Ranibizumab
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From MedlinePlus, U.S. National Library of Medicine
Vascular Endothelial Growth Factor Inhibitor
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Preparation and administration
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Preparation for Administration Vial: Using aseptic technique, all of the BYOOVIZ vial contents are withdrawn through a 5-micron (19- gauge × 1-1/2 inch), sterile filter needle attached to a 1 mL syringe (not included). The filter needle should be discarded after withdrawal of the vial contents and should not be used for intravitreal injection.
The filter needle should be replaced with a sterile 30-gauge × ½ inch needle for the intravitreal injection. Use aseptic technique to carry out the following preparation steps: Prepare for intravitreal injection with the following medical devices for single use (not included): a 5-micron sterile filter needle (18-gauge × 1-1/2 inch or 19-gauge × 1-1/2 inch) a 1 mL sterile Luer lock syringe (with marking to measure 0.05 mL) a sterile injection needle (30-gauge × 1/2-inch) Before withdrawal, disinfect the outer part of the rubber stopper of the vial.
Place a 5-micron filter needle (18-gauge × 1-1/2 inch or 19-gauge × 1-1/2 inch) onto a 1 mL Luer lock syringe using aseptic technique. Push the filter needle into the center of the vial stopper until the needle touches the bottom edge of the vial. Withdraw all the liquid from the vial, keeping the vial in an upright position, slightly inclined to ease complete withdrawal.
Ensure that the plunger rod is drawn sufficiently back when emptying the vial in order to completely empty the filter needle. The filter needle should be discarded after withdrawal of the vial contents and must not be used for the intravitreal injection. Attach a 30-gauge × 1/2-inch sterile injection needle firmly onto the syringe by screwing it tightly onto the Luer lock.
Carefully remove the needle cap by pulling it straight off. Do not wipe the needle at any time. Hold the syringe with the needle pointing up. If there are any air bubbles, gently tap the syringe with your finger until the bubbles rise to the top. Hold the syringe at eye level, and carefully push the plunger rod until the plunger tip is aligned with the line that marks 0.05 mL on the syringe.
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Administration The intravitreal injection procedure should be carried out under controlled 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 [ see Warnings and Precautions ]. Patients should also be monitored for and instructed to report any symptoms suggestive of endophthalmitis without delay following the injection [ see Warnings and Precautions ]. Each vial should only be used for the treatment of a single eye.
If the contralateral eye requires treatment, a new vial should be used and the sterile field, syringe, gloves, drapes, eyelid speculum, filter needle (vial only), and injection needles should be changed before BYOOVIZ is administered to the other eye. No special dosage modification is required for any of the populations that have been studied (e.g., gender, elderly).
Drug interactions
Check ranibizumab against a medication listLabel text (1 paragraph)
Drug interaction studies have not been conducted with ranibizumab products. Ranibizumab intravitreal injection has been used adjunctively with Photodynamic Therapy (PDT). Twelve of 105 (11%) patients with neovascular AMD developed serious intraocular inflammation; in 10 of the 12 patients, this occurred when ranibizumab was administered 7 days (± 2 days) after PDT.
Contraindications
Ocular or periocular infections ( 4.1 ) Hypersensitivity ( 4.2 )
4.1 Ocular or Periocular Infections BYOOVIZ is contraindicated in patients with ocular or periocular infections.
4.2 Hypersensitivity BYOOVIZ is contraindicated in patients with known hypersensitivity to ranibizumab products or any of the excipients in BYOOVIZ. Hypersensitivity reactions may manifest as severe intraocular inflammation.
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for ranibizumab. Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary There are no adequate and well-controlled studies of ranibizumab products administered 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 [C max ]) after a single eye treatment at the recommended clinical dose. No skeletal abnormalities were observed at serum trough levels equivalent to the predicted human exposure after a single eye treatment at the recommended clinical dose [ see Animal Data ].
Animal reproduction studies are not always predictive of human response, and it is not known whether ranibizumab products can cause fetal harm when administered to a pregnant woman. Based on the anti-VEGF mechanism of action for ranibizumab products [ see Clinical Pharmacology (12.1) ], treatment with ranibizumab products may pose a risk to human embryofetal development. BYOOVIZ should be given to a pregnant woman only if clearly needed. Data Animal Data An embryo-fetal developmental toxicity study was performed on pregnant cynomolgus monkeys.
Pregnant animals received intravitreal injections of ranibizumab every 14 days starting on Day 20 of gestation, until Day 62 at doses of 0, 0.125, and 1 mg/eye. Skeletal abnormalities including incomplete and/or irregular ossification of bones in the skull, vertebral column, and hindlimbs and shortened supernumerary ribs were seen at a low incidence in fetuses from animals treated with 1 mg/eye of ranibizumab. The 1 mg/eye dose resulted in trough serum ranibizumab levels up to 13 times higher than predicted Cmax levels with single eye treatment in humans.
No skeletal abnormalities were seen at the lower dose of 0.125 mg/eye, a dose which resulted in trough exposures equivalent to single eye treatment in humans. No effect on the weight or structure of the placenta, maternal toxicity, or embryotoxicity was observed.
Breastfeeding (LactMed)
Milk levels of ranibizumab are very low after intravitreal injection in nursing mothers. It is also likely to be partially destroyed in the infant's gastrointestinal tract and absorption by the infant is probably minimal. Premature infants who have been administered ranibizumab intravitreally in both eyes for retinopathy of prematurity have had no apparent adverse effects up to the second year of life. Since vascular endothelial growth factor-A (VEGF-A) is present in human milk and is thought to help in maturation of the infant’s gastrointestinal tract, concern has been raised about the maternal use of VEGF-A inhibitors during breastfeeding. VEGF-A milk levels may decrease, but are not absent from milk after an injection of ranibizumab. A typical alternative to breastmilk is infant formula, which contains no VEGF-A.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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