VABYSMO® INJECTION 120mg

VABYSMO® INJECTION 120 mg – Key Features and Benefits

VABYSMO® (faricimab-svoa) is an injectable medication used for treating serious eye conditions such as neovascular (wet) age-related macular degeneration (nAMD), diabetic macular edema (DME), and macular edema following retinal vein occlusion (RVO). It is a bispecific antibody that targets both vascular endothelial growth factor (VEGF-A) and angiopoietin-2 (Ang-2), crucial proteins involved in the pathological processes of these conditions. By inhibiting these proteins, VABYSMO® helps to reduce inflammation, prevent new abnormal blood vessel formation, and improve visual acuity.

• Targeted Pathways: VEGF-A and Ang-2 inhibition.
• Formulation: 120 mg/mL solution, administered via intravitreal injection.
• Benefit: Improves visual acuity and reduces macular edema.
• Dosing: Dosing is determined based on disease progression and patient response.

VABYSMO® INJECTION 120 mg – Indications

VABYSMO® is indicated for the treatment of the following retinal conditions:

• Neovascular (Wet) Age-Related Macular Degeneration (nAMD): Improves vision and reduces macular edema caused by abnormal blood vessel growth in the retina.
• Diabetic Macular Edema (DME): Reduces retinal thickness and improves vision in patients with DME.
• Macular Edema Following Retinal Vein Occlusion (RVO): Reduces macular edema and improves visual acuity in patients with RVO.

Each of these conditions involves the leakage of fluids into the retina, leading to swelling and vision impairment, which VABYSMO® helps to manage by targeting VEGF-A and Ang-2.

VABYSMO® INJECTION 120 mg – Ingredients

The key active ingredient in VABYSMO® is faricimab-svoa, a humanized bispecific antibody. It is specifically engineered to inhibit both VEGF-A and Ang-2 to address the underlying causes of retinal diseases.

• Active Ingredient: Faricimab-svoa (6 mg in 0.05 mL dose).
• Excipients: L-histidine, L-methionine, polysorbate 20, sodium chloride, D-sucrose, Water for Injection.
• Formulation: Clear to opalescent, colorless to brownish-yellow solution.

VABYSMO® INJECTION 120 mg – How To Use

VABYSMO® is administered as an intravitreal injection by a healthcare professional. The administration process includes thorough preparation and aseptic technique to prevent infection and other complications.

• For Neovascular (Wet) AMD: Initially, 6 mg (0.05 mL) is injected every 4 weeks for the first 4 doses. After this, the dosing frequency is adjusted based on the results of eye exams.
• For Diabetic Macular Edema: The starting regimen involves 6 mg every 4 weeks for the first 4 doses, followed by assessments to adjust the dosing frequency.
• For Macular Edema Following RVO: 6 mg is administered every 4 weeks for the first 6 months.

Preparation steps include allowing the vial to reach room temperature and ensuring no contamination or particle presence in the solution before injection.

VABYSMO® INJECTION 120 mg – Side Effects

As with any medication, VABYSMO® can cause side effects. The most common adverse reactions include eye-related issues such as cataracts and conjunctival hemorrhage.

• Common Side Effects:
  • Cataract (15% of patients).
  • Conjunctival hemorrhage (8% of patients).
  • Increased intraocular pressure (3-4%).
• Serious Side Effects:
  • Endophthalmitis (infection inside the eye).
  • Retinal detachments.
  • Thromboembolic events, including stroke or heart attacks.
  • Retinal vasculitis and/or retinal vascular occlusion, particularly in patients with intraocular inflammation.

Patients should be closely monitored for these side effects following injection.

VABYSMO® INJECTION 120 mg – Clinical Studies

Clinical trials have demonstrated VABYSMO®’s effectiveness in improving visual acuity and reducing macular edema across the three indicated conditions: nAMD, DME, and RVO. In studies, it was shown to be non-inferior to other treatments such as aflibercept.

• nAMD: In the TENAYA and LUCERNE studies, VABYSMO® was non-inferior to aflibercept in improving visual acuity at 48 weeks.
• DME: In the YOSEMITE and RHINE studies, VABYSMO® demonstrated consistent efficacy, with patients achieving significant improvements in visual acuity compared to the baseline.
• RVO: In the BALATON and COMINO studies, VABYSMO® showed similar efficacy to aflibercept, with improvements in Best Corrected Visual Acuity (BCVA) and reduction in macular edema.

VABYSMO® INJECTION 120 mg – Contraindications

VABYSMO® should not be used in patients with:

• Ocular or periocular infections.
• Active intraocular inflammation.
• Hypersensitivity to faricimab or any of its ingredients.

VABYSMO® INJECTION 120 mg – Warnings and Precautions

VABYSMO® can cause serious complications if proper injection technique is not followed:

• Endophthalmitis (eye infection) and retinal detachments are rare but serious side effects.
• Increased intraocular pressure may occur shortly after injection, so monitoring is necessary.
• Thromboembolic events such as stroke or heart attack may occur in rare cases.

VABYSMO® INJECTION 120 mg – Manufacturer Information

VABYSMO® is developed and manufactured by Genentech, Inc., a biotechnology company and a member of the Roche Group. The company specializes in pioneering treatments for various medical conditions, including ocular diseases, oncology, and immunology.

• Manufacturer: Genentech, Inc., South San Francisco, CA.
• Licensing: U.S. License No. 1048.

VABYSMO® INJECTION 120 mg – FAQ

How Should VABYSMO® Be Stored?

• Storage: VABYSMO® should be stored refrigerated at 2°C to 8°C. It should not be frozen or shaken. The vial can be kept at room temperature for up to 24 hours before use.

What If I Miss a Dose?

• If a dose is missed, it should be administered as soon as possible. Dosing schedules should be adjusted as needed based on the patient’s condition and treatment plan.

Is VABYSMO® Safe for Use During Pregnancy or Breastfeeding?

• Pregnancy: VABYSMO® is not recommended during pregnancy unless the benefits outweigh potential risks to the fetus.
• Breastfeeding: The safety of VABYSMO® during breastfeeding has not been established, and caution should be exercised.

What Are the Most Common Side Effects?

• The most common side effects are cataract (15%) and conjunctival hemorrhage (8%). Other potential side effects include eye pain, increased intraocular pressure, and visual disturbances.