法瑞西单抗(Vabysmo)注射剂说明书（FDA）
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HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
VABYSMO safely and effectively.See full prescribing information for
VABYSMO.
VABYSMO®(faricimab-svoa)injection,for intravitreal use
Initial U.S.Approval:2022
RECENT MAJOR CHANGES
Indications and Usage,Macular Edema Following Retinal
Vein Occlusion(RVO)(1.3)
Dosage and Administration,General Dosing Information(2.1)
Dosage and Administration,Macular Edema Following Retinal
Vein Occlusion(2.4)
Dosage and Administration,Preparation for Administration -
Prefilled Syringe(2.5)
Dosage and Administration,Injection Procedure(2.7)
Warnings and PrecautionsRetinal Vasculitis and/or Retinal
Vascular Occlusion (5.4)
10/2023
6/2024
10/2023
6/2024
6/2024
10/2023
—
INDICATIONS AND USAGE—
VABYSMO is a vascular endothelial growth factor(VEGF)and
angiopoietin-2(Ang-2)inhibitor indicated for the treatment of patients with:
·Neovascular(Wet)Age-Reated Macular Degeneration(nAMD)(1.1)
● Diabetic Macular Edema(DME)(1.2)
·Macular Edema Following Retinal Vein Occlusion(RVO)(13)
DOSAGE AND ADMINISTRATION—
For intravitreal injection.(2.1)
●Neovascular(Wet)Age-Related Macular Degeneration(nAMD)
o The recommended dose for VABYSMO is 6mg(0.05 mL of 120
mg/mL solution)administered by intravitreal injection every 4 weeks
(approximately every 28±7 days,monthly)for the first 4 doses,
followed by optical coherence tomography and visual acuity
evaluations 8 and 12 weeks later to inform whether to give a 6mg dose
via intravitreal injection on one of the following three regimens:1)
Weeks 28 and 44;2)Weeks 24,36 and 48;or 3)Weeks 20,28,36 and
44.Although additional efficacy was not demonstrated in most patients
when VABYSMO was dosed every 4 weeks compared to every 8
weeks,some patients may need every 4 week(monthly)dosing after
the first 4 doses.Patients should be assessed regularly.(2.2)
· Diabetic Macular Edema(DME)
o VABYSMO is recommended to be dosed by following one of these
two dose regimens:1)6mg(0.05 mL of 120 mg/mL solution)
administered by intravitreal injection every 4 weeks(approximately
every 28 days±7 days,monthly)for at least 4 doses.If after at least 4
doses,resolution of edema based on the central subfield thickness
(CST)of the macula as measured by optical coherence tomography is
achieved,then the interval of dosing may be modified by extensions of
up to 4 week interval increments or reductions ofup to 8 week interval
increments based on CST and visual acuity evaluations;or 2)6mg
dose of VABYSMO can be administered every 4 weeks for the first 6
doses,followed by 6mg dose via intravitreal injection at intervals of
every 8 weeks(2 months).Although additional efficacy was not
demonstrated in most patients when VABYSMO was dosed every 4
weeks compared to every 8 weeks,some patients may need every 4
week(monthly)dosing after the first 4 doses.Patients should be
assessed regularly.(2.3)
· Macular Edema Following Retinal Vein Occlusion(RVO)
o The recommended dose for VABYSMO is 6mg(0.05mL of 120
mg/mL)administered by intravitreal injection every 4 weeks
(approximately every 28±7 days,monthly)for 6 months.(2.4)
—
DOSAGE FORMS AND STRENGTHS
—
·Injection:6mg(0.05mL of 120 mg/mL solution)in a single-dose preilled
syringe(3)
·Injection:6mg(0.05mL of 120 mg/mL solution)in a single-dose vial(3)
CONTRAINDICATIONS—
·Ocular or periocular infection(4.1)
·Active intraocular inflammation(4.2)
·Hypersensitivity(4.3)
-WARNINGS AND PRECAUTIONS—
·Endophthalmitis and retinal detachments may occur following intravitreal
injections.Patients should be instructed to report any symptoms suggestive
of endophthalmitis or retinal detachment without delay,to permit prompt
and appropriate management.(5.1)
·Increases in intraocular pressure have been seen within 60 minutes of an
intravitreal injection.(5.2)
·There is a potential risk of arterial thromboembolic events(ATEs)
associated with VEGF inhibition.(5.3)
ADVERSE REACTIONS—
The most common adverse reactions(≥5%)reported in patients receiving
VABYSMO were cataract(15%)and conjunctival hemorrhage(8%).(6.1)
To report SUSPECTED ADVERSE REACTIONS,contact Genentech at
1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION.
Revised:7/2024
FULL PRESCRIBING INFORMATION:CONTENTS*
1INDICATIONS AND USAGE
1.1 Neovascular(Wet)Age-Related Macular Degeneration(nAMD)
1.2 Diabetic Macular Edema(DME)
1.3 Macular Edema Following Retinal Vein Occlusion(RVO)
2 DOSAGE AND ADMINISTRATION
2.1 General Dosing Information
2.2 Neovascular(Wet)Age-Related Macular Degeneration(nAMD)
2.3 Diabetic Macular Edema(DME)
2.4 Macular Edema Following Retinal Vein Occlusion(RVO)
2.5 Preparation for Administration -Prefilled Syringe
2.6 Preparation for Administration -Vial
2.7 Injection Procedure
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
4.1 Ocular or Periocular Infections
4.2 Active Intraocular Inflammation
4.3 Hypersensitivity
5WARNINGS AND PRECAUTIONS
5.1 Endophthalmitis and Retinal Detachments
5.2 Increase in Intraocular Pressure
5.3 Thromboembolic Events
5.4 Retinal Vasculitis and/or Retinal Vascular Occlusion
6ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Postmarketing Experience
8USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.3 Females and Males of Reproductive Potential
8.4 Pediatric Use
8.5 Geriatric Use
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
12.6 Immunogenicity
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis,Mutagenesis,Impairment of Fertility
14 CLINICAL STUDIES
14.1 Neovascular(Wet)Age-Related Macular Degeneration(nAMD)
14.2 Diabetic Macular Edema(DME)
14.3 Macular Edema Following Retinal Vein Occlusion(RVO)
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
16.2 Storage and Handling
17 PATIENT COUNSELING INFORMATION
*Sections or subsections omtted from the full prescribing information are not
listed.
