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Generic Name
Ranibizumab
Brand Names
Byooviz, Cimerli, Lucentis, Nufymco, Susvimo
FDA approval date: June 30, 2006
Classification: Vascular Endothelial Growth Factor Inhibitor
Form: Injection
What is Byooviz (Ranibizumab)?
BYOOVIZ is indicated for the treatment of patients with: BYOOVIZ, a vascular endothelial growth factor inhibitor, is indicated for the treatment of patients with: Neovascular Age-Related Macular Degeneration .
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Brand Information
Byooviz (ranibizumab-nuna)
1INDICATIONS AND USAGE
BYOOVIZ is indicated for the treatment of patients with:
2DOSAGE FORMS AND STRENGTHS
Single-dose glass vial designed to provide 0.05 mL for intravitreal injection. Clear to slightly opalescent and colorless to pale yellow, 10 mg/mL solution.
3ADVERSE REACTIONS
The following adverse reactions are discussed in greater detail in other sections of the label:
- Endophthalmitis and Retinal Detachments [
- Increases in Intraocular Pressure [
- Thromboembolic Events [
3.1Injection Procedure
Serious adverse reactions related to the injection procedure have occurred in < 0.1% of intravitreal injections, including endophthalmitis [
3.2Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of the same or another drug and may not reflect the rates observed in practice.
The data below reflect exposure to 0.5 mg ranibizumab in 440 patients with neovascular AMD in Studies AMD-1, AMD-2, and AMD-3; in 259 patients with macular edema following RVO.
Safety data observed in 224 patients with mCNV, as well as Studies AMD-4 and D-3, were consistent with these results. On average, the rates and types of adverse reactions in patients were not significantly affected by dosing regimen.
3.3Immunogenicity
The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies in the studies described below with the incidence of anti-drug antibodies in other studies, including those of ranibizumab or of other ranibizumab products.
The pre-treatment incidence of immunoreactivity to ranibizumab was 0%-5% across treatment groups. After monthly dosing with ranibizumab for 6 to 24 months, antibodies to ranibizumab were detected in approximately 1%-9% of patients.
The clinical significance of immunoreactivity to ranibizumab products are unclear at this time. Among neovascular AMD patients with the highest levels of immunoreactivity, some were noted to have iritis or vitritis.
Intraocular inflammation was not observed in patients with RVO patients with the highest levels of immunoreactivity.
3.4Postmarketing Experience
The following adverse reactions have been identified during post-approval use of ranibizumab products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Ocular: Tear of retinal pigment epithelium among patients with neovascular AMD
4DRUG INTERACTIONS
Drug interaction studies have not been conducted with ranibizumab products.
Ranibizumab intravitreal injection has been used adjunctively with Photodynamic Therapy (PDT). Twelve of 105 (11%) patients with neovascular AMD developed serious intraocular inflammation; in 10 of the 12 patients, this occurred when ranibizumab was administered 7 days (± 2 days) after PDT.
5OVERDOSAGE
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.
6DESCRIPTION
BYOOVIZ (ranibizumab-nuna) is a recombinant humanized IgG1 kappa isotype monoclonal antibody fragment designed for intraocular use. Ranibizumab-nuna binds to and inhibits the biologic activity of human vascular endothelial growth factor A (VEGF-A). Ranibizumab-nuna, which lacks an Fc region, has a molecular weight of approximately 48 kilodaltons and is produced by an E. coli expression system in a nutrient medium containing the antibiotic tetracycline. Tetracycline is not detectable in the final product.
BYOOVIZ (ranibizumab-nuna) injection is a sterile, clear to slightly opalescent and colorless to pale yellow solution in a single-dose glass vial for intravitreal use. BYOOVIZ is supplied as a preservative-free, sterile solution in a single-dose container designed to deliver 0.05 mL of 10 mg/mL BYOOVIZ (0.5 mg dose vial) aqueous solution with 10 mM histidine HCl, 10% α,α-trehalose dihydrate, 0.01% polysorbate 20, pH 5.5.
7CLINICAL STUDIES
Unless otherwise noted, visual acuity was measured at a distance of 4 meters.
