Lytenava (bevacizumab-vikg) is filed as VEGF inhibitor. The sections below restate public label fields stored for this profile.
1 INDICATIONS AND USAGE LYTENAVA is indicated for the treatment of patients with neovascular (wet) age-related macular degeneration (nAMD). LYTENAVA is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with neovascular (wet) age-related macular degeneration (nAMD) ( 1 ).
12.1 Mechanism of Action Bevacizumab is a human vascular endothelial growth factor (VEGF) inhibitor. Bevacizumab binds VEGF and prevents the interaction of VEGF to its receptors (Flt-1 and KDR) on the surface of endothelial cells. LYTENAVA binds to all isoforms of VEGF-A, thereby preventing interaction with receptors VEGFR-1 and VEGFR-2. By inhibiting VEGF-A, LYTENAVA suppresses endothelial cell proliferation, neovascularization, and vascular permeability. Inhibition of such activity targets a pathophysiologic process that contributes to vision loss.
5 WARNINGS AND PRECAUTIONS Endophthalmitis and retinal detachments may occur following intravitreal injections. Patients should be instructed to report any symptoms suggestive of endophthalmitis or retinal detachment without delay, to permit prompt and appropriate management ( 5.1 ). Increases in intraocular pressure have been seen within 60 minutes of an intravitreal injection ( 5.2 ). There is a potential risk of arterial thromboembolic events (ATEs) associated with VEGF inhibition ( 5.3 ). 5.1 Endophthalmitis and Retinal Detachments Intravitreal injections have been associated with endophthalmitis and retinal detachments. Proper aseptic injection technique should always be used when administering LYTENAVA. In addition, patients should be monitored following the injection to permit early treatment should an infection occur [ see Dosage and Administration ( 2.3 ) and Patient Counseling Information ( 17 )]. 5.2 Increases in Intraocular Pressure Increases in intraocular pressure have been noted post-injection (up to 60 minutes) while being treated with LYTENAVA. Monitor intraocular pressure prior to and following intravitreal injection with LYTENAVA and manage appropriately [ see Dosage and Administration ( 2.4 )]. 5.3 Thromboembolic Events Although there was a low rate of arterial thromboembolic events (ATEs) observed in the LYTENAVA clinical trials, there is a potential risk of ATEs following intravitreal use of VEGF inhibitors. ATEs are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause).
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.
Conjunctival hemorrhage (4%)
6 ADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the label: Hypersensitivity [see Contraindications ( 4 )] Endophthalmitis and Retinal Detachments [see Warnings and Precautions ( 5.1 )] Increases in Intraocular Pressure [see Warnings and Precautions ( 5.2 )] Thromboembolic Events [see Warnings and Precautions ( 5.3 )] Most common adverse reaction (≥ 4%) reported in patients receiving LYTENAVA was conjunctival hemorrhage (4%) ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Outlook Therapeutics Inc. at 1-833-999-OTLK (6855) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in one clinical trial of a drug cannot be directly compared with rates in the clinical trials of the same or another drug and may not reflect the rates observed in practice. The data described below reflect exposure to LYTENAVA in 601 patients, in five clinical trials [ see Clinical Studies ( 14 )]. Table 1 shows the most common ocular adverse reactions in LYTENAVA treated patients compared with ranibizumab 0.5 mg. Table 1. Common Adverse Reactions (≥ 1%) Adverse Reactions LYTENAVA 1.25 mg (N = 601) Ranibizumab 0.5 mg (N = 345) Conjunctival hemorrhage 4% 3% Eye pain 2% 1% Vitreous floaters 2% 1% Less common ocular adverse reactions reported in the study eye in <1% of patients treated with LYTENAVA were corneal abrasion, dry eye, eye irritation, and intraocular pressure increased.
2 DOSAGE AND ADMINISTRATION The recommended dose for LYTENAVA is 1.25 mg (0.05 mL of 25 mg/mL) administered by intravitreal injection once monthly (approximately 28 days) ( 2 ). 2.1 General Dosing Information FOR OPHTHALMIC INTRAVITREAL INJECTION. LYTENAVA must only be administered by a qualified physician. A 5-micron sterile filter needle (18-gauge x 1½-inch), a 1-mL syringe (with marking to measure 0.05 mL), and a 30-gauge x ½-inch sterile injection needle are needed. 2.2 Neovascular (Wet) Age-Related Macular Degeneration The recommended dose for LYTENAVA is 1.25 mg (0.05 mL of 25 mg/mL) administered by intravitreal injection once monthly (approximately 28 days). 2.3 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. 2.4 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 ( 5.2 )]. Patients should also be monitored for and instructed to report any symptoms suggestive of endophthalmitis without delay following the injection [ see Warnings and Precautions ( 5.1 )]. 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.
17 PATIENT COUNSELING INFORMATION Advise patients that in the days following LYTENAVA administration, patients are at risk of developing endophthalmitis, retinal detachment, and intraocular inflammation. If the eye becomes red, sensitive to light, painful, or develops a change in vision, advise the patient to seek immediate care from an ophthalmologist [see Warnings and Precautions ( 5.1 , 5.3 )]. Patients may experience temporary visual disturbances after an intravitreal injection with LYTENAVA and the associated eye examinations [see Adverse Reactions ( 6 )] . Advise patients not to drive or use machinery until visual function has recovered sufficiently. LYTENAVA™ (bevacizumab-vikg) Manufactured by: LYTENAVA is a trademark of Outlook Therapeutics, Inc. Outlook Therapeutics, Inc. ©2026 Outlook Therapeutics Inc. 111 S. Wood Ave, Unit #100 Iselin, NJ 08830 U.S. U.S. License No.: 2292
According to its FDA label, Lytenava (bevacizumab-vikg) is approved for: 1 INDICATIONS AND USAGE LYTENAVA is indicated for the treatment of patients with neovascular (wet) age-related macular degeneration (nAMD). LYTENAVA is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with neovascular (wet) age-related… For medical advice, please talk to your prescriber or pharmacist.
Lytenava (bevacizumab-vikg) belongs to the VEGF inhibitor class of medications.
The FDA label lists Lytenava (bevacizumab-vikg) as: 3 DOSAGE FORMS AND STRENGTHS Injection: 1.25 mg (0.05 mL of 25 mg/mL) colorless to light brown, opalescent solution for intravitreal injection in a single-dose vial. Injection: 1.25 mg (0.05 mL of 25 mg/mL) in a single-dose glass vial ( 3 ).. Available strengths and packaging vary by manufacturer.
Yes. A generic version of Lytenava (bevacizumab-vikg) is available in the U.S. Ask your pharmacist about substitution.
Our ingest of the FDA label for Lytenava (bevacizumab-vikg) does not include a Boxed Warning at this time. See the full label on DailyMed for the current, authoritative version.
The FDA Enforcement Report does not show an active/ongoing recall for Lytenava (bevacizumab-vikg) in our latest ingest. Recall data can change daily — verify at FDA.gov.
The FDA record lists the approval date for Lytenava (bevacizumab-vikg) as 2026-07-24.
The FDA label states: "Storage and Handling Store LYTENAVA refrigerated at 2ºC to 8ºC (36ºF to 46ºF) in the original carton until use to protect from light. DO NOT FREEZE. Prior to use, the unopened glass vial of LYTENAVA may be kept at room t…" Follow the packaging insert for the authoritative guidance.
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