Bevacizumab (ophthalmic)
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From MedlinePlus, U.S. National Library of Medicine
Specialty pharmacy: therapy management checklist, storage and cold chain, dosing calendar, Medicare Part D coverage.
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 Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The glass vial is for one-time use in one eye only. Using aseptic technique, the total vial volume of a LYTENAVA vial should be withdrawn through a 5-micron (18-gauge x 1½-inch) sterile filter needle attached to a 1 mL syringe.
The filter needle should be discarded after withdrawal of the vial contents and should not be used for the intravitreal injection. The filter needle should be replaced with a sterile 30-gauge x ½-inch needle for the intravitreal injection. The contents should be expelled until the plunger tip is aligned with the line that marks 0.05 mL on the syringe.
Use aseptic technique to carry out the following preparation steps: 1. Prepare for intravitreal injection with the following recommended devices for one-time use (not provided):
5-micron sterile filter needle (18-gauge x 1½-inch)
1 mL sterile syringe (with marking to measure 0.05 mL)
sterile injection needle (30-gauge x ½-inch)
alcohol swab 2. Remove the protective plastic cap from the vial. Clean the top of the vial with an alcohol swab. 3. Attach the 5-micron filter needle (18-gauge x 1½-inch) to the syringe by twisting it onto the syringe tip. 4. Push the filter needle into the center of the vial stopper and ensure the tip of the needle remains within the solution to minimize the potential for air bubbles. 5.
Withdraw the total volume of LYTENAVA, keeping the vial in an upright position, slightly inclined to ease sufficient withdrawal. 6. Ensure that the plunger rod is drawn sufficiently back when drawing up LYTENAVA in order to completely empty the filter needle. 7. The filter needle should be discarded after withdrawal of the vial contents and must not be used for the intravitreal injection. 8.
Attach the 30-gauge x ½-inch sterile injection needle to the syringe by firmly screwing it onto the syringe hub. Carefully remove the needle cap by pulling it straight off. Do not wipe the needle at any time. 9. 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. 10.
Hold the syringe at eye level and slowly push the plunger rod until the plunger tip is aligned with the line that marks 0.05 mL on the syringe.
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 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 single-dose 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, and injection needles should be changed before LYTENAVA is administered to the other eye.
Drug interactions
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- Bevacizumab (ophthalmic)
Contraindications
4 CONTRAINDICATIONS • Ocular or periocular infections ( 4.1 ) • Active intraocular infections ( 4.2 ) • Hypersensitivity ( 4.3 )
4.1 Ocular or Periocular Infections LYTENAVA is contraindicated in patients with ocular or periocular infections.
4.2 Active Intraocular Inflammation LYTENAVA is contraindicated in patients with active intraocular inflammation.
4.3 Hypersensitivity LYTENAVA is contraindicated in patients with known hypersensitivity to bevacizumab products or any of the ingredients in LYTENAVA. Hypersensitivity reactions may manifest as severe intraocular inflammation.
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
ELikelihood score E: Unlikely cause of clinically apparent liver injury.
Bevacizumab is a humanized monoclonal antibody to human vascular endothelial growth factor (VEGF) and an anti-angiogenesis agent used in the therapy of colorectal, ovarian, renal and brain cancers. Bevacizumab has not been linked to serum enzyme elevations during therapy or to idiosyncratic acute liver injury. Bevacizumab may be partially protective against the vascular hepatic damage caused by other chemotherapeutic agents.
ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Based on the anti-VEGF mechanism of action for bevacizumab products [ see Clinical Pharmacology ( 12.1 )], treatment with LYTENAVA may pose a risk to human embryofetal development. There are no adequate and well-controlled studies of LYTENAVA administration in pregnant women or pregnant animals. It is not known whether bevacizumab-vikg can cause fetal harm when administered to a pregnant woman. LYTENAVA should be given to a pregnant woman only if clearly needed. All pregnancies have a background risk of birth defect, loss, and other adverse outcomes. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S.
general population, the estimated background risk of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies.
Breastfeeding (LactMed)
No information is available on the intravenous use of bevacizumab during breastfeeding. Because bevacizumab is a large protein molecule with a molecular weight of about 149,000 Da, the amount in milk is likely to be very low. It is also likely to be partially destroyed in the infant's gastrointestinal tract and absorption by the infant is probably minimal. Until more data become available, intravenous bevacizumab should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant. The manufacturer recommends that breastfeeding be discontinued during systemic bevacizumab therapy and for 6 months following the last dose. Bevacizumab is a vascular endothelial growth factor (VEGF) inhibitor. A few infants have been breastfed, without apparent harm, following maternal intravitreal bevacizumab injections.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
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