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Imlygic talimogene laherparepvec 1000000 [PFU]/mL Injection, Suspension, 1 vial
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Antineoplastic cell and gene therapy class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Talimogene laherparepvec injection is used to treat certain melanoma (a type of skin cancer) tumors that cannot be removed surgically or that came back after being treated with surgery. Talimogene laherparepvec is in a class of medications called oncolytic viruses. It is a weakened and changed form of Herpes Simplex Virus Type I (HSV-1 'cold sore virus') that works by helping to kill cancer cells.
Read the full MedlinePlus article ↗- Imlygic is a genetically modified herpes virus — not a chemotherapy drug. Instead of using chemicals to kill cancer cells, it's injected directly into your melanoma lesions, where...
- What exactly is Imlygic and how is it different from chemotherapy?
- Your first injection is followed by a second one three weeks later. After that, you'll come in every two weeks. In general, treatment continues for at least six months, as long as...
- How often will I need to come in for injections?
Patient education
Supplement & herbal interactions
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Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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40 mg / 1 mL
UNII 4L6452S749
Inositol is a naturally occurring sugar-like compound. It acts as an osmotic agent and sweetener in medications, helping draw water into the formulation and improve taste.
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8.5 mg / 1 mL
UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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15.4 mg / 1 mL
UNII 94255I6E2T
Sodium phosphate dibasic dihydrate is a salt that helps control the acidity level of a medicine. It acts as a buffer and pH regulator to keep the medication stable and effective.
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2.44 mg / 1 mL
UNII 5QWK665956
A salt derived from phosphoric acid and sodium, used primarily as a buffer to control the acidity or pH of a medication, helping keep it stable during storage and use.
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20 mg / 1 mL
UNII 506T60A25R
Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
6 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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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 mL | 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. | |
| Medicare Part B allowsASP · J9999 | No ASP payment limit on file for J9999 this quarter. | |
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🧾 Billing & reimbursement
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Imlygic 1000000 [PFU]/mLthis 55513-0078-01 | Amgen | 1 vial | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.
🛈 What do these terms mean?
- Biologic patent
- A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
- Reference-product exclusivity
- A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
- Interchangeable exclusivity
- The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
- Earliest biosimilar (LOE)
- The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.
Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.
| Code | What it grants | Expires |
|---|---|---|
| RefProduct | Reference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this date | Oct 27, 2027 |
Is there a biosimilar for IMLYGIC 1 MILLION PFU/ML VIAL?
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🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 55513-0078-01 You're viewing this | 1 VIAL in 1 CARTON (55513-078-01) / 1 mL in 1 VIAL | 2015-11-02 | 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) | ✓ 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 | ✓ Available |
| HCPCS J-code billing crosswalk | ✓ Available |
| 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 IMLYGIC is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery. Limitations of use : IMLYGIC has not been shown to improve overall survival or have an effect on visceral metastases. IMLYGIC is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery.
Limitations of use : IMLYGIC has not been shown to improve overall survival or have an effect on visceral metastases. ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION For intralesional injection only. Do not administer intravenously. Administer IMLYGIC by injection into cutaneous, subcutaneous, and/or nodal lesions. ( 2.1 ) Recommended starting dose is up to a maximum of 4 mL of IMLYGIC at a concentration of 10 6 (1 million) plaque-forming units (PFU) per mL. Subsequent doses should be administered up to 4 mL of IMLYGIC at a concentration of 10 8 (100 million) PFU per mL. ( 2.1 )
2.1Dose Administer IMLYGIC by injection into cutaneous, subcutaneous, and/or nodal lesions that are visible, palpable, or detectable by ultrasound guidance. IMLYGIC is provided in single-dose vials of 1 mL each in two different dose strengths: 10 6 (1 million) plaque-forming units (PFU) per mL (light green cap) – for initial dose only 10 8 (100 million) PFU per mL (royal blue cap) – for all subsequent doses Recommended Dose and Schedule The total injection volume for each treatment visit should not exceed 4 mL for all injected lesions combined.
