Brolucizumab Intravitreal

Brolucizumab Intravitreal is a prescription medication used to treat the symptoms of macular degeneration and diabetic macular edema.

• Brolucizumab Intravitreal is available under the following different brand names: Beovu, brolucizumab-dbll

Common side effects of Brolucizumab Intravitreal include:

• Blurred vision,
• Hazy vision,
• Increased sensitivity to light,
• Eye pain, and
• Seeing floaters

Serious side effects of Brolucizumab Intravitreal include:

• Hives,
• Difficulty breathing,
• Swelling of the face, lips, tongue, or throat,
• Eye pain,
• Eye redness,
• Swelling around the eyes,
• Discharge or bleeding from the eye,
• Seeing “floaters” in the vision,
• Increased sensitivity to light,
• Decreased vision,
• Tunnel vision,
• Seeing halos around lights,
• Sudden numbness or weakness, and
• Problems with speech or balance

Rare side effects of Brolucizumab Intravitreal include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injectable solution for intravitreal use

• 6 mg/0.05 mL (single-dose vial or prefilled syringe)

Macular Degeneration

Adult dosage

• 6 mg (0.05 mL of 120 mg/mL solution) by intravitreal injection monthly (approximately every 25-31 days) for 3 doses, THEN 6 mg every 8-12 weeks

Diabetic Macular Edema

Adult dosage

• 6 mg (0.05 mL of 120 mg/mL solution) by intravitreal injection every 6 weeks (approximately 39-45 days) for the first 5 doses, followed by 6 mg every 8-12 weeks

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Brolucizumab Intravitreal has no noted severe interactions with any other drugs.
• Brolucizumab Intravitreal has no noted serious interactions with any other drugs.
• Brolucizumab Intravitreal has no noted moderate interactions with any other drugs.
• Brolucizumab Intravitreal has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Ocular or periocular infections
• Active intraocular inflammation
• Hypersensitivity

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Brolucizumab Intravitreal?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Brolucizumab Intravitreal?”

Cautions

• Hypersensitivity reactions may manifest as rash, pruritus, urticaria, erythema, or severe intraocular inflammation
• Intravitreal injections are associated with endophthalmitis and retinal detachments; instruct patients to immediately report any symptoms suggestive of endophthalmitis or retinal detachment
• Acute increases in intraocular pressure (IOP) have been seen within 30 minutes of intravitreal injection; sustained IOP increases have also been reported; both IOP and perfusion of the optic nerve head must be monitored and managed appropriately
• A low rate of arterial thromboembolic events was observed during clinical trials following the intravitreal use of vascular endothelial growth factor (VEGF) inhibitors
• Retinal vasculitis
  • Retinal vasculitis and/or retinal vascular occlusion, typically in presence of intraocular inflammation, reported with therapy
  • Retinal vasculitis and/or retinal vascular occlusion, typically in presence of intraocular inflammation, are immune-mediated adverse events related to exposure to the drug; this treatment-emergent antibody response may develop following the first intravitreal injection
  • The immune-mediated adverse events may occur following the first intravitreal injection; discontinue treatment in patients who develop these events
  • Patients who experience intraocular inflammation following treatment may be at risk of developing retinal vasculitis and/or retinal vascular occlusion and should be closely monitored; patients should be instructed to report any change in vision without delay

Pregnancy and Lactation

• There are no adequate and well-controlled studies on pregnant women
• Based on the anti-VEGF mechanism of action, treatment may pose a risk to human embryofoetal development
• Use during pregnancy only if the potential benefit outweighs the potential fetal risk
• Contraception
  • Females of reproductive potential should use highly effective contraception (methods that result in below 1% pregnancy rates) during treatment and for at least 1 month after the last dose following brolucizumab discontinuation
• Infertility
  • No studies have been conducted and it is not known whether brolucizumab can affect reproductive capacity
  • Based on its anti-VEGF mechanism of action, treatment may pose a risk to reproductive capacity
• Lactation
  • No data are available regarding the presence of brolucizumab in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production/excretion
  • Because many drugs are transferred in human milk and because of the potential for absorption and adverse reactions in the breastfed child, breastfeeding is not recommended during treatment and for at least 1 month after the last dose following discontinuation