Vsiqq Injection
Brolucizumab Intravitreal Inj
6mg/0.05ml
Novartis (Bangladesh) Ltd.
| Pack size | 0.05ml |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 32030.00 AED |
Available as:
Indications
Vsiqq Injection is used for:
Neovascular (Wet) Age-Related, Macular Degeneration (AMD), Diabetic Macular Edema (DME)
Adult Dose
Intravitreal Injections
Neovascular (Wet) Age-Related Macular Degeneration (AMD): The recommended dose for Brolucizumab 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.
Diabetic Macular Edema (DME): The recommended dose for Brolucizumab is 6 mg (0.05 mL of 120 mg/mL solution) every six weeks (approximately every 39-45 days) for the first five doses, followed by one dose of 6 mg (0.05 mL of 120 mg/mL solution) every 8-12 weeks.
Child Dose
Renal Dose
Renal impairment
Effect of severe renal impairment or any degree of hepatic impairment on the pharmacokinetics of brolucizumab is unknown
Significant increases in serum brolucizumab exposures are not expected with intravitreal route of administration; no dosage adjustment is needed based on renal impairment status
Administration
Intravitreal Preparation
Before use, unopened glass vial may be kept at room temperature (20-25ºC [68-77ºF]) for up to 24 hr
After vial is opened, proceed under aseptic conditions
Inspect visually before administration; do not use if particulates, cloudiness, or discoloration are visible
Kit includes sterile glass vial and filter needle which are for single use only
Do not use if packaging, vial and/or filter needle are damaged or expired
See prescribing information with diagrams for precise steps to aseptically prepare dose
Intravitreal Administration
Administer immediately after dose preparation
Intravitreal injection procedure must be carried out under aseptic conditions, which includes the use of surgical hand disinfection, sterile gloves, a sterile drape and 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 beforehand
Inject slowly until the rubber stopper reaches the end of the syringe to deliver the volume of 0.05 mL; confirm delivery of the full dose by checking that the rubber stopper has reached the end of the syringe barrel
Immediately following the intravitreal injection, monitor for elevated IOP; check for perfusion of the optic nerve head or tonometry; if required, a sterile paracentesis needle should be available
Following injection, instruct patient to report any symptoms suggestive of endophthalmitis or retinal detachment (eg, eye pain, redness of the eye, photophobia, blurring of vision) without delay
Vial is for treatment of a single eye; if the contralateral eye requires treatment, a new vial should be used and the sterile field, syringe, gloves, drapes, eyelid speculum, filter, and injection needles should be changed before brolucizumab is administered to the other eye
Dispose of unused medicinal product or waste material according to local regulations
Contra Indications
Hypersensitivity
Ocular or periocular infections
Active intraocular inflammation
Precautions
Hypersensitivity reactions may manifest as rash, pruritus, urticaria, erythema, or severe intraocular inflammation
Endophthalmitis and retinal detachment may occur following intravitreal injections. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay.
Retinal vasculitis and/or retinal vascular occlusion, typically in the presence of intraocular inflammation, have been reported following BEOVU injections. Patients should be instructed to report any change in vision without delay.
Increases in intraocular pressure (IOP) have been seen within 30 minutes of an intravitreal injection.
There is a potential risk of arterial thromboembolic events (ATE) following intravitreal use of VEGF inhibitors
MONITORING PARAMETERS
Monitor intra-ocular pressure, perfusion of the optic nerve head, and for signs of ocular infection following injection.
Monitor visual acuity.
Pregnancy-Lactation
Pregnancy
There are no adequate and well-controlled studies in pregnant women
Based on anti-VEGF mechanism of action, treatment may pose risk to human embryofetal development
Use during pregnancy only if the potential benefit outweighs the potential fetal risk
Animal data
VEGF inhibition has been shown to cause malformations, embryofetal resorption, and decreased fetal weight
VEGF inhibition has also been shown to affect follicular development, corpus luteum function, and fertility
Contraception
Females of reproductive potential should use highly effective contraception (methods that result in <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
Interactions
Adverse Effects
Side effects of Brolucizumab Intravitreal Inj :
1-10%
Blurred vision (10%)
Cataract (7%)
Conjunctival hemorrhage (6%)
Vitreous floaters (5%)
Eye pain (5%)
Intraocular inflammation (4%)
Intraocular pressure increased (4%)
Retinal hemorrhage (4%)
Vitreous detachment (4%)
Conjunctivitis (3%)
Retinal pigment epithelial tear (3%)
Corneal abrasion (2%)
Hypersensitivity (2%)
Punctate keratitis (1%)
Retinal tear (1%)
Endophthalmitis (1%)
Blindness (1%)
Retinal artery occlusion (1%)
Retinal detachment (1%)
Conjunctival hyperemia (1%)
Lacrimation increased (1%)
Abnormal sensation in eye (1%)
Detachment of retinal pigment epithelium (1%)
Mechanism of Action
Human VEGF inhibitor; binds to the 3 major VEGF-A isoforms (eg, VEGF110, VEGF121, VEGF165), thereby preventing interaction with receptors VEGFR-1 and VEGFR-2
By inhibiting VEGF-A, brolucizumab suppresses endothelial cell proliferation, neovascularization, and vascular permeability
Note
Vsiqq 6mg/0.05ml Injection manufactured by Novartis (Bangladesh) Ltd.. Its generic name is Brolucizumab Intravitreal Inj. Vsiqq is availble in Bangladesh.
Farmaco BD drug index information on Vsiqq Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.