Dosing & Uses
Dosage Forms & Strengths
intravitreal injectable preservative-free solution
- 6mg/mL (0.05mL [0.3mg/vial]) (Lucentis, Cimerli)
- 10mg/mL (0.05mL [0.5mg/vial]) (Lucentis, Byooviz, Cimerli)
- 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 or Cimerli 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 or Cimerli 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
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (0)
Monitor Closely (1)
- 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)
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
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
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.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)
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
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Lucentis intravitreal - | 0.5 mg/0.05 mL solution |  | |
| Lucentis intravitreal - | 0.3 mg/0.05 mL vial |  | |
| Lucentis intravitreal - | 0.5 mg/0.05 mL vial |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
ranibizumab intravitreal
RANIBIZUMAB - INTRAOCULAR
(ra-ni-BIZ-oo-mab)
COMMON BRAND NAME(S): Byooviz, Cimerli, 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.This monograph is about the following ranibizumab products: ranibizumab, ranibizumab-nuna, and ranibizumab-eqrn.
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 or increased tears may occur in the affected eye(s). If either of these effects lasts or gets worse, 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, get medical help right away 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 to other ranibizumab products; 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 cause blurred vision. Do not drive, use machinery, or do anything that needs clear vision until you can do it safely.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: 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: Medical tests (such as eye exams) should be done while you are using this medication. Keep all medical appointments. Consult your doctor for more details.
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 March 2023. Copyright(c) 2023 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.
Formulary
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