ranibizumab intravitreal implant (Rx)

Brand and Other Names:Susvimo
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

solution, intravitreal (via implant)

  • 100mg/mL single-dose glass vial
  • Initial kit and refill also contain fill needle (34-gauge needle with a 5-micron integrated filter)

Neovascular (Wet) Age-related Macular Degeneration

Indicated for treatment of neovascular (wet) AMD in patients who have previously responded to ≥2 intravitreal injections of a vascular endothelial growth factor (VEGF) inhibitor medication

2 mg (0.02 mL of 100 mg/mL solution) continuously delivered via ocular implant q24Weeks (~6 months)

Supplemental treatment: 0.5 mg (0.05 mL of 10 mg/mL) ranibizumab intravitreal injection in the affected eye while implant is in place and if clinically necessary

Dosage Modifications

Withhold dose (refill-exchange) for the following:

  • Intraocular inflammation ≥1+ cells or flare
  • Sight threatening events (eg, rhegmatogenous retinal detachment, vitreous hemorrhage, unexplained vision loss)
  • Local infections of either eye
  • Infectious endophthalmitis
  • Severe systemic infection
  • Observed damage to the implant; consider implant removal

Renal impairment

  • Systemic clearance of ranibizumab was slightly lower in renally impaired patients, but was not clinically significant

Dosing Considerations

Do not administer ranibizumab intravitreal implant as a bolus intravitreal injection

Do not substitute with other ranibizumab products

Safety and efficacy not established

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Interactions

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                    Adverse Effects

                    >10%

                    Conjunctival hemorrhage (72%)

                    Conjunctival hyperemia (26%)

                    Iritis (23%)

                    1-10%

                    Eye pain (10%)

                    Vitreous floaters (9%)

                    Conjunctival bleb/ filtering bleb leak (9%)

                    Foreign body sensation in eyes (7%)

                    Headache (7%)

                    Hypotony of eye (6%)

                    Vitreous detachment (6%)

                    Vitreous hemorrhage (5%)

                    Conjunctival edema (5%)

                    Corneal disorder (4%)

                    Corneal abrasion (4%)

                    Corneal edema (4%)

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                    Warnings

                    Black Box Warnings

                    Endophthalmitis

                    • Implant associated with 3-fold higher rate of endophthalmitis than monthly intravitreal injections
                    • 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

                    Contraindications

                    Ocular or periocular infections

                    Active intraocular inflammation

                    Hypersensitivity to ranibizumab or product excipients

                    Cautions

                    Rhegmatogenous retinal detachments (eg, pneumatic retinopexy, vitrectomy, or laser photocoagulation) occurred and may result in vision loss; if this occurs, delay refill-exchange if retinal detachment or retinal break is present; carefully evaluate retinal periphery and treat any suspected areas of abnormal vitreoretinal adhesion or retinal breaks before inserting the implant

                    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

                    Conjunctival erosions or retractions have been associated with increased risk of endophthalmitis; especially when implant is exposed; perform surgical intervention (eg, conjunctival/Tenon’s capsule repair) is recommended if conjunctival erosion or retraction with or without exposure of the implant flange is present

                    Conjunctival blebs may require surgical management to avoid further complications, especially if implant septum is no longer identifiable due to the conjunctival bleb

                    Visual acuity was decreased by 4 letters on average in the first postoperative month and 2 letters on average in the second postoperative month following initial implantation

                    Use caution when performing ophthalmic procedures (eg, B-scan ophthalmic ultrasound, scleral depression, gonioscopy) that may cause deflection of the implant and subsequent injury

                    Endophthalmitis

                    • Risk of endophthalmitis or retinal detachment with intravitreous injections; cases more prevalent in intravitreal implant
                    • Always use proper aseptic injection technique when administering therapy
                    • Monitor and treat promptly to reduce the risk of vision loss and maximize recovery
                    • Patients should not have an active or suspected ocular or periocular infection or severe systemic infection at the time of any 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

                    Air bubbles in implant reservoir

                    • Minimize air bubbles within implant reservoir as they may cause slower drug release
                    • During initial fill procedure, if an air bubble is present, it must be ≤1/3 of the widest diameter of the implant; if excess air is observed after initial fill, do not use the implant
                    • During refill-exchange procedure, if excess air is present in the syringe and needle do not use the syringe and needle; if excess air bubbles are observed after the refill-exchange procedure, consider repeating the refill-exchange procedure.

                    Vitreous hemorrhages

                    • Vitreous hemorrhages may result in temporary vision loss; vitrectomy may be needed in the case of a non-clearing vitreous hemorrhage
                    • Patients on antithrombotic medication (eg, oral anticoagulants, aspirin, nonsteroidal anti-inflammatory drugs) may be at increased risk of vitreous hemorrhage; temporarily hold antithrombotic medications before implant insertion
                    • Delay dose (refill-exchange) in the event of sight-threatening vitreous hemorrhage
                    • Use of pars plana laser ablation and perform scleral cauterization to reduce the risk of vitreous hemorrhage

                    Septum dislodgement

                    • Appropriate handling and insertion of refill needle into septum (avoid twisting and/or rotation) required to minimize risk of septum dislodgement
                    • Implant damage where the septum has dislodged into implant body reported
                    • Perform a dilated slit lamp exam and/or dilated indirect ophthalmoscopy to inspect the implant in vitreous cavity through the pupil before and after refill-exchange procedure to identify if septum dislodgement has occurred
                    • Discontinue treatment following septum dislodgement and consider implant removal should benefit outweigh the risk
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                    Pregnancy & Lactation

