BYOOVIZ- ranibizumab-nuna injection, solution

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

ranibizumab (UNII: ZL1R02VT79) (ranibizumab - UNII:ZL1R02VT79)

Prieinama:

BIOGEN INC.

Vartojimo būdas:

INTRAVITREAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

BYOOVIZ is indicated for the treatment of patients with: BYOOVIZ is contraindicated in patients with ocular or periocular infections. BYOOVIZ is contraindicated in patients with known hypersensitivity to ranibizumab products or any of the excipients in BYOOVIZ. Hypersensitivity reactions may manifest as severe intraocular inflammation. Risk Summary There are no adequate and well-controlled studies of ranibizumab products administered 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 13-times the predicted human exposure (based on maximal serum trough levels [Cmax ]) after a single eye treatment at the recommended clinical dose. No skeletal abnormalities were observed at serum trough levels equivalent to the predicted human exposure after a single eye treatment at the recommended clinical dose [see Animal Data ]. Animal reproduction studies are not always predictive of human re

Produkto santrauka:

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. Prior to use, the unopened vial can be stored at temperatures up to 86°F (30°C) for up to 72 hours.

Autorizacija statusas:

Biologic Licensing Application

Prekės savybės

BYOOVIZ- RANIBIZUMAB-NUNA INJECTION, SOLUTION
BIOGEN INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BYOOVIZ SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BYOOVIZ.
BYOOVIZ™ (RANIBIZUMAB-NUNA) INJECTION, FOR INTRAVITREAL USE
INITIAL U.S. APPROVAL: 2021
BYOOVIZ (RANIBIZUMAB-NUNA) IS BIOSIMILAR TO LUCENTIS (RANIBIZUMAB
INJECTION)
INDICATIONS AND USAGE
BYOOVIZ, a vascular endothelial growth factor (VEGF) inhibitor, is
indicated for the treatment of patients
with:
Neovascular (Wet) Age-Related Macular Degeneration (AMD) (1.1)
Macular Edema Following Retinal Vein Occlusion (RVO) (1.2)
Myopic Choroidal Neovascularization (mCNV) (1.3)
DOSAGE AND ADMINISTRATION
For ophthalmic intravitreal injection only (2.1)
Neovascular (Wet) Age-Related Macular Degeneration (AMD) (2.2):
BYOOVIZ 0.5 mg (0.05 mL) is recommended to be administered by
intravitreal injection once a month
(approximately 28 days).
-
-
Macular Edema Following Retinal Vein Occlusion (RVO) (2.3):
BYOOVIZ 0.5 mg (0.05 mL) is recommended to be administered by
intravitreal injection once a month
(approximately 28 days).
Myopic Choroidal Neovascularization (mCNV) (2.4):
BYOOVIZ 0.5 mg (0.05 mL) is recommended to be initially administered
by intravitreal injection once a
month (approximately 28 days) for up to three months. Patients may be
retreated if needed.
DOSAGE FORMS AND STRENGTHS
Single-dose glass vial designed to provide 0.05 mL for intravitreal
injections: 10 mg/mL solution. (3)
CONTRAINDICATIONS
Ocular or periocular infections (4.1)
Hypersensitivity (4.2)
WARNINGS AND PRECAUTIONS
Endophthalmitis and retinal detachments may occur following
intravitreal injections. Patients should be
monitored following the injection (5.1).
Increases in intraocular pressure (IOP) have been noted both pre- and
post-intravitreal injection (5.2).
There is a potential risk of arterial thromboembolic events following
intravitreal use of VEGF inhibitors
(5.3).
ADVERSE REACTIONS
The most common a