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BYOOVIZ Dosing and
Administration

Offers the Same 0.5-mg
Dosing Regimen as
Lucentis for1:

Not actual size.

Neovascular (Wet) Age-Related Macular Degeneration (AMD)

  • BYOOVIZ 0.5 mg (in 0.05 mL) is recommended to be administered by intravitreal injection once per month (~28 days)
  • Although not as effective, patients may be treated with 3 monthly doses followed by less-frequent dosing with regular assessment. In the 9 months after 3 initial monthly doses, less-frequent dosing with 4-5 doses on average is expected to maintain visual acuity while monthly dosing may be expected to result in an additional average 1-2 letter gain. Patients should be assessed regularly
  • Although not as effective, patients may also be treated with 1 dose every 3 months after 4 monthly doses. Compared with continued monthly dosing, dosing every 3 months over the next 9 months will lead to an ~5-letter (1-line) loss of visual acuity benefit, on average. Patients should be assessed regularly

Macular Edema Following Retinal Vein Occlusion (RVO)

  • BYOOVIZ 0.5 mg (in 0.05 mL) is recommended to be administered by intravitreal injection once per month (~28 days)
  • In Studies RVO-1 and RVO-2, patients received monthly injections of ranibizumab for 6 months. Despite being guided by optical coherence tomography and visual acuity re-treatment criteria, patients who were then not treated at month 6 experienced, on average, a loss of visual acuity at month 7, whereas patients who were treated at month 6 did not. Patients should be treated monthly

Myopic Choroidal Neovascularization (mCNV)

  • BYOOVIZ 0.5 mg (in 0.05 mL) is recommended to be initially administered by intravitreal injection once per month (~28 days) for up to 3 months. Patients may be retreated, if needed

How Supplied

  • Each BYOOVIZ 0.5-mg carton (NDC 64406-019-01) 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
  • BYOOVIZ should be refrigerated at 2°C to 8°C (36°F to 46°F). DO NOT FREEZE
  • Do not use beyond the date stamped on the label
  • Protect BYOOVIZ vials from light and store in the original carton until time of use

Patients with nAMD may be treated with 3 monthly doses followed by continued monthly dosing (optimal), or less-frequent dosing with regular assessment1

Indications and Important
Safety Information

INDICATIONS

BYOOVIZ™ (ranibizumab-nuna), a vascular endothelial growth factor (VEGF) inhibitor, is indicated for the treatment of patients with:

  • Neovascular (Wet) Age-Related Macular Degeneration (AMD)
  • Macular Edema Following Retinal Vein Occlusion (RVO)
  • Myopic Choroidal Neovascularization (mCNV)

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

  • BYOOVIZ is contraindicated in patients with ocular or periocular infections or known hypersensitivity to ranibizumab products or any of the excipients in BYOOVIZ
  • Hypersensitivity reactions may manifest as severe intraocular inflammation

WARNINGS AND PRECAUTIONS

Endophthalmitis and Retinal Detachments

  • Intravitreal injections, including those with ranibizumab products, have been associated with endophthalmitis and retinal detachments. Proper aseptic injection technique should always be used when administering BYOOVIZ. In addition, patients should be monitored following the injection to permit early treatment should an infection occur

Increases in Intraocular Pressure

  • Increases in intraocular pressure have been noted both pre-injection and post-injection (at 60 minutes) while being treated with ranibizumab products. Monitor intraocular pressure prior to and following intravitreal injection with BYOOVIZ and manage appropriately

Thromboembolic Events

  • Although there was a low rate of arterial thromboembolic events (ATEs) observed in the ranibizumab clinical trials, there is a potential risk of ATEs following intravitreal use of VEGF inhibitors. Arterial thromboembolic events are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause)
    • Neovascular (Wet) Age-Related Macular Degeneration
    • The ATE rate in the three controlled neovascular AMD studies (AMD-1, AMD-2, AMD-3) during the first year was 1.9% (17 of 874) in the combined group of patients treated with 0.3 mg or 0.5 mg ranibizumab compared with 1.1% (5 of 441) in patients from the control arms. In the second year of Studies AMD-1 and AMD-2, the ATE rate was 2.6% (19 of 721) in the combined group of ranibizumab-treated patients compared with 2.9% (10 of 344) in patients from the control arms. In Study AMD-4, the ATE rates observed in the 0.5 mg arms during the first and second year were similar to rates observed in Studies AMD-1, AMD-2, and AMD-3
      In a pooled analysis of 2-year controlled studies [AMD-1, AMD-2, and a study of ranibizumab used adjunctively with verteporfin photodynamic therapy (PDT)], the stroke rate (including both ischemic and hemorrhagic stroke) was 2.7% (13 of 484) in patients treated with 0.5 mg of ranibizumab compared to 1.1% (5 of 435) in patients in the control arms [odds ratio 2.2 (95% confidence interval (0.8-7.1)]
    • Macular Edema Following Retinal Vein Occlusion
    • The ATE rate in the two controlled RVO studies during the first 6 months was 0.8% in both the ranibizumab and control arms of the studies (4 of 525 in the combined group of patients treated with 0.3 mg or 0.5 mg ranibizumab and 2 of 260 in the control arms). The stroke rate was 0.2% (1 of 525) in the combined group of ranibizumab-treated patients compared to 0.4% (1 of 260) in the control arms

