Drug Safety-related Labeling Changes (SrLC)

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BEOVU (BLA-761125)

(brolucizumab-dbll)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

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02/18/2022 (SUPPL-10)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.2 Retinal Vasculitis and/or Retinal Vascular Occlusion

Additions and/or revisions underlined:

Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, have been reported with the use of BEOVU. These immune mediated adverse events may occur following the first intravitreal injection. Discontinue treatment with BEOVU in patients who develop these events. Patients treated with BEOVU who experience intraocular inflammation may be at risk of developing retinal vasculitis and/or retinal vascular occlusion and should be closely monitored [see Contraindications (4.2) and Adverse Reactions (6.1, 6.2)]. Patients should be instructed to report any change in vision without delay.

6 Adverse Reactions

6.1 Clinical Trials Experience

Table 1: Common Adverse Reactions (greater than or equal to 1%) in the HAWK and HARRIER wet AMD Clinical Trials

Newly added information:

In a clinical study (MERLIN), patients with nAMD who received BEOVU every 4-week maintenance dosing experienced a higher incidence of intraocular inflammation (including retinal vasculitis) and retinal vascular occlusion than patients who received BEOVU every 8 or 12-week maintenance dosing in the clinical studies (HAWK and HARRIER). The interval between two BEOVU doses during maintenance treatment should not be less than 8 weeks.

6.2 Immunogenicity

Additions and/or revisions underlined:

… 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. Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, are immune mediated adverse events related to exposure to BEOVU. This treatment emergent antibody response may develop following the first intravitreal injection.

Anti-brolucizumab antibodies were not associated with an impact on clinical efficacy.

02/18/2022 (SUPPL-12)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.2 Retinal Vasculitis and/or Retinal Vascular Occlusion

5.2 Retinal Vasculitis and/or Retinal Vascular Occlusion

Additions and/or revisions underlined:

Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, have been reported with the use of BEOVU. These immune mediated adverse events may occur following the first intravitreal injection. Discontinue treatment with BEOVU in patients who develop these events. Patients treated with BEOVU who experience intraocular inflammation may be at risk of developing retinal vasculitis and/or retinal vascular occlusion and should be closely monitored [see Contraindications (4.2) and Adverse Reactions (6.1, 6.2)]. Patients should be instructed to report any change in vision without delay.

6 Adverse Reactions

6.1 Clinical Trials Experience

Table 1: Common Adverse Reactions (greater than or equal to 1%) in the HAWK and HARRIER wet AMD Clinical Trials

Newly added information:

In a clinical study (MERLIN), patients with nAMD who received BEOVU every 4-week maintenance dosing experienced a higher incidence of intraocular inflammation (including retinal vasculitis) and retinal vascular occlusion than patients who received BEOVU every 8 or 12-week maintenance dosing in the clinical studies (HAWK and HARRIER). The interval between two BEOVU doses during maintenance treatment should not be less than 8 weeks.

6.2 Immunogenicity

Additions and/or revisions underlined:

… 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. Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, are immune mediated adverse events related to exposure to BEOVU. This treatment emergent antibody response may develop following the first intravitreal injection.

Anti-brolucizumab antibodies were not associated with an impact on clinical efficacy.

02/18/2022 (SUPPL-13)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.2 Retinal Vasculitis and/or Retinal Vascular Occlusion

Additions and/or revisions underlined:

Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, have been reported with the use of BEOVU. These immune mediated adverse events may occur following the first intravitreal injection. Discontinue treatment with BEOVU in patients who develop these events. Patients treated with BEOVU who experience intraocular inflammation may be at risk of developing retinal vasculitis and/or retinal vascular occlusion and should be closely monitored [see Contraindications (4.2) and Adverse Reactions (6.1, 6.2)]. Patients should be instructed to report any change in vision without delay.

6 Adverse Reactions

6.1 Clinical Trials Experience

Table 1: Common Adverse Reactions (greater than or equal to 1%) in the HAWK and HARRIER wet AMD Clinical Trials

Newly added information:

In a clinical study (MERLIN), patients with nAMD who received BEOVU every 4-week maintenance dosing experienced a higher incidence of intraocular inflammation (including retinal vasculitis) and retinal vascular occlusion than patients who received BEOVU every 8 or 12-week maintenance dosing in the clinical studies (HAWK and HARRIER). The interval between two BEOVU doses during maintenance treatment should not be less than 8 weeks.

6.2 Immunogenicity

Additions and/or revisions underlined:

… 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. Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, are immune mediated adverse events related to exposure to BEOVU. This treatment emergent antibody response may develop following the first intravitreal injection.

Anti-brolucizumab antibodies were not associated with an impact on clinical efficacy.

06/09/2020 (SUPPL-4)

Approved Drug Label (PDF)

5 Warnings and Precautions

5.2 Retinal Vasculitis and/or Retinal Vascular Occlusion

(Newly added subsection)

Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, have been reported with the use of BEOVU. Patients should be instructed to report any change in vision without delay.

6 Adverse Reactions

(Additions and/or revisions underlined)

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

  • Hypersensitivity

  • Endophthalmitis and Retinal Detachment

  • Retinal Vasculitis and/or Retinal Vascular Occlusion

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

17 PATIENT COUNSELING INFORMATION

(Additions and/or revisions underlined)

Advise patients that in the days following BEOVU administration, patients are at risk of developing endophthalmitis., retinal detachment, retinal vasculitis and/or retinal vascular occlusion. If the eye becomes red, sensitive to light, painful, or if a patient develops any change in vision, instruct the patient to seek immediate care from an ophthalmologist.

Patients may experience temporary visual disturbances after an intravitreal injection with BEOVU and the associated eye examination. Advise patients not to drive or use machinery until visual function has recovered sufficiently.

Questions related to the drug data in these files should be directed to the Center for Drug Evaluation and Research, Division of Drug Information
druginfo@fda.hhs.gov.

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