VABYSMO- faricimab injection, solution

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

FARICIMAB (UNII: QC4F7FKK7I) (FARICIMAB - UNII:QC4F7FKK7I)

Tillgänglig från:

Genentech, Inc.

Administreringssätt:

INTRAVITREAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

VABYSMO is a vascular endothelial growth factor (VEGF) and angiopoietin 2 (Ang-2) inhibitor indicated for the treatment of patients with: VABYSMO is contraindicated in patients with ocular or periocular infections. VABYSMO is contraindicated in patients with active intraocular inflammation. VABYSMO is contraindicated in patients with known hypersensitivity to faricimab or any of the excipients in VABYSMO. Hypersensitivity reactions may manifest as rash, pruritus, urticaria, erythema, or severe intraocular inflammation. Risk Summary There are no adequate and well-controlled studies of VABYSMO administration in pregnant women. Administration of VABYSMO to pregnant monkeys throughout the period of organogenesis resulted in an increased incidence of abortions at intravenous (IV) doses 158 times the human exposure (based on Cmax ) of the maximum recommended human dose [see Animal Data] . Based on the mechanism of action of VEGF and Ang-2 inhibitors, there is a potential risk to female reproductive capacity, and t

Produktsammanfattning:

VABYSMO (faricimab-svoa) injection is supplied as a clear to opalescent, colorless to brownish-yellow 120 mg/mL solution in a single-dose glass vial. Each glass vial contains an overfill amount to allow for administration of a single 0.05 mL dose of solution containing 6 mg of VABYSMO. Each VABYSMO carton (NDC 50242-096-01) contains one glass vial and one sterile 5-micron blunt transfer filter needle (18-gauge × 1½ inch, 1.2 mm × 40 mm). Store VABYSMO in the refrigerator between 2°C to 8°C (36°F to 46°F). Do not freeze. Do not shake. Keep the vial in the original carton to protect from light. Prior to use, the unopened glass vial of VABYSMO may be kept at room temperature, 20°C to 25°C (68°F to 77°F), for up to 24 hours. Ensure that the injection is given immediately after preparation of the dose.

Bemyndigande status:

Biologic Licensing Application

Produktens egenskaper

VABYSMO- FARICIMAB INJECTION, SOLUTION
GENENTECH, INC.
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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)
10/2023
Dosage and Administration, Diabetic Macular Edema (2.3)
1/2023
Dosage and Administration, Macular Edema Following Retinal Vein
Occlusion (2.4)
10/2023
Warnings and Precautions, Retinal Vasculitis and/or Retinal Vascular
Occlusion (5.4)
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-Related Macular Degeneration (nAMD) (1.1)
Diabetic Macular Edema (DME) (1.2)
Macular Edema Following Retinal Vein Occlusion (RVO) (1.3)
DOSAGE AND ADMINISTRATION
For intravitreal injection. (2.1)
Neovascular (Wet) Age-Related Macular Degeneration (nAMD)
The recommended dose for VABYSMO is 6 mg (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 6 mg 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)
VABYSMO is recommended to be dosed by following one of these two dose
regimens: 1) 6 mg (0.05
mL of 120 mg/mL solution) administered by intravitreal injection every
4 weeks (ap