SUSVIMO- ranibizumab injection, solution

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

RANIBIZUMAB (UNII: ZL1R02VT79) (RANIBIZUMAB - UNII:ZL1R02VT79)

Beszerezhető a:

Genentech, Inc.

Az alkalmazás módja:

INTRAVITREAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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. SUSVIMO (ranibizumab injection) is contraindicated in patients with ocular or periocular infections. SUSVIMO (ranibizumab injection) is contraindicated in patients with active intraocular inflammation. SUSVIMO (ranibizumab injection) is contraindicated in patients with known hypersensitivity to ranibizumab products or any of the excipients in SUSVIMO (ranibizumab injection). Risk Summary There are no adequate and well-controlled studies of SUSVIMO (ranibizumab injection) administration 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 up to 41 times the human exposure (based on serum levels following the re

Termék összefoglaló:

Each SUSVIMO initial fill needle kit (NDC 50242-078-55) contains: Each SUSVIMO (ranibizumab injection) carton (NDC 50242-078-12) contains one SUSVIMO (ranibizumab injection) 100 mg/mL that is clear to slightly opalescent, colorless to pale brown solution in a single-dose glass vial. Each SUSVIMO refill needle carton contains a SUSVIMO refill needle (34-gauge vented needle with a 5 μm integrated filter) with a clear cap. Materials List Materials that are required and supplied to perform the procedure are: Additional materials required to perform the procedure but are not provided are: Store SUSVIMO initial fill needle kit at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from light. Do not shake. The SUSVIMO initial fill needle has been sterilized with electron beam processing. Store SUSVIMO (ranibizumab injection) 100 mg/ mL vial at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from light. Do not shake. Prior to use, the unopened vial may be kept at 9°C to 30°C (48°F to 86°F) for up to 24 hours provided it is protected from light. Store the SUSVIMO implant and insertion tool assembly, refill needle and explant tool at room temperature 15°C to 25°C (59°F to 77°F). The SUSVIMO implant and insertion tool assembly has been sterilized with ethylene oxide gas. The SUSVIMO refill needle and explant tool have been sterilized with electron beam processing. SUSVIMO components are supplied sterile and are for single-use only. Do not reprocess, re-sterilize, or reuse SUSVIMO components. Do not use if the sterility has been compromised or the contents have been dropped, damaged or tampered with. Do not use past the expiration date printed on the label. Do not open sealed tray until time of use. Avoid contact between sharp surgical instruments and the SUSVIMO implant as the material of the septum and silicone encasing is soft and susceptible to damage. Important Device Handling Information Ocular Implant Initial Fill Procedure Ocular Implant Insertion Procedure Ocular Implant Removal Procedure

Engedélyezési státusz:

Biologic Licensing Application

Betegtájékoztató

Genentech, Inc.
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This Medication Guide has been approved by the
U.S. Food and Drug Administration
Approved: 4/2022
MEDICATION GUIDE
SUSVIMO™ (suss-VIH-moh)
(ranibizumab injection)
for intravitreal use via SUSVIMO ocular implant
What is the most important information I should know about SUSVIMO?
SUSVIMO (ranibizumab injection) is delivered into the eye using the
SUSVIMO implant. The SUSVIMO
implant and the procedures to insert, fill, refill and remove the eye
(ocular) implant can cause serious side
effects including:
•
an eye infection (endophthalmitis). Endophthalmitis is an infection of
the eyeball that can cause
permanent damage to your eye including blindness. Call your healthcare
provider right away if you
have increasing eye pain, vision loss, sensitivity to light, or
redness in the white of the eye.
Endophthalmitis requires urgent (same day) medical or surgical
treatment.
•
a missing layer on top of the white part of the eye (conjunctival
erosion). Conjunctival erosion is an
area that becomes missing (defect) in the layer (conjunctiva) that
covers the white part of the eye
which may result in exposure of the implant. Call your healthcare
provider right away if you have a
sudden feeling that something is in your eye, if you have eye
discharge, or watering of the eye.
Conjunctival erosion may require surgical treatment.
•
an opening of the layer that covers the white part of the eye
(conjunctival retraction). Conjunctival
retraction is an opening or gaping in the layer (conjunctiva) that
covers the white part of the eye
which may cause the implant to be exposed. Call your healthcare
provider right away if you have a
sudden feeling that something is in your eye, if you have eye
discharge, or watering of the eye.
Conjunctival retraction may require surgical treatment.
See "What are the possible side effects of SUSVIMO?" for other serious
side effects that may happen while
in treatment with SUSVIMO.
To help prevent or keep these side effects from becoming more serious
follow all post-procedure

Termékjellemzők

SUSVIMO- RANIBIZUMAB INJECTION, SOLUTION
GENENTECH, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SUSVIMO SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SUSVIMO.
SUSVIMO™ (RANIBIZUMAB INJECTION) FOR INTRAVITREAL USE VIA SUSVIMO
OCULAR IMPLANT
INITIAL U.S. APPROVAL: 2006
WARNING: ENDOPHTHALMITIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
THE SUSVIMO IMPLANT HAS BEEN ASSOCIATED WITH A 3-FOLD HIGHER RATE OF
ENDOPHTHALMITIS
THAN MONTHLY INTRAVITREAL INJECTIONS OF RANIBIZUMAB. IN CLINICAL
TRIALS, 2.0% OF PATIENTS
RECEIVING AN IMPLANT EXPERIENCED AN EPISODE OF ENDOPHTHALMITIS.
RECENT MAJOR CHANGES
DOSAGE AND ADMINISTRATION (2.4, 2.7)
4/2022
WARNINGS AND PRECAUTIONS (5.4)
4/2022
INDICATIONS AND USAGE
SUSVIMO (ranibizumab injection), a vascular endothelial growth factor
(VEGF) inhibitor, 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 VEGF
inhibitor (1.0).
DOSAGE AND ADMINISTRATION
For intravitreal use via SUSVIMO ocular implant. (2.1)
The recommended dose of SUSVIMO (ranibizumab injection) is 2 mg (0.02
mL of 100 mg/mL solution)
continuously delivered via the SUSVIMO implant with refills every 24
weeks (approximately 6 months).
(2.2)
Supplemental treatment with 0.5 mg intravitreal ranibizumab injection
may be administered in the
affected eye if clinically necessary. (2.3)
Perform the initial implantation, refill-exchange, and implant removal
(if necessary) procedures under
strict aseptic conditions. (2.4, 2.5, 2.6, 2.7)
DOSAGE FORMS AND STRENGTHS
Injection: 100 mg/mL solution in a single-dose vial (3)
CONTRAINDICATIONS
Ocular or periocular infections (4.1)
Active intraocular inflammation (4.2)
Hypersensitivity (4.3)
WARNINGS AND PRECAUTIONS
The SUSVIMO implant and/or implant-related procedures have been
associated with endophthalmitis,
rhegmatogenous retinal detachment, implant disl