ranibizumab (Rx)

Brand and Other Names:Lucentis
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

intravitreal injectable preservative-free solution

  • 6mg/mL (0.05mL [0.3mg/vial])
  • 10mg/mL (0.05mL [0.5mg/vial])
  • 6mg/mL (0.05mL [0.3mg/prefilled syringe])
  • 10mg/mL (0.05mL [0.5mg/prefilled syringe])
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Neovascular (Wet) Age-related Macular Degeneration

Indicated for the treatment of patients with neovascular (wet) age-related macular degeneration (AMD)

0.5 mg (0.05 mL of 10 mg/mL solution) intravitreal qMonth (~q28 days)

May give q3month after 3 or 4 monthly injections (if continued monthly dosing not feasible) but is less effective than once monthly dosing

Macular Edema

Indicated for macular edema following retinal vein occlusion

0.5 mg (0.05 mL of 10 mg/mL solution) intravitreal injection qMonth (~q28 days) x6 months

Diabetic Macular Edema

Indicated for diabetic macular edema (DME)

0.3 mg (0.05 mL of 6 mg/mL solution) intravitreally qMonth (~q28 days)

Diabetic Retinopathy

Indicated for treatment of diabetic retinopathy in patients with or without diabetic macular edema (DME)

0.3 mg (0.05 mL of 6 mg/mL solution) intravitreally qMonth (~q28 days)

Myopic Choroidal Neovascularization

Indicated for treatment of myopic choroidal neovascularization (mCNV)

0.5 mg (0.05 mL of 10 mg/mL solution) intravitreal injection qMonth initially, for up to 3 months

May retreat if needed, based on assessment of mean baseline change in visual acuity (BCVA)

Dosage Modifications

Renal impairment

  • No dosage adjustment necessary

Safety and efficacy not established

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Interactions

Interaction Checker

and ranibizumab

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Conjunctival hemorrhage (43-77%)

            Eye pain (17-37%)

            Vitreous floaters (3-32%)

            Increased intraocular pressure (IOP) (8-24%)

            Vitreous detachment (7-22%)

            Eye irritation (4-19%)

            Intraocular inflammation (5-18%)

            Headache (2-15%)

            Upper respiratory tract infection (2-15%)

            Retinal disorder (13%)

            Blepharitis (3-13%)

            Retinal degeneration (1-11%)

            1-10%

            Conjunctival hyperemia (9%)

            Posterior capsule opacification (8%)

            Injection site hemorrhage (5%)

            Vitreous hemorrhage (4%)

            Postmarketing Reports

            Ocular: Tear of retinal pigment epithelium among patients with neovascular AMD

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            Warnings

            Contraindications

            Hypersensitivity

            Ocular/periocular infections

            Cautions

            Risk of endophthalmitis or retinal detachment with intravitreous injections

            Possibility of IOP increase within 60 min of intravitreal injection

            Potential for adverse thromboembolic events (eg, nonfatal stroke, nonfatal MI, vascular death)

            Temporary visual disturbances may occur

            Fatal events occurred more frequently in patients with diabetic macular edema and diabetic retinopathy at baseline, who were treated monthly compared with control

            No studies on effects of ranibizumab on fertility conducted; not known whether ranibizumab can affect reproduction capacity; based on anti-VEGF mechanism of action for ranibizumab, therapy may pose risk to reproductive capacity

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            Pregnancy & Lactation

            Pregnancy

            There are no adequate and well-controlled studies in pregnant women

            Administration of ranibizumab to pregnant monkeys throughout the period of organogenesis resulted in a low incidence of skeletal abnormalities at intravitreal doses 13-times the predicted human exposure (based on maximal serum trough levels [Cmax]) after a single eye treatment at the recommended clinical dose

            Ranibizumab should be given to a pregnant woman only if clearly needed

            Lactation

            There are no data available on presence of ranibizumab in human milk; effects of ranibizumab on breastfed infant or effects of ranibizumab on milk production/excretion; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from ranibizumab

            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

            Humanized monoclonal antibody to VEGF-A, inhibits VEGF-A-induced ocular neovascularization

            Absorption

            Peak plasma time: ~1 day

            Peak plasma concentration: 1.7 ng/mL (0.5 mg-dose)

            Excretion

            Half-life: ~9 days (vitreous)

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            Administration

            Intravitreal Preparation

            Use aseptic technique

            Prior to and 30 minutes following intravitreal injection, monitor for elevation in intraocular pressure using tonometry

            Solution should appear colorless to pale yellow

            Inspect solution; do not use if particulates, cloudiness, or discoloration are visible

            Each prefilled syringe or vial should only be used for the treatment of a single eye

            If contralateral eye requires treatment, a new prefilled syringe or vial should be used and the sterile field, syringe, gloves, drapes, eyelid speculum, filter needle (vial only), and injection needles should be changed before administration to the other eye

            Single-use vial

            • Use 5-micron, 19-ga filter needle attached to a 1-mL tuberculin syringe to withdraw vial contents
            • Discard filter needle; do not use for intravitreal injection
            • Replace filter needle with a sterile 30-gauge x 0.5-inch sterile injection needle
            • Expel solution until plunger tip is aligned with the line that marks 0.05 mL on the syringe

            Prefilled syringe

            • Open the sealed tray
            • Snap off (do not turn or twist) the syringe cap
            • Firmly attach a 30-gauge x 0.5-inch sterile injection needle to the syringe by screwing it tightly onto the Luer lock
            • See complete instructions for syringe preparation in the prescribing information

            Intravitreal Administration

            Patient preparation and instructions

            • Injection procedure should be carried out under aseptic conditions, which include the use of sterile gloves, a sterile drape, and a sterile eyelid speculum (or equivalent)
            • Adequate anesthesia and a broad-spectrum microbicide should be given prior to the injection
            • Prior to and 30 minutes following the intravitreal injection, patients should be monitored for elevation in intraocular pressure using tonometry
            • Monitoring may also consist of a check for perfusion of the optic nerve head immediately after the injection
            • Patients should also be monitored for and instructed to report any symptoms suggestive of endophthalmitis without delay following the injection

            Injection procedure

            • Insert the needle into the injection site
            • Inject slowly until rubber stopper reaches the bottom of the syringe to deliver the 0.05 mL volume
            • After injection, do not recap the needle or detach it from the syringed; dispose of the used syringe together with the needle in a sharps disposal container or in accordance with local requirements

            Storage

            Unused vials and syringes

            • Refrigerate at 2-8ºC (36-46ºF)
            • Do not freeze
            • Protect from light
            • Store in original carton until time of use
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            Images

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            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
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.