ranibizumab intravitreal injection (Rx)

Brand and Other Names:Lucentis, Byooviz, more...ranibizumab-nuna
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

intravitreal injectable preservative-free solution

  • 6mg/mL (0.05mL [0.3mg/vial]) (Lucentis)
  • 10mg/mL (0.05mL [0.5mg/vial]) (Lucentis, Byooviz)
  • 6mg/mL (0.05mL [0.3mg/prefilled syringe]) (Lucentis)
  • 10mg/mL (0.05mL [0.5mg/prefilled syringe]) (Lucentis)

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)

Less frequent dosing

  • Although not as effective, patients may be treated with initial 3 once monthly doses followed by less frequent dosing with regular assessment
  • Over 9 months after 3 initial monthly doses, less frequent dosing with 4-5 doses on average is expected to maintain visual acuity while monthly dosing may be expected to result in an additional average 1-2 letter gain
  • Assess patients regularly

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

Lucentis only

Indicated for diabetic macular edema (DME)

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

Diabetic Retinopathy

Lucentis only

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

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                • verteporfin

                  ranibizumab intravitreal injection increases toxicity of verteporfin by unspecified interaction mechanism. Use Caution/Monitor. Risk of severe intraocular inflammation, even when separated by 7 days.

                Minor (0)

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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

                  Hypersensitivity reactions may manifest as severe intraocular inflammation

                  Risk of endophthalmitis or retinal detachment with intravitreous injections; proper aseptic injection technique should always be used when administering therapy; patients should be monitored following the injection to permit early treatment should an infection occur

                  Possibility of IOP increase within 60 min of intravitreal injection; monitor intraocular pressure prior to and following intravitreal injection with drug and manage appropriately

                  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

                  BRAND FORM. UNIT PRICE PILL IMAGE
                  Lucentis intravitreal
                  -
                  0.3 mg/0.05 mL vial
                  Lucentis intravitreal
                  -
                  0.5 mg/0.05 mL solution
                  Lucentis intravitreal
                  -
                  0.5 mg/0.05 mL vial

                  Copyright © 2010 First DataBank, Inc.

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                  Patient Handout

                  Patient Education
                  ranibizumab intravitreal

                  RANIBIZUMAB - INTRAOCULAR

                  (ra-ni-BIZ-oo-mab)

                  COMMON BRAND NAME(S): Lucentis

                  USES: This medication is used to treat certain serious eye conditions (such as age-related macular degeneration, macular edema, diabetic retinopathy). It is used to help prevent decreased vision and blindness. Ranibizumab works by slowing the growth of abnormal new blood vessels in the eye and decreasing leakage from these blood vessels.

                  HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start receiving ranibizumab and each time you get a refill. If you have any questions, ask your doctor or pharmacist.This medication is given by injection into the affected eye(s) by a health care professional. The affected eye is numbed before each injection. Your eye will be monitored before the injection. After the injection, you will remain in the doctor's office for a while, and your eye will continue to be monitored.The dosage is based on your medical condition and response to treatment. This medication is given as directed by your doctor, usually once a month for most conditions.When treating age-related macular degeneration, if you are not able to have monthly injections after your first few doses, getting injections once every 2 or 3 months may be an option, although not as effective as monthly injections. Consult your doctor for more details.Use this medication regularly to get the most benefit from it.Tell your doctor if your condition does not improve or if it worsens.

                  SIDE EFFECTS: Mild discomfort and increased tears may occur in the affected eye(s). Feeling of spinning and dizziness may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.This medication may rarely increase your risk for developing a certain serious eye condition (endophthalmitis), especially during the first week after receiving a dose. Tell your doctor right away if you notice any of these symptoms in the affected eye(s): pain, redness, sensitivity to light, sudden change in vision.This medication may sometimes increase the risk of serious (possibly fatal) blood clots. This may lead to stroke, heart attack, and other blood vessel problems. Get medical help right away if you develop: symptoms of stroke (such as weakness on one side of the body, trouble speaking, sudden vision changes, confusion), symptoms of a heart attack (such as chest/jaw/left arm pain).A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

                  PRECAUTIONS: Before receiving ranibizumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: a current eye infection, stroke.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).This drug may make you dizzy or blur your vision. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is not known whether this drug passes into breast milk. However, this medication is unlikely to pass into breast milk. Consult your doctor before breast-feeding.

                  DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

                  OVERDOSE: This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

                  NOTES: Your doctor will schedule periodic eye exams to monitor your progress and check for side effects.

                  MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor right away for a new dosing schedule.

                  STORAGE: Not applicable. This medication is given in a clinic or doctor's office and will not be stored at home.

                  Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

                  IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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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.