Home › NDC Lookup › Ingredients › Vusolimogene Oderparepvec-Wtpg › 83616-0107-11
Tudriqev vusolimogene oderparepvec-wtpg 10000000 [PFU]/mL Injection, Suspension, 1 vial — NDC 83616-0107-11 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Tudriqev vusolimogene oderparepvec-wtpg 10000000 [PFU]/mL Injection, Suspension, 1 vial — NDC 83616-107-11 (Billing 83616-0107-11)

by Replimune, Inc. · 1 VIAL, SINGLE-DOSE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-DOSE

This is a package of 1 vial of Tudriqev vusolimogene oderparepvec-wtpg 10000000 [PFU]/mL Injection, Suspension from Replimune, Inc., marketed since Sep 2026 and currently FDA-listed. It is this product's only package size.

NDC 83616-0107-11
🏷️ FDA NDC (as labeled) 83616-107-11 billing pads the product segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 1, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 83616-107-11 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
83616 labeler · 107 product · 11 package
Package marketed since
Sep 4, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 8361610711 1
FDA record last changed
Oct 1, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 83616-107-11
Product NDC 83616-107
11-digit billing NDC 83616010711
Application # BLA125827
SPL Set ID 26627b8d-91ac-4f76-a213-7e25efd024d1
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-09-04
Route INTRATUMOR
Dosage form INJECTION, SUSPENSION
Substance VUSOLIMOGENE ODERPAREPVEC
Why two NDCs? The FDA registers this code as 83616-107-11 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 83616-0107-11. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

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 systemPer mLPer 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.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
83616-0107-11 You're viewing this Main listing 1 VIAL, SINGLE-DOSE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-DOSE 2026-09-04 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Tudriqev 10000000 [PFU]/mLthis 83616-0107-11 Replimune, 1 vial — — FDA listed —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & biosimilar status

🏛️
2026
On the market since
Sep 2026
📍
2026
Currently FDA-listed
listed with the FDA
🧬
·
Biosimilars
see Purple Book
🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerReplimune, Inc.
FDA applicationBLA125827 (BLA)
Labeler code83616
First marketedSep 2026
Product typeHuman Prescription Drug
Portfolio2 products on file

More NDCs from Replimune, Inc. labeler code 83616

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 147 words ▾

1 INDICATIONS AND USAGE TUDRIQEV™ is indicated in combination with nivolumab for the treatment of adult patients with unresectable advanced cutaneous melanoma who experienced disease progression with a programmed death receptor-1 (PD-1)-blocking antibody-based regimen. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response [ see Clinical Studies (14) ]. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s).

TUDRIQEV is a genetically modified oncolytic viral therapy indicated in combination with nivolumab for the treatment of adult patients with unresectable advanced cutaneous melanoma who experienced disease progression with a programmed death receptor-1 (PD-1)-blocking antibody-based regimen. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s).

( 1 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Recommended dosage of TUDRIQEV is 1 mL/cm of the largest dimension of the tumor for a maximum of 10 mL across all lesions treated with each dose. ( 2.1 ) Administer intratumor injections of TUDRIQEV every two weeks for 8 consecutive doses starting at a concentration of 10 6 plaque-forming units (PFU) per mL at Week 1 followed by 10 7 PFU per mL for subsequent weeks. ( 2.1 ) Administer nivolumab intravenously starting at Week 3, according to nivolumab prescribing information.

( 2.1 ) See full prescribing information for TUDRIQEV preparation, and administration instructions. ( 2.2 , 2.3 )

2.1Recommended Dosage For intratumor injection only. DO NOT administer intravenously. The recommended dosage of TUDRIQEV is 1 mL/cm of the largest dimension of the tumor for a maximum of 10 mL across all lesions treated with each dose.

Administer intratumor injections of TUDRIQEV every two weeks for 8 consecutive doses starting at a concentration of 10 6 plaque-forming units (PFU) per mL at Week 1 followed by 10 7 PFU per mL for subsequent weeks. Assess the size of each injectable lesion on each treatment day to determine the required TUDRIQEV volume. If multiple tumors are present, prioritize the most rapidly growing and largest new or existing lesions suitable for injection.

Patients with no confirmed disease progression could be retreated with TUDRIQEV at a concentration of 10 7 PFU/mL every two weeks. Administer nivolumab as intravenous injection starting at Week 3. Refer to the nivolumab prescribing information for the dosage and administration information including dose modifications, preparation, and administration [see Clinical Studies (14) ].