It may not be possible to inject all lesions at each treatment visit or over the full course of treatment. Previously injected and/or uninjected lesion(s) may be injected at subsequent treatment visits. The initial recommended dose is up to 4 mL of IMLYGIC at a concentration of 10 6 (1 million) PFU per mL.
The recommended dose for subsequent administrations is up to 4 mL of IMLYGIC at a concentration of 10 8 (100 million) PFU per mL. The recommended dosing schedule for IMLYGIC is shown in Table 1. Table 1.
Recommended Dose and Schedule for IMLYGIC Treatment Treatment I nterval Maximum I njection V olume per T reatme n t V isit (all lesions combined) Dose S trength Prioritization of L esions to be I njected Initial – 4 mL 10 6 (1 million) PFU per mL Inject largest lesion(s) first. Prioritize injection of remaining lesion(s) based on lesion size until maximum injection volume is reached or until all injectable lesion(s) have been treated. Second 3 weeks after initial treatment 4 mL 10 8 (100 million) PFU per mL Inject any new lesion(s) (lesions that have developed since initial treatment) first.
Prioritize injection of remaining lesion(s) based on lesion size until maximum injection volume is reached or until all injectable lesion(s) have been treated. All subsequent treatments (including reinitiation) 2 weeks after previous treatment 4 mL 10 8 (100 million) PFU per mL Inject any new lesion(s) (lesions that have developed since previous treatment) first. Prioritize injection of remaining lesion(s) based on lesion size until maximum injection volume is reached or until all injectable lesion(s) have been treated.
Dose Volume Determination (per Lesion) Use Table 2 to determine the volume of IMLYGIC injection for each lesion. Table 2. Determination of IMLYGIC Injection Volume Based on Lesion Size Lesion Size (longest dimension) Injection Volume > 5 cm up to 4 mL > 2.5 cm to 5 cm up to 2 mL > 1.5 cm to 2.5 cm up to 1 mL > 0.5 cm to 1.5 cm up to 0.5 mL ≤ 0.5 cm up to 0.1 mL When lesions are clustered together, inject them as a single lesion according to Table 2.
Continue IMLYGIC treatment for at least 6 months unless other treatment is required or until there are no injectable lesions to treat. Reinitiate IMLYGIC treatment if new unresectable cutaneous, subcutaneous, or nodal lesions appear after a complete response.
2.2Preparation and Handling Healthcare providers who are immunocompromised or pregnant should not prepare or administer IMLYGIC and should not come into direct contact with the IMLYGIC injection sites, dressings, or body fluids of treated patients [see Warnings and Precautions ( 5.1 )] . Avoid accidental exposure to IMLYGIC and follow below instructions for preparation, administration, and handling of IMLYGIC: Wear personal protective equipment (protective gown or laboratory coat, safety glasses or face shield, and gloves) while preparing or administering IMLYGIC.
Avoid accidental exposure to IMLYGIC, especially contact with skin, eyes, and…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Initial dose only: 10 6 (1 million) PFU per mL solution in 1 mL single-dose vial (light green cap) Subsequent doses: 10 8 (100 million) PFU per mL solution in 1 mL single-dose vial (royal blue cap) Injection: 10 6 (1 million) PFU per mL, 10 8 (100 million) PFU per mL in single-dose vials ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Immunocompromised Patients ( 4.1 ) Pregnant Patients ( 4.2 )
4.1Immunocompromised Patients IMLYGIC is a live, attenuated herpes simplex virus and may cause life-threatening disseminated herpetic infection in patients who are immunocompromised. Do not administer IMLYGIC to immunocompromised patients, including those with a history of primary or acquired immunodeficient states, leukemia, lymphoma, AIDS or other clinical manifestations of infection with human immunodeficiency viruses, and those on immunosuppressive therapy [see Nonclinical Toxicology ( 13.2 )] .
4.2Pregnant Patients Do not administer IMLYGIC to pregnant patients.
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Accidental Exposure to IMLYGIC: Accidental exposure may lead to transmission of IMLYGIC and herpetic infection. Healthcare providers and close contacts should avoid direct contact with injected lesions, dressings, or body fluids of treated patients. Accidental Exposure to IMLYGIC continued: Healthcare providers who are immunocompromised or pregnant should not prepare or administer IMLYGIC.
