Susvimo
Generic: RANIBIZUMAB
Basic Information
Manufacturer
Genentech, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVITREAL
FDA Set ID
9c6d9e2a-9a77-4d11-b692-de87cfde3444
Indications & Usage
1 INDICATIONS AND USAGE 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 ).
Diabetic Retinopathy (DR) who have previously responded to at least two intravitreal injections of a VEGF inhibitor ( 1.3 ).
1.1 Neovascular (wet) Age-related Macular Degeneration (AMD) 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 two intravitreal injections of a Vascular Endothelial Growth Factor (VEGF) inhibitor medication.
1.2 Diabetic Macular Edema (DME) SUSVIMO (ranibizumab injection) is indicated for the treatment of patients with Diabetic Macular Edema (DME) who have previously responded to at least two intravitreal injections of a Vascular Endothelial Growth Factor (VEGF) inhibitor medication.
1.3 Diabetic Retinopathy (DR) SUSVIMO (ranibizumab injection) is indicated for the treatment of patients with Diabetic Retinopathy (DR) who have previously responded to at least two intravitreal injections of a Vascular Endothelial Growth Factor (VEGF) inhibitor medication.
Diabetic Macular Edema (DME) who have previously responded to at least two intravitreal injections of a VEGF inhibitor ( 1.2 ).
Diabetic Retinopathy (DR) who have previously responded to at least two intravitreal injections of a VEGF inhibitor ( 1.3 ).
1.1 Neovascular (wet) Age-related Macular Degeneration (AMD) 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 two intravitreal injections of a Vascular Endothelial Growth Factor (VEGF) inhibitor medication.
1.2 Diabetic Macular Edema (DME) SUSVIMO (ranibizumab injection) is indicated for the treatment of patients with Diabetic Macular Edema (DME) who have previously responded to at least two intravitreal injections of a Vascular Endothelial Growth Factor (VEGF) inhibitor medication.
1.3 Diabetic Retinopathy (DR) SUSVIMO (ranibizumab injection) is indicated for the treatment of patients with Diabetic Retinopathy (DR) who have previously responded to at least two intravitreal injections of a Vascular Endothelial Growth Factor (VEGF) inhibitor medication.
Adverse Reactions
6 ADVERSE REACTIONS 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.
In clinical trials of SUSVIMO in AMD patients, the most common (≥ 10%) adverse reactions up to Week 40 were conjunctival hemorrhage (72%), conjunctival hyperemia (26%), iritis (23%), and eye pain (10%).
Septum dislodgement was reported in 0.4% of the AMD patient population.
In clinical trials of SUSVIMO in DME patients, patient population the most common (≥ 10%) adverse reactions up to Week 64 were conjunctival hemorrhage (62%), conjunctival hyperemia (15%), iritis (14%), eye pain (13%), cataract (11%), conjunctival disorder (10%) and vitreous hemorrhage (10%).
In clinical trials of SUSVIMO in DR patients, the most common (≥ 10%) adverse reactions up to Week 52 were conjunctival hemorrhage (73%), conjunctival disorder (14%), iritis (12%) and conjunctival hyperemia (11%).
Table 2 Adverse Reactions occurring in ≥ 4% of patients in the SUSVIMO arm Adverse Reactions AMD Week 40 DME Week 64 DR Week 52 SUSVIMO n = 248 Intravitreal ranibizumab n = 167 SUSVIMO n = 320 Intravitreal ranibizumab 0.5 mg n = 314 SUSVIMO n = 105 Conjunctival hemorrhage 72% 6% 62% 18% 73% Conjunctival hyperemia 26% 2% 15% 0 11% Iritis Iritis includes: iritis, anterior chamber flare, anterior chamber inflammation, and anterior chamber cell.
23% 0.6% 14% 2% 12% Eye pain 10% 5% 13% 6% 9% Conjunctival disorder Conjunctival disorder includes: conjunctival adhesion, conjunctival disorder, conjunctival edema, conjunctival erosion, conjunctival retraction, and subconjunctival fibrosis.
