Vabysmo (faricimab-svoa)

No dosing information is available for this tab.

Faricimab-svoa is administered by intravitreal injection. It is available as a 120 mg/mL, clear to opalescent, colorless to brownish-yellow solution in single-dose vials. It must be administered by a qualified physician. Each vial should be used for the treatment of a single eye only.

The intravitreal injection must be prepared using aseptic technique. Withdraw the solution from the vial using the sterile 5-micron blunt transfer filter needle provided by the manufacturer. Attach the filter needle to a 1 mL Luer lock syringe with a 0.05 mL dose mark, push the filter needle all the way into the vial, then tilt the vial so that the filter needle touches the bottom edge of the vial. Hold the vial slightly inclined and slowly withdraw all the liquid from the vial, avoiding introduction of air, by keeping the bevel of the needle submerged in the liquid. The filter needle is for single use only. Once the solution has been transferred from the vial to the syringe, disconnect and discard the filter needle; do not use the filter needle for administration of the intravitreal injection. Use a sterile 30-gauge, 0.5-inch needle to administer the intravitreal injection. Administer the injection immediately after preparation of the dose under aseptic conditions.

Each syringe should only be used for treatment of a single eye. If the contralateral eye also requires treatment, a new syringe should be used, and the sterile field and other necessary supplies should be changed before administration.

Store unopened vials in the refrigerator at 2--8degreesC; keep the vials in their original carton to protect the drug from light. Allow the vial to reach 20--25degreesC prior to administration; the unopened vial may be kept at 20--25degreesC for up to 24 hours prior to use.

No dosing information is available for this tab.

No dosing information is available for this tab.

Formal drug interaction studies have not been conducted.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*Ocular or periocular infection.

*Active intraocular inflammation.

*Hypersensitivity to faricimab or any excipients in the formulation.

• Ocular infection
• Ocular inflammation

• Ocular hypertension
• Pregnancy
• Retinal detachment

There are no moderate contraindications for this drug.

Adverse effects reported in >=5% of patients receiving faricimab-svoa included cataract (15%) and conjunctival hemorrhage (8%).

Less Frequent

• Acute arterial thromboembolism
• Retinal pigment epithelial detachment
• Vitreous hemorrhage

Rare or Very Rare

• Corneal abrasion
• Endophthalmitis
• Ocular hypertension
• Retinal detachment
• Retinal tear
• Retinal vascular occlusion
• Retinal vasculitis
• Thromboembolic disorder

More Frequent

• Cataracts
• Conjunctival hemorrhage

Less Frequent

• Ocular discomfort
• Ocular inflammation
• Ocular irritation
• Ocular pain
• Vitreous floater

Rare or Very Rare

• Blurred vision
• Conjunctival hyperemia
• Eye tearing
• Foreign body sensation of eye
• Ocular itching
• Ocular redness
• Reduced visual acuity
• Temporary visual acuity loss

No enhanced messaging available.

Safety and effectiveness of faricimab-svoa have not been established in pediatric patients.

Based on the mechanism of action of faricimab-svoa as a VEGF inhibitor and angiopoetin-2 (Ang-2) inhibitor, there is a potential risk to female reproductive capacity and embryo-fetal development. Faricimab-svoa should not be used during pregnancy unless the potential benefit to the patient outweighs the risk to the fetus.

Increased rates of abortion were observed when faricimab-svoa was administered to pregnant monkeys during organogenesis at IV doses 158 times the human exposure at the maximum recommended human dose (MRHD).

It is not known if faricimab-svoa is present in human milk. The effects of faricimab-svoa on milk production and on the breast-fed child are not known. Consider the developmental and health benefits of breastfeeding in addition to the mother's clinical need for the drug and the potential for adverse effects on the breast-fed child.

The manufacturer states that no dosage adjustment is necessary for geriatric patients.

In clinical studies of faricimab-svoa, approximately 58% of patients randomized to faricimab-svoa were 65 years of age and older. No differences in safety or effectiveness were observed with increased age. No dosage adjustment is necessary for patients 65 years of age and older.