faricimab (Rx)

Brand and Other Names:Vabysmo, faricimab-svoa
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution for intravitreal use

  • 120mg/mL (single-dose vial)

Neovascular Age-Related Macular Degeneration

Indicated for treatment of neovascular (wet) age-related macular degeneration (nARMD)

6 mg (0.05 mL) by intravitreal injection q4Weeks (q28days ± 7 days) for first 4 doses; followed by optical coherence tomography and visual acuity evaluations 8 and 12 weeks later to inform whether to give 1 of the following regimens

Regimens

  • 6 mg by intravitreal injection at Weeks 28 and 44, OR
  • 6 mg by intravitreal injection at Weeks 24, 36, and 48, OR
  • 6 mg by intravitreal injection at Weeks 20, 28, 36, and 44

No additional efficacy was demonstrated in most patients when dosed q4Weeks compared to q8Weeks; some patients may need q4Week-dosing after the first 4 doses

Assess regularly

Diabetic Macular Edema

Indicated for treatment of diabetic macular edema (DME)

Dose by 1 of the following 2 regimens

Regimen 1

  • 6 mg (0.05 mL) by intravitreal injection q4Weeks (every 28 days ± 7 days) for at least 4 doses
  • If after at least 4 doses, edema resolves based on central subfield thickness (CST) of macula as measured by optical coherence tomography, then dosing may be modified by extending the interval up to 4-week increments or reducing up to 8-week increments based on CST and visual acuity evaluations through week 52, OR

Regimen 2

  • 6 mg (0.05 mL) by intravitreal injection q4Weeks for 6 doses; followed by 6 mg by intravitreal injection q8Weeks (2 months) over the next 28 weeks

No additional efficacy was demonstrated in most patients when dose was q4Weeks compared to q8Weeks; some patients may need q4Week-dosing after first 4 doses

Assess regularly

Dosage Modifications

Renal impairment

  • Mild-to-moderate (CrCl 15-89 mL/min/1.73 m2): No dosage adjustment necessary
  • Severe: Pharmacokinetics unknown

Hepatic impairment

  • All severities: Pharmacokinetics unknown

Safety and efficacy not established

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Adverse Effects

1-10%

ARMD

  • Conjunctival hemorrhage (7%)
  • Vitreous floaters (3%)
  • Retinal pigment epithelial tear (3%)
  • Intraocular pressure increased (3%)
  • Eye pain (3%)
  • Intraocular inflammation (2%)
  • Eye irritation (1%)
  • Ocular discomfort (1%)

DME

  • Conjunctival hemorrhage (7%)
  • Vitreous floaters (3%)
  • Intraocular pressure increased (3%)
  • Eye pain (2%)
  • Intraocular inflammation (1%)
  • Eye irritation (1%)
  • Ocular discomfort (1%)
  • Vitreous hemorrhage (1%)

<1%

Corneal abrasion

Eye pruritus

Lacrimation increased

Ocular hyperemia

Blurred vision

Eye irritation

Sensation of foreign body

Endophthalmitis

Visual acuity reduced transiently

Retinal tear

Rhegmatogenous retinal detachment

ARMD

  • Vitreous hemorrhage (<1%)
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Warnings

Contraindications

Ocular or periocular infection

Active intraocular inflammation

Hypersensitivity to faricimab or excipients

Cautions

Endophthalmitis and retinal detachments may occur following intravitreal injection; instruct patients to report any symptoms suggestive of endophthalmitis or retinal detachment (eg, vision loss, eye pain, eye redness, photophobia, blurred vision) without delay, to treat promptly and appropriately

Increases in intraocular pressure observed within 60 minutes of administration

Potential risk of arterial thromboembolic events (ATEs) associated with vascular endothelial growth factor (VEGF) inhibition; ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause)

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Pregnancy & Lactation

Pregnancy

There are no adequate and well-controlled studies on use in pregnant females

Do not use during pregnancy unless potential benefit to patient outweighs potential risk of fetus

Contraception

  • Females of reproductive potential: Use effective contraception before initiating, during treatment, and for ≥3 months following last dose

Infertility

  • No studies conducted and unknown whether faricimab can affect reproduction capacity
  • Based on mechanism of action, treatment may pose a risk to reproductive capacity

Animal data

  • IV administration to pregnant monkeys during organogenesis resulted in an increased incidence of abortions at doses 158x the human exposure
  • Based on mechanism of action of VEGF and angiopoietin-2 (Ang-2) inhibitors, there is potential risks to female reproductive capacity and embryofetal development

