Susvimo

SUSVIMO- ranibizumab injection, solution
Genentech, Inc.

WARNING: ENDOPHTHALMITIS

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)].

1 INDICATIONS AND USAGE

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.

2 DOSAGE AND ADMINISTRATION

2.1 General Information

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.

2.2 Neovascular (Wet) Age-Related Macular Degeneration (AMD)

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).

2.3 Supplemental Treatment with Intravitreal Ranibizumab Injection

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)].

2.4 Ocular Implant Initial Fill

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.
  • One SUSVIMO ocular implant with insertion tool assembly (included)
  • One SUSVIMO initial fill needle (34-gauge with integrated 5 μm filter) with blue cap (included)
  • One SUSVIMO (ranibizumab injection) 100 mg/mL vial (included)
  • One sterile 5-micron filter needle (19-gauge × 1½ inch) (not included)
  • One sterile 1 mL Luer Lock syringe (not included)
Step 2: Transfer Dose from Vial to Syringe
Note: Use the filter needle (not included) to withdraw SUSVIMO (ranibizumab injection) from the vial.
Figure 1
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Figure 1
Do not use the SUSVIMO initial fill needle for this step.
  • Prepare SUSVIMO (ranibizumab injection) vial by removing the flip-off cap and disinfecting the rubber vial septum with alcohol.
  • Attach a filter needle to the syringe by screwing it tightly onto the Luer lock (see Figure 1).
  • Carefully remove the needle cap by pulling it straight off.
  • Using aseptic technique, withdraw all of the contents of the SUSVIMO (ranibizumab injection) vial through the filter needle into the syringe.
Step 3: Remove Air from Syringe
  • With the filter needle attached, hold the syringe with the needle pointing up.
  • If there are any air bubbles, gently tap the syringe with your finger until the bubbles rise to the top (Figure 2).
  • Slowly push the plunger rod just until all air is expelled from the syringe and needle.
    It is important to preserve as much drug as possible in order to completely fill the implant.
  • Remove and properly dispose of the filter needle after air is removed from syringe.
Figure 2Figure2
Step 4: Attach SUSVIMO Initial Fill Needle Do not use the filter needle to fill the implant.
  • Attach the SUSVIMO initial fill needle (included) firmly onto the syringe by screwing it tightly onto the Luer lock (see Figure 3). Ensure that the initial fill needle is attached to the syringe.
  • Carefully remove the needle cap by pulling straight off.
  • Do not wipe the needle at any time.
Figure 3Figure 3
Step 5: Remove Any Remaining Air from Syringe
  • With the initial fill needle attached, hold the syringe with the needle pointing up.If there are any air bubbles, gently tap the syringe with your finger until the bubbles rise to the top (see Figure 4).
  • Slowly push the plunger rod just until all air is expelled from the syringe and needle, and a drop of drug solution is seen at the needle tip (see Figure 5).
Figure 4
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Figure 4
Figure 5
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Figure 5
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
  • Inspect the syringe and the needle hub to ensure that no air bubbles are present (see Figure 6).
  • If air bubbles are present, continue to remove air from the syringe and reinspect.
Figure 6
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Figure 6
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.
  • Retrieve insertion tool carrier with pre-positioned implant from the inner tray.
  • Align the syringe Luer lock above the Luer lock slot in the carrier to protect the needle from being damaged.
  • Lower the syringe into the carrier (see Figure 7).
  • Push the syringe forward until it stops, taking care to avoid touching the plunger rod (see Figure 8)
  • With the syringe loaded, (see Figure 9) the initial fill needle should now be penetrating the implant septum.
Figure 7Figure 7: Align and lower the syringe into the carrierFigure 8Figure 8: Push the syringe into the carrier
Figure 9
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Figure 9: Syringe with initial fill needle inserted through the implant septum
Step 8: Fill Ocular Implant with SUSVIMO (ranibizumab injection) Under Microscope
  • Under the microscope, slowly administer SUSVIMO (ranibizumab injection) into the ocular implant by slightly tilting the carrier upwards (see Figure 10).
  • The ocular implant should be filled over approximately 5 to 10 seconds, to help avoid air entrapment in the implant reservoir.
Figure 10
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Figure 10: Administer ranibizumab into the implant
Figure 11
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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.
  • Continue filling the ocular implant until the implant is completely full of drug solution and all air has been expelled as evidenced by a dome of drug solution formed at the tip of the implant on the release control element (see Figure 11).
Step 9: Inspect the Filled Ocular Implant Under the Microscope
  • Inspect the ocular implant under the microscope to ensure that the ocular implant is completely full of drug solution (see Figure 12).
Figure 12Figure 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
  • Remove the syringe and guide sleeve from the carrier by pulling back on the syringe (see Figure 13). The syringe will be locked into the guide sleeve.
  • Properly dispose of the used syringe together with the needle and guide sleeve in a sharps disposal container or in accordance with local requirements.
Figure 13
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Figure 13: Remove the syringe and guide sleeve from the insertion tool carrier
Step 11: Slide the Insertion Tool Handle into the Carrier
  • Slide the insertion tool handle into the guide channel of the carrier, ensuring that both components are facing upwards (see Figure 14).
  • Push the handle forward as far as it will go into the gripper tips (see Figure 15).
Figure 14
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Figure 14: Insert the handle into the insertion tool carrier
Figure 15
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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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