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BEOVU is a brand name for Brolucizumab, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: BEOVU® (brolucizumab injection) is indicated for: • The treatment of neovascular (wet) age-related macular degeneration (AMD). • The treatment of diabetic macular edema (DME). 1.1 Pediatrics Pediatrics (< 18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • Single-use pre-filled syringe or single-use vial* for intravitreal injection only. • Each pre-filled syringe or vial should only be used for the treatment of a single eye. • Beovu must be administered by a qualified physician experienced in administering intravitreal injections.
• The safety and efficacy of Beovu administered in both eyes concurrently have not been studied. 05 mL) administered by intravitreal injection every 4 weeks (monthly) for the first three doses. Thereafter, the physician may modify treatment intervals based on disease activity as assessed by visual acuity and/or anatomical parameters.
A disease activity assessment is suggested 16 weeks (4 months) after treatment start and assessed regularly after that. In patients without disease activity, treatment up to every 12 weeks (3 months) could be considered. 1 Clinical Trials by Indication, Treatment of wet AMD); however, the interval between two doses should not be less than every 8 weeks (2 months) (see 7 WARNINGS AND PRECAUTIONS).
05 mL) administered by intravitreal injection every 6 weeks for the first five doses. Thereafter, the physician may modify treatment intervals based on disease activity as assessed by visual acuity and/or anatomical parameters. In patients without disease activity, treatment up to every 12 weeks (3 months) could be considered.
1 Clinical Trials by Indication, Treatment of DME); however, the interval between two doses should not be less than every 8 weeks (2 months) (see 7 WARNINGS AND PRECAUTIONS). Special populations Renal impairment (see 10 CLINICAL PHARMACOLOGY).
Hepatic impairment Brolucizumab has not been studied in patients with hepatic impairment (see 10 CLINICAL PHARMACOLOGY). Pediatric patients (below 18 years) The safety and efficacy of Beovu in pediatric patients have not been established.
No data are available to Health Canada. Geriatrics (65 years or above) In the HAWK and HARRIER clinical studies, approximately 90% (978/1088) of patients randomized to treatment with Beovu were ≥ 65 years of age and approximately 60% (648/1088) were ≥ 75 years of age.
In the KESTREL and KITE clinical studies, approximately 45% (164/368) of patients randomized to treatment with Beovu were ≥ 65 years of age and approximately 10% (37/368) were ≥ 75 years of age. No dosage regimen adjustment is required for geriatric use (see 10 CLINICAL PHARMACOLOGY).
). Proper aseptic injection techniques must always be used when administering Beovu. Intraocular inflammation, including retinal vasculitis and/or retinal vascular occlusion Intraocular inflammation (IOI), including retinal vasculitis and/or retinal vascular occlusion, have been reported with the use of Beovu.
These immune mediated adverse events may occur following the first intravitreal injection and at any time of treatment. These events were observed more frequently at the beginning of the treatment. Discontinue treatment with Beovu in patients who develop these events.
Patients treated with Beovu who experience IOI may be at risk of developing retinal vasculitis and/or retinal vascular occlusion and should be closely monitored (see 2 CONTRAINDICATIONS and 8 ADVERSE REACTIONS). Patients treated with Beovu with a medical history of intraocular inflammation and/or retinal vascular occlusion (within 12 months prior to the first brolucizumab injection) should be closely monitored, since they are at increased risk of developing retinal vasculitis and/or retinal vascular occlusion.
Based on clinical studies, intraocular inflammation related adverse events, including retinal vasculitis and retinal vascular occlusion, were reported more frequently in female patients treated with Beovu than in male patients (see 8 ADVERSE REACTIONS).
2 Recommended Dose and Dosage Adjustment). 0%). The incidences of IOI and retinal vascular occlusion were also higher than what was previously observed in patients who received Beovu every 8 or 12 week maintenance dosing in the pivotal Phase III clinical studies (HAWK and HARRIER).
Patients should be instructed to report any symptoms suggestive of the above mentioned events without delay and should be managed appropriately. PrBEOVU® (brolucizumab injection) Page 12 of 35 Increase in Intraocular Pressure Transient increases in intraocular pressure have been seen within 30 minutes of intravitreal injection with VEGF inhibitors, including Beovu.
). 05 mL) administered by intravitreal injection every 6 weeks for the first five doses. Thereafter, the physician may modify treatment intervals based on disease activity as assessed by visual acuity and/or anatomical parameters. In patients without disease activity, treatment up to every 12 weeks (3 months) could be considered.
1 Clinical Trials by Indication, Treatment of DME); however, the interval between two doses should not be less than every 8 weeks (2 months) (see 7 WARNINGS AND PRECAUTIONS). Special populations Renal impairment (see 10 CLINICAL PHARMACOLOGY).