If accidental exposure occurs, exposed individuals should clean the affected area. ( 5.1 ) Herpetic Infection: Patients who develop herpetic infections should be advised to follow standard hygienic practices to prevent viral transmission. ( 5.2 ) Injection Site Complications: Consider the risks and benefits before continuing IMLYGIC treatment if persistent infection or delayed healing develops.
( 5.3 ) Immune-Mediated Events: Consider the risks and benefits of IMLYGIC before initiating treatment in patients who have underlying autoimmune disease or before continuing treatment in patients who develop immune-mediated events. ( 5.4 ) Plasmacytoma at the Injection Site: Consider the risks and benefits in patients with multiple myeloma or in whom plasmacytoma develops during treatment. ( 5.5 ) Obstructive Airway Disorder: Use caution when injecting lesions close to major airways.
( 5.6 ) Hepatic Hemorrhage from Transcutaneous Intrahepatic Route of Administration: IMLYGIC is not indicated for treatment via transcutaneous intrahepatic route of administration. ( 5.7 )
5.1Accidental Exposure to IMLYGIC Accidental exposure may lead to transmission of IMLYGIC and herpetic infection. Accidental needle stick and splashback to the eyes have been reported in healthcare providers during preparation and administration of IMLYGIC. Healthcare providers, close contacts (household members, caregivers, sex partners, or persons sharing the same bed), pregnant women, and newborns should avoid direct contact with injected lesions, dressings, or body fluids of treated patients [ see Dosage and Administration ( 2.2 )] .
Healthcare providers who are immunocompromised or pregnant should not prepare or administer IMLYGIC. Caregivers should wear protective gloves when assisting patients in applying or changing occlusive dressings and observe safety precautions for disposal of used dressings, gloves, and cleaning materials [ see Dosage and Administration ( 2.2 ) ] . In the event of an accidental exposure to IMLYGIC, exposed individuals should clean the affected area thoroughly with soap and water and/or a disinfectant.
If signs or symptoms of herpetic infection develop, the exposed individuals should contact their healthcare provider for appropriate treatment [ see Warnings and Precautions ( 5.2 )] . Patients should avoid touching or scratching injection sites or their occlusive dressings, as doing so could lead to inadvertent transfer of IMLYGIC to other areas of the body.
5.2Herpetic Infection Herpetic infections (including but not limited to cold sores and herpetic keratitis) and serious cases of disseminated herpetic infections have been reported in patients treated with IMLYGIC, including fatal disseminated herpetic infection in the immunocompromised patient population [see Clinical Trials Experience (6.1) and Postmarketing Experience (6.2) ] . Immunocompromised patients may be at increased risk of life-threatening disseminated herpetic infection [see Contraindications (4.1) ] . Patients who develop suspicious herpes-like lesions should follow standard hygienic practices to prevent viral transmission.
Patients or close contacts with suspected herpetic infections should also contact their healthcare provider to evaluate the lesions. Suspected herpetic lesions should be reported to Amgen at 1-855-IMLYGIC (1-855-465-9442); patients or close contacts have the option of follow-up testing for further characterization of the infection. IMLYGIC is sensitive to acyclovir.
Acyclovir or other antiviral agents may interfere with the effectiveness of I…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The most commonly reported adverse drug reactions (≥ 25%) in IMLYGIC-treated patients were fatigue, chills, pyrexia, nausea, influenza-like illness, and injection site pain. The following adverse reactions are discussed in greater detail in another section of the label: Herpetic Infection [see Warnings and Precautions ( 5.2 )] Injection Site Complications [see Warnings and Precautions ( 5.3 )] The most commonly reported adverse drug reactions (≥ 25%) in IMLYGIC-treated patients were fatigue, chills, pyrexia, nausea, influenza-like illness, and injection site pain.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Amgen at 1-855-IMLYGIC (1-855-465-9442) 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 of IMLYGIC was evaluated in 419 patients who received at least 1 dose of either IMLYGIC (n = 292) or subcutaneously administered granulocyte-macrophage colony-stimulating factor (GM-CSF) (n = 127) in an open-label, randomized clinical study of patients with stage IIIB, IIIC, and IV melanoma that was not considered to be surgically resectable [see Clinical Studies ( 14 )] .
