What is VABYSMO used for?

1 INDICATIONS AND USAGE VABYSMO is a vascular endothelial growth factor (VEGF) and angiopoietin 2 (Ang-2) inhibitor indicated for the treatment of patients with: 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 ) 1.1 Neovascular (w

How does VABYSMO work?

11 DESCRIPTION Faricimab-svoa is a humanized bispecific immunoglobulin G1 (IgG1) antibody that binds both vascular endothelial growth factor A (VEGF-A) and angiopoietin-2 (Ang-2).

What pharmaceutical form is VABYSMO available in?

VABYSMO: Roztwór do wstrzykiwań 120 mg/ml (do ciałka szklistego)

Is VABYSMO OTC or prescription only?

VABYSMO requires a doctor's prescription.

What are the side effects of VABYSMO?

6 ADVERSE REACTIONS The following potentially serious adverse reactions are described elsewhere in the labeling: Hypersensitivity [see Contraindications (4) ] Endophthalmitis and retinal detachments [see Warnings and Precautions (5.1) ] Increase in intraocular pressure [see Warnings and Precautions (5.2) ] Thromboembolic events [see Warnings and Precautions (5.3) ] Retinal Vasculitis and/or Retinal Vascular Occlusion [see Warnings and Precautions (5.4) ] The most common adverse reactions (≥ 5%)

Who should NOT take VABYSMO?

4 CONTRAINDICATIONS Ocular or periocular infection ( 4.1 ) Active intraocular inflammation ( 4.2 ) Hypersensitivity ( 4.3 ) 4.1 Ocular or Periocular Infections VABYSMO is contraindicated in patients with ocular or periocular infections. 4.2 Active Intraocular Inflammation VABYSMO is contraindicated in patients with active intraocular inflammation. 4.3 Hypersensitivity VABYSMO is contraindicated in patients with known hypersensitivity to faricimab or any of the excipients in VAB

Does VABYSMO interact with other medications?

No studies evaluating the drug interaction potential of Vabysmo have been performed.

Can VABYSMO be used during pregnancy?

8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy 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 C max ) of the maximum recommended human dose [see Animal Data ] . Based on the mechanism of action of VEGF and Ang-2 inhibitors, th

What precautions should be taken with VABYSMO?

Do not shake. The vial contains more than the recommended dose of 6 mg. The fill volume of the vial (0.24 mL) is not to be used in total. The excess volume should be expelled prior to injection. Injecting the entire volume of the vial results in overdose. The injection dose must be set to the 0.05 mL dose mark, i.e. 6 mg faricimab. Vabysmo should be inspected visually upon removal from the refrigerator and prior to administration. If particulates or cloudiness are visible, the

Who manufactures VABYSMO?

Roche Registration GmbH (Niemcy)

What ATC class does VABYSMO belong to?

VABYSMO: ATC S01LA09. ATC is the WHO Anatomical Therapeutic Chemical classification — it groups drugs by organ system and pharmacological mechanism.

VABYSMO

120 mg/ml, Roztwór do wstrzykiwań

INN: Faricimabum

Data updated: 2026-04-13

Available in:

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Form

Roztwór do wstrzykiwań

Dosage

120 mg/ml

Route

do ciałka szklistego

Storage

16.2 Storage and Handling Store VABYSMO in the refrigerator between 2°C to 8°C (36°F to 46°F).‍‍‍‍‍‍‍ Do not freeze. Do not shake. Keep the sealed tray containing the prefilled syringe or the vial in the original carton to protect from light. Prior to use, the unopened prefilled syringe or 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.

User Reviews

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