Hepatic impairment Brolucizumab has not been studied in patients with hepatic impairment (see 10 CLINICAL PHARMACOLOGY). Pediatric patients (below 18 years) The safety and efficacy of Beovu in pediatric patients have not been established.
No data are available to Health Canada. Geriatrics (65 years or above) In the HAWK and HARRIER clinical studies, approximately 90% (978/1088) of patients randomized to treatment with Beovu were ≥ 65 years of age and approximately 60% (648/1088) were ≥ 75 years of age.
In the KESTREL and KITE clinical studies, approximately 45% (164/368) of patients randomized to treatment with Beovu were ≥ 65 years of age and approximately 10% (37/368) were ≥ 75 years of age. No dosage regimen adjustment is required for geriatric use (see 10 CLINICAL PHARMACOLOGY).
4 Administration As with all medicinal products for intravitreal use, Beovu should be inspected visually prior to administration (see 12 SPECIAL HANDLING INSTRUCTIONS). The injection procedure must be carried out under aseptic conditions, which include the use of surgical hand disinfection, sterile gloves, a sterile drape and a sterile eyelid speculum (or equivalent).
Sterile paracentesis equipment should be available as a precautionary measure. Adequate anesthesia and a broad-spectrum topical microbicide to disinfect the periocular skin, eyelid and ocular surface should be administered prior to the injection.
• Patients with hypersensitivity to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
• Patients with active or suspected ocular or periocular infection. • Patients with active intraocular inflammation.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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4 Administration As with all medicinal products for intravitreal use, Beovu should be inspected visually prior to administration (see 12 SPECIAL HANDLING INSTRUCTIONS). The injection procedure must be carried out under aseptic conditions, which include the use of surgical hand disinfection, sterile gloves, a sterile drape and a sterile eyelid speculum (or equivalent).
Sterile paracentesis equipment should be available as a precautionary measure. Adequate anesthesia and a broad-spectrum topical microbicide to disinfect the periocular skin, eyelid and ocular surface should be administered prior to the injection.
Patient’s medical history for hypersensitivity reactions should be carefully evaluated prior to performing the intravitreal procedure (see 2 CONTRAINDICATIONS). Immediately following the intravitreal injection, patients should be monitored for elevation in intraocular pressure.
Appropriate monitoring may consist of a check for perfusion of the optic nerve head or tonometry. g. eye pain, redness of the eye, photophobia, blurring of vision) without delay. For information on preparation of Beovu, see Instructions for use below.
0 mm posterior to the limbus into the vitreous cavity, avoiding the horizontal meridian and aiming towards the center of the globe. 05 mL is then delivered slowly; a different scleral site should be used for subsequent injections. Instruction for use of the Beovu pre-filled syringe Storage and inspection Store Beovu in the refrigerator (2°C to 8°C).
Do not freeze. Keep the pre- filled syringe in its sealed blister and the outer carton in order to protect from light. Prior to use, the unopened blister with pre-filled syringe of Beovu may be kept at room temperature (below 25°C) for up to 24 hours.
Make sure that your pack contains a sterile pre-filled syringe in a sealed blister. After opening the blister pack, proceed under aseptic conditions. Beovu is a clear to slightly opalescent and colourless to slightly brownish- yellow aqueous solution.
The solution should be inspected visually upon removal from the refrigerator and prior to administration. If particulates or cloudiness are visible, the pre-filled syringe must not be used and appropriate replacement procedures followed.
The pre-filled syringe is sterile and for single-use only. Do not use if the packaging, or pre-filled syringe are damaged or expired. How to prepare and administer Beovu The intravitreal injection procedure must be carried out under aseptic conditions, which includes the use of surgical hand disinfection, sterile gloves, a sterile drape, a sterile eyelid speculum (or equivalent), and the availability of sterile paracentesis equipment (if required).
Adequate anesthesia and a broad-spectrum topical microbicide to disinfect the periocular skin, eyelid and ocular surface should […]
Sustained intraocular pressure increases have also been reported (see 8 ADVERSE REACTIONS). Both intraocular pressure and perfusion of the optic nerve head must be monitored and managed appropriately. Beovu has not been studied in patients with poorly controlled glaucoma.
Do not inject Beovu while the intraocular pressure is ≥30 mmHg.
Reproductive Health:
Female and Male Potential Females of reproductive potential should use effective contraception (methods that result in less than 1 % pregnancy rates) during treatment with Beovu and for at least one month after the last dose when stopping treatment with Beovu.
• Fertility and Teratogenic Risk In an enhanced pre- and postnatal development (ePPND) study in pregnant cynomolgus monkeys, brolucizumab was administered to all animals by intravitreal (IVT) injection to one eye at doses of 3 or 6 mg once every 4 weeks until delivery.
One additional injection was administered to a subset of animals 28 days post-partum and had blood and milk collected for toxicokinetic evaluations. Second trimester-pregnancy fetal losses were observed in the 6 mg/eye group (10-fold the maximum recommended human dose [MRHD] on a mg/kg basis).