The median duration of exposure to IMLYGIC was 23 weeks (5.3 months). Twenty-six patients were exposed to IMLYGIC for at least 1 year. Most adverse reactions reported were mild or moderate in severity and generally resolved within 72 hours.
The most common grade 3 or higher adverse reaction was cellulitis [see Warnings and Precautions ( 5.3 )] . Pyrexia, chills, and influenza-like illness can occur any time during IMLYGIC treatment but were more frequent during the first 3 months of treatment. Table 4 below lists adverse reactions with a 5% or greater incidence in the IMLYGIC arm compared to the GM-CSF arm in the clinical study [see Clinical Studies ( 14 )] .
Table 4. Adverse Reactions Reported with At Least a 5% Greater Incidence in Patients Treated with IMLYGIC Compared to GM-CSF Adverse Reactions IMLYGIC ( n = 292) GM-CSF ( n = 127) Any Grade n (%) Grade 3 n (%) Any Grade n (%) Grade 3 n (%) General disorders and administration site conditions Fatigue 147 (50.3) 6 (2.1) 46 (36.2) 1 (< 1) Chills 142 (48.6) 11 (8.7) Pyrexia 125 (42.8) 11 (8.7) Influenza-like illness 89 (30.5) 2 (< 1) 19 (15.0) Injection site pain 81 (27.7) 2 (< 1) 8 (6.3) Gastrointestinal disorders Nausea 104 (35.6) 1 (< 1) 25 (19.7) Vomiting 62 (21.2) 5 (1.7) 12 (9.5) Diarrhea 55 (18.8) 1 (< 1) 14 (11.0) Constipation 34 (11.6) 8 (6.3) 1 (< 1) Abdominal pain 26 (8.9) 2 (< 1) 3 (2.4) Musculoskeletal and connective tissue disorders Myalgia 51 (17.5) 1 (< 1) 7 (5.5) Arthralgia 50 (17.1) 2 (< 1) 11 (8.7) Pain in extremity 48 (16.4) 4 (1.4) 12 (9.5) 1 (< 1) Nervous system disorders Headache 55 (18.8) 2 (< 1) 12 (9.5) Dizziness 28 (9.6) 4 (3.2) Respiratory, thoracic , and mediastinal disorders Oropharyngeal pain 17 (5.8) 1 (< 1) Investigations Weight decreased 17 (5.8) 1 (< 1) 1 (< 1) Other adverse reactions associated with IMLYGIC in the open-label, randomized study include rash, dermatitis, glomerulonephritis, vitiligo, worsening psoriasis, cellulitis, pneumonitis, vasculitis, herpetic keratitis, obstructive airway disorder, plasmacytoma at the injection site, deep vein thrombosis, and oral herpes.
6.2Postmarketing Experience The following adverse reactions have been identified during postapproval use of IMLYGIC. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Herpetic infections including disseminated herpetic infections [see Warnings and Precautions (5.2) ].
Serious including fatal disseminated herpetic infections in imm…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS IMLYGIC is sensitive to acyclovir. Acyclovir or other antiherpetic viral agents may interfere with the effectiveness of IMLYGIC. No drug interaction studies have been conducted with IMLYGIC.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pregnancy: Women of childbearing potential should be advised to use an effective method of contraception to prevent pregnancy during treatment with IMLYGIC. ( 8.1 ) Lactation: Discontinue drug or nursing. ( 8.2 )
8.1Pregnancy Risk Summary Adequate and well-controlled studies with IMLYGIC have not been conducted in pregnant women. No effects on embryo-fetal development have been observed in a study conducted in pregnant mice. The design of the study limits application of the animal data to humans [see Data].
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations If the patient becomes pregnant while taking IMLYGIC, the patient should be apprised of the 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 IMLYGIC.
