Talimogene Laherparepvec Injection
Talimogene laherparepvec (Imlygic) is a genetically modified oncolytic viral therapy injected directly into melanoma lesions that cannot be surgically removed.
🧬 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 →
📖 Talimogene Laherparepvec Injection: Patient Information Guide
A plain-language walkthrough of Talimogene Laherparepvec Injection — 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▾
Imlygic (talimogene laherparepvec) is approved for one specific use in melanoma treatment:
- Imlygic is used for the local treatment of unresectable (surgically unremovable) cutaneous (skin surface), subcutaneous (just beneath the skin), and nodal (lymph node) melanoma lesions in patients whose melanoma has returned after initial surgery.
- Imlygic is injected directly into lesions that are visible, felt by touch (palpable), or detected by ultrasound.
- Important limitation: Imlygic has not been shown to improve overall survival or to affect melanoma that has spread to internal organs (visceral metastases).
⚙️How it works▾
Imlygic is a herpes simplex virus that has been genetically engineered to do two things inside tumor tissue: replicate (multiply) within cancer cells until they burst open (lyse), and produce GM-CSF, an immune-stimulating protein. When tumor cells burst, they release cancer-associated proteins that, together with GM-CSF, may help the body's immune system recognize and attack cancer cells. The exact chain of events that leads to any anti-tumor effect is not fully understood.
💊How it's taken▾
Imlygic is given by a healthcare provider as a direct injection into lesions — it is never given into a vein or by any other route. The first dose is followed by a second dose three weeks later; all doses after that are given every two weeks. Treatment is typically continued for at least six months, unless all injectable lesions resolve or another treatment becomes necessary.
- The total injection volume at any single visit cannot exceed 4 mL across all lesions combined.
- The largest lesions are injected first; new lesions appearing since the last visit are prioritized in subsequent sessions.
- If a complete response is achieved and new unresectable lesions later appear, treatment may be restarted.
🤒Side effects — in detail▾
Most side effects reported with Imlygic were mild to moderate and tended to resolve within about 72 hours. The most common ones include:
- Fatigue
- Chills
- Fever
- Nausea
- Flu-like illness
- Injection site pain
- Vomiting
- Headache
- Muscle aches (myalgia)
- Joint pain (arthralgia)
Serious reactions to watch for include spreading herpes infection (especially in immunocompromised individuals), skin or tissue breakdown at the injection site, immune-mediated events like kidney inflammation or pneumonitis (lung inflammation), and airway problems. Call your doctor right away if any of these occur.
⚠️Warnings & precautions▾
- Live virus risk: Imlygic is a live, modified herpes virus. It can be transmitted through accidental contact with injection sites, dressings, or body fluids. Close contacts — especially those who are immunocompromised or pregnant — must avoid direct contact with treated areas.
- Herpetic infection: Serious and even fatal herpes infections have been reported, particularly in immunocompromised patients. Patients who develop herpes-like sores should follow hygiene precautions and contact their doctor.
- Injection site complications: Tissue breakdown (necrosis), ulceration, poor wound healing, and bacterial infections including cellulitis have occurred. One patient required limb amputation after a non-healing infected wound.
- Immune-mediated events: Imlygic can trigger immune reactions including kidney inflammation (glomerulonephritis), blood vessel inflammation (vasculitis), lung inflammation (pneumonitis), and worsening of pre-existing autoimmune conditions.
- Airway risk: Airway obstruction has been reported when lesions near major airways were injected — use with caution in those locations.
- Do NOT give via the liver: Imlygic is not approved for injection through the skin into the liver. This route has caused hospitalizations and deaths from liver bleeding.
🔀What it interacts with▾
There is only one known drug interaction class identified for Imlygic:
- Antiviral agents (e.g., acyclovir, valacyclovir): These medicines treat herpes infections but can also interfere with Imlygic's ability to work, since Imlygic is itself a herpes-based virus that is sensitive to acyclovir. If you develop a herpes infection during treatment, your doctor will need to weigh the risk of treating the infection against the impact on Imlygic's effectiveness.
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▾
- Weakened immune system (immunocompromised): Do not use Imlygic if you have HIV/AIDS, leukemia, lymphoma, or are on immunosuppressive therapy — risk of life-threatening herpes infection.
- Pregnancy: Do not use Imlygic during pregnancy. Women who can become pregnant should use effective contraception throughout treatment.
- Breastfeeding: It is unknown whether Imlygic passes into breast milk. Discuss with your doctor whether to stop breastfeeding or stop treatment.
- Children: Safety and effectiveness have not been established in pediatric patients.
- Older adults (65+): No meaningful differences in safety or effectiveness were seen compared to younger patients in clinical studies.
- Autoimmune disease: Discuss risks and benefits with your doctor before starting Imlygic if you have an underlying autoimmune condition.