2.2Preparation and Handling Avoid accidental exposure to TUDRIQEV by wearing appropriate personal protective equipment (PPE). Observe standard precautions when preparing and administering TUDRIQEV [see Warnings and Precautions (5.1) ]. Clean surfaces that may have come in contact with TUDRIQEV (including spills) with broad spectrum virucidal agent such as 70% isopropanol alcohol or 1% sodium hypochlorite.

Dispose of the used vials and all materials that may have come in contact with TUDRIQEV as biohazardous waste. TUDRIQEV should be prepared by a healthcare professional experienced in the use of anticancer therapy. Determine the volume required for injection [see Dosage and Administration (2.1) ] .

Thaw TUDRIQEV vials inside the original carton at room temperature [15°C to 25°C (59°F to 77°F)] or during refrigeration [2°C to 8°C (36° to 46°F)]. DO NOT refreeze TUDRIQEV after thawing [see How Supplied/Storage and Handling (16.2) ] . Swirl gently, inspect vial.

Particles may be visible [see Description (11) ] . If settlement occurs, re-suspend by gently swirling. DO NOT shake.

Using aseptic technique, withdraw the required TUDRIQEV dosage volume from the vial(s) into the syringe(s) to be used for administration. Select needles gauged between 17G and 27G based on the location and characteristics of the tumors to be injected. A higher needle gauge will allow for a smaller puncture in tissue and will reduce leakage of TUDRIQEV along the needle tract.

A lower needle gauge is needed for fibrotic or deeper lesions. Administer TUDRIQEV within 2 hours of syringe preparation [see How Supplied/Storage and Handling (16.2) ] .

2.3Administration DO NOT administer TUDRIQEV into brain or spinal cord tumors or scalp tumors with moderate to extensive bone erosion. Avoid tumors that encase, invade, or occlude major blood vessels, major nerve structures, or airways. Avoid direct injection into blood vessels.

Pre-Injection Clean the skin areas where the needle will be inserted with an alcohol swab and let dry. Treat the injection site with a topical or local anesthetic agent, if necessary. DO NOT inject anesthetic agent directly into the lesion.

Inject anesthetic agent around the periphery of the lesion. Intratumor Injection into Nonulcerated Superficial Tumors Administer TUDRIQEV via dir… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 69 words ▾

3 DOSAGE FORMS AND STRENGTHS TUDRIQEV is a colorless, translucent to opaque suspension provided as a 1 mL extractable volume in a single-dose vial in the following concentrations: Starting dose: 10 6 (1 million) PFU per mL suspension (white cap) Subsequent doses: 10 7 (10 million) PFU per mL suspension (blue cap) Injection: 10 6 PFU per mL, 10 7 PFU per mL in single-dose vials. ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None. ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Accidental exposure to TUDRIQEV: Healthcare providers, caregivers, close contacts, pregnant women, newborns, and patients should avoid direct contact with injected tumors, dressings, or bodily fluids of patients. Should accidental exposure occur, clean the affected area. ( 5.1 ) Herpetic infection or reactivation: Assess and treat suspected herpetic lesions as clinically warranted.

( 5.2 ) Injection procedure complications, including but not limited to hemorrhage, infection, and visceral injury. Monitor patients for signs and symptoms of visceral injury during and after TUDRIQEV administration and manage according to clinical practice. ( 5.3 ) Immune-mediated events: TUDRIQEV in combination with nivolumab may result in immune-mediated events.

In clinical studies, immune-mediated events, including colitis, hepatitis, myocarditis, neuropathy, capillary leak syndrome, dermatitis, and vitiligo have been reported in patients treated with TUDRIQEV and nivolumab. ( 5.4 )

5.1Accidental Exposure Accidental exposure of TUDRIQEV to close contacts may lead to transmission of herpetic infection. Healthcare providers, caregivers, close contacts, pregnant women, newborns, and patients should avoid direct contact with injected tumors, dressings, or bodily fluids of patients [see Use in Specific Populations (8.1) ]. Healthcare providers and caregivers must wear protective gloves when applying or changing dressings and dispose of used dressings, gloves, and cleaning materials as biohazardous waste [see Dosage and Administration (2.2) ] .

If an accidental exposure to TUDRIQEV occurs (e.g. touching or scratching the unprotected injection site or dressings), exposed individuals should clean the affected area with soap and water. If signs and symptoms of herpetic infection develop, exposed individuals should contact their healthcare provider for assessment and treatment as clinically warranted.

5.2Herpetic Infection or Reactivation There is a potential risk for herpetic infection or reactivation after TUDRIQEV administration. Patients with suspected herpetic infections should contact their healthcare provider for assessment and antiviral treatment of the suspected herpetic infection as clinically warranted.

