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Side Effect Reporting

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch.
You may also report side effects to Genentech at (888) 835-2555.


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Indication

SUSVIMO (ranibizumab injection) is indicated for the treatment of patients with neovascular (wet) age-related macular degeneration (AMD) who have previously responded to at least 2 intravitreal injections of a vascular endothelial growth factor (VEGF) inhibitor medication.

Important Safety Information

WARNING: ENDOPHTHALMITIS

The SUSVIMO implant has been associated with a 3-fold higher rate of endophthalmitis than monthly intravitreal injections of ranibizumab. In clinical trials, 2.0% of patients receiving an implant experienced at least 1 episode of endophthalmitis.

Contraindications

  • Ocular or periocular infections
  • Active intraocular inflammation
  • Hypersensitivity

Warnings and Precautions

  • The SUSVIMO implant and/or implant-related procedures have been associated with endophthalmitis, rhegmatogenous retinal detachment, implant dislocation, vitreous hemorrhage, conjunctival retraction, conjunctival erosion, and conjunctival bleb. Patients should be instructed to report signs or symptoms that could be associated with these events without delay. Additional surgical and/or medical management may be required
  • Vitreous hemorrhage: Temporarily discontinue antithrombotic medication prior to the implant insertion procedure to reduce the risk of vitreous hemorrhage. Vitrectomy may be needed
  • Postoperative decrease in visual acuity: A decrease in visual acuity usually occurs over the first 2 postoperative months

Adverse Reactions

The most common adverse reactions were conjunctival hemorrhage (72%), conjunctival hyperemia (26%), iritis (23%), and eye pain (10%).

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

Please see additional Important Safety Information in the full SUSVIMO Prescribing Information, including BOXED WARNING.