Brolucizumab–dbll
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Omid Afkhami-Ardakani
Disclaimer
WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.
Overview
Brolucizumab–dbll is a Vascular Endothelial Growth Factor (VEGF) Inhibitor that is FDA approved for the treatment of Neovascular (Wet) Age-Related Macular Degeneration (AMD) and Diabetic Macular Edema (DME). Common adverse reactions include Vision blurred, Cataract, Conjunctival hemorrhage, Eye pain, and Vitreous floaters..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Neovascular (Wet) Age-Related Macular Degeneration (AMD): The recommended dose is 6 mg (0.05 mL of 120 mg/mL solution) administered by intravitreal injection monthly (approximately every 25-31 days) for the first three doses, followed by 6 mg (0.05 mL) by intravitreal injection once every 8-12 weeks.
Diabetic Macular Edema (DME): The recommended dose is 6 mg (0.05 mL of 120 mg/mL solution) administered by intravitreal injection every six weeks (approximately every 39-45 days) for the first five doses, followed by 6 mg (0.05 mL) by intravitreal injection once every 8-12 weeks.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Brolucizumab–dbll in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Brolucizumab–dbll in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Not applicable, as Brolucizumab-dbll is not approved for use in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Brolucizumab–dbll in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Brolucizumab–dbll in pediatric patients.
Contraindications
Ocular or Periocular Infections: Brolucizumab-dbll is contraindicated in patients with ocular or periocular infections.
Active Intraocular Inflammation: Brolucizumab-dbll is contraindicated in patients with active intraocular inflammation.
Hypersensitivity: Brolucizumab-dbll is contraindicated in patients with known hypersensitivity to brolucizumab-dbll or any of the excipients in this product. Hypersensitivity reactions may manifest as rash, pruritus, urticaria, erythema, or severe intraocular inflammation.
Warnings
Endophthalmitis and Retinal Detachment: Intravitreal injections, including those with Brolucizumab-dbll, may be associated with endophthalmitis and retinal detachment. Proper aseptic injection techniques must be used. Patients should be instructed to report any symptoms suggestive of these conditions without delay.
Retinal Vasculitis and/or Retinal Vascular Occlusion: Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, have been reported following Brolucizumab-dbll injections. These events may result in severe vision loss. Patients should be instructed to report any change in vision without delay.
Increase in Intraocular Pressure: Increases in intraocular pressure have been seen within 30 minutes of intravitreal injection.
Thromboembolic Events: There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors.
Adverse Reactions
Clinical Trials Experience
Vision blurred, Cataract, Conjunctival hemorrhage, Eye pain, and Vitreous floaters.
Serious Ocular Adverse Reactions: Endophthalmitis Retinal detachment Retinal vasculitis Retinal vascular occlusion
Postmarketing Experience
There is limited information regarding Brolucizumab–dbll Postmarketing Experience in the drug label.
Drug Interactions
No formal drug interaction studies have been conducted. Brolucizumab-dbll is a recombinant human VEGF inhibitor administered via intravitreal injection, resulting in minimal systemic exposure.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Brolucizumab–dbll in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Brolucizumab–dbll in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Brolucizumab–dbll during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Brolucizumab–dbll in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Brolucizumab–dbll in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Brolucizumab–dbll in geriatric settings.
Gender
There is no FDA guidance on the use of Brolucizumab–dbll with respect to specific gender populations.
Race
There is no FDA guidance on the use of Brolucizumab–dbll with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Brolucizumab–dbll in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Brolucizumab–dbll in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Brolucizumab–dbll in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Brolucizumab–dbll in patients who are immunocompromised.
Administration and Monitoring
Administration
Neovascular (Wet) Age-Related Macular Degeneration (AMD): The recommended dose is 6 mg (0.05 mL of 120 mg/mL solution) administered by intravitreal injection monthly (approximately every 25-31 days) for the first three doses, followed by 6 mg (0.05 mL) by intravitreal injection once every 8-12 weeks.
Diabetic Macular Edema (DME): The recommended dose is 6 mg (0.05 mL of 120 mg/mL solution) administered by intravitreal injection every six weeks (approximately every 39-45 days) for the first five doses, followed by 6 mg (0.05 mL) by intravitreal injection once every 8-12 weeks.
Monitoring
Intraocular Pressure: Monitor intraocular pressure immediately after the injection and manage appropriately.
Infection and Inflammation: Patients should be monitored following the injection to permit early treatment if an infection or inflammation occurs.
IV Compatibility
Not Applicable.
Overdosage
Overdosing with larger than recommended intravitreal doses may increase intraocular pressure. In the event of an overdose, intraocular pressure should be monitored and managed appropriately.
Pharmacology
There is limited information regarding Brolucizumab–dbll Pharmacology in the drug label.
Mechanism of Action
Brolucizumab-dbll is a human vascular endothelial growth factor (VEGF) inhibitor. It binds to the three major isoforms of VEGF-A (e.g., VEGF110, VEGF121, and VEGF165), thereby preventing interaction with receptors VEGFR-1 and VEGFR-2. By inhibiting VEGF-A, brolucizumab suppresses endothelial cell proliferation, neovascularization, and vascular permeability.
Structure
There is limited information regarding Brolucizumab–dbll Structure in the drug label.
Pharmacodynamics
Leakage of blood and fluid from choroidal neovascularization (CNV) may cause retinal thickening or edema. Reductions in central retinal subfield thickness (CST) were observed across all treatment arms.
Pharmacokinetics
Absorption: Following a single intravitreal dose of 6 mg BEOVU to 25 AMD patients, the mean (range) serum Cmax of free brolucizumab was 49.0 ng/mL (8.97 – 548 ng/mL) and was attained within 1 day post-dose.
Elimination: The estimated mean (± standard deviation) half-life of free brolucizumab in serum was 4.4 ± 2.0 days.
Nonclinical Toxicology
There is limited information regarding Brolucizumab–dbll Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Brolucizumab–dbll Clinical Studies in the drug label.
How Supplied
Intravitreal injection: 6 mg/0.05 mL solution in a single-dose pre-filled syringe or single-dose vial.
Storage
Store Brolucizumab-dbll in the refrigerator between 2°C to 8°C (36°F to 46°F); do not freeze. Keep Brolucizumab-dbll in the outer carton to protect from light. Prior to use, the unopened glass vial or sealed blister pack of Brolucizumab-dbll may be kept at room temperature, 20°C to 25°C (68°F to 77°F) for up to 24 hours.
Images
Drug Images
{{#ask: Page Name::Brolucizumab–dbll |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}
Package and Label Display Panel
{{#ask: Label Page::Brolucizumab–dbll |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
Patient Counseling Information
Inform patients that transient visual disturbances may occur after the injection. Recommend that patients avoid driving or operating machinery until their vision has recovered.
Precautions with Alcohol
Alcohol-Brolucizumab–dbll interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
Brolucizumab-dbll is marketed under the brand name BEOVU.
Look-Alike Drug Names
There is limited information regarding Brolucizumab–dbll Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.