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Brolucizumab: Drug information

Brolucizumab: Drug information
(For additional information see "Brolucizumab: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Beovu
Brand Names: Canada
  • Beovu
Pharmacologic Category
  • Ophthalmic Agent;
  • Vascular Endothelial Growth Factor (VEGF) Inhibitor
Dosing: Adult
Age-related macular degeneration, neovascular

Age-related macular degeneration, neovascular (wet): Intravitreal: 6 mg once per month (approximately every 25 to 31 days) for 3 months, followed by 6 mg once every 8 to 12 weeks.

Diabetic macular edema

Diabetic macular edema: Intravitreal: 6 mg every 6 weeks (approximately every 39 to 45 days) for 5 doses, followed by 6 mg once every 8 to 12 weeks.

Dosing: Kidney Impairment: Adult

No dosage adjustment necessary.

Dosing: Hepatic Impairment: Adult

No dosage adjustment necessary.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults.

>10%: Immunologic: Antibody development (53% to 67%)

1% to 10%:

Cardiovascular: Arterial thromboembolism (5%)

Hypersensitivity: Hypersensitivity reaction (1% to 2%)

Ophthalmic: Abnormal sensation in eyes (≤1%), blindness (1%), blurred vision (2% to10%), cataract (4% to 7%), conjunctival hemorrhage (6%), conjunctival hyperemia (≤1%), conjunctivitis (2% to 3%), corneal abrasion (1% to 2%), endophthalmitis (≤1%), eye pain (3% to 5%), increased intraocular pressure (2% to 4%), increased lacrimation (≤1%), intraocular inflammation (3% to 6%), punctate keratitis (1%), retinal artery occlusion (1%), retinal detachment (1%), retinal hemorrhage (4%), retinal hole without detachment (≤1%), retinal pigment epithelium detachment (1%), retinal pigment epithelium tear (3%), vitreous detachment (2% to 4%), vitreous hemorrhage (≤1%), vitreous opacity (3% to 5%)

Postmarketing: Ophthalmic: Retinopathy (retinal vasculitis and retinal vein occlusion)

Contraindications

Hypersensitivity (eg, rash, pruritus, urticaria, erythema, severe intraocular inflammation) to brolucizumab or any component of the formulation; ocular or periocular infections; active intraocular inflammation.

Warnings/Precautions

Concerns related to adverse effects:

• Endophthalmitis and retinal detachment: Intravitreal injections may be associated with endophthalmitis and retinal detachment. Use proper aseptic injection technique. Monitor for and report symptoms (eg, eye pain, redness of the eye, photophobia, blurred vision) immediately.

• Increased intraocular pressure: Acute (within 30 minutes) and sustained increases in increased intraocular pressure (IOP) have occurred. Monitor IOP (via tonometry) and optic nerve head perfusion immediately following administration and manage appropriately.

• Retinal vasculitis/retinal vascular occlusion: Cases of retinal vasculitis and/or retinal vascular occlusion have been reported, usually associated with intraocular inflammation, and are attributed to an immune-mediated adverse event; may occur with the first intravitreal injection. Discontinue therapy if signs and symptoms occur.

• Thromboembolic events: Risk of arterial thromboembolic events (eg, nonfatal stroke, nonfatal myocardial infarction, vascular death) may be increased with intravitreal use of vascular endothelial growth factor inhibitors.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, Intravitreal [preservative free]:

Beovu: Brolucizumab-dbll 6 mg/0.05 mL (0.05 mL [DSC]) [contains polysorbate 80]

Solution Prefilled Syringe, Intravitreal:

Beovu: Brolucizumab-dbll 6 mg/0.05 mL (0.05 mL) [contains polysorbate 80]

Generic Equivalent Available: US

No

Pricing: US

Solution Prefilled Syringe (Beovu Intravitreal)

6 mg/0.05 mL (per 0.05 mL): $2,355.88

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Prefilled Syringe, Intravitreal:

Beovu: Brolucizumab-dbll 6 mg/0.05 mL (0.05 mL) [contains polysorbate 80]

Administration: Adult

Intravitreal: For ophthalmic intravitreal injection only. Each prefilled syringe or vial should only be used for the treatment of a single eye. If the contralateral eye requires treatment, a new prefilled syringe or 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. Adequate anesthesia and a topical broad-spectrum antimicrobial agent should be administered prior to the procedure. Refer to manufacturer's labeling for additional detailed information.

Use: Labeled Indications

Age-related macular degeneration, wet (neovascular): Treatment of neovascular (wet) age-related macular degeneration.

Diabetic macular edema: Treatment of diabetic macular edema.

Medication Safety Issues
Sound-alike/look-alike issues:

Brolucizumab may be confused with bevacizumab

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Reproductive Considerations

Evaluate pregnancy status prior to use in patients who could become pregnant. Patients who could become pregnant should use highly effective contraception (methods with pregnancy rates <1%) during therapy and for ≥1 month following the last brolucizumab dose.

Pregnancy Considerations

Brolucizumab is a vascular endothelial growth factor (VEGF) inhibitor; VEGF is required to achieve and maintain normal pregnancies (Peracha 2016). Based on the mechanism of action, brolucizumab may cause fetal harm if administered to a pregnant patient.

Breastfeeding Considerations

It is not known if brolucizumab is present in breast milk.

Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended by the manufacturer during therapy and for ≥1 month following the last brolucizumab dose.

Monitoring Parameters

Intraocular pressure (via tonometry) and optic nerve head perfusion immediately following administration; symptoms of endophthalmitis and retinal detachment; symptoms of retinal vasculitis and retinal vascular occlusion (especially in patients with intraocular inflammation), vision changes.

Mechanism of Action

Brolucizumab is a recombinant humanized monoclonal antibody vascular endothelial growth factor (VEGF) inhibitor that binds to the 3 major isoforms of VEGF-A, thereby suppressing endothelial cell proliferation, neovascularization, and vascular permeability to slow vision loss.

Pharmacokinetics (Adult Data Unless Noted)

Metabolism: Not fully characterized; free brolucizumab is expected to undergo proteolysis.

Half-life elimination: 4.4 ± 2 days.

Time to peak: Serum: 24 hours (free brolucizumab).

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (QA) Qatar: Beovu
  1. Beovu (brolucizumab) [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; September 2023.
  2. Beovu (brolucizumab) [prescribing information]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; May 2022.
  3. Peracha ZH, Rosenfeld PJ. Anti-vascular endothelial growth factor therapy in pregnancy: what we know, what we don't know, and what we don't know we don't know. Retina. 2016;36(8):1413-1417. doi: 10.1097/IAE.0000000000001200. [PubMed 27388726]
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