7.1Neovascular (Wet) Age-Related Macular Degeneration (AMD)
The safety and efficacy of ranibizumab were assessed in three randomized, double-masked, sham- or active-controlled studies in patients with neovascular AMD. A total of 1323 patients (ranibizumab 879, control 444) were enrolled in the three studies.
7.2Macular Edema Following Retinal Vein Occlusion (RVO)
The safety and efficacy of ranibizumab were assessed in two randomized, double-masked, 1-year studies in patients with macular edema following RVO. Sham controlled data are available through Month 6. Patient age ranged from 20 to 91 years, with a mean age of 67 years. A total of 789 patients (ranibizumab 0.3 mg, 266 patients; ranibizumab 0.5 mg, 261 patients; sham, 262 patients) were enrolled, with 739 (94%) patients completing through Month 6. All patients completing Month 6 were eligible to receive ranibizumab injections guided by pre-specified re-treatment criteria until the end of the studies at Month 12.
In Study RVO-1, patients with macular edema following branch or hemi-RVO, received monthly ranibizumab 0.3 mg or 0.5 mg intravitreal injections or monthly sham injections for 6 months. All patients were eligible for macular focal/grid laser treatment beginning at Month 3 of the 6-month treatment period. Macular focal/grid laser treatment was given to 26 of 131 (20%) patients treated with 0.5 mg ranibizumab and 71 of 132 (54%) patients treated with sham.
In Study RVO-2, patients with macular edema following central RVO received monthly ranibizumab 0.3 mg or 0.5 mg intravitreal injections or monthly sham injections for 6 months.
At Month 6, after monthly treatment with 0.5 mg ranibizumab, the following clinical results were observed:
7.3Myopic Choroidal Neovascularization (mCNV)
The efficacy and safety data of ranibizumab were assessed in a randomized, double-masked, active-controlled 3- month study in patients with mCNV. Patients age ranged from 18 to 87 years, with a mean age of 55 years. A total of 276 patients (222 patients in the ranibizumab treated Groups I and II; 55 patients in the active control PDT group) were enrolled. Patients randomized to the ranibizumab groups received injections guided by pre- specified re-treatment criteria. The retreatment criteria in Group I were vision stability guided, with the Best Corrected Visual Acuity (BCVA) at the current visit being assessed for changes compared with the two preceding monthly BCVA values. The retreatment criteria in Group II were disease activity guided, based on BCVA decrease from the previous visit that was attributable to intra- or sub-retinal fluid or active leakage secondary to mCNV as assessed by OCT and/or FA compared to the previous monthly visit.
Visual gains for the two ranibizumab 0.5 mg treatment arms were superior to the active control arm. The mean change in BCVA from baseline at Month 3 was: +12.1 letters for Group I, +12.5 letters for Group II and +1.4 letters for the PDT group. (Figure 6; Table 6). Efficacy was comparable between Group I and Group II.
The proportion of patients who gained ≥15 letters (ETDRS) by Month 3 was 37.1% and 40.5% for ranibizumab Groups I and II, respectively and 14.5% for the PDT group. The mean number of injections between baseline and Month 3 was 2.5 and 1.8 for Groups I and II, respectively. 41% of patients received 1, 2 or 3 injections between baseline and Month 3 with no injections afterwards.
8HOW SUPPLIED/STORAGE AND HANDLING
Each BYOOVIZ 0.5 mg carton (NDC 82667-018-05) contains a single-dose, 2-mL glass vial designed to deliver 0.05 mL of 10 mg/mL ranibizumab-nuna solution that is clear to slightly opalescent and colorless to pale yellow.
EACH CARTON IS FOR SINGLE-EYE USE ONLY.
9PATIENT COUNSELING INFORMATION
Advise patients that in the days following BYOOVIZ administration, patients are at risk of developing endophthalmitis and retinal vasculitis with or without occlusion. If the eye becomes red, sensitive to light, painful, or develops a change in vision, advise the patient to seek immediate care from an ophthalmologist [
10PRINCIPAL DISPLAY PANEL - 0.5 mg Vial Carton
NDC 82667-018-05
Rx only
Byooviz
0.5 mg | wAMD | RVO | mCNV
Injection
IMPORTANT:
For intravitreal injection.
INDICATED FOR:
- Neovascular (wet) age-related
- Macular edema following retinal
- Myopic choroidal
KEEP REFRIGERATED.
SAMSUNG
HARROW
