choroidal Neovascularization (mCNV) (
  
  
  2.5):
  
  
  
  
  
  CIMERLI 0.5 mg (0.05 mL) is recommended to be initially administered by intravitreal injection once a month (approximately 28 days) for up to three months. Patients may be retreated if needed.
  
  

Single-dose glass vial designed to provide 0.05 mL for intravitreal injection.

• Colorless to pale yellow 10 mg/mL solution (0.5 mg)
• Colorless to pale yellow 6 mg/mL solution (0.3 mg)

There are no adequate and well-controlled studies of ranibizumab products administered in pregnant women.

Administration of ranibizumab to pregnant monkeys throughout the period of organogenesis resulted in a low incidence of skeletal abnormalities at intravitreal doses 13-times the predicted human exposure (based on maximal serum trough levels [C

_max]) after a single eye treatment at the recommended clinical dose. No skeletal abnormalities were observed at serum trough levels equivalent to the predicted human exposure after a single eye treatment at the recommended clinical dose

Animal reproduction studies are not always predictive of human response, and it is not known whether ranibizumab products can cause fetal harm when administered to a pregnant woman. Based on the anti-VEGF mechanism of action for ranibizumab products

CIMERLI should be given to a pregnant woman only if clearly needed.