If a pregnant woman has an infection with wild-type Herpes Simplex Virus Type 1 (HSV-1) (primary or reactivation), there is potential for the virus to cross the placental barrier and also a risk of transmission during birth due to viral shedding. Infections with wild-type HSV-1 have been associated with serious adverse effects, including multi-organ failure and death, if a fetus or neonate contracts the wild-type herpes infection. While there are no clinical data to date on IMLYGIC infections in pregnant women, there could be a risk to the fetus or neonate if IMLYGIC were to act in the same manner.
Data Animal Data No effects on embryo-fetal development were observed when IMLYGIC was intravenously administered during organogenesis to immunocompetent pregnant mice at doses up to 4 x 10 8 (400 million) PFU per kg (60-fold higher, on a PFU per kg basis, compared to the maximum clinical dose). Levels of IMLYGIC DNA in pooled fetal blood were at or below the assay detection level. Study design limitations included: 1) administration of IMLYGIC expressing human granulocyte-macrophage colony-stimulating factor (huGM-CSF), which is not biologically active in mice; 2) unknown transplacental kinetics of IMLYGIC following intravenous administration in pregnant mice; and 3) unknown significance of IMLYGIC dose extrapolation from animal to human based on body weight.
8.2Lactation Risk Summary There is no information regarding the presence of IMLYGIC 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 IMLYGIC and any potential adverse effects on the breastfed infant from IMLYGIC or from the underlying maternal condition. Clinical Considerations Because medicinal products can be found in human milk, a decision should be made whether to discontinue nursing or to discontinue IMLYGIC while nursing.
8.3Females and Males of Reproductive Potential No nonclinical or clinical studies were performed to evaluate the effect of IMLYGIC on fertility.
8.4Pediatric Use Safety and effectiveness of IMLYGIC have not been established in pediatric patients.
8.5Geriatric Use In clinical studies, no overall differences in safety or efficacy were observed between geriatric patients (≥ 65 years old) and younger patients.
8.6Renal Impairment No clinical studies have been conducted to evaluate the effect of renal impairment on the pharmacokinetics of IMLYGIC.
8.7Hepatic Impairment No clinical studies have been conducted to evaluate the effect of hepatic impairment on the pharmacokinetics of IMLYGIC.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Adequate and well-controlled studies with IMLYGIC have not been conducted in pregnant women. No effects on embryo-fetal development have been observed in a study conducted in pregnant mice. The design of the study limits application of the animal data to humans [see Data].
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations If the patient becomes pregnant while taking IMLYGIC, the patient should be apprised of the 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 IMLYGIC.
If a pregnant woman has an infection with wild-type Herpes Simplex Virus Type 1 (HSV-1) (primary or reactivation), there is potential for the virus to cross the placental barrier and also a risk of transmission during birth due to viral shedding. Infections with wild-type HSV-1 have been associated with serious adverse effects, including multi-organ failure and death, if a fetus or neonate contracts the wild-type herpes infection. While there are no clinical data to date on IMLYGIC infections in pregnant women, there could be a risk to the fetus or neonate if IMLYGIC were to act in the same manner.
Data Animal Data No effects on embryo-fetal development were observed when IMLYGIC was intravenously administered during organogenesis to immunocompetent pregnant mice at doses up to 4 x 10 8 (400 million) PFU per kg (60-fold higher, on a PFU per kg basis, compared to the maximum clinical dose). Levels of IMLYGIC DNA in pooled fetal blood were at or below the assay detection level. Study design limitations included: 1) administration of IMLYGIC expressing human granulocyte-macrophage colony-stimulating factor (huGM-CSF), which is not biologically active in mice; 2) unknown transplacental kinetics of IMLYGIC following intravenous administration in pregnant mice; and 3) unknown significance of IMLYGIC dose extrapolation from animal to human based on body weight.
🧒 Pediatric Use ▾
8.4Pediatric Use Safety and effectiveness of IMLYGIC have not been established in pediatric patients.
🧓 Geriatric Use ▾
8.5Geriatric Use In clinical studies, no overall differences in safety or efficacy were observed between geriatric patients (≥ 65 years old) and younger patients.