5.3Injection Procedure Complications Complications related to injection procedure have occurred, including but not limited to hemorrhage, infection, and visceral injury (for example: pneumothorax). [see Adverse Reaction (6.1) ]. Monitor patients for signs and symptoms of visceral injury during and after TUDRIQEV administration and manage according to clinical practice.

5.4Immune-Mediated Events TUDRIQEV in combination with nivolumab may result in immune-mediated events. In clinical studies, immune-mediated events, including colitis, hepatitis, myocarditis, neuropathy, capillary leak syndrome, dermatitis, and vitiligo have been reported in patients treated with TUDRIQEV and nivolumab [see Adverse Reaction (6.1) ].

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS Most common non-laboratory adverse reactions (incidence > 10%) are fatigue, pyrexia, infections, chills, musculoskeletal pain, nausea, diarrhea, injection site reaction, headache, cough, influenza like illness, rash, vomiting, pruritus, arthralgia, constipation, decreased appetite, dizziness, dyspnea, hemorrhage, edema, and abdominal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Replimune, Inc. at 1-877-375-0095 or [email protected] 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 the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety data described in this section reflect exposure of TUDRIQEV administered with nivolumab in 140 patients evaluated in the IGNYTE Study [ see Clinical Studies (14) ]. Patients received a median of 8 doses (range 1 to 32) of TUDRIQEV, and 7 (range 0 to 29) doses of nivolumab during the study.

The median duration of the first course of TUDRIQEV and nivolumab exposure was 3.3 months (range 0.5 to 5.1 months) and 3.2 months (range 0 to 24.4 months), respectively. Serious adverse reactions occurring in >1% patients include pleural effusion (n=3), acute kidney injury (n=2), arthralgia (n=2), atrial fibrillation (n=2), atrial flutter (n=2), cancer pain (n=2), hypophysitis (n=2), immune-mediated enterocolitis (n=2), pyrexia (n=2), sepsis (n=2), urinary tract infection (n=2), and myocardial infarction (n=2). Serious adverse reactions leading to death include myocardial infarction (n=1) and multiple organ dysfunction (n=1).

Adverse reactions leading to discontinuation of treatment occurred in 22 (16%) patients. Table 1 summarizes the most common adverse reactions that occurred in ≥10% patients in the IGNYTE Study. Table 1: Adverse Reactions Occurring in ≥10% of Patients in IGNYTE Study (N=140) Adverse Reactions Graded per National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0.

None of the common adverse reactions were Grade 4 or 5 All Grades n (%) Grade ≥ 3 n (%) Gastrointestinal - - Nausea 40 (29) 0 (0) Diarrhea a composite that includes multiple related terms 41 (29) 3 (2) Vomiting 24 (17) 0 (0) Constipation 22 (16) 0 (0) Decreased appetite 18 (13) 2 (1) Abdominal pain 14 (10) 3 (2) General disorders and administration site conditions - - Fatigue 82 (59) 4 (3) Pyrexia 54 (39) 0 (0) Chills 45 (32) 0 (0) Injection site reaction 37 (26) 0 (0) Influenza like illness 25 (18) 0 (0) Edema 14 (10) 4 (3) Infections and Infestations - - Infections 47 (34) 8 (6) Musculoskeletal and connective tissue disorders - - Musculoskeletal pain 45 (32) 4 (3) Arthralgia 23 (16) 2 (1) Nervous system disorders - - Headache 26 (19) 0 (0) Dizziness 21 (15) 1 (1) Respiratory, thoracic and mediastinal disorders - - Cough 25 (18) 0 (0.0) Dyspnea 16 (11) 1 (1) Skin and subcutaneous tissue disorders - - Rash 25 (18) 2 (1) Pruritus 24 (17) 0 (0.0) Vascular disorders Hemorrhage 15 (11) 2 (1) Other clinically significant adverse reactions occurring less than 10% include visceral injury including pneumothorax (n= 3), oral herpes (n=2), herpes simplex (n=1), and herpes simplex reactivation (n=1).

Table 2 presents the most common laboratory abnormalities that worsened from baseline in ≥10% of patients in the IGNYTE Study. Table 2: Laboratory Values Worsening from Baseline in ≥10% in IGNYTE (N=140) Laboratory Abnormalities Graded per National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. All Grades (%) Grades 3-4 (%) Anemia 57 (41) 7 (5) Lymphocyte count decreased 40 (29) 7 (5) Lipase increased 36 (26) 13 (9) Hyponatremia 34 (24) 3 (2) Hypophosphatemia 33 (24) 3 (2) Alkaline phosphatase (ALP) increased 30 (21) 1 (1) Hypoalbuminemia 28 (20) 1 (1) Aspartate aminotransferase (AST) increased 26 (19) 2… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 55 words ▾