- Multiple myeloma: A plasmacytoma (a type of plasma cell tumor) was reported near an injection site in a patient with smoldering multiple myeloma — discuss risks carefully with your doctor.
- Poor wound healing history: Prior radiation at injection sites or poor blood supply to lesion areas may increase the risk of wound complications.
🚑If you take too much▾
There is no clinical experience with an Imlygic overdose. No dose-limiting toxicity was observed in clinical studies at the maximum studied doses. If an overdose is suspected, treatment is supportive and symptomatic — meaning your care team will monitor and treat any symptoms that arise.
🔬Pharmacokinetics — how your body processes it▾
After injection, Imlygic DNA spreads beyond the injection site and has been detected in blood, urine, oral mucosa (mouth lining), and the anogenital area during treatment. The highest concentration is found at the injected tumor itself. In clinical studies, Imlygic DNA was no longer detectable in blood and urine within 30 days after the end of treatment, and not detectable at injection sites within 60 days after treatment ended. Infectious (active) virus was detected at injection sites in a small number of patients early in treatment but was not found after the second cycle of treatment.
📦How to store it▾
Store and transport IMLYGIC at −90°C to −70°C (−130°F to −94°F). Store IMLYGIC in the carton until use.
📄 Written from Talimogene Laherparepvec Injection’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 Talimogene Laherparepvec Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Imlygic and how is it different from chemotherapy? ▾
How often will I need to come in for injections? ▾
What side effects should I expect, and when should I call my doctor? ▾
Is Imlygic contagious — can I spread it to my family? ▾
Can I take acyclovir or other cold sore medicines while on Imlygic? ▾
Is Imlygic safe if I'm pregnant or trying to get pregnant? ▾
Is Talimogene Laherparepvec Injection available over the counter? ▾
When was Talimogene Laherparepvec Injection first available? ▾
Who makes Talimogene Laherparepvec Injection? ▾
💬 Answers drafted from Talimogene Laherparepvec Injection’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 Talimogene Laherparepvec Injection comes
Talimogene Laherparepvec Injection 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
- Imlygic is injected directly into unresectable (cannot be surgically removed) cutaneous, subcutaneous, or nodal melanoma lesions that have returned after initial surgery
- Imlygic is not for melanoma that has spread to internal organs, and has not been shown to improve overall survival
- Imlygic is administered by a healthcare provider by direct intralesional injection only — never into a vein
- Imlygic vials must be thawed at room temperature before use and administered immediately or stored under specific conditions; they must never be refrozen
- After each treatment visit, Imlygic injection sites must be kept covered with an occlusive dressing for at least one week or until the site stops weeping
- Imlygic is generally given on a schedule: initial dose, then a second dose three weeks later, then every two weeks thereafter for at least six months
📊 Talimogene Laherparepvec Injection across the U.S. market
How Talimogene Laherparepvec Injection 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.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
📈 How widely Talimogene Laherparepvec Injection is used
A general measure of how commonly Talimogene Laherparepvec Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Talimogene Laherparepvec Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Talimogene Laherparepvec Injection prescribed? Of the 1,597 medications we measure, Talimogene Laherparepvec Injection ranks #1,571 by Medicaid prescriptions — more than 2% of them.
Utilization by Talimogene Laherparepvec Injection product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
Other Talimogene Laherparepvec Injection products — combination packs and listings not yet matched to a specific clinical product (kept visible so every prescription is accounted for)
Summed across the 1 of 4 listed NDC products with Medicaid activity.
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Talimogene Laherparepvec Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 4 listed Talimogene Laherparepvec Injection NDCs with Medicaid activity.
🔍 Compare Talimogene Laherparepvec Injection products
A representative set of FDA-listed product records for Talimogene Laherparepvec Injection — 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 | Intralesional | Amgen Inc × 3 listings | BLA | View NDC → |
| 100000000 [PFU]/mL | Intralesional | Amgen Inc × 3 listings | BLA | View NDC → |
| 1000000 [PFU]/mL | — | IDT Biologika GmbH | DRUG FOR FURTHER PROCESSING | View NDC → |
| 100000000 [PFU]/mL | — | IDT Biologika GmbH | DRUG FOR FURTHER PROCESSING | View NDC → |
Showing 8 of 8 products — FDA National Drug Code Directory. See every product, package size and price: browse all 8 Talimogene Laherparepvec Injection 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 Talimogene Laherparepvec Injection — 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 Talimogene Laherparepvec Injection 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 Talimogene Laherparepvec Injection 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 Talimogene Laherparepvec Injection 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
RxNorm drug class
Talimogene Laherparepvec Injection belongs to the Antineoplastic cell and gene therapy class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 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.
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. Amgen 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.