🆘 Overdosage ▾
10 OVERDOSAGE There is no clinical experience with an overdose with IMLYGIC. Doses up to 4 mL at dose strength of 10 8 (100 million) PFU per mL every 2 weeks (maximum cumulative dose of 222.5 x 10 8 PFU) have been administered in clinical studies, with no evidence of dose-limiting toxicity. The maximum dose of IMLYGIC that can be safely administered has not been determined.
In the event of a suspected overdose, the patient should be treated symptomatically and supportive measures instituted as required [see Warnings and Precautions ( 5 )] .
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action IMLYGIC has been genetically modified to replicate within tumors and to produce the immune stimulatory protein GM-CSF. IMLYGIC causes lysis of tumors, followed by release of tumor-derived antigens, which together with virally derived GM-CSF may promote an antitumor immune response. However, the exact mechanism of action is unknown.
12.3Pharmacokinetics Biodistribution (within the body) and Viral Shedding (excretion/secretion) IMLYGIC viral DNA levels in various tissues and secretions were determined using a quantitative polymerase chain reaction (qPCR) assay. Infectious IMLYGIC at the injection sites and at some potential herpetic lesions was also quantified using viral infectivity assays. Nonclinical data Following repeat intratumoral administration in mice, IMLYGIC DNA was primarily detected in the tumor, blood, spleen, lymph node, liver, heart, and kidney.
IMLYGIC DNA was not detected in bone marrow, eyes, lachrymal glands, nasal mucosa, or feces. The highest level of IMLYGIC DNA was found in the injected tumor. IMLYGIC DNA was found in the injected tumor through 84 days and in blood samples through 14 days after the last administration of IMLYGIC.
Clinical data The biodistribution and shedding of intralesionally administered IMLYGIC were investigated in a clinical study that measured IMLYGIC DNA in blood, urine, injection site, occlusive dressings, oral mucosa, anogenital area, and suspected herpetic lesions. Occlusive dressings samples were collected during treatment. Blood and urine samples were collected during treatment and for up to 30 days after the end of treatment.
Injection site, oral mucosa, and anogenital area samples were collected during treatment and for up to 60 days after the end of treatment. Suspected herpetic lesion samples were collected any time a patient experienced lesions of suspected herpetic origin. If the qPCR testing for IMLYGIC DNA was positive, then a TCID 50 assay was performed to measure viral infectivity.
In the 60 patients with melanoma who received IMLYGIC intralesional injection at a dose and schedule same as the clinical study [see Clinical Studies ( 14 )] , data indicate that IMLYGIC DNA was present in all sites during the study (see Table 5 ). Table 5. Patients with Detectable DNA During Treatment Body fluid/Site Patients with detectable DNA during treatment (n = 60) Injection site 60 (100%) Blood 59 (98%) Urine 19 (32%) Injection site 60 (100%) Occlusive dressing 48 (80%) Oral mucosa 8 (13%) Anogenital area 5 (out of 26) For the anogenital area, 26 patients were tested.
The proportion of samples and subjects with IMLYGIC DNA was highest during cycle 2 of treatment for the blood, urine, injection site, and occlusive dressings; highest in cycle 1 of treatment for the oral mucosa; and highest in cycles 1 and 2 for the anogenital area. Among patients with detectable IMLYGIC DNA in the blood, urine, oral mucosa and anogenital area, no samples had detectable IMLYGIC DNA 30 days after the end of treatment. For patients with detectable DNA in injected lesions, no samples had detectable IMLYGIC DNA 60 days after the end of treatment.
Overall 3 of 19 patients with lesions of suspected herpetic origin had IMLYGIC DNA present at any time during the study. Of the three subjects who had lesions of suspected herpetic origin that had IMLYGIC DNA detected during the study, none of the suspected lesions were injected with IMLYGIC. None of the subjects with the lesions of the suspected herpetic origin with IMLYGIC DNA had disseminated lesions or received antiviral therapy and these events were non-serious, lasting from 16 days to 4 months.