Lactation

There is no information regarding presence of faricimab in human milk, its effects on breastfed infants, or its effects on milk production

Many drugs are transferred in human milk with potential for absorption and adverse reactions in breastfed children

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

Humanized bispecific immunoglobulin G1 (IgG1) antibody binds to both vascular endothelial growth factor A (VEGF-A) and Ang-2

By inhibiting VEGF-A, faricimab suppresses endothelial cell proliferation, neovascularization, and vascular permeability

By inhibiting Ang-2, faricimab is believed to promote vascular stability and desensitize blood vessels to the effects of VEGF-A; some nARMD and DME patients have an increase in Ang-2 levels

Absorption

Peak plasma concentration: 0.23 mcg/mL (nARMD); 0.22 mcg/mL (DME)

Peak plasma time: 2 days

Trough plasma concentrations: 0.002-0.003 mcg/mL (q8Week-dosing)

Metabolism

Not fully characterized

Expected to be catabolized in lysosomes to small peptides and amino acids, which may be excreted renally, in a similar manner to elimination of endogenous IgG

Elimination

Half-life: 7.5 days

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Administration

Intravitreal Preparation

Remove vial from refrigerator and allow it to reach room temperature (20-25ºC [68-77ºF]) before administering; may keep vial at room temperature for up to 24 hr; keep vial in original carton to protect from light

Visually inspect vial for particulate matter and discoloration before administering; solution is clear to opalescent and colorless to brownish-yellow; discard if particulates, cloudiness, or discoloration are visible; do not use if packaging, vial, and/or transfer filter needle are expired, damaged, or have been tampered with

Use aseptic technique to prepare intravitreal injection

Gather 1 vial of faricimab, 1 sterile 5-micron transfer filter needle 18-gauge x 1.5 inch, a 1-mL Luer lock syringe with a 0.05 mL dose mark, and 1 sterile 30-gauge x 0.5 inch injection needle

Place vial upright on a flat surface (for ~1 minute) after removal from packaging; gently tap vial with finger, as liquid may stick to top of vial

Remove cap from vial and wipe vial septum with alcohol swab

Aseptically and firmly attach 18-gauge x 1.5 inch transfer filter needle onto 1-mL Luer lock syringe

Push filter needle into center of vial septum, then tilt vial slightly so that needle touches bottom edge of vial

Hold vial slightly inclined and slowly withdraw all liquid from vial; keep bevel of filter needle submerged in liquid, to avoid introduction of air

Ensure that plunger rod is drawn sufficiently back when emptying vial, to completely empty filter needle

Disconnect transfer filter needle from syringe and discard in accordance with local regulations

Aseptically and firmly attach a 30-gauge x 0.5-inch injection needle onto Luer lock syringe

Hold syringe with needle pointing up; if there are any air bubbles, gently tap syringe with finger until bubbles rise to the top; carefully expel air from syringe and needle, and slowly depress plunger to align rubber stopper tip to 0.05 mL-dose mark

Use injection immediately after preparation

Intravitreal Administration

Must be administered by qualified physician

Use aseptic conditions for intravitreal injection, including use of surgical hand disinfection, sterile gloves, a sterile drape, a sterile eyelid speculum (or equivalent), and availability of sterile paracentesis equipment (if required)

Administer adequate anesthesia and a broad-spectrum microbicide before injecting

Slowly inject until rubber stopper reaches end of syringe to deliver 0.05 mL; confirm full dose was delivered by checking that the rubber stopper has reached end of syringe barrel; discard any unused medicinal product or waste materials in accordance with local regulations

Monitor for elevated intraocular pressure immediately following intravitreal injection

Appropriate monitoring may consist of a check for perfusion of optic nerve head or tonometry; if required, a sterile paracentesis needle should be available

Following intravitreal injection, instruct patients to report any symptoms suggestive of endophthalmitis or retinal detachment (eg, vision loss, eye pain, eye redness, photophobia, blurred vision) without delay

Each syringe should only be used for treatment of a single eye

If contralateral eye requires treatment, use a new syringe, and change sterile field, syringe, gloves, drapes, eyelid speculum, filter, and injection needles before administering to other eye

Storage

Unopened vials

Refrigerate at 2-8ºC (36-46ºF); do not freeze

Do not shake

Protect from light

Store in original carton until time of use

If removed from refrigerator, may store in original carton at room temperature (20-25°C [68-77°F]) for up to 24 hr

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Images

No images available for this drug.
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Patient Handout

A Patient Handout is not currently available for this monograph.
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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.