brolucizumab intravitreal (Rx)

Brand and Other Names:Beovu, brolucizumab-dbll
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution for intravitreal use

  • 6mg/0.05mL (single-dose vial)

Macular Degeneration

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

6 mg (0.05 mL of 120 mg/mL solution) by intravitreal injection monthly (~q25-31 days) x3 doses, THEN 6 mg q8-12weeks

Dosage Modifications

Hepatic or renal impairment

  • Effect of severe renal impairment or any degree of hepatic impairment on the pharmacokinetics of brolucizumab is unknown
  • Significant increases in serum brolucizumab exposures are not expected with intravitreal route of administration; no dosage adjustment is needed based on renal or hepatic impairment status

Safety and efficacy not established

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Adverse Effects

1-10%

Blurred vision (10%)

Cataract (7%)

Conjunctival hemorrhage (6%)

Vitreous floaters (5%)

Eye pain (5%)

Intraocular inflammation (4%)

Intraocular pressure increased (4%)

Retinal hemorrhage (4%)

Vitreous detachment (4%)

Conjunctivitis (3%)

Retinal pigment epithelial tear (3%)

Corneal abrasion (2%)

Hypersensitivity (2%)

Punctate keratitis (1%)

Retinal tear (1%)

Endophthalmitis (1%)

Blindness (1%)

Retinal artery occlusion (1%)

Retinal detachment (1%)

Conjunctival hyperemia (1%)

Lacrimation increased (1%)

Abnormal sensation in eye (1%)

Detachment of retinal pigment epithelium (1%)

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Warnings

Contraindications

Ocular or periocular infections

Active intraocular inflammation

Hypersensitivity

Cautions

Hypersensitivity reactions may manifest as rash, pruritus, urticaria, erythema, or severe intraocular inflammation

Intravitreal injections are associated with endophthalmitis and retinal detachments; instruct patients to immediately report any symptoms suggestive of endophthalmitis or retinal detachment

Acute increases in intraocular pressure (IOP) have been seen within 30 minutes of intravitreal injection; sustained IOP increases have also been reported; both IOP and perfusion of the optic nerve head must be monitored and managed appropriately

A low rate of arterial thromboembolic events observed during clinical trials following intravitreal use of vascular endothelial growth factor (VEGF) inhibitors

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Pregnancy & Lactation

Pregnancy

There are no adequate and well-controlled studies in pregnant women

Based on anti-VEGF mechanism of action, treatment may pose risk to human embryofetal development

Use during pregnancy only if the potential benefit outweighs the potential fetal risk

Animal data

  • VEGF inhibition has been shown to cause malformations, embryofetal resorption, and decreased fetal weight
  • VEGF inhibition has also been shown to affect follicular development, corpus luteum function, and fertility

Contraception

  • Females of reproductive potential should use highly effective contraception (methods that result in <1% pregnancy rates) during treatment and for at least 1 month after the last dose following brolucizumab discontinuation

Infertility

  • No studies have been conducted and it is not known whether brolucizumab can affect reproductive capacity
  • Based on its anti-VEGF mechanism of action, treatment may pose a risk to reproductive capacity

Lactation

No data are available regarding the presence of brolucizumab in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production/excretion

Because many drugs are transferred in human milk and because of the potential for absorption and adverse reactions in the breastfed child, breastfeeding is not recommended during treatment and for at least 1 month after the last dose following discontinuation

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

Human VEGF inhibitor; binds to the 3 major VEGF-A isoforms (eg, VEGF110, VEGF121, VEGF165), thereby preventing interaction with receptors VEGFR-1 and VEGFR-2

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

Absorption

Peak plasma time: 24 hr

Peak plasma level: 49 ng/mL

Metabolism

Not fully characterized; however, free brolucizumab is expected to undergo metabolism via proteolysis

Elimination

Half-life: 4.4 days

Excretion: Not fully characterized; however, free brolucizumab is expected to undergo target-mediated disposition and/or passive renal excretion

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Administration

Intravitreal Preparation

Before use, unopened glass vial may be kept at room temperature (20-25ºC [68-77ºF]) for up to 24 hr

After vial is opened, proceed under aseptic conditions

Inspect visually before administration; do not use if particulates, cloudiness, or discoloration are visible

Kit includes sterile glass vial and filter needle which are for single use only

Do not use if packaging, vial and/or filter needle are damaged or expired

See prescribing information with diagrams for precise steps to aseptically prepare dose

Intravitreal Administration

Administer immediately after dose preparation

Intravitreal injection procedure must be carried out under aseptic conditions, which includes the use of surgical hand disinfection, sterile gloves, a sterile drape and a sterile eyelid speculum (or equivalent), and the availability of sterile paracentesis equipment (if required)

Adequate anesthesia and a broad-spectrum topical microbicide to disinfect the periocular skin, eyelid, and ocular surface should be administered beforehand

Inject slowly until the rubber stopper reaches the end of the syringe to deliver the volume of 0.05 mL; confirm delivery of the full dose by checking that the rubber stopper has reached the end of the syringe barrel

Immediately following the intravitreal injection, monitor for elevated IOP; check for perfusion of the optic nerve head or tonometry; if required, a sterile paracentesis needle should be available

Following injection, instruct patient to report any symptoms suggestive of endophthalmitis or retinal detachment (eg, eye pain, redness of the eye, photophobia, blurring of vision) without delay

Vial is for treatment of a single eye; if the contralateral eye requires treatment, a new vial should be used and the sterile field, syringe, gloves, drapes, eyelid speculum, filter, and injection needles should be changed before brolucizumab is administered to the other eye

Dispose of unused medicinal product or waste material according to local regulations

Storage

Refrigerate at 2-8ºC (36-46ºF)

Do not freeze

Keep vial in carton to protect from light

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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.
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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.