The data suggest that IMLYGIC may cause herpetic lesions in treated patients. In addition to the presence of IMLYGIC DNA, viral activity was measured in samples that were positive for IMLYGIC DNA from the injection site, occlusive dressings, oral mucosa, anogenital area, and suspected herpetic lesions. No viral activ…
🧬 Mechanism of Action ▾
12.1Mechanism of Action IMLYGIC has been genetically modified to replicate within tumors and to produce the immune stimulatory protein GM-CSF. IMLYGIC causes lysis of tumors, followed by release of tumor-derived antigens, which together with virally derived GM-CSF may promote an antitumor immune response. However, the exact mechanism of action is unknown.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied IMLYGIC is provided as a sterile frozen suspension in a single-dose, cyclic olefin polymer (COP) plastic resin vial with a chlorobutyl elastomer stopper, aluminum seal, and polypropylene cap in two different presentations: Figure 4: Single-dose vial permanently inserted into a clear copolyester plastic sleeve OR Figure 5: Single-dose vial without a clear plastic sleeve Each vial contains a retrievable minimal volume of 1 mL. The vial cap is color coded: 10 6 (1 million) PFU per mL is light green (NDC 55513-078-01).
10 8 (100 million) PFU per mL is royal blue (NDC 55513-079-01). Storage and Handling Store and transport IMLYGIC at −90°C to −70°C (−130°F to −94°F). Protect IMLYGIC from light.
Store IMLYGIC in the carton until use. Thaw IMLYGIC immediately prior to administration [ see Dos ag e and Administration ( 2.2 ) ] . Do not draw IMLYGIC into a syringe until immediately prior to administration [ see Dos ag e and Administration ( 2.2 ) ] .
Figure 4: Single-use vial permanently inserted into a clear copolyester plastic sleeve Figure 5: Single-use vial without a clear plastic sleeve
📋 Description ▾
11 DESCRIPTION IMLYGIC (talimogene laherparepvec) is a sterile suspension for intralesional injection. IMLYGIC is a live, attenuated HSV-1 that has been genetically modified to express huGM-CSF. The parental virus for IMLYGIC was a primary isolate, which was subsequently altered using recombinant methods to result in gene deletions and insertions.
Each vial contains 1 mL deliverable volume of IMLYGIC at either 1 x 10 6 (1 million) PFU per mL or 1 × 10 8 (100 million) PFU per mL concentrations and the following excipients: di-sodium hydrogen phosphate dihydrate (15.4 mg), sodium dihydrogen phosphate dihydrate (2.44 mg), sodium chloride (8.5 mg), myo-inositol (40 mg), sorbitol (20 mg), and water for injection. The 10 6 (1 million) PFU per mL vial of IMLYGIC contains a clear to semi-translucent liquid following thaw from its frozen state. The 10 8 (100 million) PFU per mL vial of IMLYGIC contains a semi-translucent to opaque liquid following thaw from its frozen state.
The liquid in each vial may contain white, visible, variously shaped, virus-containing particles. Each vial of IMLYGIC may also contain residual components of VERO cells including DNA and protein and trace quantities of fetal bovine serum. The product contains no preservative.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise patients and/or close contacts to: Read the FDA-approved patient labeling ( Medication Guide ). Follow instructions below to prevent viral transmission [see Warnings and Precautions ( 5.1 )] : ○ Avoid direct contact with injection sites, dressings, or body fluids of patients. ○ Wear gloves when changing dressing. ○ Avoid touching or scratching injection sites. ○ Keep injection sites covered for at least the first week after each treatment visit or longer if the injection site is weeping or oozing.
Replace dressing if it falls off. ○ Dispose of used dressings and cleaning materials in household waste in a sealed plastic bag. Female patients of childbearing potential should use an effective method of contraception to prevent pregnancy during treatment with IMLYGIC [see Contraindications ( 4.2 ) and Use in Specific Populations ( 8.1 )] . Close contacts who are pregnant or immunocompromised should not change dressings or clean injection sites [see Warnings and Precautions ( 5.1 )] .
