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RANOPTO 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: Indications have been granted on the basis of similarity between RANOPTO™ (ranibizumab injection) and the reference biologic drug Lucentis®. RANOPTO™ (ranibizumab injection) is indicated in adults for: • the treatment of neovascular (wet) age-related macular degeneration (AMD). • the treatment of visual impairment due…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Single-use vial for intravitreal use only. Use of more than one injection from a vial can lead to contamination and subsequent infection. Ranopto (ranibizumab injection) vials do not contain any preservative agent (see
). Patients who experience these For management of a suspected drug overdose, contact your regional Poison Control Centre. RANOPTO (ranibizumab injection) Page 10 of 97 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 Ranopto. Patients should be instructed to report if an intraocular inflammation increases in severity, which may be a clinical sign attributable to intraocular antibody formation.
5 Clinical Trials – Reference Biologic Drug) Ranopto has not been studied in patients with active systemic infections. Ophthalmologic Endophthalmitis and Retinal detachments Intravitreal injections, including those with Ranopto, 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 Ranopto. 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 Ranopto (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 optic nerve head immediately after the injection and /or tonometry within 30 minutes following the injection. Ranopto has not been studied in patients who have previously received other types of intravitreal injections.
General Treatment with Ranopto (ranibizumab injection) is for intravitreal injection only. Driving and Operating Machinery The Ranopto treatment procedure may induce temporary visual disturbances, which may affect the ability to drive or use machines (see
Ranopto is contraindicated in: • Patients who are hypersensitive 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 infections. • Patients with active intraocular inflammation. RANOPTO (ranibizumab injection) Page 5 of 97
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Ranibizumab in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Ranopto should not be administered concurrently with other anti-VEGF agents (systemic or ocular). Bilateral Treatment and Populations with Limited Data Available data do not suggest an increased risk of systemic adverse events with bilateral treatment.
The efficacy of Ranopto therapy administered to both eyes concurrently has not been studied. Ranopto 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 with ranibizumab on a limited number of patients with prior episodes of RVO and of patients with ischemic branch RVO (BRVO) and central RVO (CRVO).
In patients with RVO presenting with clinical signs of irreversible ischemic visual function loss, treatment is not recommended. 3 Pharmacokinetics). The clinical significance of increased systemic exposure to ranibizumab is unknown.
RANOPTO (ranibizumab injection) Page 11 of 97 Reproductive Health:
Female and Male Potential Fertility There is no fertility data available. Teratogenic Risk Women of childbearing potential should use effective contraception during treatment. Systemic Effects Thromboembolic events Although there was a low rate of arterial thromboembolic events (ATEs) observed in the ranibizumab 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 Ranopto is appropriate, and the benefit outweighs the potential risk. , if the benefit to the patient outweighs the risk.
Non-ocular hemorrhages Non-ocular hemorrhages have been reported following intravitreal injection of VEGF inhibitors, including Ranopto in clinical trials for adults (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 Ranopto during human pregnancy are available. Studies in cynomolgus monkeys do not indicate direct or indirect harmful effects with respect to pregnancy or embryonal/fetal development (see 16 NON-CLINICAL TOXICOLOGY).
The systemic exposure to ranibizumab is low after ocular administration, but due to its mechanism of action, Ranopto must be regarded as potentially teratogenic and embryo-/fetotoxic. Therefore, Ranopto 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 Ranopto, it is recommended to wait at least 3 months after the last dose of Ranopto before conceiving a child. 2 Breast-feeding Based on limited data, ranibizumab is present in human milk following the intravitreal administration of ranibizumab 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 Ranopto. 3 Pediatrics Pediatrics (< 18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.
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