General MedicinePrescription OnlyPregnancy Cat. Not classifiedFDA Yes
Beovu
BROLUCIZUMAB
1 INDICATIONS AND USAGE BEOVU ® is indicated for the treatment of: BEOVU is a human vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of: Neovascular (Wet) Age-Related Macular Degeneration (AMD) ( 1.1 ) Diabetic Macular Edema (DME) ( 1.2 ) 1.1 Neovascular (Wet) Age-related Macular Degeneration (AMD) 1.2 Diabetic Macular Edema (DME)
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Brand names:BEOVU
Quick Reference
Medicine ClassGeneral Medicine
FDA ApprovedYes
PregnancyCategory Not classified
Quick Facts
- Active ingredient
- BROLUCIZUMAB
- Medicine class
- General Medicine
- Brand names
- BEOVU
- Availability
- Prescription only (Rx)
- Pregnancy category
- Not classified
- Half-life
- half-life of brolucizumab is 4
- FDA approved
- Yes
What Is Beovu?
1 INDICATIONS AND USAGE BEOVU ® is indicated for the treatment of: BEOVU is a human vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of: Neovascular (Wet) Age-Related Macular Degeneration (AMD) ( 1.1 ) Diabetic Macular Edema (DME) ( 1.2 ) 1.1 Neovascular (Wet) Age-related Macular Degeneration (AMD) 1.2 Diabetic Macular Edema (DME)
Beovu (BROLUCIZUMAB) belongs to the General Medicine class of medications. It was first approved by the FDA in Yes. This medication requires a prescription from a licensed healthcare provider.
Key Safety Information
- •Always follow the dose recommended by your healthcare professional. Taking more than prescribed increases the risk of side effects including serious complications.
- •Seek emergency care if you experience signs of an allergic reaction — hives, swelling, difficulty breathing, or rash. Stop the medication and call your doctor immediately.
- •Some medications can increase the risk of cardiovascular events. Tell your doctor if you have high blood pressure, a history of heart attack or stroke, or any pre-existing health condition.
- •Avoid or limit alcohol while taking Beovu. Do not drink alcohol without first discussing it with your healthcare provider as it may increase adverse effects.
- •Take Beovu with food or a full glass of water if stomach upset occurs. Stop use and talk to your doctor if you experience persistent stomach pain or GI symptoms.
- •Tell your doctor about all medications, supplements, and vitamins you take. Some combinations significantly increase the risk of harm.
This is a summary only. Always read the full prescribing information and consult your healthcare provider for personalized medical advice.
Uses & Indications
Beovu is prescribed for the following conditions. Some uses are FDA-approved indications; others may be evidence-based off-label uses. Consult your healthcare provider for personalized guidance.
1 INDICATIONS AND USAGE BEOVU ® is indicated for the treatment of: BEOVU is a human vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of: Neovascular (Wet) Age-Related Macular Degeneration (AMD) ( 1.1 ) Diabetic Macular Edema (DME) ( 1.2 ) 1.1 Neovascular (Wet) Age-related Macular Degeneration (AMD) 1.2 Diabetic Macular Edema (DME)
Dosage Guide
The following are general dosing guidelines only. Your actual dose should be determined by your healthcare provider based on your condition, renal/hepatic function, and other medications.
AD
Adult Dosage
2 DOSAGE AND ADMINISTRATION Neovascular (Wet) Age-Related Macular Degeneration (AMD) The recommended dose for BEOVU is 6 mg (0.05 mL of 120 mg/mL solution) monthly (approximately every 25-31 days) for the first three doses, followed by one dose of 6 mg (0.05 mL) every 8-12 weeks ( 2.2 ). Diabetic Macular Edema (DME) The recommended dose for BEOVU is 6 mg (0.05 mL of 120 mg/mL solution) every six weeks (approximately every 39-45 days) for the first five doses, followed by one dose of 6 mg (0.05 mL of 120 mg/mL solution) every 8-12 weeks ( 2.3 ). 2.1 General Dosing Information For ophthalmic intravitreal injection. BEOVU must be administered by a qualified physician. BEOVU is available packaged as follows [see How Supplied/Storage and Handling (16)] : Pre-filled Syringe Vial kit with injection components (vial, filter needle) 2.2 Neovascular (Wet) Age-Related Macular Degeneration (AMD) The recommended dose for BEOVU is 6 mg (0.05 mL of 120 mg/mL solution) administered by intravitreal inj
Available Forms
Available Strengths
Side Effects
Common
- 6 ADVERSE REACTIONS The following potentially serious adverse reactions are described elsewhere in the labeling: Hypersensitivity [see Contraindications (4.3)] Endophthalmitis and Retinal Detachment [see Warnings and Precautions (5.1)] Retinal Vasculitis and/or Retinal Vascular Occlusion [see Warnings and Precautions (5.2)] Increase in Intraocular Pressure [see Warnings and Precautions (5.3)] Thromboembolic Events [see Warnings and Precautions (5.4)] The most common adverse reactions reported in patients receiving BEOVU are vision blurred, cataract, conjunctival hemorrhage, eye pain, and vitreous floaters ( 6.1 ).
