Brolucizumab
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From MedlinePlus, U.S. National Library of Medicine
Specialty pharmacy: therapy management checklist, storage and cold chain, dosing calendar, Medicare Part D coverage.
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Preparation and administration
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Preparation for Administration – Pre-filled Syringe and Vial [See table below.] Use aseptic technique for preparation of the intravitreal injection. Pre-filled Syringe The BEOVU pre-filled glass syringe is sterile and for the treatment of a single eye. It should be inspected visually prior to administration. Do not use if the packaging, or pre-filled syringe are opened, damaged, or expired [see How Supplied/Storage and Handling] . [See table below.] Vial The BEOVU vial kit includes the sterile glass vial and filter needle which are sterile and for the treatment of a single eye.
It should be inspected visually prior to administration. Do not use if the packaging, vial, and/or filter needle are damaged or expired [see How Supplied/Storage and Handling] . [See table below.] Preparation for Administration - Store BEOVU in the refrigerator between 2 to 8°C (36 to 46°F); do not freeze. Keep the vial in the outer carton to protect from light.
Preparation for Administration - Prior to use, the unopened glass vial of BEOVU may be kept at room temperature, 20 to 25°C (68 to 77°F) for up to 24 hours. After opening the glass vial, proceed under aseptic conditions. Preparation for Administration - BEOVU should be inspected visually upon removal from the refrigerator and prior to administration.
If particulates, cloudiness, or discoloration are visible, the glass vial must not be used. The BEOVU kit includes the sterile glass vial and filter needle which are for single use only. Do not use if the packaging, vial and/or filter needle are damaged or expired [see How Supplied/Storage and Handling]. Vial-Figure 4: Vial-Figure 5: Vial-Figure 6: Vial-Figure 7: Pre-filled Syringe Pre-filled Syringe-Figure 1: Pre-filled Syringe-Figure 2: Pre-filled Syringe-Figure 3:
Injection Procedure Ensure that the injection is given immediately after preparation of the dose. The 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 prior to the injection. 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, patients should be monitored for elevation in intraocular pressure (IOP). Appropriate monitoring may consist of a check for perfusion of the optic nerve head or tonometry. If required, a sterile paracentesis needle should be available. Following intravitreal injection, patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment (e.g., eye pain, redness of the eye, photophobia, blurring of vision) without delay [see Patient Counseling Information] .
Each vial or pre-filled syringe should only be used for the treatment of a single eye. If the contralateral eye requires treatment, a new vial or pre-filled syringe should be used and the sterile field, syringe, gloves, drapes, eyelid speculum, filter, and injection needles should be changed before BEOVU is administered to the other eye.
Any unused medicinal product or waste material should be disposed of in accordance with local regulations.
Drug interactions
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- Brolucizumab
Contraindications
Ocular or Periocular Infections ( 4.1 ) Active Intraocular Inflammation ( 4.2 ) Hypersensitivity ( 4.3 )
4.1 Ocular or Periocular Infections BEOVU is contraindicated in patients with ocular or periocular infections.
4.2 Active Intraocular Inflammation BEOVU is contraindicated in patients with active intraocular inflammation.
4.3 Hypersensitivity BEOVU is contraindicated in patients with known hypersensitivity to brolucizumab or any of the excipients in BEOVU. Hypersensitivity reactions may manifest as rash, pruritus, urticaria, erythema, or severe intraocular inflammation.
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for brolucizumab. Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies of BEOVU administration in pregnant women. In an animal reproduction study, intravitreal administration of brolucizumab to pregnant monkeys once every 4 weeks in one eye from organogenesis to birth did not indicate any harmful effects with respect to pre- or postnatal development at 10-fold the maximum recommended human dose (MRHD) on a mg/kg basis ( see Data ). Based on the anti-VEGF mechanism of action for brolucizumab [see Clinical Pharmacology (12.1)] , treatment with BEOVU may pose a risk to human embryo-fetal development.
BEOVU should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus. All pregnancies have a background risk of birth defect, loss, and other adverse outcomes. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies.
Data Animal Data In an enhanced pre- and postnatal development (ePPND) study in pregnant cynomolgus monkeys, brolucizumab was administered to all animals by intravitreal (IVT) injection to one eye at doses of 3 or 6 mg once every 4 weeks until delivery. There was no impact of IVT administration of brolucizumab on embryo-fetal development, pregnancy or parturition; or on the survival, growth, or postnatal development of offspring at 6 mg/eye (10-fold the MRHD on a mg/kg basis). VEGF inhibition has been shown to cause malformations, embryo-fetal resorption, and decreased fetal weight. VEGF also has been shown to affect follicular development, corpus luteum function, and fertility.
Breastfeeding (LactMed)
No information is available on the use of brolucizumab during breastfeeding. Brolucizumab inhibits vascular endothelial growth factor (VEGF). Because it is a large protein molecule with a molecular weight of 26,000 Da, the amount in milk is likely to be very low. It is also likely to be partially destroyed in the infant's gastrointestinal tract and absorption by the infant is probably minimal. It is also likely to be partially destroyed in the infant's gastrointestinal tract and absorption by the infant is probably minimal. The manufacturer states that breastfeeding is not recommended during treatment and for at least one month after the last dose. Since VEGF is present in human milk and is thought to help in maturation of the infant’s gastrointestinal tract, concern has been raised about the maternal use of VEGF inhibitors during breastfeeding.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
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