9% 0 10% 0.3% 14% Vitreous floaters 9% 2% 4% 5% 2% Conjunctival bleb/ filtering bleb leak Conjunctival bleb/filtering bleb leak includes: conjunctival bleb, conjunctival filtering bleb leak, conjunctival cyst, subconjunctival cyst, and implant site cyst.
8% 0 8% 0 2% Foreign body sensation in eyes 7% 1% 3% 2% 9% Headache Headache includes: headache and procedural headache.
6% 2% 6% 4% 9% Hypotony of eye 6% 0 3% 0 0 Vitreous detachment 6% 5% 8% 5% 9% Vitreous hemorrhage 5% 2% 10% 2% 6% Cataract Cataract includes: cataract, cortical cataract, nuclear cataract, and subcapsular cataract.
4% 4% 11% 7% 7% Corneal disorder 4% 0 1% 0 1% Corneal abrasion Corneal abrasion includes: corneal abrasion and vital dye staining cornea present.
4% 0.6% 4% 1% 4% Corneal edema 4% 0 4% 0.3% 4% In clinical trials of SUSVIMO, hyphema was reported in 0.4% of AMD patients, 1.9% of DME patients, and 1.9% of DR patients.
( 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.
In clinical trials of SUSVIMO in AMD patients, the most common (≥ 10%) adverse reactions up to Week 40 were conjunctival hemorrhage (72%), conjunctival hyperemia (26%), iritis (23%), and eye pain (10%).
Septum dislodgement was reported in 0.4% of the AMD patient population.
In clinical trials of SUSVIMO in DME patients, patient population the most common (≥ 10%) adverse reactions up to Week 64 were conjunctival hemorrhage (62%), conjunctival hyperemia (15%), iritis (14%), eye pain (13%), cataract (11%), conjunctival disorder (10%) and vitreous hemorrhage (10%).
In clinical trials of SUSVIMO in DR patients, the most common (≥ 10%) adverse reactions up to Week 52 were conjunctival hemorrhage (73%), conjunctival disorder (14%), iritis (12%) and conjunctival hyperemia (11%).
Table 2 Adverse Reactions occurring in ≥ 4% of patients in the SUSVIMO arm Adverse Reactions AMD Week 40 DME Week 64 DR Week 52 SUSVIMO n = 248 Intravitreal ranibizumab n = 167 SUSVIMO n = 320 Intravitreal ranibizumab 0.5 mg n = 314 SUSVIMO n = 105 Conjunctival hemorrhage 72% 6% 62% 18% 73% Conjunctival hyperemia 26% 2% 15% 0 11% Iritis Iritis includes: iritis, anterior chamber flare, anterior chamber inflammation, and anterior chamber cell.
23% 0.6% 14% 2% 12% Eye pain 10% 5% 13% 6% 9% Conjunctival disorder Conjunctival disorder includes: conjunctival adhesion, conjunctival disorder, conjunctival edema, conjunctival erosion, conjunctival retraction, and subconjunctival fibrosis.
9% 0 10% 0.3% 14% Vitreous floaters 9% 2% 4% 5% 2% Conjunctival bleb/ filtering bleb leak Conjunctival bleb/filtering bleb leak includes: conjunctival bleb, conjunctival filtering bleb leak, conjunctival cyst, subconjunctival cyst, and implant site cyst.
8% 0 8% 0 2% Foreign body sensation in eyes 7% 1% 3% 2% 9% Headache Headache includes: headache and procedural headache.
6% 2% 6% 4% 9% Hypotony of eye 6% 0 3% 0 0 Vitreous detachment 6% 5% 8% 5% 9% Vitreous hemorrhage 5% 2% 10% 2% 6% Cataract Cataract includes: cataract, cortical cataract, nuclear cataract, and subcapsular cataract.
4% 4% 11% 7% 7% Corneal disorder 4% 0 1% 0 1% Corneal abrasion Corneal abrasion includes: corneal abrasion and vital dye staining cornea present.
4% 0.6% 4% 1% 4% Corneal edema 4% 0 4% 0.3% 4% In clinical trials of SUSVIMO, hyphema was reported in 0.4% of AMD patients, 1.9% of DME patients, and 1.9% of DR patients.