Susvimo Generic Name & Formulations
Legal Class
Rx
General Description
Ranibizumab 100mg/mL; soln for intravitreal use (via ocular implant); preservative-free.
Pharmacological Class
Vascular endothelial growth factor (VEGF) inhibitor.
How Supplied
Kit (single-dose vial + initial fill needle)—1; Single-dose vial—1; Refill needle—1
Manufacturer
Generic Availability
NO
Susvimo Indications
Indications
In adults with neovascular (wet) age-related macular degeneration (AMD) who have previously responded to at least 2 intravitreal injections of a VEGF inhibitor.
Susvimo Dosage and Administration
Adult
See full labeling. Give by intravitreal implant. 2mg (0.02mL of 100mg/mL) continuously delivered via implant. Refill every 24 weeks (approx. 6 months). Supplemental treatment: 0.5mg (0.05mL of 10mg/mL) intravitreal inj into the affected eye while implant is in place, as clinically needed.
Children
Not established.
Susvimo Contraindications
Contraindications
Ocular or periocular infections. Active intraocular inflammation.
Susvimo Boxed Warnings
Boxed Warning
Endophthalmitis.
Susvimo Warnings/Precautions
Warnings/Precautions
Do not administer as bolus intravitreal inj. Do not substitute with other ranibizumab products. Monitor routinely following insertion. Endophthalmitis: treat promptly if occurs; delay dose (refill-exchange) until resolved. Rhegmatogenous retinal detachment: treat promptly; delay dose in presence of retinal detachment or retinal breaks. Evaluate retinal periphery prior to implant insertion. Risk of implant dislocation, septum dislodgement, vitreous hemorrhage, conjunctival blebs, conjunctival erosion or retraction. Decreased visual acuity for 2 months post-op. Improper filling of the implant due to air bubbles; see full labeling. Deflection of the implant due to eye procedures (eg, B-scan ultrasound, scleral depression, gonioscopy). Advise females of reproductive potential to use effective contraception during and for at least 12 months after the last dose. Pregnancy. Nursing mothers.
Susvimo Pharmacokinetics
See Literature
Susvimo Interactions
Interactions
Increased risk of vitreous hemorrhage with antithrombotic medication (eg, oral anticoagulants, aspirin, NSAIDs); temporarily interrupt these prior to implant insertion.
Susvimo Adverse Reactions
Adverse Reactions
Conjunctival hemorrhage/hyperemia/edema, iritis, eye pain, vitreous floaters, foreign body sensation in eyes, headache, hypotony of eye, vitreous detachment, corneal disorder/abrasion/edema.
Susvimo Clinical Trials
See Literature
Susvimo Note
Not Applicable
Susvimo Patient Counseling
See Literature