7 DRUG INTERACTIONS Antivirals: Antiviral medications may reduce the efficacy of TUDRIQEV. Delay TUDRIQEV administration for 72 hours after antivirals. ( 7.1 )

7.1Effects of Antivirals Antiviral medications may reduce the efficacy of TUDRIQEV. Patients receiving systemic antiviral treatment for herpetic infection should delay TUDRIQEV treatment for 72 hours after completion of antiviral therapy.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS Females and Males of Reproductive Potential: Advise females of reproductive potential, and males with a female partner of reproductive potential to use effective contraception during TUDRIQEV treatment and for 90 days after the last dose. ( 8.3 )

8.1Pregnancy Risk Summary There are no available data with TUDRIQEV in pregnant women to inform a drug-associated risk. The estimated 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 and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical Considerations If the patient becomes pregnant during treatment with TUDRIQEV, the patient should be apprised that there may be potential hazards to the fetus and neonate. Women of childbearing potential should be advised to use an effective method of contraception to prevent pregnancy during treatment with TUDRIQEV, and 90 days after the last dose of TUDRIQEV. Animal Data In an embryofetal development study in pregnant rats, TUDRIQEV was intravenously administered at 5x10 6 (5 million) PFU per kg once every three days during fetal organogenesis (gestational days 4 through 16) and was not associated with placental transfer of TUDRIQEV, adverse maternal findings, or treatment-related effects on embryo-fetal development.

8.2Lactation Risk Summary There are no data available on the presence of TUDRIQEV in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for TUDRIQEV and any potential adverse effects on the breastfed child from TUDRIQEV or from the underlying maternal condition.

8.3Females and Males of Reproductive Potential Pregnancy Testing Verify the pregnancy status of females of reproductive potential prior to initiating TUDRIQEV [see Use in Specific Populations (8.1) ] . Contraception Females Advise females of reproductive potential to use effective contraception during treatment with TUDRIQEV and for 90 days after the last dose [see Use in Specific Populations (8.1) ] . Males Advise males with a female partner of reproductive potential to use effective contraception, and to refrain from donating sperm during treatment with TUDRIQEV and for 90 days after the last dose [see Use in Specific Populations (8.1) ] .

Infertility Females and Males No nonclinical or clinical studies were performed to evaluate the effect of TUDRIQEV on fertility.

8.4Pediatric Use Safety and efficacy of TUDRIQEV have not been established in pediatric patients.

8.5Geriatric Use In the IGNYTE Study, 57 out of 140 patients (41%) were 65 years of age or older, and 20 (14%) were 75 years of age and older. No overall difference in safety or effectiveness was observed in patients over 65 years of age, including patients over 75 years of age, when compared with younger adult patients.

🤰 Pregnancy 172 words ▾

8.1Pregnancy Risk Summary There are no available data with TUDRIQEV in pregnant women to inform a drug-associated risk. The estimated 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 and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical Considerations If the patient becomes pregnant during treatment with TUDRIQEV, the patient should be apprised that there may be potential hazards to the fetus and neonate. Women of childbearing potential should be advised to use an effective method of contraception to prevent pregnancy during treatment with TUDRIQEV, and 90 days after the last dose of TUDRIQEV. Animal Data In an embryofetal development study in pregnant rats, TUDRIQEV was intravenously administered at 5x10 6 (5 million) PFU per kg once every three days during fetal organogenesis (gestational days 4 through 16) and was not associated with placental transfer of TUDRIQEV, adverse maternal findings, or treatment-related effects on embryo-fetal development.

🧒 Pediatric Use 15 words ▾

8.4Pediatric Use Safety and efficacy of TUDRIQEV have not been established in pediatric patients.

🧓 Geriatric Use 59 words ▾

8.5Geriatric Use In the IGNYTE Study, 57 out of 140 patients (41%) were 65 years of age or older, and 20 (14%) were 75 years of age and older. No overall difference in safety or effectiveness was observed in patients over 65 years of age, including patients over 75 years of age, when compared with younger adult patients.

🧬 Clinical Pharmacology ~2 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action TUDRIQEV is an oncolytic viral therapy which preferentially replicates within the tumor leading to tumor lysis, release of tumor and viral antigens, proinflammatory molecules, and infiltration of T cells. The GALV-GP-R – expressed by TUDRIQEV increases direct tumor killing and the GM-CSF expressed by TUDRIQEV is intended to activate and mature dendritic cells and monocytes. In the anti-PD-1 resistant setting, TUDRIQEV and nivolumab in combination may promote an anti-tumor immune response.

