LYTENAVA bevacizumab-vikg 1.25 mg Injection, 1 vial
🆔 Identity & classification
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🏭 Manufacturer & labeler
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🩺 Clinical
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🧪 Inactive Ingredients / Excipients
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Lytenava 1.25 mgthis 82491-0025-10 | Outlook | 1 vial | — | — | FDA listed | — |
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⏳ Availability & biosimilar status
6 biosimilars are FDA-licensed for this reference biologic — see the list below. (Biologics have no small-molecule generics.)
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 82491-0025-10 You're viewing this | 1 VIAL, GLASS in 1 CARTON (82491-025-10) / 1 INJECTION in 1 VIAL, GLASS | 2026-07-16 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
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 ).
⏱️ Dosage and Administration ▾
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 ).
2.1General 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.
2.2Neovascular (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).
2.3Preparation 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.
2.4Administration 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…
💊 Dosage Forms and Strengths ▾
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 ).
⛔ Contraindications ▾
4 CONTRAINDICATIONS • Ocular or periocular infections ( 4.1 ) • Active intraocular infections ( 4.2 ) • Hypersensitivity ( 4.3 )
4.1Ocular or Periocular Infections LYTENAVA is contraindicated in patients with ocular or periocular infections.
4.2Active Intraocular Inflammation LYTENAVA is contraindicated in patients with active intraocular inflammation.
4.3Hypersensitivity 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.
⚠️ Warnings and Cautions ▾
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 ).
5.1Endophthalmitis 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 )].
5.2Increases 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 )].
5.3Thromboembolic 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).
🤒 Adverse Reactions ▾
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 .
6.1Clinical 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.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy 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.
8.2Lactation Risk Summary There are no data available on the presence of bevacizumab-vikg in human milk, the effects of bevacizumab-vikg on the breastfed infant or the effects of bevacizumab-vikg on milk production/excretion. Because many drugs are excreted in human milk, and because the potential for absorption and harm to infant growth and development exists, caution should be exercised when LYTENAVA is administered to a nursing woman. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for LYTENAVA and any potential adverse effects on the breastfed child from bevacizumab-vikg.
8.3Females and Males of Reproductive Potential Contraception Females of reproductive potential should use effective contraception during treatment with LYTENAVA and for at least 3 months after the last dose when stopping treatment with LYTENAVA. Infertility There are no data regarding the effects of LYTENAVA on human fertility. Based on the anti-VEGF mechanism of action LYTENAVA may pose a risk to reproductive capacity [ see Clinical Pharmacology ( 12.1 )].
8.4Pediatric Use The safety and effectiveness of LYTENAVA in pediatric patients have not been established.
8.5Geriatric Use In the three completed Phase 3 clinical studies, approximately 70% (238/341) of patients treated with LYTENAVA were ≥ 65 years of age and approximately 47 % (160/341) were ≥ 75 years of age. No overall differences in efficacy or safety were seen with increasing age in these studies [see Clinical Studies ( 14 )] .
🤰 Pregnancy ▾
8.1Pregnancy 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.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of LYTENAVA in pediatric patients have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use In the three completed Phase 3 clinical studies, approximately 70% (238/341) of patients treated with LYTENAVA were ≥ 65 years of age and approximately 47 % (160/341) were ≥ 75 years of age. No overall differences in efficacy or safety were seen with increasing age in these studies [see Clinical Studies ( 14 )] .
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism 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.
12.2Pharmacodynamics Increased retinal thickness (e.g., central foveal thickness (CFT)) and leakage of blood and fluid from choroidal neovascularization is associated with nAMD. CFT is known to be a reproducible, early indication of pharmacodynamic response to anti-VEGF treatments. Changes in CFT were assessed using optical coherence tomography in NORSE TWO and NORSE EIGHT [ see Clinical Studies ( 14 )].
Increasingly greater reductions in CFT were observed at Weeks 4, 8, and 12 across both treatment arms. Anatomic data were not used to influence LYTENAVA treatment decisions.
12.3Pharmacokinetics Following intravitreal administration of LYTENAVA, the systemic exposure to bevacizumab-vikg is minimal. In 14 subjects who received a single 1.25 mg dose of LYTENAVA, the serum bevacizumab-vikg concentration was assessed up to Day 4. The serum bevacizumab-vikg concentrations gradually increased over time, so the highest concentrations observed were approximately at Day 4 (the last collection time) ranging from 33 to 270 ng/mL, which was <1% of the C max after intravenous infusion of 2 mg/kg bevacizumab-vikg.
However, due to the limited sample collection, C max or AUC could not be adequately characterized.
12.6Immunogenicity The observed incidence of anti-drug antibodies (ADA) is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of ADA in the studies described below with the incidence of ADA in other studies, including those of LYTENAVA or of other bevacizumab products. In a 52-week study, a total of 14 subjects who received LYTENAVA and were subsequently evaluated for immunogenicity did not show detectable ADA at any timepoint but the ADA assay sensitivity data in the presence of free drug was insufficient.
However, due to the minimal systemic exposure to LYTENAVA following intravitreal injection, the risk of immunogenicity is not expected to be clinically significant.
🧬 Mechanism of Action ▾
12.1Mechanism 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.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied LYTENAVA (bevacizumab-vikg) injection is a colorless to light brown, opalescent solution. Each carton (NDC 82491-025-10) contains LYTENAVA 1.25 mg (0.05 mL of 25 mg/mL bevacizumab-vikg solution) in a single-dose glass vial with a BLUE CAP. EACH CARTON IS FOR SINGLE-EYE USE ONLY.
16.2Storage 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 temperature, 20ºC to 25ºC (68ºF to 77ºF), for up to 12 hours. Ensure the injection is given immediately after preparation of the dose.
📋 Description ▾
11 DESCRIPTION Bevacizumab-vikg is a recombinant humanized IgG1 monoclonal antibody specific for human vascular endothelial growth factor (VEGF). Bevacizumab-vikg has a molecular weight of approximately 149 kDa (kilodaltons) and was produced using recombinant CHO cells. LYTENAVA (bevacizumab-vikg) injection is a sterile, colorless to light brown, opalescent solution for intravitreal use.
LYTENAVA does not contain an anti-microbial preservative. LYTENAVA is supplied in a single-dose vial designed to deliver 0.05 mL of 25 mg/mL (1.25 mg) aqueous solution that also contains dibasic sodium phosphate (0.06 mg), monobasic sodium phosphate (0.29 mg), polysorbate 20 (0.02 mg), trehalose (2.71 mg), and Water for Injection. The pH is 6.
💬 Information for Patients ▾
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.
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