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LUCENTIS is a brand name for Ranibizumab, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: LUCENTIS® (ranibizumab injection) is indicated in adults for: the treatment of neovascular (wet) age related macular degeneration (AMD). the treatment of visual impairment due to diabetic macular edema (DME). the treatment of visual impairment due to macular edema secondary to retinal vein occlusion (RVO). the…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Single-use vial (adults and preterm infants) or single-use pre-filled syringe (adults only) for intravitreal use only. Use of more than one injection from a vial can lead to product contamination and subsequent ocular infection.
Lucentis (ranibizumab injection) vials and pre- filled syringes do not contain any preservative agent (see
). Patients who experience these signs must not drive or use machines until these temporary visual disturbances subside. Immune Hypersensitivity As with all therapeutic proteins, there is a potential for immunogenicity with Lucentis.
Patients should be instructed to report if an intraocular inflammation increases in severity, which may be a clinical sign attributable to intraocular antibody formation. 3 Immunogenicity section). Lucentis has not been studied in patients with active systemic infections.
Neurologic Neurodevelopment impairment have been reported in preterm infants treated for ROP with anti- VEGF, including Lucentis (see 8 ADVERSE REACTIONS). Long-term neurodevelopment has not been studied in preterm infants treated for ROP with Lucentis beyond two years.
Ophthalmologic Endophthalmitis and Retinal detachments Intravitreal injections, including those with Lucentis, have been associated with endophthalmitis, intraocular inflammation, hypopyon, rhegmatogenous retinal detachment, retinal tear and iatrogenic traumatic cataract (see 8 ADVERSE REACTIONS).
Proper aseptic injection techniques must always be used when administering Lucentis. In addition, patients should be monitored during the week following the injection to permit early treatment if an infection occurs. Patients should be instructed to report any symptoms suggestive of endophthalmitis or any of the aforementioned events without delay.
Increases in Intraocular Pressure Transient increases in intraocular pressure (IOP) have been seen within 60 minutes of injection of Lucentis (see 8 ADVERSE REACTIONS). Sustained IOP increases have also been reported. Both intraocular pressure and the perfusion of the optic nerve head must therefore be monitored and managed appropriately.
Monitoring may consist of a check for perfusion of the NOC/c NOC/c Page 17 of 112 optic nerve head immediately after the injection and / or tonometry within 30 minutes following the injection. Lucentis has not been studied in patients who have previously received other types of intravitreal injections.
General Treatment with Lucentis (ranibizumab injection) is for intravitreal injection only. The WARNINGS AND PRECAUTIONS for adults also apply to preterm infants with ROP. Potential systemic suppression of VEGF cannot be excluded following intravitreal administration of ranibizumab in premature infants with ROP (see 10 CLINICAL PHARMACOLOGY, Pediatrics population -Preterm infants with ROP).
The safety in preterm infants beyond two years has not been studied. Long-term safety has not been established. Driving and Operating Machinery The Lucentis treatment procedure may induce temporary visual disturbances, which may affect the ability to drive or use machines (see
Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION and PACKAGING section . Patients with active or suspected ocular or periocular infections.
Patients with active intraocular inflammation.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Lucentis should not be administered concurrently with other anti-VEGF agents (systemic or ocular). Bilateral treatment Available data do not suggest an increased risk of systemic adverse events with bilateral treatment. The efficacy of Lucentis therapy administered to both eyes concurrently has not been studied.
Lucentis has not been studied in patients with concurrent eye conditions such as retinal detachment or macular hole. Additional experience has been gained from post-approval studies on a limited number of patients with prior episodes of RVO and of patients with ischemic branch RVO (BRVO) and ischemic central RVO (CRVO).
In patients with RVO presenting with clinical signs of irreversible ischemic visual function loss, treatment is not recommended. Renal Systemic exposure to Lucentis may be increased in patients with renal impairment (see 10 CLINICAL PHARMACOLOGY – Special Populations and Conditions).
The clinical significance of increased systemic exposure to Lucentis is unknown.
Reproductive Health:
Female and Male Potential Women of childbearing potential Women of childbearing potential should use effective contraception during treatment. Fertility There is no fertility data available. Systemic Effects Thromboembolic events Although there was a low rate of arterial thromboembolic events (ATEs) observed in the Lucentis clinical trials, there is a potential risk of ATEs following intravitreal use of VEGF inhibitors.
ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause). The risk of stroke may be greater in patients with known risk factors, including history of prior stroke or transient ischemic attack [see 8 ADVERSE REACTIONS].
Therefore, these patients should be carefully evaluated by their physician to determine whether treatment with Lucentis is appropriate, and the benefit outweighs the potential risk. , if the benefit to the patient outweighs the risk.
Non-ocular hemorrhages LUCENTIS® (ranibizumab injection) Page 18 of 112 Non-ocular hemorrhages have been reported following intravitreal injection of VEGF inhibitors, including Lucentis in clinical trials for adults and preterm infants with ROP (see 8 ADVERSE REACTIONS), and there is a potential risk that these may relate to VEGF inhibition.
1 Pregnant Women No clinical data concerning exposure to ranibizumab during human pregnancy are av ailable. Studies in cynomolgus monkeys do not indicate direct or indirect harmful effects with respect to pregnancy or embryonal/fetal development (see 16 NON-CLINICALTOXICOLOGY).
The systemic exposure to ranibizumab is low after ocular administration, but due to its mechanism of action, ranibizumab must be regarded as potentially teratogenic and embryo-/fetotoxic. Therefore, ranibizumab should not be used during pregnancy unless the potential benefit outweighs the potential risk to the fetus.
For women who wish to become pregnant and have been treated with ranibizumab, it is recommended to wait at least 3 months after the last dose of ranibizumab before conceiving a child. 2 Breast-feeding Based on limited data, ranibizumab is present in human milk following the intravitreal administration of Lucentis in lactating women and may suppress VEGF levels in breast milk.
The effects of VEGF suppression in breast milk on the breastfed infant or the effects of ranibizumab on milk production/excretion are unknown. As a precautionary measure, breast- feeding is not recommended during the use of Lucentis.
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