12.2Pharmacodynamics No studies have been performed to evaluate the pharmacodynamics of TUDRIQEV.

12.3Pharmacokinetics Biodistribution and Viral Shedding In the IGNYTE Study, TUDRIQEV biodistribution and viral shedding were assessed using a quantitative polymerase chain reaction (qPCR) assay. Blood, urine, and swab samples were collected from injection site(s), injection-site(s) dressings, and oral mucosa of 278 patients receiving TUDRIQEV. Samples were collected before dosing, during treatment, at 30 and 60 days following the last TUDRIQEV injection, and up to 100 days after the last dose of study treatment (either TUDRIQEV or nivolumab).

Patients were asked to report any appearance of herpetic-like lesions in caregivers or close contacts. As the presence of DNA does not equate to live/infectious TUDRIQEV, DNA-positive swab samples were further assessed in a validated 50% tissue culture infectious dose (TCID50) assay, which detects live TUDRIQEV. TUDRIQEV DNA was detected in blood samples from 53 out of 274 (19%) patients within 6 hours of injection with decreasing levels thereafter.

TUDRIQEV DNA was detected in 3 out of 1976 (0.2%) urine samples. TUDRIQEV is cleared from both blood and urine after 30 days, with all samples from follow-up visits testing negative for TUDRIQEV DNA. No sample had detectable TUDRIQEV DNA 30-days after the end of treatment in blood, urine, swab samples collected from injection site(s), injection-site(s) dressing, or oral mucosa.

TUDRIQEV DNA was detected on the surface of injected lesions in 112 of 266 (42%) patients, and 358 of 1947 (18%) tested samples. Consistent with the kinetics of TUDRIQEV replication in tumors, TUDRIQEV DNA was present at the injection site up to 15 days post injection in approximately 20% of patients. The incidence of detection of TUDRIQEV DNA in the exterior of injection site dressings was lower than at the injection site with samples from 43 of 207 (21%) patients' exterior of injection-site dressing samples testing positive for TUDRIQEV DNA.

Positive samples were further assessed for live TUDRIQEV. Out of 314 samples, 4 tested positive by TCID50. The reported incidence of TUDRIQEV transmission to close contacts was 0%.

No differences in the incidence of detectable TUDRIQEV DNA were observed between patients who were HSV-1 seronegative or seropositive at baseline.

🧬 Mechanism of Action 75 words ▾

12.1Mechanism of Action TUDRIQEV is an oncolytic viral therapy which preferentially replicates within the tumor leading to tumor lysis, release of tumor and viral antigens, proinflammatory molecules, and infiltration of T cells. The GALV-GP-R – expressed by TUDRIQEV increases direct tumor killing and the GM-CSF expressed by TUDRIQEV is intended to activate and mature dendritic cells and monocytes. In the anti-PD-1 resistant setting, TUDRIQEV and nivolumab in combination may promote an anti-tumor immune response.

📦 How Supplied / Storage and Handling 205 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied TUDRIQEV is supplied as a sterile frozen liquid in a single-dose borosilicate glass vial with a bromobutyl stopper, aluminum seal, and a flip-off plastic cap. TUDRIQEV is a suspension that is not under pressure and is not aerosolized. Each vial contains an extractable volume of 1 mL for injection.

The vial polypropylene cap is color coded: 10 6 PFU per mL is white [NDC: 83616-106-01 (vial); NDC: 83616-106-11 (carton)] 10 7 PFU per mL is blue [NDC: 83616-107-01 (vial); NDC: 83616-107-11 (carton)]

16.2Storage and Handling Protect TUDRIQEV from light. Store in the original carton until use. Store TUDRIQEV at -70°C to -90°C (-94°F to -130°F).

If a freezer is not available, refer to Table 4 for refrigeration guidelines. Thaw TUDRIQEV immediately prior to administration [see Dosage and Administration (2.2) ]. DO NOT refreeze.

Table 4: Storage of Thawed TUDRIQEV in Vial and Syringe Storage Condition Thawed Vial Prepared Syringe Refrigeration: 2°C to 8°C (36°F to 46°F) 10 6 PFU/mL vial up to 2 days 10 7 PFU/mL vial up to 10 days Use within 2 hours of preparation Room temperature: 15°C to 25°C (59°F to 77°F) Up to 24 hours Use within 2 hours of preparation

📦 Storage and Handling 115 words ▾

16.2Storage and Handling Protect TUDRIQEV from light. Store in the original carton until use. Store TUDRIQEV at -70°C to -90°C (-94°F to -130°F).

If a freezer is not available, refer to Table 4 for refrigeration guidelines. Thaw TUDRIQEV immediately prior to administration [see Dosage and Administration (2.2) ]. DO NOT refreeze.

