Vusolimogene Oderparepvec-Wtpg
Vusolimogene oderparepvec-wtpg is a genetically modified oncolytic virus (a virus that attacks cancer cells), given by injection into tumors together with nivolumab, for adults with advanced melanoma that can't be surgically removed and has grown despite anti-PD-1 treatment.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
📖 Vusolimogene Oderparepvec-Wtpg: Patient Information Guide
A plain-language walkthrough of Vusolimogene Oderparepvec-Wtpg — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Vusolimogene oderparepvec-wtpg is an oncolytic viral therapy used in one setting:
- Tudriqev, given by injection into tumors together with nivolumab, treats adults with unresectable advanced cutaneous melanoma whose disease progressed after a PD-1-blocking antibody-based regimen.
- This use has accelerated approval based on response rate and duration of response. Continued approval may depend on a confirmatory trial.
⚙️How it works▾
Tudriqev is a modified virus that multiplies mainly inside tumors. This breaks down tumor cells and releases tumor and viral material that alerts the immune system. T cells then move into the area.
The virus also makes two added proteins. One boosts direct tumor killing. The other, GM-CSF, is meant to activate and mature immune cells. With nivolumab, this may promote an anti-tumor immune response in melanoma that no longer responds to anti-PD-1 treatment.
💊How it's taken▾
Tudriqev is injected straight into tumors by a healthcare professional. It is never given into a vein.
- It is given every two weeks for 8 doses in a row.
- The volume depends on the size of the tumor, with a set maximum per visit.
- Nivolumab is given separately by vein starting at Week 3.
- Some people without confirmed progression may be retreated.
Your care team schedules each visit, so missed-visit questions should go to them.
🤒Side effects — in detail▾
Common side effects seen in the study included:
- Fatigue (most common)
- Fever and chills
- Infections
- Musculoskeletal pain and joint pain
- Nausea, diarrhea, vomiting, constipation, and decreased appetite
- Injection site reactions
- Headache, dizziness, and cough
- Flu-like illness, rash, and itching
Serious reactions included herpes infections, bleeding, lung or organ injury from the injection, immune-related problems, and heart events. About 1 in 6 people stopped treatment because of side effects.
⚠️Warnings & precautions▾
- Accidental exposure: The virus can pass to others through injected tumors, dressings, or body fluids and may cause herpes infection. Wash any exposed area with soap and water.
- Herpes infection or reactivation: Contact your provider about any suspected herpes sores for assessment and antiviral treatment.
- Injection complications: Bleeding, infection, and organ injury (such as pneumothorax, a collapsed lung) can occur. You are monitored after injection.
- Immune-related events with nivolumab: These include colitis, hepatitis, myocarditis, neuropathy, capillary leak syndrome, dermatitis, and vitiligo.
🔀What it interacts with▾
The main interaction is with antiviral medicines.
- Antivirals may reduce how well Tudriqev works.
- If you take a systemic antiviral for a herpes infection, Tudriqev should be delayed until 72 hours after you finish.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- There are no listed contraindications.
- Pregnancy status should be verified before starting. Use effective contraception during treatment and for 90 days after the last dose.
- Men with a female partner who could become pregnant should use contraception and not donate sperm during treatment and for 90 days afterward.
- Breastfeeding: discuss risks and benefits with your doctor, since there are no data.
- Not established in children.
- Adults 65 and older had no overall difference in safety or effectiveness.
- Tumors in the brain or spinal cord are not injected.
🔬Pharmacokinetics — how your body processes it▾
In a study, the virus's DNA showed up briefly in the blood of about 1 in 5 people within 6 hours of injection, then dropped. It was rarely found in urine. Blood and urine were clear by 30 days.
Viral DNA was often found on the surface of injected tumors, sometimes for up to 15 days. Live virus was rarely detected on swabs, and no spread to close contacts was reported. Results were similar whether or not people had prior herpes (HSV-1) exposure.
📦How to store it▾
Store in the original carton until use. Store TUDRIQEV at -70°C to -90°C (-94°F to -130°F). refrigeration guidelines.
📄 Written from Vusolimogene Oderparepvec-Wtpg’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Vusolimogene Oderparepvec-Wtpg — the kind of thing our pharmacy team would talk through with you at the counter.
What is Tudriqev used for? ▾
How will I receive it? ▾
What should I do about the injection site? ▾
Can I pass the virus to my family? ▾
What side effects should I expect? ▾
Do I need contraception? ▾
Is Vusolimogene Oderparepvec-Wtpg available over the counter? ▾
When was Vusolimogene Oderparepvec-Wtpg first available? ▾
💬 Answers drafted from Vusolimogene Oderparepvec-Wtpg’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Vusolimogene Oderparepvec-Wtpg comes
Vusolimogene Oderparepvec-Wtpg is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- Tudriqev is used with nivolumab for adults with unresectable advanced cutaneous melanoma that progressed after a PD-1-blocking antibody-based regimen.
- Tudriqev is for intratumor injection only and must not be given into a vein.
- Tudriqev is given every two weeks for 8 consecutive doses, with nivolumab by vein starting at Week 3.
- Tudriqev injection sites should stay covered with a dressing for at least 48 hours.
- Tudriqev is prepared and given by a healthcare professional experienced in anticancer therapy.
📊 Vusolimogene Oderparepvec-Wtpg across the U.S. market
How Vusolimogene Oderparepvec-Wtpg appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
🔍 Compare Vusolimogene Oderparepvec-Wtpg products
A representative set of FDA-listed product records for Vusolimogene Oderparepvec-Wtpg — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 1000000 [PFU]/mL | Intratumor | Replimune, Inc. × 2 listings | BLA | View NDC → |
| 10000000 [PFU]/mL | Intratumor | Replimune, Inc. × 2 listings | BLA | View NDC → |
Showing 4 of 4 products — FDA National Drug Code Directory. See every product, package size and price: browse all 4 Vusolimogene Oderparepvec-Wtpg NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Vusolimogene Oderparepvec-Wtpg — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Vusolimogene Oderparepvec-Wtpg in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Vusolimogene Oderparepvec-Wtpg went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
📦 Supply & shortage status
Whether Vusolimogene Oderparepvec-Wtpg is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Replimune, Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.