Introduction

Faricimab-svoa is a vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2) inhibitor.

Uses for Faricimab

Faricimab-svoa has the following uses:

Faricimab-svoa 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) or diabetic macular edema (DME).

Faricimab Dosage and Administration

General

Faricimab-svoa is available in the following dosage form(s) and strength(s):

Injection for intravitreal use: 120 mg/mL solution in a single-dose vial.

Dosage

It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

Adults

Dosage and Administration

For intravitreal injection. Faricimab must be administered by a qualified physician. Each vial should be used only for the treatment of a single eye.

• Neovascular (Wet) Age-Related Macular Degeneration (nAMD)

  The recommended dose for faricimab-svoa 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 faricimab-svoa 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.

• Diabetic Macular Edema (DME)

  Faricimab-svoa 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 (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 through week 52; or 2) 6 mg dose of faricimab-svoa can be administered every 4 weeks for the first 6 doses, followed by 6 mg dose via intravitreal injection at intervals of every 8 weeks (2 months) over the next 28 weeks. Although additional efficacy was not demonstrated in most patients when faricimab-svoa 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.

Contraindications

• Ocular or periocular infection.

• Active intraocular inflammation.

• Hypersensitivity.

Warnings/Precautions

Endophthalmitis and Retinal Detachments

Intravitreal injections have been associated with endophthalmitis and retinal detachments. Proper aseptic injection techniques must always be used when administering faricimab-svoa. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay, to permit prompt and appropriate management.

Increase in Intraocular Pressure

Transient increases in intraocular pressure (IOP) have been seen within 60 minutes of intravitreal injection, including with faricimab-svoa IOP and the perfusion of the optic nerve head should be monitored and managed appropriately.

Thromboembolic Events

Although there was a low rate of arterial thromboembolic events (ATEs) observed in the faricimab-svoa clinical trials, there is a potential risk of ATEs following intravitreal use of VEGF inhibitors. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause).

The incidence of reported ATEs in the nAMD studies during the first year was 1% (7 out of 664) in patients treated with faricimab-svoa compared with 1% (6 out of 662) in patients treated with aflibercept.

The incidence of reported ATEs in the DME studies during the first year was 2% (25 out of 1,262) in patients treated with faricimab-svoa compared with 2% (14 out of 625) in patients treated with aflibercept.

Specific Populations

Pregnancy

There are no adequate and well-controlled studies of faricimab-svoa administration in pregnant females.

Administration of faricimab-svoa 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 peak plasma concentrations) of the maximum recommended human dose. Based on the mechanism of action of VEGF and Ang-2 inhibitors, there is a potential risk to female reproductive capacity, and to embryo-fetal development. Faricimab-svoa should not be used during pregnancy unless the potential benefit to the patient outweighs the potential risk to the fetus.

Lactation

There is no information regarding the presence of faricimab in human milk, the effects of the drug on the breast-fed infant, or the effects of the drug on milk production. Many drugs are transferred in human milk with the potential for absorption and adverse reactions in the breast-fed child.

The developmental and health benefits of breast-feeding should be considered along with the mother's clinical need for faricimab-svoa and any potential adverse effects on the breast-fed child from faricimab-svoa.

Females and Males of Reproductive Potential

Females of reproductive potential are advised to use effective contraception prior to the initial dose, during treatment and for at least 3 months following the last dose of faricimab-svoa.

No studies on the effects of faricimab on human fertility have been conducted and it is not known whether faricimab can affect reproduction capacity. Based on the mechanism of action, treatment with faricimab-svoa may pose a risk to reproductive capacity.

Pediatric Use

The safety and efficacy of faricimab-svoa in pediatric patients have not been established.

Geriatric Use

In the four clinical studies, approximately 60% of patients randomized to treatment with faricimab-svoa were ≥ 65 years of age. No significant differences in efficacy or safety of faricimab were seen with increasing age in these studies. No dose adjustment is required in patients 65 years and above.

Common Adverse Effects

The most common adverse reaction (≥ 5%) reported in patients receiving faricimab-svoa was conjunctival hemorrhage (7%).

General

Faricimab-svoa is available in the following dosage form(s) and strength(s):

Injection for intravitreal use: 120 mg/mL solution in a single-dose vial.

Dosage

It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

Adults

Dosage and Administration

For intravitreal injection. Faricimab must be administered by a qualified physician. Each vial should be used only for the treatment of a single eye.

• Neovascular (Wet) Age-Related Macular Degeneration (nAMD)

  The recommended dose for faricimab-svoa 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 faricimab-svoa 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.

• Diabetic Macular Edema (DME)

  Faricimab-svoa 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 (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 through week 52; or 2) 6 mg dose of faricimab-svoa can be administered every 4 weeks for the first 6 doses, followed by 6 mg dose via intravitreal injection at intervals of every 8 weeks (2 months) over the next 28 weeks. Although additional efficacy was not demonstrated in most patients when faricimab-svoa 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.