Table 4: Storage of Thawed TUDRIQEV in Vial and Syringe Storage Condition Thawed Vial Prepared Syringe Refrigeration: 2°C to 8°C (36°F to 46°F) 10 6 PFU/mL vial up to 2 days 10 7 PFU/mL vial up to 10 days Use within 2 hours of preparation Room temperature: 15°C to 25°C (59°F to 77°F) Up to 24 hours Use within 2 hours of preparation

📋 Description 172 words ▾

11 DESCRIPTION TUDRIQEV (vusolimogene oderparepvec-wtpg) is a genetically modified herpes simplex virus, type 1 (HSV-1) oncolytic viral therapy that encodes a fusogenic glycoprotein derived from gibbon ape leukemia virus with the R sequence deleted (GALV-GP-R – ) and human granulocyte-macrophage colony-stimulating factor (GM-CSF). The genes encoding the HSV-1 neurovirulence factor ICP34.5 and the transporter associated with antigen presentation inhibitor ICP47 are deleted from TUDRIQEV. TUDRIQEV is a sterile frozen, preservative free, suspension for intratumor injection provided in single-dose glass vials.

Each vial contains an extractable volume of 1 mL of TUDRIQEV at a concentration of either 10 6 PFU/mL or 10 7 PFU/mL formulated in disodium hydrogen phosphate dihydrate (7 mg), sodium dihydrogen phosphate dihydrate (1.4 mg), sodium chloride (1.3 mg), myo-inositol (39 mg), d-sorbitol (19.5 mg), recombinant human serum albumin (5.1 mg) with water for injection. After thawing, TUDRIQEV is a colorless, translucent to opaque suspension and may contain visible, white to off-white, or colorless particles or fibers that may appear globular or amorphous.

These particulates are inherent to the formulation.

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Discuss following with patients and/or caregivers. Accidental exposure to TUDRIQEV: Inform patients and/or caregivers that accidental exposure of TUDRIQEV to close contacts and caregivers may lead to transmission of herpetic infection. To prevent the risk of accidental exposure and viral transmission, instruct patients, caregiver, and close contacts on following.

Avoid unprotected direct contact with injection sites, dressing, and bodily fluid of patients. Avoid touching or scratching the injection sites. Wash hands thoroughly in case of direct contact and prior to and after changing the dressing.

Keep the injection site(s) covered with the dressing for at least 48 hours. Replace the dressing if it falls off. Wear gloves when removing and replacing the dressing.

Place used dressing, gloves, and cleaning materials in sealed plastic bags prior to disposal in household waste. If an accidental exposure to TUDRIQEV occurs (e.g. touching or scratching the unprotected injection site or dressings), exposed individuals should clean the affected area with soap and water. If signs and symptoms of herpetic infection develop, exposed individuals should contact their healthcare provider for assessment and treatment as clinically warranted [see Dosage and Administration (2.2) , Warnings and Precautions (5.1) , and Use in Specific Populations (8.1 , 8.3) ].

Herpetic infection or reactivation: Inform patients and or caregivers that there is potential risk of herpetic infection or reactivation after TUDRIQEV administration. Instruct patients to immediately report to their healthcare provider suspected herpetic lesions (e.g., small bumps that turn into blisters or sores) [see Warnings and Precautions (5.2) ]. Injection procedure complications: Inform patients and/or caregivers that there is potential for hemorrhage, infection, and if administered into visceral sites, visceral injury (for example, pneumothorax), with TUDRIQEV administration.

Seek immediate medical care if sign and symptoms of hemorrhage, infection, or visceral injury occur [see Warnings and Precautions (5.3) ]. Patients receiving anti-viral therapy: Advise patients that TUDRIQEV treatment may be delayed due to the administration of anti-viral therapy or certain vaccines [see Drug Interactions (7.1) . Pregnancy: Advise pregnant female patients of the risks.

Advise females of reproductive potential and males with a female partner of reproductive potential to use effective contraception during treatment with TUDRIQEV and for 90 days after the final dose of TUDRIQEV. Advise male patients to refrain from donating sperm during treatment with TUDRIQEV and for 90 days after the final dose of TUDRIQEV. Lactation : Advise women not to breastfeed during treatment with TUDRIQEV and for 90 days after the final dose of TUDRIQEV [see Use in Specific Populations (8.2) ].

