Susvimo®

GoodRx

Ranibizumab · intravitreal implant

Injections & Implants

Indication

Neovascular (wet) age-related macular degeneration, diabetic macular edema, and diabetic retinopathy, in patients who have previously responded to at least two intravitreal injections of a VEGF inhibitor.

Contraindications

Ocular or periocular infections
Active intraocular inflammation
Hypersensitivity to ranibizumab products or any of the excipients

Available Forms

100 mg/mL single-dose vial, initial fill needle, refill needle

Mechanism of Action

Ranibizumab binds to the receptor binding site of multiple biologically active forms of VEGF-A, including VEGF 110. The binding of ranibizumab 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.

Dosage

For intravitreal use via the SUSVIMO ocular implant. The recommended dose is 2 mg (0.02 mL of 100 mg/mL solution) continuously delivered via the implant, with refills every 24 weeks in neovascular AMD and diabetic macular edema, and every 36 weeks in diabetic retinopathy. Supplemental treatment with 0.5 mg intravitreal ranibizumab injection may be administered in the affected eye if clinically necessary. The initial fill, implant insertion and implant removal procedures must be performed under aseptic conditions by a physician experienced in vitreoretinal surgery. Do not administer as a bolus intravitreal injection, and do not substitute other ranibizumab products.

Warnings & Precautions

Endophthalmitis: the implant has been associated with a 3-fold higher rate of endophthalmitis than monthly intravitreal injections of ranibizumab (1.7% vs 0.5%). Many, but not all, of the cases reported a preceding or concurrent conjunctival retraction or erosion event.
Rhegmatogenous retinal detachment: associated with the implant and implant-related procedures.
Implant dislocation: associated with the implant and implant-related procedures.
Septum dislodgement: associated with the implant and implant-related procedures.
Vitreous hemorrhage: temporarily discontinue antithrombotic medication prior to the implant insertion procedure to reduce the risk.
Conjunctival erosion, retraction or bleb: the implant and the tissue overlying the implant flange should be monitored routinely following the implant insertion and refill-exchange procedures.
Postoperative decrease in visual acuity: a decrease in visual acuity usually occurs over the first two postoperative months.

Common Side Effects

The most common adverse reactions, each in at least 10% of patients, were conjunctival hemorrhage, conjunctival hyperemia, iritis, eye pain, conjunctival disorder, cataract and vitreous hemorrhage.

Pregnancy & Lactation

Pregnancy: There are no adequate and well-controlled studies of SUSVIMO administration in pregnant women. Administration of ranibizumab to pregnant monkeys throughout the period of organogenesis resulted in a low incidence of skeletal abnormalities, and based on the anti-VEGF mechanism of action treatment may pose a risk to human embryofetal development.

Lactation: There are no data available on the presence of ranibizumab in human milk, the effects of ranibizumab on the breastfed infant or the effects of ranibizumab on milk production. Caution should be exercised when SUSVIMO is administered to a nursing woman.

Pediatric Use

The safety and efficacy of SUSVIMO in pediatric patients have not been established.