Beovu

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 10/26/2021
Beovu Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Beovu?

Beovu (brolucizumab-dbll) Injection is a human vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of Neovascular (Wet) Age-Related Macular Degeneration (AMD).

What Are Side Effects of Beovu?

Common side effects of Beovu include:

Dosage for Beovu

Beovu is administered by intravitreal injection. 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.

What Drugs, Substances, or Supplements Interact with Beovu?

Beovu may interact with other drugs. Tell your doctor all medications and supplements you use.

Beovu During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Beovu; it may harm a fetus. Females of reproductive potential should use highly effective contraception during treatment with Beovu and for at least one month after the last dose. Because of the potential for absorption and adverse reactions in a breastfed child, breastfeeding is not recommended during treatment with Beovu and for at least one month after the last dose.

Additional Information

Our Beovu (brolucizumab-dbll) Injection, for Intravitreal Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Pink Eye (Conjunctivitis) Symptoms, Causes, Treatments See Slideshow
Beovu Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • eye pain or redness, swelling around your eyes;
  • discharge or bleeding from the eye;
  • seeing "floaters" in your vision;
  • increased sensitivity to light;
  • decreased vision, tunnel vision, or seeing halos around lights; or
  • sudden numbness or weakness, problems with speech or balance.

Common side effects may include:

  • blurred vision, hazy vision;
  • increased sensitivity to light;
  • eye pain; or
  • seeing floaters.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Beovu (Brolucizumab-dbll for Intravitreal Injection)

QUESTION

What causes dry eyes? See Answer
Beovu Professional Information

SIDE EFFECTS

The following potentially serious adverse reactions are described elsewhere in the labeling:

  • Hypersensitivity [see CONTRAINDICATIONS]
  • Endophthalmitis and Retinal Detachment [see WARNINGS AND PRECAUTIONS]
  • Retinal Vasculitis and/or Retinal Vascular Occlusion [see WARNINGS AND PRECAUTIONS]
  • Increase in Intraocular Pressure [see WARNINGS AND PRECAUTIONS]
  • Thromboembolic Events [see WARNINGS AND PRECAUTIONS]

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 1088 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].

Adverse reactions reported to occur in ≥ 1% of patients who received treatment with BEOVU pooled across HAWK and HARRIER, are listed below in Table 1.

Table 1: Common Adverse Reactions (≥ 1%) in the HAWK and HARRIER wet AMD Clinical Trials

Adverse Drug Reactions BEOVU
(N = 730)
Active Control (aflibercept)
(N = 729)
Vision blurreda 10% 11%
Cataract 7% 11%
Conjunctival hemorrhage 6% 7%
Vitreous floaters 5% 3%
Eye pain 5% 6%
Intraocular inflammationb 4% 1%
Intraocular pressure increased 4% 5%
Retinal hemorrhage 4% 3%
Vitreous detachment 4% 3%
Conjunctivitis 3% 2%
Retinal pigment epithelial tear 3% 1%
Corneal abrasion 2% 2%
Hypersensitivityc 2% 1%
Punctate keratitis 1% 2%
Retinal tear 1% 1%
Endophthalmitis 1% < 1%
Blindnessd 1% < 1%
Retinal artery occlusion 1% < 1%
Retinal detachment 1% < 1%
Conjunctival hyperemia 1% 1%
Lacrimation increased 1% 1%
Abnormal sensation in eye 1% 2%
Detachment of retinal pigment epithelium 1% < 1%
aIncluding vision blurred, visual acuity reduced, visual acuity reduced transiently, and visual impairment.
bIncluding anterior chamber cell, anterior chamber flare, anterior chamber inflammation, chorioretinitis, eye inflammation, iridocyclitis, iritis, retinal vasculitis, retinal vascular occlusion, uveitis, vitreous haze, vitritis.
cIncluding urticaria, rash, pruritus, erythema.
dIncluding blindness, blindness transient, amaurosis, and amaurosis fugax.

Immunogenicity

As with all therapeutic proteins, there is a potential for an immune response in patients treated with BEOVU. The immunogenicity of BEOVU was evaluated in serum samples. The immunogenicity data reflect the percentage of patients whose test results were considered positive for antibodies to BEOVU in immunoassays. The detection of an immune response is highly dependent on the sensitivity and specificity of the assays used, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to BEOVU with the incidence of antibodies to other products may be misleading.

Anti-brolucizumab antibodies were detected in the pre-treatment sample of 36% to 52% of treatment naive patients. After initiation of dosing, anti-brolucizumab antibodies were detected in at least one serum sample in 53% to 67% of patients treated with BEOVU. Intraocular inflammation was observed in 6% of patients with anti-brolucizumab antibodies detected during dosing with BEOVU.

The significance of anti-brolucizumab antibodies on the clinical effectiveness and safety of BEOVU is not known.

DRUG INTERACTIONS

No Information provided

Read the entire FDA prescribing information for Beovu (Brolucizumab-dbll for Intravitreal Injection)

© Beovu Patient Information is supplied by Cerner Multum, Inc. and Beovu Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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