pharmacopeia
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Boxed warning

ENDOPHTHALMITIS The SUSVIMO implant has been associated with an up to 3-fold higher rate of endophthalmitis than monthly intravitreal injections of ranibizumab. Many of these events were associated with conjunctival retractions or erosions. Appropriate conjunctiva management and early detection with surgical repair of conjunctival retractions or erosions may reduce the risk of endophthalmitis. [see Contraindications (4.1) , Warnings and Precautions (5.1) ] . WARNING: ENDOPHTHALMITIS See full prescribing information for complete boxed warning. The SUSVIMO implant has been associated with an up to 3-fold higher rate of endophthalmitis than monthly intravitreal injections of ranibizumab.

Mechanism of action

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Ranibizumab binds to the receptor binding site of multiple biologically active forms of VEGF-A, including VEGF 110 . VEGF-A has been shown to cause neovascularization and leakage in models of ocular angiogenesis and vascular occlusion and is thought to contribute to pathophysiology of neovascular AMD.

Vascular Endothelial Growth FactorVascular Endothelial Growth Factor Receptor

Indications

Sourced from openFDA
  • SUSVIMO (ranibizumab injection) is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with: Neovascular (wet) Age-related Macular Degeneration (AMD) who have previously responded to at least two intravitreal injections of a VEGF inhibitor ( 1.1 ). Diabetic Macular Edema (DME) who have previously responded to at least two intravitreal injections of a VEGF inhibitor ( 1.2 ).ICD-10: R60.9

Contraindications

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  • Ocular or periocular infections ( 4.1 ) Active intraocular inflammation ( 4.2 ) Hypersensitivity ( 4.3 ) 4.1 Ocular or Periocular Infections SUSVIMO (ranibizumab injection) is contraindicated in patients with ocular or periocular infections. 4.2 Active Intraocular Inflammation SUSVIMO (ranibizumab injection) is contraindicated in patients with active intraocular inflammation.contraindicated

Dosage & administration

Sourced from openFDA

For intravitreal use via SUSVIMO ocular implant. ( 2.1 ) Neovascular (wet) Age-related Macular Degeneration (AMD) and Diabetic Macular Edema (DME) The recommended dose of SUSVIMO (ranibizumab injection) is 2 mg (0.02 mL of 100 mg/mL solution) continuously delivered via the SUSVIMO implant with refills every 24 weeks (approximately 6 months). ( 2.2 ) Diabetic Retinopathy (DR) The recommended dose of SUSVIMO (ranibizumab injection) is 2 mg (0.02 mL of 100 mg/mL solution) continuously delivered via the SUSVIMO implant with refills every 36 weeks (approximately 9 months). ( 2.3 ) Supplemental treatment with 0.5 mg intravitreal ranibizumab injection may be administered in the affected eye if clinically necessary. ( 2.4 ) Perform the initial implantation, refill-exchange, and implant removal (if necessary) procedures under strict aseptic conditions. ( 2.5 , 2.6 , 2.7 , 2.8 ) 2.1 General Information For Intravitreal Use via SUSVIMO ocular implant. The SUSVIMO initial fill and ocular implant insertion and implant removal procedures must be performed under aseptic conditions by a physician experienced in vitreoretinal surgery. The SUSVIMO ocular implant must be surgically implanted in the eye or removed from the eye (if medically necessary) in an operating room using aseptic technique. See SUSVIMO Instructions for Use and the standardized steps to optimize surgical outcomes. SUSVIMO refill-exchange procedures must be performed under aseptic conditions by a physician experienced in ophthalmic surgery [see Dosage and Administration (2.7) ] .

Warnings & precautions

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The SUSVIMO implant and/or implant-related procedures have been associated with endophthalmitis, rhegmatogenous retinal detachment, implant dislocation, septum dislodgement, vitreous hemorrhage, conjunctival erosion, conjunctival retraction, and conjunctival blebs. Patients should be instructed to report any signs or symptoms that could be associated with these events without delay. In some cases, these events can present asymptomatically. The implant and the tissue overlying the implant flange should be monitored routinely following the implant insertion, and refill-exchange procedures to permit early medical or surgical intervention as necessary. Special precautions need to be taken when handling SUSVIMO components [see How Supplied/Storage and Handling (16.3) ]. The SUSVIMO implant and/or implant-related procedures have been associated with endophthalmitis, rhegmatogenous retinal detachment, implant dislocation, septum dislodgement, 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. ( 5.1 , 5.2 , 5.3 , 5.4 , 5.5 , 5.6 , 5.7 ) Vitreous Hemorrhage : Temporarily discontinue antithrombotic medication prior to the implant insertion procedure to reduce the risk of vitreous hemorrhage. Vitrectomy may be needed. ( 5.5 ) Postoperative Decrease in Visual Acuity : A decrease in visual acuity usually occurs over the first two postoperative months.