In case of accidental exposure to IMLYGIC, clean the exposed area with soap and water and/or a disinfectant. Patients or close contacts with suspected herpetic infections should contact their healthcare provider to evaluate the lesions. Suspected herpetic lesions should be reported to Amgen at 1-855-IMLYGIC (1-855-465-9442); patients or close contacts have the option of follow-up testing for further characterization of the infection [see Warnings and Precautions ( 5.1 ) and ( 5.2 )] .
IMLYGIC ® (talimogene laherparepvec) Manufactured by: BioVex LLC, a subsidiary of Amgen Inc. One Amgen Center Drive Thousand Oaks, California 91320-1799 Patent: http://pat.amgen.com/Imlygic/ © 2015-2024 Amgen Inc. All rights reserved. v9
💬 Medication Guide ▾
Medication Guide IMLYGIC ® (imm-LY-jik) (talimogene laherparepvec) Read the Medication Guide before you start treatment with IMLYGIC and before each IMLYGIC treatment. There may be new information. This Medication Guide does not tell you everything about IMLYGIC.
Talk with your healthcare provider if you have any questions about treatment with IMLYGIC. What is IMLYGIC? IMLYGIC is a prescription medicine used to treat a type of cancer called melanoma when it is on your skin or in your lymph glands.
IMLYGIC is a weakened form of Herpes Simplex Virus Type 1, which is commonly called the cold sore virus. Your healthcare provider will inject IMLYGIC directly into your tumor(s). IMLYGIC may not help you live longer and may not shrink cancer in your organs (for example, lung or liver).
Who should not get IMLYGIC? You should not get IMLYGIC if you are pregnant or have a weakened immune system (for example, an immune deficiency, blood or bone marrow cancer, steroid use, or HIV/AIDS). What should I tell my healthcare provider before I get IMLYGIC?
Before getting IMLYGIC, tell your healthcare provider if you: Are taking steroids or other medicines that suppress your immune system. Are taking antiviral medicines to treat or prevent herpes, such as acyclovir. Have or ever had medical conditions such as: ○ HIV infection or AIDS. ○ Blood or bone marrow cancer. ○ Autoimmune disease. ○ Other medical conditions that can weaken your immune system.
Have close contact with someone who has a weakened immune system or is pregnant. Are pregnant or plan to become pregnant. ○ IMLYGIC may harm your unborn baby. ○ You should not become pregnant during treatment with IMLYGIC. ○ Talk to your healthcare provider about effective birth control methods. Are breastfeeding or plan to breastfeed.
Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. IMLYGIC may affect the way other medicines work and other medicines may affect how IMLYGIC works. How is IMLYGIC given?
Your healthcare provider will inject IMLYGIC directly into your tumor(s) with a needle and syringe. You will get a second treatment 3 weeks after the first treatment. After that, you will get treatments every 2 weeks for as long as you have tumor(s).
You can get treated for 6 months or longer. Your healthcare provider will decide which tumor(s) to inject and may not inject every one. It is important to care for the treatment sites properly so that IMLYGIC does not spread to other people.
Your healthcare provider will show you how to do this. What should I avoid while getting IMLYGIC? IMLYGIC virus can spread to other areas of your body or to your close contacts (household members, caregivers, sex partners, or persons sharing the same bed).
Do the following to avoid spreading IMLYGIC to other areas of your body or to your close contacts: Avoid direct contact between your treatment sites, dressings, or body fluids and close contacts (for example, use condoms when engaging in sexual activity, avoid kissing close contacts if either has an open mouth sore). Wear gloves while putting on or changing your dressings. Keep treatment sites covered with airtight and watertight dressings for at least 1 week after each treatment (or longer if the treatment site is weeping or oozing).
If the dressing comes loose or falls off, replace it right away with a clean dressing. Place all used dressings and cleaning materials in a sealed plastic bag and throw them away in the garbage. Do not touch or scratch the treatment sites.
What are possible side effects of IMLYGIC? The most common side effects of IMLYGIC include: Tiredness Chills Fever Nausea Flu-like symptoms Pain at treatment site Tell your doctor right away if you get any of the signs and symptoms of herpes infection, including but not limited to: Pain, burning, tingling, or blister formation around the mouth, genitals, or any part of the body, near or far from the i…