🧬 Pharmacokinetics ~2 min read ▾

12.3Pharmacokinetics Biodistribution and Viral Shedding In the IGNYTE Study, TUDRIQEV biodistribution and viral shedding were assessed using a quantitative polymerase chain reaction (qPCR) assay. Blood, urine, and swab samples were collected from injection site(s), injection-site(s) dressings, and oral mucosa of 278 patients receiving TUDRIQEV. Samples were collected before dosing, during treatment, at 30 and 60 days following the last TUDRIQEV injection, and up to 100 days after the last dose of study treatment (either TUDRIQEV or nivolumab).

Patients were asked to report any appearance of herpetic-like lesions in caregivers or close contacts. As the presence of DNA does not equate to live/infectious TUDRIQEV, DNA-positive swab samples were further assessed in a validated 50% tissue culture infectious dose (TCID50) assay, which detects live TUDRIQEV. TUDRIQEV DNA was detected in blood samples from 53 out of 274 (19%) patients within 6 hours of injection with decreasing levels thereafter.

TUDRIQEV DNA was detected in 3 out of 1976 (0.2%) urine samples. TUDRIQEV is cleared from both blood and urine after 30 days, with all samples from follow-up visits testing negative for TUDRIQEV DNA. No sample had detectable TUDRIQEV DNA 30-days after the end of treatment in blood, urine, swab samples collected from injection site(s), injection-site(s) dressing, or oral mucosa.

TUDRIQEV DNA was detected on the surface of injected lesions in 112 of 266 (42%) patients, and 358 of 1947 (18%) tested samples. Consistent with the kinetics of TUDRIQEV replication in tumors, TUDRIQEV DNA was present at the injection site up to 15 days post injection in approximately 20% of patients. The incidence of detection of TUDRIQEV DNA in the exterior of injection site dressings was lower than at the injection site with samples from 43 of 207 (21%) patients' exterior of injection-site dressing samples testing positive for TUDRIQEV DNA.

Positive samples were further assessed for live TUDRIQEV. Out of 314 samples, 4 tested positive by TCID50. The reported incidence of TUDRIQEV transmission to close contacts was 0%.

No differences in the incidence of detectable TUDRIQEV DNA were observed between patients who were HSV-1 seronegative or seropositive at baseline.

🧬 Pharmacodynamics 13 words ▾

12.2Pharmacodynamics No studies have been performed to evaluate the pharmacodynamics of TUDRIQEV.

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES The efficacy of TUDRIQEV in combination with nivolumab was evaluated in an open-label, multiregional, single-arm study (IGNYTE; NCT03767348). The study enrolled adult patients with stage IIIB, IIIC, or IV unresectable advanced melanoma who had previously been treated with at least eight consecutive weeks of immediate prior anti-PD-1-based therapy and experienced disease progression while being on the anti-PD-1-based therapy and subsequently confirmed by imaging, biopsy or clinical observation. The study excluded patients who had received prior oncolytic virus therapy, uncontrolled or untreated central nervous system (CNS) metastasis, an active or history of hepatitis B, hepatitis C, HIV infection, prior severe complications from HSV-1 infection, and patients requiring chronic systemic corticosteroids.

Patients received TUDRIQEV by intratumor injection every 2 weeks for 8 consecutive injections, starting at a concentration of 10 6 PFU/mL at week 1 followed by TUDRIQEV at a concentration of 10 7 PFU/mL for the remaining doses. Starting with the second dose of TUDRIQEV, nivolumab was administered at a dose of 240 mg by intravenous infusion every 2 weeks for 16 weeks followed by nivolumab single agent at a dose of 480 mg by intravenous infusion every 4 weeks for up to a total of 24 months. At investigator discretion, patients could receive up to 16 additional doses of TUDRIQEV at a concentration of 10 7 PFU/mL every 2 weeks either in combination with nivolumab or as monotherapy if nivolumab was previously stopped due to toxicity related to nivolumab.

Among the 140 patients, 91 patients with at least one noninjected lesion were included in the efficacy population (Table 3). Of those 91, the population characteristics were as follows: median age was 62 years (range: 23 to 91), 68% were male, 68% were White, 30% were of "unknown" race; Eastern Cooperative Oncology Group (ECOG) performance status was 0 (68%), 1 (32%); 80% had Stage IV disease. Of these 91 patients, 45%, 24%, and 7% of patients had lung, liver, and brain lesions, respectively.

All patients received at least one prior anti-PD-1 based therapy. Prior anti-PD-1 therapy was given in the adjuvant treatment setting for 13% of patients. Tumor PD-L1 expression was negative (<1%) in 54% of patients.

The primary efficacy outcome was objective response rate (ORR) and the secondary outcome measure was duration of response (DOR). Tumor responses were assessed using radiographic imaging and/or caliper measurements with photography every 8 weeks. The main efficacy results are summarized in Table 3.

