SUSVIMO- ranibizumab injection, solution
The SUSVIMO implant has been associated with a 3-fold higher rate of endophthalmitis than monthly intravitreal injections of ranibizumab. Many of these events were associated with conjunctival retractions or erosions. Appropriate conjunctiva management and early detection with surgical repair of conjunctival retractions or erosions may reduce the risk of endophthalmitis. In clinical trials, 2.0% of patients receiving a ranibizumab implant experienced at least one episode of endophthalmitis [see Contraindications (4.1), Warnings and Precautions (5.1)].
SUSVIMO (ranibizumab injection) is indicated for the treatment of patients with Neovascular (wet) Age-related Macular Degeneration (AMD) who have previously responded to at least two intravitreal injections of a Vascular Endothelial Growth Factor (VEGF) inhibitor medication.
For Intravitreal Use via SUSVIMO ocular implant.
The SUSVIMO initial fill and ocular implant insertion and implant removal procedures must be performed under aseptic conditions by a physician experienced in vitreoretinal surgery. The SUSVIMO ocular implant must be surgically implanted in the eye or removed from the eye (if medically necessary) in an operating room using aseptic technique. See SUSVIMO Instructions for Use and the standardized steps to optimize surgical outcomes.
SUSVIMO refill-exchange procedures must be performed under aseptic conditions by a physician experienced in ophthalmic surgery [see Dosage and Administration (2.7)].
Do not administer SUSVIMO (ranibizumab injection) as a bolus intravitreal injection. Do not substitute SUSVIMO (ranibizumab injection) with other ranibizumab products.
Initial Fill: One SUSVIMO initial fill needle (34-gauge, with integrated 5 μm filter and blue cap) is included. A 5-micron sterile filter needle (19-gauge × 1½ inch), and a 1 mL Luer lock syringe are needed but not included.
Refill-Exchange: One SUSVIMO refill needle (34-gauge with integrated 5 μm filter and clear cap) is included. A 5-micron sterile filter needle (19-gauge × 1½ inch), and a 1 mL Luer lock syringe are needed but not included.
The recommended dose of SUSVIMO (ranibizumab injection) is 2 mg (0.02 mL of 100 mg/mL solution) continuously delivered via the SUSVIMO ocular implant with refills administered every 24 weeks (approximately 6 months).
Supplemental treatment with 0.5 mg (0.05 mL of 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 Clinical Studies (14)].
The implant initial fill procedure must be performed by a physician experienced in vitreoretinal surgery [ see Dosage and Administration (2.1)]. The implant will be filled using aseptic technique with 0.02 mL of SUSVIMO (ranibizumab injection) prior to insertion of the implant into the patient’s eye [see Dosage and Administration (2.5)]. Refer to the complete SUSVIMO Instructions for Use for the initial fill and implant procedure included in the insertion tool assembly carton for further details.
Use aseptic technique to carry out the following preparation steps prior to insertion of the ocular implant into the patient’s eye:
|Step 1: Gather the supplies needed. |
|Step 2: Transfer Dose from Vial to Syringe|
|Note:||Use the filter needle (not included) to withdraw SUSVIMO (ranibizumab injection) from the vial.|
|Do not use the SUSVIMO initial fill needle for this step.|
|Step 3: Remove Air from Syringe ||Figure2|
|Step 4: Attach SUSVIMO Initial Fill Needle Do not use the filter needle to fill the implant.||Figure 3|
|Step 5: Remove Any Remaining Air from Syringe |
|Note:||It is important to preserve as much drug as possible in order to completely fill the implant.|
|Step 6: Inspect the Syringe for Air Bubbles |
|Note:||Use the syringe within 15 minutes of removing all air to avoid ranibizumab drying in the needle and impeding fluid flow.Do not use the initial fill needle if the needle is clogged.|
|Step 7: Load Syringe into the Carrier Do not hold or push on the plunger rod of the syringe while inserting the needle into the implant septum.||Figure 7: Align and lower the syringe into the carrierFigure 8: Push the syringe into the carrier|
|Step 8: Fill Ocular Implant with SUSVIMO (ranibizumab injection) Under Microscope ||Figure 10: Administer ranibizumab into the implant Figure 11: Dome of drug solution forms at tip of implant as viewed under magnification|
|Note:||When filling the ocular implant, drug solution should only exit the ocular implant from the release control element. If drug solution is leaking from the implant at a different location, such as the side of the implant, do not use the ocular implant.If fluid is leaking from the septum at the needle insertion site, the needle may not be fully penetrating the implant septum. Fully push the syringe forward before continuing to fill the ocular implant.|
|Step 9: Inspect the Filled Ocular Implant Under the Microscope ||Figure 12: Proper appearance of implant after initial filling with ranibizumab|
|Note:||Minimize air bubbles within the implant reservoir as they may cause slower drug release. If an air bubble is present, it must be no larger than 1/3 of the widest diameter of the implant. If excess air is observed, do not use the ocular implant.|
|Note:||No more than 30 minutes should pass between the initial fill of the implant and the insertion into the patient’s eye to ensure that the release control element remains saturated with SUSVIMO (ranibizumab injection). If SUSVIMO (ranibizumab injection) dries in the release control element, the implant may not release the drug properly into the vitreous after insertion.|
|Step 10: Remove the Syringe and Guide Sleeve from the Carrier |
|Step 11: Slide the Insertion Tool Handle into the Carrier||Figure 15: Fully inserted handle|
|Note:||Do not withdraw the handle and implant until the eye is ready for insertion. Contact between the implant and any surface or object – even within the sterile field – may result in the introduction of a foreign body into the vitreous.|
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