ADVERSE REACTIONS

  • Serious adverse reactions related to the injection procedure have occurred in < 0.1% of intravitreal injections, including endophthalmitis, rhegmatogenous retinal detachment, and iatrogenic traumatic cataract
  • The most common adverse reactions (reported more frequently in ranibizumab-treated subjects than control subjects) are conjunctival hemorrhage, eye pain, vitreous floaters, and increased intraocular pressure
  • As with all therapeutic proteins, there is potential for immunogenicity. The clinical significance of immunoreactivity to ranibizumab products is unclear at this time

Please see full Prescribing Information.

Reference

  1. BYOOVIZ Prescribing Information, Cambridge, MA: Biogen, 2022.

INDICATIONS

BYOOVIZ™ (ranibizumab-nuna), a vascular endothelial growth factor (VEGF) inhibitor, is indicated for the treatment of patients with:

  • Neovascular (Wet) Age-Related Macular Degeneration (AMD)
  • Macular Edema Following Retinal Vein Occlusion (RVO)
  • Myopic Choroidal Neovascularization (mCNV)

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

  • BYOOVIZ is contraindicated in patients with ocular or periocular infections or known hypersensitivity to ranibizumab products or any of the excipients in BYOOVIZ
  • Hypersensitivity reactions may manifest as severe intraocular inflammation

WARNINGS AND PRECAUTIONS

Endophthalmitis and Retinal Detachments

  • Intravitreal injections, including those with ranibizumab products, have been associated with endophthalmitis and retinal detachments. Proper aseptic injection technique should always be used when administering BYOOVIZ. In addition, patients should be monitored following the injection to permit early treatment should an infection occur

Increases in Intraocular Pressure

  • Increases in intraocular pressure have been noted both pre-injection and post-injection (at 60 minutes) while being treated with ranibizumab products. Monitor intraocular pressure prior to and following intravitreal injection with BYOOVIZ and manage appropriately

Thromboembolic Events

  • Although there was a low rate of arterial thromboembolic events (ATEs) observed in the ranibizumab clinical trials, there is a potential risk of ATEs following intravitreal use of VEGF inhibitors. Arterial thromboembolic events are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause)
    • Neovascular (Wet) Age-Related Macular Degeneration
    • The ATE rate in the three controlled neovascular AMD studies (AMD-1, AMD-2, AMD-3) during the first year was 1.9% (17 of 874) in the combined group of patients treated with 0.3 mg or 0.5 mg ranibizumab compared with 1.1% (5 of 441) in patients from the control arms. In the second year of Studies AMD-1 and AMD-2, the ATE rate was 2.6% (19 of 721) in the combined group of ranibizumab-treated patients compared with 2.9% (10 of 344) in patients from the control arms. In Study AMD-4, the ATE rates observed in the 0.5 mg arms during the first and second year were similar to rates observed in Studies AMD-1, AMD-2, and AMD-3
      In a pooled analysis of 2-year controlled studies [AMD-1, AMD-2, and a study of ranibizumab used adjunctively with verteporfin photodynamic therapy (PDT)], the stroke rate (including both ischemic and hemorrhagic stroke) was 2.7% (13 of 484) in patients treated with 0.5 mg of ranibizumab compared to 1.1% (5 of 435) in patients in the control arms [odds ratio 2.2 (95% confidence interval (0.8-7.1)]
    • Macular Edema Following Retinal Vein Occlusion
    • The ATE rate in the two controlled RVO studies during the first 6 months was 0.8% in both the ranibizumab and control arms of the studies (4 of 525 in the combined group of patients treated with 0.3 mg or 0.5 mg ranibizumab and 2 of 260 in the control arms). The stroke rate was 0.2% (1 of 525) in the combined group of ranibizumab-treated patients compared to 0.4% (1 of 260) in the control arms

ADVERSE REACTIONS

  • Serious adverse reactions related to the injection procedure have occurred in < 0.1% of intravitreal injections, including endophthalmitis, rhegmatogenous retinal detachment, and iatrogenic traumatic cataract
  • The most common adverse reactions (reported more frequently in ranibizumab-treated subjects than control subjects) are conjunctival hemorrhage, eye pain, vitreous floaters, and increased intraocular pressure
  • As with all therapeutic proteins, there is potential for immunogenicity. The clinical significance of immunoreactivity to ranibizumab products is unclear at this time

Please see full Prescribing Information.

Reference

  1. BYOOVIZ Prescribing Information, Cambridge, MA: Biogen, 2022.