Fetal loss was not observed in the 3 mg/eye group. Bilateral absent metatarsal and absent distal tail were observed in a single stillborn infant at 6 mg/eye. The animal appeared to be partially cannibalized, however developmental malformation could not be ruled out.
VEGF inhibition has been shown to cause malformations, embryo-fetal resorption, and decreased fetal weight. VEGF inhibition has also been shown to affect follicular development, corpus luteum function, and fertility. Based on the mechanism of action of VEGF inhibitors, there is a potential risk to female reproduction and to embryo-fetal development.
Systemic effects following intravitreal use Thromboembolic Events and Non-ocular Hemorrhages There is a potential risk of arterial thromboembolic events (ATEs) and non-ocular hemorrhage following intravitreal use of VEGF inhibitors, including Beovu (see 8 ADVERSE REACTIONS).
ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause). There are limited data on safety in the treatment of patients with AMD with a history of stroke, transient ischemic attacks or myocardial infarction within the last 3-6 months.
1 Pregnant Women There are no adequate and well-controlled studies of Beovu administration in pregnant women. The potential risk of use of Beovu in pregnancy is unknown. A study in pregnant cynomolgus monkeys showed fetal losses and a bilateral absent metatarsal in a single offspring at 10-fold MRHD on a mg/kg basis (see Fertility).
PrBEOVU® (brolucizumab injection) Page 13 of 35 Based on the anti-VEGF mechanism of action, brolucizumab must be regarded as potentially teratogenic and embryo-/fetotoxic. Therefore, Beovu should not be used during pregnancy unless the potential benefits outweigh the potential risks to the fetus.
2 Breast-feeding It is unknown if brolucizumab is transferred into human milk after administration of Beovu. There are no data on the effects of Beovu on the breastfed child or on milk production. Because of the potential for adverse drug reactions in the breastfed child, breastfeeding is not recommended during treatment with Beovu and for at least one month after the last dose when stopping treatment with Beovu.
3 […]
Patient’s medical history for hypersensitivity reactions should be carefully evaluated prior to performing the intravitreal procedure (see 2 CONTRAINDICATIONS). Immediately following the intravitreal injection, patients should be monitored for elevation in intraocular pressure.
Appropriate monitoring may consist of a check for perfusion of the optic nerve head or tonometry. g. eye pain, redness of the eye, photophobia, blurring of vision) without delay. For information on preparation of Beovu, see Instructions for use below.
0 mm posterior to the limbus into the vitreous cavity, avoiding the horizontal meridian and aiming towards the center of the globe. 05 mL is then delivered slowly; a different scleral site should be used for subsequent injections. Instruction for use of the Beovu pre-filled syringe Storage and inspection Store Beovu in the refrigerator (2°C to 8°C).
Do not freeze. Keep the pre- filled syringe in its sealed blister and the outer carton in order to protect from light. Prior to use, the unopened blister with pre-filled syringe of Beovu may be kept at room temperature (below 25°C) for up to 24 hours.
Make sure that your pack contains a sterile pre-filled syringe in a sealed blister. After opening the blister pack, proceed under aseptic conditions. Beovu is a clear to slightly opalescent and colourless to slightly brownish- yellow aqueous solution.
The solution should be inspected visually upon removal from the refrigerator and prior to administration. If particulates or cloudiness are visible, the pre-filled syringe must not be used and appropriate replacement procedures followed.
The pre-filled syringe is sterile and for single-use only. Do not use if the packaging, or pre-filled syringe are damaged or expired. How to prepare and administer Beovu The intravitreal injection procedure must be carried out under aseptic conditions, which includes the use of surgical hand disinfection, sterile gloves, a sterile drape, a sterile eyelid speculum (or equivalent), and the availability of sterile paracentesis equipment (if required).
Adequate anesthesia and a broad-spectrum topical microbicide to disinfect the periocular skin, eyelid and ocular surface should be administered prior to the injection. For intravitreal injection, use a 30G x ½ inch sterile injection needle.
The injection needle is not included in the Beovu pack. 05 mL. 05 mL), a portion of the volume contained in the pre-filled syringe must be discarded prior to administration. Injecting the entire volume in the pre-filled syringe could result in overdose.
Ensure that the injection is given immediately after preparation of the dose (Step 5). PrBEOVU® (brolucizumab injection) Page 7 of 35 Injection procedure 1 Peel the lid off the syringe tray and, using aseptic technique, remove the syringe.
2 Snap off (do not turn or twist) the syringe cap. 3 Aseptically and firmly assemble a 30G x ½” injection needle onto the syringe. 4 To check for air bubbles, hold the syringe with the needle pointing up. If there are any air bubbles, gently tap the syringe with your finger until the bubbles rise to the top.
Carefully remove the needle cap by pulling it straight off. 05 mL dose mark. The syringe is […]