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SUSVIMO is a brand name for Ranibizumab, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
). Hypersensitivity As with all therapeutic proteins, there is a theoretical risk of hypersensitivity reactions including anaphylaxis. Hypersensitivity reactions may manifest as rash, pruritus, urticaria, erythema, severe anaphylactic/anaphylactoid reactions or severe intraocular inflammation.
). 2 Clinical Trial Adverse Reactions). These events may result in severe vision loss/blindness. 5% in the intravitreal arm). 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 of the cases of endophthalmitis reported a preceding or concurrent conjunctival retraction or erosion event. Patients should be instructed to report any symptoms suggestive of endophthalmitis without delay. Endophthalmitis should be treated promptly and appropriately in an effort to reduce the risk of vision loss and maximize recovery.
2 Recommended Dose and Dosage Adjustment). 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-exchange procedure. Strict aseptic technique should always be used during Susvimo implant insertion or refill-exchange procedures.
4 Administration). Strict adherence to intraoperative handling, secure closure of the PrSUSVIMOTM (ranibizumab injection) Page 10 of 41 conjunctiva and Tenon’s capsule, and early detection and surgical repair of conjunctival erosions or retractions may reduce the risk of endophthalmitis.
2 Clinical Trial Adverse Reactions). These adverse events primarily occurred after the implant insertion surgery and during the post-operative period. In clinical trials in adult wet AMD patients, the most frequently reported type of intraocular inflammation in the study eye was iritis.
2 Recommended Dose and Dosage Adjustment). Appropriate sterility control before and during implant insertion surgery, and administration of post-operative eye medications should be used to minimize risk of intraocular inflammation. Rhegmatogenous Retinal Detachment Rhegmatogenous retinal detachment has been reported in patients receiving Susvimo and may result in severe vision loss (see 8 ADVERSE REACTIONS).
, pneumatic retinopexy, vitrectomy, or laser photocoagulation). 2 Recommended Dose and Dosage Adjustment). Patients should be instructed to report any symptoms suggestive of rhegmatogenous retinal detachment without delay. Careful evaluation of the retinal periphery by scleral indentation should be performed, and any suspected areas of abnormal vitreo-retinal adhesion or retinal breaks should be treated before inserting the implant in the eye.
g. 4 Administration). Vitreous Hemorrhage Vitreous hemorrhage has been reported in patients receiving Susvimo (see 8 ADVERSE REACTIONS). Vitreous hemorrhage may result in temporary vision loss. Vitrectomy may be needed in the case of a non-clearing vitreous hemorrhage.
2 Clinical Trial Adverse Reactions). Endophthalmitis should be treated promptly to reduce the risk of vision loss. Appropriate conjunctiva management and early detection with surgical repair of conjunctival retractions or erosions may reduce the risk of endophthalmitis.
4 Administration). Susvimo should only be administered to patients who have been well informed of the risks associated with the Susvimo procedures of insertion, refill-exchange and removal. PrSUSVIMOTM (ranibizumab injection) Page 5 of 41 Patients should be instructed on how to take care of their eyes throughout treatment with Susvimo to prevent serious adverse events, including endophthalmitis.
4 Administration). 4. 1 Dosing Considerations General Susvimo is for intravitreal use via the implant for Susvimo only. , not as a bolus intravitreal injection). The implant initial fill and implant insertion, and implant removal procedures must be performed by an ophthalmologist experienced in vitreoretinal surgery and trained in implant procedures in an operating room using aseptic technique.
The implant refill-exchange procedure should be performed under aseptic conditions by an ophthalmologist trained in the implant refill-exchange procedure. Read and refer to the manufacturer’s most up-to-date Instructions for Use for the Implant with Insertion Tool Assembly for Susvimo and Initial Fill Needle for Susvimo; Refill Needle for Susvimo; or Explant Tool for Implant for Susvimo prior to initially filling, implanting, refilling or removing the implant.
In order to prevent medication errors, it is important to check the vial labels to ensure that the drug being prepared and administered is Susvimo. Do not substitute Susvimo for or with other formulations of ranibizumab. 02mL of 100 mg/mL solution) continuously delivered via the Susvimo implant with refills administered every 24 weeks (approximately 6 months).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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2 Recommended Dose and Dosage Adjustment). 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.
g. 4 Administration). 2 Clinical Trial Adverse Reactions). A conjunctival bleb is an encapsulated elevation of the conjunctiva above the implant PrSUSVIMOTM (ranibizumab injection) Page 11 of 41 flange, which may be secondary to subconjunctival thickening or fluid.
Conjunctival blebs may require additional surgical and/or medical management to avoid further complications, especially if the implant septum is no longer identifiable due to the conjunctival bleb. g. appropriate scleral incision length, appropriate incorporation of conjunctiva and Tenon’s capsule to preserve tissue integrity and secure peritomy closure, appropriate seating of the refill needle during refill-exchange procedure) is required to minimize risks of conjunctival blebs (see […]
Monitoring between the refill dosing visits may be required by the treating physician as needed. 5 mg (10 mg/mL) intravitreal ranibizumab injection may be administered in the affected eye while the Susvimo implant is in place and if clinically necessary (see 14 CLINICAL TRIALS).
5 mg (10 mg/mL) intravitreal ranibizumab injection for supplemental treatment. Dose (Refill-exchange) interruptions related to adverse events For dose (refill-exchange) interruptions related to adverse events see Table 1. g. , septum dislodgement) or implant dislocation (see 7 WARNINGS AND PRECAUTIONS) Withhold dose (refill-exchange) Consider implant removal Risks associated with removal or retention of a damaged or non-functional implant have not been established (see 7 WARNINGS AND PRECAUTIONS, Others).
3 Pharmacokinetics; Special Populations and Conditions, Geriatrics). 3 Pharmacokinetics; Special Populations and Conditions. 3 Pharmacokinetics; Special Populations and Conditions). 3 Reconstitution Not applicable. 4 Administration Susvimo can only be administered to patients who have been well informed of the risks associated with the Susvimo procedures of insertion, refill-exchange and removal and have signed the surgical consent form as required by local clinical practice.
Susvimo should only be administered to patients who have been advised how to take care of their eyes to prevent serious adverse events, including endophthalmitis, throughout treatment with Susvimo, including after the insertion of implant surgery, refill-exchange, or removal of implant.
Patients should be advised to seek immediate care from an ophthalmologist if there are sudden changes in vision throughout Susvimo treatment. 02 mL of Susvimo (ranibizumab injection) prior to implant insertion. No more than 30 minutes should pass between the initial fill of the ocular implant and the insertion into the patient’s eye.
The initial fill needle should only be used for the initial fill. Please refer to the manufacturer’s most up-to-date Instructions for Use for the Initial Fill Needle for Susvimo. Susvimo Ocular Implant Insertion Susvimo ocular implant insertion is a surgical procedure that must be performed by an […]