Adverse reactions

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The following adverse reactions are discussed in greater detail in other sections of the label: Endophthalmitis [see Warnings and Precautions (5.1) ] Rhegmatogenous Retinal Detachment [see Warnings and Precautions (5.2) ] Implant Dislocation [see Warnings and Precautions (5.3) ] Septum Dislodgement [see Warnings and Precautions (5.4) ] Vitreous Hemorrhage [see Warnings and Precautions (5.5) ] Conjunctival Erosion or Retraction [see Warnings and Precautions (5.6) ] Conjunctival Bleb [see Warnings and Precautions (5.7) ] Postoperative Decrease in Visual Acuity [see Warnings and Precautions (5.8) ] The most common adverse reactions (≥ 10%) were conjunctival hemorrhage, conjunctival hyperemia, iritis, eye pain, conjunctival disorder, cataract and vitreous hemorrhage. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Genentech at 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in one clinical trial of a drug cannot be directly compared with rates in the clinical trials of the same or another drug and may not reflect the rates observed in practice. The data below ( Table 2 ) reflect exposure of 248 patients with AMD in the Archway study through Week 40, 320 patients with DME in the Pagoda study up to Week 64, and 105 patients with DR in the Pavillion study through Week 52 following the SUSVIMO initial fill and implant insertion, refill, and implant removal (if necessary) procedures.

Use in specific populations

Sourced from openFDA

8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies of SUSVIMO (ranibizumab injection) administration 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 up to 41 times the human exposure (based on serum levels following the recommended clinical dose). No skeletal abnormalities were observed at serum trough levels similar to the human exposure after a single eye treatment at the recommended clinical dose ( see Data ) . Animal reproduction studies are not always predictive of human response, and it is not known whether ranibizumab can cause fetal harm when administered to a pregnant woman. Based on the anti-VEGF mechanism of action for ranibizumab [see Clinical Pharmacology (12.1) ] , treatment with SUSVIMO (ranibizumab injection) may pose a risk to human embryofetal development. All pregnancies have a background risk of birth defects, loss, and other adverse outcomes. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects is 2% – 4% and of miscarriage is 15% – 20% of clinically recognized pregnancies.

Pharmacokinetics

Sourced from openFDA
Metabolism
The SUSVIMO implant provides a continuous release of ranibizumab where the release of ranibizumab into the vitreous decreases over time as the concentration in the implant decreases. The ranibizumab serum and aqueous humor concentrations with a SUSVIMO 24-week and 36-week treatment interval are maintained below the maximum and above the minimum concentrations experienced with monthly 0.5 mg intravitreal ranibizumab.

Approval history

Sourced from openFDA
  • Jun 30, 2006BLABLA125156Genentech
  • Sep 17, 2021BLABLA761202Samsung Bioepis Co Ltd
  • Oct 22, 2021BLABLA761197Genentech Inc
  • Aug 2, 2022BLABLA761165Sandoz Inc

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
26,416 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Death3,80914%
  2. 2Visual Acuity Reduced2,89211%
  3. 3Off Label Use1,7036.4%
  4. 4Visual Impairment1,6366.2%
  5. 5Cerebrovascular Accident1,2374.7%
  6. 6Drug Ineffective1,2104.6%
  7. 7Blindness1,0474.0%
  8. 8Eye Haemorrhage1,0464.0%
  9. 9No Adverse Event1,0454.0%
  10. 10Vision Blurred1,0353.9%
  11. 11Eye Pain9603.6%
  12. 12Retinal Haemorrhage7953.0%
  13. 13Endophthalmitis7332.8%
  14. 14Myocardial Infarction6892.6%
  15. 15Cataract6832.6%

Literature

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Recent PubMed references pinned to Ranibizumab as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 640 ClinicalTrials.gov registrations naming Ranibizumab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Ranibizumab work?
Ranibizumab binds to the receptor binding site of multiple biologically active forms of VEGF-A, including VEGF 110 . VEGF-A has been shown to cause neovascularization and leakage in models of ocular angiogenesis and vascular occlusion and is thought to contribute to pathophysiology of neovascular AMD.
What is Ranibizumab used for?
According to FDA labeling, Ranibizumab carries indications including: SUSVIMO (ranibizumab injection) is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with: Neovascular (wet) Age-related Macular Degeneration (AMD) who have previously responded to at least two intravitreal injections of a VEGF inhibitor ( 1.1 ). Diabetic Macular Edema (DME) who have previously responded to at least two intravitreal injections of a VEGF inhibitor ( 1.2 ).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Ranibizumab?
Ranibizumab is classified as Antineovascularisation agents, Vascular Endothelial Growth Factor Inhibitor, Vascular Endothelial Growth Factor-directed Antibody Interactions, Vascular Endothelial Growth Factor Inhibitors, Vascular Endothelial Growth Factor Receptor Inhibitors, Vascular Growth Decrease.
What are the brand names for Ranibizumab?
Ranibizumab is marketed under brand names including Byooviz, Cimerli, Lucentis, Susvimo.
What are the contraindications for Ranibizumab?
Ranibizumab labeling lists contraindications including: Ocular or periocular infections ( 4.1 ) Active intraocular inflammation ( 4.2 ) Hypersensitivity ( 4.3 ) 4.1 Ocular or Periocular Infections SUSVIMO (ranibizumab injection) is contraindicated in patients with ocular or periocular infections. 4.2 Active Intraocular Inflammation SUSVIMO (ranibizumab injection) is contraindicated in patients with active intraocular inflammation.. Always consult the full prescribing information and a clinician.
Note. Data for ranibizumab is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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