Ranibizumab intravitreal implant

Ranibizumab intravitreal implant is a prescription medication indicated for the treatment of patients with:

• Neovascular (wet) Age-related Macular Degeneration (AMD) who have previously responded to two or more intravitreal injections of a Vascular Endothelial Growth Factor (VEGF) inhibitor.
• Diabetic Macular Edema (DME) who have previously responded to two or more intravitreal injections of a VEGF inhibitor.
• Diabetic Retinopathy (DR) who have previously responded to two or more intravitreal injections of a VEGF inhibitor.

Ranibizumab intravitreal implant is available under the following different brand names: Susvimo.

Common side effects of Ranibizumab intravitreal implant include:

• conjunctival hemorrhage
• conjunctival hyperemia
• iritis
• conjunctival disorder
• eye pain
• cataract
• sensitivity to light  

Serious side effects of Ranibizumab intravitreal implant include:

• symptoms of endophthalmitis may include increasing eye pain, vision loss, sensitivity to light, or redness in the white of the eye
• symptoms of conjunctival erosion may include a sudden feeling of something in the eye, eye discharge, or excessive watering
• symptoms of conjunctival retraction may include a sudden foreign body sensation in the eye, eye discharge, or excessive watering
• symptoms of rhegmatogenous retinal detachment may include seeing flashing lights,  seeing a curtain or veil covering part of vision, changes in vision, or vision loss
• implant dislocation 
• implant damage
• vitreous hemorrhage 
• symptoms of conjunctival bleb may include a sudden foreign body sensation in the eye, bulge over the white part of the eye, eye discharge or watering of the eye
• temporary decrease in vision after the procedure

Rare side effects of Ranibizumab intravitreal implant include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Solution, intravitreal (via implant)

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

Neovascular (Wet) Age-related Macular Degeneration

Adult dosage

• 2 mg (0.02 mL of 100 mg/mL solution) continuously delivered via ocular implant with refills administered every 24 weeks (approximately 6 months)
• Supplemental treatment: 0.5 mg (0.05 mL of 10 mg/mL) ranibizumab intravitreal injection in the affected eye while the implant is in place, and if clinically necessary

Diabetic Macular Edema

Adult dosage

• 2 mg (0.02 mL of 100 mg/mL solution) continuously delivered via ocular implant with refills administered every 24 weeks (approximately 6 months)

Diabetic Retinopathy

Adult dosage

• 2 mg (0.02 mL of 100 mg/mL solution) continuously delivered via ocular implant with refills administered every 36 weeks (approximately 9 months)

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Visit the RxList Drug Interaction Checker for any drug interactions. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Ocular or periocular infections
• Active intraocular inflammation
• Hypersensitivity to Ranibizumab or product excipients

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Ranibizumab intravitreal implant?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Ranibizumab intravitreal implant?”

Cautions

Endophthalmitis

• Risk of endophthalmitis or retinal detachment with intravitreal injections; cases are more prevalent in intravitreal implants (3-fold higher incidence compared with intravitreal injections)
• 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 conjunctiva and Tenon’s capsule, and early detection and surgical repair of conjunctival erosions or retractions, may reduce endophthalmitis risk

Rhegmatogenous retinal detachment

• Rhegmatogenous retinal detachment reported; may result in vision loss
• Treat promptly with intervention (e.g., pneumatic retinopexy, vitrectomy, or laser photocoagulation)
• Delay refill-exchange if retinal detachment or retinal break is present
• Carefully evaluate the retinal periphery and treat any suspected areas of abnormal vitreoretinal adhesion or retinal breaks before implant insertion

Implant dislocation

• 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

Septum dislodgement

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

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

Conjunctival erosions or retractions

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

Conjunctival blebs

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

Decreased visual acuity

• Visual acuity decreased by 4 letters on average in the first postoperative month and 2 letters on average in the second month following initial implantation in AMD
• In DME, visual acuity was decreased by 7 letters (average) in the first postoperative month and 3 letters in the second postoperative month

Air bubbles in the implant reservoir

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

Implant deflection or movement

• Caution when performing ophthalmic procedures (e.g., B-scan ophthalmic ultrasound, scleral depression, gonioscopy) that may cause deflection of the implant and subsequent injury

Pregnancy and Lactation

• There are no adequate and well-controlled studies of ranibizumab intravitreal implant in pregnant women
• Based on mechanism of action, treatment may pose a risk to human embryofetal development

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 reproductive 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 milk production/excretion
• Use the drug with caution when administering to nursing females