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, retinal
detachments, and iatrogenic traumatic cataract. 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. ATEs 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
Retinal Vasculitis With or Without Occlusion
-
Retinal vasculitis with or without occlusion, typically in
the presence of preexisting intraocular inflammation or
post-treatment with other intravitreal agents, have been
reported with the use of ranibizumab products. Discontinue
treatment with BYOOVIZ in patients who develop these events.
Patients should be instructed to report any change in vision
without delay
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. The most common non-ocular
adverse reactions included nasopharyngitis, anemia, nausea,
and cough
-
As with all therapeutic proteins, there is potential for
immunogenicity. The clinical significance of
immunoreactivity to ranibizumab products is unclear at this
time
You are encouraged to report suspected adverse reactions to the
FDA. Visit
www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see full
Prescribing Information.
