Label: CIMERLI- ranibizumab-eqrn injection, solution

  • NDC Code(s): 61314-624-94, 61314-625-94
  • Packager: Sandoz Inc
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Biologic Licensing Application

Drug Label Information

Updated June 17, 2024

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use CIMERLI safely and effectively. See full prescribing information for CIMERLI. CIMERLI® (ranibizumab-eqrn) injection, for ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    CIMERLI is indicated for the treatment of patients with: 1.1 Neovascular (Wet) Age-Related Macular Degeneration (AMD)   1.2 Macular Edema Following Retinal Vein Occlusion (RVO)   1.3 ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 General Dosing Information - FOR OPHTHALMIC INTRAVITREAL INJECTION. Vials: A 5-micron sterile filter needle (19-gauge × 1-1/2 inch), a 1-mL Luer lock syringe and a 30-gauge × 1/2 inch ...
  • 3 DOSAGE FORMS AND STRENGTHS
    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)
  • 4 CONTRAINDICATIONS
    4.1 Ocular or Periocular Infections - CIMERLI is contraindicated in patients with ocular or periocular infections. 4.2 Hypersensitivity - CIMERLI is contraindicated in patients with known ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Endophthalmitis and Retinal Detachments - Intravitreal injections, including those with ranibizumab products, have been associated with endophthalmitis and retinal detachments. Proper aseptic ...
  • 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) ...
  • 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 ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - There are no adequate and well-controlled studies of ranibizumab products administered in pregnant women. Administration of ranibizumab to pregnant monkeys ...
  • 10 OVERDOSAGE
    More concentrated doses as high as 2 mg ranibizumab in 0.05 mL have been administered to patients. No additional unexpected adverse reactions were seen.
  • 11 DESCRIPTION
    Ranibizumab-eqrn is a recombinant humanized IgG1 kappa isotype monoclonal antibody fragment designed for intraocular use. Ranibizumab-eqrn binds to and inhibits the biologic activity of human ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Ranibizumab products bind to the receptor binding site of active forms of VEGF-A, including the biologically active, cleaved form of this molecule, VEGF110. VEGF-A has ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Animal studies have not been conducted to determine the carcinogenic potential of ranibizumab products. Based on the anti-VEGF ...
  • 14 CLINICAL STUDIES
    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 ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    CIMERLI (ranibizumab-eqrn) injection, 0.5 mg is a colorless to pale yellow solution supplied in: • Each CIMERLI 0.5 mg carton (NDC 61314-625-94) contains a single-dose, 2-mL glass vial with a ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise patients that in the days following CIMERLI administration, patients are at risk of developing endophthalmitis and retinal vasculitis with or without occlusion. If the eye becomes red ...
  • SPL UNCLASSIFIED SECTION
    CIMERLI is a registered trademark of Sandoz Inc. Manufactured by: Sandoz Inc. Princeton, NJ 08540 - US License No. 2003
  • PRINCIPAL DISPLAY PANEL - 0.3 mg Vial Carton
    NDC 61314-624-94 - CIMERLI® (ranibizumab-eqrn) injection - 0.3 mg single-dose vial - For Intravitreal Use - Rx Only - Carton contents: • One single-dose glass vial - • Prescribing ...
  • PRINCIPAL DISPLAY PANEL - 0.5 mg Vial Carton
    NDC 61314-625-94 - CIMERLI® (ranibizumab-eqrn) injection - 0.5 mg single-dose vial - For Intravitreal Use - Rx Only - Carton contents: • One single-dose glass vial - • Prescribing ...
  • INGREDIENTS AND APPEARANCE
    Product Information