                    Pregnancy

                    There are no adequate and well-controlled studies of ranibizumab intravitreal implant in pregnant females

                    Based on mechanism of action, treatment may pose a risk to human embryofetal development

                    Animal data

                    • Administration of ranibizumab to pregnant monkeys during organogenesis resulted in a low incidence of skeletal abnormalities at intravitreal doses up to 41 times of the human exposure

                    Contraception

                    • Females of reproductive potential: Use effective contraception during treatment and for at least 12 months after the last dose

                    Infertility

                    • No studies on the effects of ranibizumab on fertility have been conducted and it is not known whether ranibizumab can affect reproduction capacity
                    • Based on mechanism of action, treatment may pose a risk to reproductive capacity

                    Lactation

                    No data are available on drug presence in human milk, its effects on breastfed infants, or its effects on milk production/excretion

                    Use drug with caution when administering to nursing females

                    Pregnancy Categories

                    A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

                    B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

                    C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

                    D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

                    X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

                    NA: Information not available.

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                    Pharmacology

                    Mechanism of Action

                    Recombinant humanized monoclonal antibody binds and inhibits human vascular endothelial growth factor (VEGF-A)

                    Binding to VEGF-A prevents the interaction of VEGF-A with its receptors (VEGFR1 and VEGFR2) on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation

                    Absorption

                    Peak plasma concentration: 0.48 ng/mL

                    Peak plasma time: 26 days

                    No accumulation in serum when administered with refills every 24 weeks

                    Elimination

                    Excretion profile for ranibizumab following administration is unknown

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                    Administration

                    Intravitreal injection preparation

                    Transfer dose from 100 mg/mL-vial to 1-mL Luer lock syringe by using a 5-micron filter needle (not included in kit) to withdraw all contents of vial; do NOT use initial fill needle for this step

                    With filter needle attached, hold syringe with needle pointing up

                    Gently tap syringe with your finger to allow any air bubbles rise to the top

                    Slowly push plunger rod until air is fully expelled from syringe and needle

                    Remove and discard filter needle

                    Attach initial fill needle (34-gauge, with integrated 5-micron filter and blue cap; provided in kit)

                    Carefully remove cap by pulling straight off; do NOT wipe needle at any time

                    Gently tap syringe to remove bubbles; expel air and set dose

                    Use the syringe within 15 minutes of removing all air to avoid drug from drying in the needle and impeding fluid flow

                    Load syringe into carrier; do not hold or push on the plunger of the syringe while inserting needle into the implant septum

                    Under the microscope, slowly administer ranibizumab into the ocular implant by slightly tilting the carrier upwards; implant should be filled over ~5 to 10 seconds, to help avoid air entrapment in the implant reservoir

                    If solution is leaking from implant at a different location (eg, side of the implant), do not use the ocular implant

                    Inspect ocular implant under the microscope to ensure that implant is completely full of drug solution; ≤30 minutes should pass between initial fill of the implant and insertion into the patient’s eye to ensure that the release control element remains saturated

                    Remove syringe and guide sleeve from carrier by pulling back on the syringe; dispose used syringe and guide sleeve in accordance with local requirements

                    Slide insertion tool handle into carrier; do not withdraw handle and implant until eye is ready for insertion

                    Implant properties

                    • Implant holds 0.02 mL of drug, and is secured within the sclera, by the extrascleral flange that remains visible through the conjunctiva following insertion
                    • Implant septum is self-sealing interface through which ranibizumab is administered to fill the implant

                    Intravitreal Implant Administration

                    Do not administer ranibizumab as a bolus intravitreal injection; do not substitute ranibizumab intravitreal implant with other ranibizumab products

                    See complete instructions for implant initial fill and ocular refill-exchange procedure in the prescribing information

                    Following procedures must be performed under aseptic conditions

                    • Initial fill and ocular implant insertion and implant removal procedures by a physician experienced in vitreoretinal surgery
                    • Ocular implant must be surgically implanted in the eye or removed from the eye (if medically necessary) in an operating room
                    • Refill-exchange procedures by a physician experienced in ophthalmic surgery

                    Handling

                    Do not reprocess, resterilize, or reuse

                    Do not use if sterility has been compromised or contents have been dropped, damaged, or tampered with

                    Do not use past expiration date printed on label

                    Do not open sealed tray until time of use

                    Avoid contact between sharp surgical instruments and implant

                    Storage

                    Initial needle kit

                    • Refrigerate at 2-8ºC (36-46ºF)
                    • Do not freeze
                    • Protect from light
                    • Do NOT shake
                    • Initial fill needle has been sterilized with electron beam processing

                    Unused vials

                    • Refrigerate at 2-8ºC (36-46ºF)
                    • Do not freeze
                    • Protect from light
                    • Do NOT shake
                    • Before use, may be kept at 9-30ºC (48-86ºF) for up to 24 hr provided it is protected from light

                    Implant, insertion tool assembly, refill needle, and explant tool

                    • Store at room temperature 15-25ºC (59-77ºF)
                    • Implant and insertion tool assembly has been sterilized with ethylene oxide gas
                    • Refill needle and explant tool have been sterilized with electron beam processing
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                    Patient Handout

                    A Patient Handout is not currently available for this monograph.
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                    Formulary

                    FormularyPatient Discounts

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                    The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                    Tier Description
                    1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                    2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                    3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                    4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                    5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                    6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                    NC NOT COVERED – Drugs that are not covered by the plan.
                    Code Definition
                    PA Prior Authorization
                    Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                    QL Quantity Limits
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