- To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
- 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in one clinical trial of a drug cannot be directly compared with rates in the clinical trials of the same or another drug and may not reflect the rates observed in practice.
- A total of 1,646 patients treated with brolucizumab constituted the safety population in four Phase 3 studies.
- Among these, 1,098 patients were treated with the recommended dose of 6 mg.
- A total of 1,088 patients treated with brolucizumab, constituted the safety population in the two controlled neovascular AMD Phase 3 studies (HAWK and HARRIER) with a cumulative 96-week exposure to BEOVU, and 730 patients treated with the recommended dose of 6 mg [see Clinical Studies (14.1)] .
- A total of 558 patients treated with brolucizumab constituted the safety population in the two controlled DME Phase 3 studies (KESTREL and KITE) from baseline to week 52, including 368 patients treated with the recommended dose of 6 mg [see Clinical Studies (14.2)] .
Serious
- 5 WARNINGS AND PRECAUTIONS Endophthalmitis and retinal detachment may occur following intravitreal injections.
- Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay ( 5.1 ).
- Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, have been reported following BEOVU injections.
- Patients should be instructed to report any change in vision without delay ( 5.2 ).
- Increases in intraocular pressure (IOP) have been seen within 30 minutes of an intravitreal injection ( 5.3 ).
Rare
Medicine Interactions
Always inform your healthcare provider and pharmacist about ALL medications you take, including prescriptions, OTC medicines, vitamins, and supplements.
MajorModerateMinor
Warnings & Contraindications
5 WARNINGS AND PRECAUTIONS Endophthalmitis and retinal detachment may occur following intravitreal injections. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay ( 5.1 ). Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, have been reported following BEOVU injections. Patie
How Beovu Works
12.1 Mechanism of Action Brolucizumab is a human VEGF inhibitor. Brolucizumab binds to the three major isoforms of VEGF-A (e.g., VEGF 110 , VEGF 121 , and VEGF 165 ), thereby preventing interaction with receptors VEGFR-1 and VEGFR-2. By inhibiting VEGF-A, brolucizumab suppresses endothelial cell proliferation, neovascularization, and vascular permeability.
Pharmacokinetics
Half-Life
half-life of brolucizumab is 4
Metabolism
Metabolism Metabolism of brolucizumab has not been fully characterized
Excretion
Excretion The excretion of brolucizumab has not been fully characterized
Pregnancy & Breastfeeding Safety
Not classified
Breastfeeding
Many medications pass into breast milk in varying amounts. Before using Beovuwhile breastfeeding, discuss the benefits and risks with your healthcare provider or pharmacist — they can weigh your dose, your infant's age, and available lactation safety data to find the safest option for you and your baby.
Storage & Handling
Store at room temperature. Keep away from moisture and heat. Keep out of reach of children.
Frequently Asked Questions
Related on MedCentralHub
Sources & References
- • FDA Prescribing Information — Official labeling and package insert for Beovu
- • U.S. National Library of Medicine — MedlinePlus drug information
- • American Hospital Formulary Service (AHFS) — Clinical pharmacology monograph
- • PubMed / MEDLINE — View clinical studies
Last reviewed by MedCentralHub Medical Review Board · MedCentralHub Editorial Policy
Medical Disclaimer
The information on this page is for educational purposes only and is not intended as medical advice, diagnosis, or treatment. Always consult your doctor, pharmacist, or qualified healthcare provider before starting, stopping, or changing any medication.