Brolucizumab (Beovu)

Trade Name : BEOVU

Novartis Pharmaceuticals Corporation

INJECTION, SOLUTION

Strength 6 mg/.05mL

BROLUCIZUMAB

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Brolucizumab (Beovu) which is also known as BEOVU and Manufactured by Novartis Pharmaceuticals Corporation. It is available in strength of 6 mg/.05mL per ml. Read more

Brolucizumab (Beovu) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • BEOVU is indicated for the treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD).
  • BEOVU is a human vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of Neovascular (Wet) Age-Related Macular Degeneration (AMD) ().
  • 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 ().
  • Intravitreal Injection: 6 mg/0.05 mL, clear to slightly opalescent and colorless to slightly brownish-yellow solution in a single-dose vial.
  • Injection: 6 mg/0.05 mL solution for intravitreal injection in a single-dose vial ().
  • No data
  • Ocular or periocular infections ().
  • Active intraocular inflammation ().
  • Hypersensitivity ().
  • No data
  • Endophthalmitis and retinal detachments may occur following intravitreal injections. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay ().nttttttttt
  • Increases in intraocular pressure (IOP) have been seen within 30 minutes of an intravitreal injection ().nttttttttt
  • There is a potential risk of arterial thromboembolic events (ATE) following intravitreal use of VEGF inhibitors ().
  • The following potentially serious adverse reactions are described elsewhere in the labeling:
  • The most common adverse reactions (u2265 5%) reported in patients receiving BEOVU are vision blurred (10%), cataract (7%), conjunctival hemorrhage (6%), eye pain (5%), and vitreous floaters (5%) ().
  • No data
  • Brolucizumab-dbll is a recombinant human vascular endothelial growth factor inhibitor. Brolucizumab-dbll is a humanized monoclonal single-chain Fv (scFv) antibody fragment. Brolucizumab-dbll has a molecular weight of ~26 kilodaltons and is produced in cells by recombinant DNA technology.
  • BEOVU (brolucizumab-dbll) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to slightly brownish-yellow solution in a single-dose vial for intravitreal administration. Each vial is designed to deliver 0.05 mL of solution containing 6 mg brolucizumab-dbll, polysorbate 80 (0.02%), sodium citrate (10 mM), sucrose (5.8%), and Water for Injection, USP and with a pH of approximately 7.2.
  • No data
  • No studies have been conducted on the carcinogenic or mutagenic potential of BEOVU. Based on the anti-VEGF mechanism of action, treatment with BEOVU may pose a risk to reproductive capacity .
  • The safety and efficacy of BEOVU were assessed in two randomized, multi-center, double-masked, active-controlled studies (HAWK - NCT02307682 and HARRIER - NCT02434328) in patients with neovascular AMD. A total of 1817 patients were treated in these studies for two years (1088 on brolucizumab and 729 on control). Patient ages ranged from 50 to 97 years with a mean of 76 years.
  • In HAWK, patients were randomized in a 1:1:1 ratio to the following dosing regimens:
  • u00a0u00a0u00a0u00a0u00a01)tbrolucizumab 3 mg administered every 8 or 12 weeks after the first 3 monthly doses,
  • u00a0u00a0u00a0u00a0u00a02)tbrolucizumab 6 mg administered every 8 or 12 weeks after the first 3 monthly doses,
  • u00a0u00a0u00a0u00a0u00a03)taflibercept 2 mg administered every 8 weeks after the first 3 monthly doses.
  • In HARRIER, patients were randomized in a 1:1 ratio to the following dosing regimens:
  • u00a0u00a0u00a0u00a0u00a01)tbrolucizumab 6 mg administered every 8 or 12 weeks after the first 3 monthly doses,
  • u00a0u00a0u00a0u00a0u00a02)taflibercept 2 mg administered every 8 weeks after the first 3 monthly doses.
  • In both studies, after three initial monthly doses (Week 0, 4, and 8), treating physicians decided whether to treat each individual patient on an every 8 week or 12 week dosing interval guided by visual and anatomical measures of disease activity, although the utility of these measures has not been established. Patients on 12 week dosing intervals could be changed based on the same measures to an 8 week schedule after subsequent treatment visits. Any patient placed on an 8 week schedule, remained on the 8 week dosing interval until the end of the study. Protocol-specified visits in the initial three months occurred every 28 u00b1 3 days followed by every 28 u00b1 7 days for the remainder of the studies. Baseline anatomical measures may have contributed to the regimen selection because the majority of patients on the 12-week dosing schedule at the end of the trial had less baseline macular edema and/or smaller baseline lesions.
  • Both studies demonstrated efficacy in the primary endpoint defined as the change from baseline in Best Corrected Visual Acuity (BCVA) at Week 48, measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score. In both studies, BEOVU treated patients had a similar mean change from baseline in BCVA as the patients treated with aflibercept 2 mg (fixed every 8 weeks). Detailed results of both studies are shown in Table 2 and Figures 5 and 6 below.
  • Figure 5: Mean Change in Visual Acuity From Baseline to Week 96 in HAWK
  • Figure 6: Mean Change in Visual Acuity From Baseline to Week 96 in HARRIER
  • Through Week 48, 56% (HAWK) and 51% (HARRIER) of patients remained on BEOVU every 12 weeks. The proportion of patients who were maintained on every 12 week dosing through Week 96 was 45% and 39% in HAWK and HARRIER, respectively. The probability of remaining on every 12 week dosing from Week 20 to Week 48 was 85% and 82%, and from Week 48 to Week 96 was 82% and 75% in HAWK and HARRIER, respectively.
  • Treatment effects in evaluable subgroups (e.g., age, gender, race, baseline visual acuity) in each study were generally consistent with the results in the overall populations.
  • No data
  • Endophthalmitis and Retinal Detachments
  • Advise patients that in the days following BEOVU administration, patients are at risk of developing endophthalmitis. If the eye becomes red, sensitive to light, painful, or develops a change in vision, advise 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.
  • Manufactured by:Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936U.S. License Number: 1244
  • u00a9 Novartis
  • T2019-105
  • NDC 0078-0827-61
  • Rx only
  • Beovun
  • (brolucizumab-dbll)Injection
  • 6 mg/0.05 mL
  • Single-dose Vial; Discard unused portion.
  • For Intravitreal Use
  • Carton contains:
  • 1 x 2 mL vial, 1 x filter needle
  • NOVARTIS

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