Reference ID:5410254
FULL PRESCRIBING INFORMATION
1INDICATIONS AND USAGE
VABYSMO is a vascular endothelial growth factor(VEGF)and angiopoietin 2(Ang-2)inhibitor
indicated for the treatment of patients with:
1.1 Neovascular(wet)Age-Related Macular Degeneration (nAMD)
1.2 Diabetic Macular Edema (DME)
1.3 Macular Edema Following Retinal Vein Occlusion (RVO)
2 DOSAGE AND ADMINISTRATION
2.1 General Dosing Information
For intravitreal injection.VABYSMO must be administered by a qualified physician.
VABYSMO is available as:
● Prefilled syringe:A sterile injection filter needle(30-gaugex↓2-inch,Extra Thin Wall)
with an integrated filter in the hub is provided.Each prefilled syringe should only be used
for the treatment of a single eye.
· Vial:A sterile 5-micron,blunt transfer filter needle(18-gauge x 1/2-inch)is provided.
Each vial should only be used for the treatment of a single eye.
[see How Supplied/Storage and Handling(16)]
2.2 Neovascular(wet)Age-Related Macular Degeneration (nAMD)
The recommended dose for VABYSMO is 6mg(0.05mL of 120 mg/mL solution)administered
by intravitreal injection every 4 weeks(approximately every 28±7 days,monthly)for the first 4
doses,followed by optical coherence tomography and visual acuity evaluations 8 and 12 weeks
later to inform whether to give a 6mg dose via intravitreal injection on one of the following
three regimens:1)Weeks 28 and 44;2)Weeks 24,36 and 48;or 3)Weeks 20,28,36 and 44.
Although additional efficacy was not demonstrated in most patients when VABYSMO was
dosed every 4 weeks compared to every 8 weeks,some patients may need every 4 week
(monthly)dosing after the first 4 doses.Patients should be assessed regularly.
2.3 Diabetic Macular Edema(DME)
VABYSMO is recommended to be dosed by following one of these two dose regimens:1)6mg
(0.05 mL of 120 mg/mL solution)administered by intravitreal injection every 4 weeks
(approximately every 28 days±7 days,monthly)for at least 4 doses.If after at least 4 doses,
resolution of edema based on the central subfield thickness(CST)of the macula as measured by
optical coherence tomography is achieved,then the interval of dosing may be modified by
extensions of up to 4 week interval increments or reductions of up to 8 week interval increments
based on CST and visual acuity evaluations;or 2)6mg dose of VABYSMO can be
administered every 4 weeks for the first 6 doses,followed by 6mg dose via intravitreal injection
at intervals of every 8 weeks(2months).Although additional efficacy was not demonstrated in
most patients when VABYSMO was dosed every 4 weeks compared to every 8 weeks,some
patients may need every 4 week(monthly)dosing after the first 4 doses.Patients should be
assessed regularly.
Reference ID:5410254
2.4 Macular Edema Following Retinal Vein Occlusion(RVO)
The recommended dose for VABYSMO is 6mg(0.05mL of 120 mg/mL solution)administered
by intravitreal injection every 4 weeks (approximately every 28±7 days,monthly)for 6 months.
2.5 Preparation for Administration-Prefilled Syringe
Before you start
Read all the instructions carefully before using VABYSMO.
The VABYSMO carton includes:
A sterile prefilled syringe in a sealed tray.The prefilled syringe is for
treatment of a single eye.
A sterile injection filter needle(30-gauge x/2 inch,Extra Thin Wall)with
an integrated filter in the hub.The injection filter needle is for single use
only.
Only use the provided injection filter needle for the administration.
VABYSMO should be refrigerated at temperatures between 2℃ to 8℃
(36F to 46°F).
Do not freeze.
Allow VABYSMO to reach room temperature,20℃ to 25℃(68°F to
77°F)before proceeding with the administration.
Prior to use,keep the sealed tray in the original carton to protect the
prefilled syringe from light. The prefilled syringe may be kept at room
temperature in the original carton for up to 24 hours.
VABYSMO should be inspected visually prior to administration.
Do not use if the carton seals have been tampered with.
Do not use if the packaging,prefilled syringe,injection filter needle is
expired,damaged,or have been tampered with.
Do not use if the injection filter needle is missing.
Do not remove the finger grip from the syringe.
Do not use if the syringe cap is detached from the Luer lock.
Do not use if particulates,cloudiness,or discoloration are visible.
VABYSMO is a clear to opalescent and colorless to brownish-yellow liquid
solution.
Reference ID:5410254
摘要：
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HIGHLIGHTSOFPRESCRIBINGINFORMATIONThesehighlightsdonotincludealltheinformationneededtouseVABYSMOsafelyandeffectively.SeefullprescribinginformationforVABYSMO.VABYSMO®(faricimab-svoa)injection,forintravitrealuseInitialU.S.Approval:2022RECENTMAJORCHANGESIndicationsandUsage,MacularEdemaFollowingRetinalV...
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作者：冒牌货
分类：专业资料
价格：50质量币
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大小：616.44KB
格式：PDF
时间：2026-01-13