Table 3: Efficacy Results for the IGNYTE Study Endpoints N=91 Objective Response Rate NR, not reached. ORR % (95% CI) 24.2 (15.8, 34.3) Duration of response (DoR) Median DoR in months (95% CI) Estimated by Kaplan-Meier method. 14.1 (10.7, NR) DoR range, months 3.9 to 34.6+ % Patients with DoR ≥ 6 months 86.1 % Patients with DoR ≥ 12 months 54.6

🧪 Nonclinical Toxicology 41 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis, Mutagenesis, Impairment of Fertility No studies have been conducted with TUDRIQEV to assess its mutagenic or carcinogenic potential or effects on male fertility [see Use in Specific Populations (8.1) ] .

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 38 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis, Mutagenesis, Impairment of Fertility No studies have been conducted with TUDRIQEV to assess its mutagenic or carcinogenic potential or effects on male fertility [see Use in Specific Populations (8.1) ] .

📄 Patient Package Insert ~2 min read ▾

PATIENT PACKAGE INSERT TUDRIQEV™ (TOO-drih-kev) (vusolimogene oderparepvec-wtpg) suspension for intratumor injection The content of this Patient Medication Information has been approved by the U.S. Food and Drug Administration Revised: 08/2026 TUDRIQEV Is: Used with nivolumab to treat adults with advanced melanoma who have previously received an anti-PD-1-based regimen. Important Safety Information Warnings: Avoid touching or scratching the injection sites and dressing to prevent the transfer of TUDRIQEV.

You or your caregiver should always wear gloves when replacing or changing your injection site dressings. TUDRIQEV may cause a new or a reactivation of the common cold sore (herpes simplex virus, type 1). If you develop a cold sore after treatment with TUDRIQEV, contact your doctor to provide a swab for testing.

You may also call TUDRIQEV Medical Information for guidance at 1-877-375-0095. Injections of TUDRIQEV into tumors in your liver, lung or other organs may cause injury that requires further monitoring or treatment. Serious side effects: TUDRIQEV may cause serious side effects.

Call your healthcare provider right away if you develop any of the following signs and symptoms: Joint pain Headache, vision changes, dizziness or tiredness, which may be signs of inflammation of the pituitary gland Abdominal pain, cramping, diarrhea, nausea Fever Drug Interactions Tell your doctor if you have received antiviral medicine such as acyclovir. TUDRIQEV might not be effective if given within 72 hours of these medicines. Special Population Both men and women should use effective birth control during treatment and for 90 days after the last TUDRIQEV injection.

Talk to your healthcare provider for more information. Tell your health care provider: If you are breastfeeding or plan to breastfeed. You should not breastfeed during your treatment and for 90 days after your last injection of TUDRIQEV.

If you are pregnant or plan to become pregnant. For women, your healthcare provider should advise you to take a pregnancy test before starting your TUDRIQEV treatment. If you become pregnant during your TUDRIQEV treatment.

About all the medications you take including prescription and over-the-counter medicines, vitamins, and herbal supplements. Common Side Effects: The most common side effects of TUDRIQEV with nivolumab treatment include: Tiredness Chills Diarrhea Infection Joint or muscle pain Fever Nausea Injection Site Reactions (redness, pain, or swelling) Flu-like illness or symptoms These are not all of the possible side effects of TUDRIQEV. Call your health care provider if you have side effects that worsen or do not go away.

You may also report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Directions for Use TUDRIQEV is given by your healthcare provider and is not self-administered. After injection, keep the injection site(s) covered for at least 48 hours.

Marketed by Replimune, Inc. Woburn, MA 01801

📄 Package Label / Principal Display Panel 84 words ▾

PRINCIPAL DISPLAY PANEL - 10 6 PFU/mL Vial Carton NDC 83616-106-11 Rx Only vusolimogene oderparepvec-wtpg TUDRIQEV™ 10 6 PFU/mL For intratumor injection only Single-dose vial Discard unused portion 1 vial per carton Replimune ® PRINCIPAL DISPLAY PANEL - 10^6 PFU/mL Vial Carton

PRINCIPAL DISPLAY PANEL - 10 7 PFU/mL Vial Carton NDC 83616-107-11 Rx Only vusolimogene oderparepvec-wtpg TUDRIQEV™ 10 7 PFU/mL For intratumor injection only Single-dose vial Discard unused portion 1 vial per carton Replimune ® PRINCIPAL DISPLAY PANEL - 10^7 PFU/mL Vial Carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

About this NDC listing & data coverage

Finished prescription product
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.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Replimune, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Replimune, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 83616-0106-11 · Replimune, 83623-0161-02 · Lifeline →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.