Susvimo (Page 3 of 7)
2.8 Delayed or Missed Doses
If a planned dose (refill-exchange) of SUSVIMO (ranibizumab injection) is missed, it should be administered as soon as possible and the subsequent refill-exchange procedures should be performed 24 weeks (approximately 6 months) thereafter.
2.9 Dosage (Refill-Exchange) Modifications for Adverse Reactions
Table 1 describes dosage modifications for specific adverse Reactions [see Warnings and Precautions (5)]. No dosage reductions for SUSVIMO are recommended.
|Adverse Reactions||Dosage Modification|
|Intraocular inflammation ≥ 1 + cells or flare||Withhold dose (refill-exchange)|
|Sight threatening events (e.g., rhegmatogenous retinal detachment, vitreous hemorrhage, unexplained vision loss, etc.)||Withhold dose (refill-exchange)|
|Local infections of either eye||Withhold dose (refill-exchange)|
|Infectious endophthalmitis||Withhold dose (refill-exchange)|
|Severe systemic infection||Withhold dose (refill-exchange)|
|Observed damage to the implant||Withhold dose (refill-exchange) and consider SUSVIMO implant removal [see Dosage and Administration (2.6, 2.7)].|
3 DOSAGE FORMS AND STRENGTHS
Injection: 100 mg/mL, clear to slightly opalescent, colorless to pale brown solution in a single-dose vial
4.1 Ocular or Periocular Infections
SUSVIMO (ranibizumab injection) is contraindicated in patients with ocular or periocular infections.
4.2 Active Intraocular Inflammation
SUSVIMO (ranibizumab injection) is contraindicated in patients with active intraocular inflammation.
SUSVIMO (ranibizumab injection) is contraindicated in patients with known hypersensitivity to ranibizumab products or any of the excipients in SUSVIMO (ranibizumab injection).
5 WARNINGS AND PRECAUTIONS
The SUSVIMO implant and/or implant-related procedures have been associated with endophthalmitis, rhegmatogenous retinal detachment, implant dislocation, septum dislodgement, vitreous hemorrhage, conjunctival erosion, conjunctival retraction, and conjunctival blebs. Patients should be instructed to report any signs or symptoms that could be associated with these events without delay. In some cases, these events can present asymptomatically. The implant and the tissue overlying the implant flange should be monitored routinely following the implant insertion, and refill-exchange procedures to permit early medical or surgical intervention as necessary. Special precautions need to be taken when handling SUSVIMO components [see How Supplied/Storage and Handling (16.3)].
In the active comparator period of controlled clinical trials, the ranibizumab implant has been associated with a 3-fold higher rate of endophthalmitis than monthly intravitreal injections of ranibizumab (1.7% in the SUSVIMO arm vs 0.5% in the intravitreal arm). When including extension phases of clinical trials, 2.0% (11/555) of patients receiving the ranibizumab implant experienced an episode of endophthalmitis. Reports occurred between days 5 and 853, with a median of 173 days. Many, but not all, of the cases of endophthalmitis reported a preceding or concurrent conjunctival retraction or erosion event.
Endophthalmitis should be treated promptly in an effort to reduce the risk of vision loss and maximize recovery. The SUSVIMO (ranibizumab injection) dose (refill-exchange) should be delayed until resolution of endophthalmitis [see Dosage and Administration (2.9) and Adverse Reactions (6.1)].
Patients should not have an active or suspected ocular or periocular infection or severe systemic infection at the time of any SUSVIMO implant or refill procedure. Appropriate intraoperative handling followed by secure closure of the conjunctiva and Tenon’s capsule, and early detection and surgical repair of conjunctival erosions or retractions may reduce the risk of endophthalmitis [see Warnings and Precautions (5.5)].
5.2 Rhegmatogenous Retinal Detachment
Rhegmatogenous retinal detachments have occurred in clinical trials of SUSVIMO and may result in vision loss. Rhegmatogenous retinal detachments should be promptly treated with an intervention (e.g., pneumatic retinopexy, vitrectomy, or laser photocoagulation). SUSVIMO (ranibizumab injection) dose (refill-exchange) should be delayed in the presence of a retinal detachment or retinal break [see Dosage and Administration (2.9)].
Careful evaluation of the retinal periphery is recommended to be performed, and any suspected areas of abnormal vitreo-retinal adhesion or retinal breaks should be treated before inserting the implant in the eye.
5.3 Implant Dislocation
In clinical trials, the device has dislocated/subluxated into the vitreous cavity or has extended outside the vitreous cavity into or beyond the subconjunctival space. Device dislocation requires urgent surgical intervention. Strict adherence to the scleral incision length and appropriate targeting of the pars plana during laser ablation may reduce the risk of implant dislocation.
5.4 Septum Dislodgement
In clinical trials, a type of implant damage where the septum has dislodged into the implant body has been reported. Perform a dilated slit lamp exam and/or dilated indirect ophthalmoscopy to inspect the implant in the vitreous cavity through the pupil prior to and after the refill-exchange procedure to identify if septum dislodgement has occurred. Discontinue treatment with SUSVIMO (ranibizumab injection) following septum dislodgement and consider implant removal should the benefit of the removal procedure outweigh the risk [see Dosage and Administration (2.8)].
Appropriate handling and insertion of the refill needle into the septum (avoid twisting and/or rotation) is required to minimize the risk of septum dislodgement [see Dosage and Administration (2.7) ].
5.5 Vitreous Hemorrhage
Vitreous hemorrhages may result in temporary vision loss. Vitrectomy may be needed in the case of a non-clearing vitreous hemorrhage [see Dosage and Administration (2.9)].
In clinical trials of SUSVIMO including extension phases, vitreous hemorrhages were reported in 5.2% (23/443) of patients receiving SUSVIMO. The majority of these hemorrhages occurred within the first post-operative month following surgical implantation and the majority of vitreous hemorrhages resolved spontaneously. Patients on antithrombotic medication (e.g., oral anticoagulants, aspirin, nonsteroidal anti-inflammatory drugs) may be at increased risk of vitreous hemorrhage. Antithrombotic medications are recommended to be temporarily interrupted prior to the implant insertion procedure. The SUSVIMO (ranibizumab injection) dose (refill-exchange) should be delayed in the event of sight-threatening vitreous hemorrhage. The use of pars plana laser ablation and scleral cauterization should be performed to reduce the risk of vitreous hemorrhage.
5.6 Conjunctival Erosion or Retraction
A conjunctival erosion is a full thickness degradation or breakdown of the conjunctiva in the area of the implant flange. A conjunctival retraction is a recession or opening of the limbal and/or radial peritomy. Conjunctival erosions or retractions have been associated with an increased risk of endophthalmitis, especially if the implant becomes exposed. Surgical intervention (e.g., conjunctival/Tenon’s capsule repair) is recommended to be performed in case of conjunctival erosion or retraction with or without exposure of the implant flange.
In clinical trials of SUSVIMO including extension phases, 3.6% (16/443) of patients receiving SUSVIMO reported conjunctival erosion and 1.6% (7/443) of patients receiving SUSVIMO reported conjunctival retraction in the study eye.
Appropriate intraoperative handling of conjunctiva and Tenon’s capsule to preserve tissue integrity and secure closure of peritomy while ensuring placement of sutures away from implant edge may reduce the risk of conjunctival erosion or retraction. The implant and the tissue overlying the implant flange should be monitored routinely following the implant insertion.
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