AMTAGVI lifileucel 72000000000 1/500mL Suspension
🆔 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
Patient education
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🧪 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.
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UNII M89N0Q7EQR
Aldesleukin is a manufactured protein that mimics a natural immune signaling substance. In medicines, it acts as the active therapeutic agent rather than an inactive ingredient, working to stimulate immune system cells.
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UNII YOW8V9698H
Dimethyl sulfoxide is a clear liquid solvent derived from wood pulp. In medicines, it helps dissolve or carry active ingredients and improve how the body absorbs the drug.
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UNII MZD2VV6EW6
A balanced salt solution containing electrolytes like sodium, potassium, and magnesium. It's used as a vehicle and buffer in injectable medicines to maintain proper pH and electrolyte balance, mimicking the body's natural fluid composition.
3 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. | |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Amtagvi 72000000000 1/500mLthis 73776-0001-12 | Iovance | 1 cartridge | — | — | FDA listed | — |
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⏳ 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 | Feb 16, 2036 |
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 73776-0001-12 You're viewing this | 1 BAG in 1 CARTRIDGE (73776-001-12) / 125 mL in 1 BAG (73776-001-11) | 2024-02-16 | Active |
🧭 About this NDC listing & data coverage
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| 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 | — Not published for this NDC No photo available yet for this listing. |
| 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 | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full FDA label FDA SPL
🚨 Boxed Warning ▾
WARNING: TREATMENT-RELATED MORTALITY, PROLONGED SEVERE CYTOPENIA, SEVERE INFECTION, CARDIOPULMONARY and RENAL IMPAIRMENT Monitor patients for prolonged severe cytopenia and monitor for internal organ hemorrhage [see Warnings and Precautions (5.1 , 5.2 , 5.3) ]. Administer filgrastim or a biosimilar product to patients beginning Day 1 after AMTAGVI and continuing daily until the absolute neutrophil count (ANC) is greater than 1000 per mm 3 for 3 consecutive days, or per institutional standard. Treat severe infections [see Warnings and Precautions (5.1 , 5.4) ].
Monitor cardiopulmonary and renal functions throughout the treatment course. [see Warnings and Precautions (5.1 , 5.5 , 5.6 , 5.7) ]. Administer in an inpatient hospital setting. An intensive care facility and specialists skilled in cardiopulmonary or intensive care medicine must be available [see Dosage and Administration (2.1) , and Adverse Reactions (6.1) ] .
WARNING: TREATMENT-RELATED MORTALITY, PROLONGED SEVERE CYTOPENIA, SEVERE INFECTION, CARDIOPULMONARY and RENAL IMPAIRMENT See full prescribing information for complete boxed warning. Monitor patients for prolonged severe cytopenia and monitor for internal organ hemorrhage ( 5.1 , 5.2 , 5.3 ) Treat severe infections ( 5.1 , 5.4 ) Monitor cardiopulmonary and renal functions throughout the treatment course ( 5.1 , 5.5 , 5.6 , 5.7 ) Administer in an inpatient hospital setting. An intensive care facility and specialists skilled in cardiopulmonary or intensive care medicine must be available ( 2.1 , 6.1 )
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE AMTAGVI is a tumor-derived autologous T cell immunotherapy indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. This indication is approved under accelerated approval based on objective response rate (ORR) [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
AMTAGVI is a tumor-derived autologous T cell immunotherapy indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. This indication is approved under accelerated approval based on objective response rate (ORR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s) ( 1 )
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION For autologous use only. For intravenous use only. Verify the patient's identity prior to infusion.
For autologous use only. For intravenous use only. Verify the patient's identity prior to infusion.
Administer AMTAGVI in an inpatient hospital setting with an intensive care facility ( 2.1 ) The AMTAGVI dose is between 7.5 × 10 9 and 72 × 10 9 viable cells ( 2.1 ) Administer a lymphodepleting regimen before infusion of AMTAGVI ( 2.2 ) Do NOT use a leukocyte depleting filter with AMTAGVI ( 2.2 ) Premedicate the patient with acetaminophen, or equivalent, and diphenhydramine, or another H1-antihistamine ( 2.2 ) Avoid prophylactic use of systemic corticosteroids ( 2.2 ) Administer entire dose of AMTAGVI ( 2.2 ) Administer IL-2 (aldesleukin) after infusion of AMTAGVI ( 2.2 ) See Full Prescribing Information for instructions on receipt, preparation, and administration of AMTAGVI ( 2.2 , 16 )
2.1Dose Administer in an inpatient hospital setting under the supervision of a physician experienced in the use of anticancer agents. An intensive care facility and specialists skilled in cardiopulmonary or intensive care medicine must be available. AMTAGVI is provided as a single dose for infusion containing a suspension of tumor-derived T cells.
The dose is supplied in 1 to 4 patient-specific IV infusion bag(s) in individual protective metal cassettes. Each dose contains 7.5 × 10 9 to 72 × 10 9 viable cells.
2.2Administration AMTAGVI is for autologous use only. The patient's identity must match the patient identifiers on the AMTAGVI cassette(s) and infusion bag(s). Preparing Patient for AMTAGVI Infusion Confirm availability of AMTAGVI and IL-2 (aldesleukin) prior to starting the lymphodepleting regimen.
Pretreatment Administer a lymphodepleting chemotherapy regimen of cyclophosphamide 60 mg/kg intravenously with mesna daily for 2 days followed by fludarabine 25 mg/m 2 intravenously daily for 5 days before infusion of AMTAGVI. Infuse AMTAGVI as soon as possible after 24 hours have elapsed following the last dose of fludarabine, but no later than 4 days. Premedication Pre-medicate the patient with acetaminophen and diphenhydramine or another H1-antihistamine, approximately 30 to 60 minutes prior to AMTAGVI infusion.
Avoid prophylactic use of systemic corticosteroids which may interfere with the activity of AMTAGVI. Receipt of AMTAGVI AMTAGVI is shipped directly to the treatment center in the vapor phase of a liquid nitrogen cryoshipper. All treatment centers should have onsite storage in vapor phase of liquid nitrogen.
Product and patient-specific labels are located on both the product infusion bag(s) and protective metal cassette(s), which are inside the liquid nitrogen cryoshipper. Match the identity of the patient with the patient identifiers on the cassette(s) and infusion bag(s) upon receipt. Confirm the number of AMTAGVI cassette(s) and infusion bag(s) matches the total number of cassettes and infusion bags on the shipment packing slip.
Store AMTAGVI frozen in the vapor phase of liquid nitrogen (less than or equal to minus 150°C). Administration of AMTAGVI The AMTAGVI dose is contained in 1 to 4 cryopreserved patient-specific infusion bag(s) in individual protective metal cassette(s). Thaw and infuse 1 bag at a time if more than 1 bag has been provided.
Wait to thaw the next bag until the previous bag has been safely and completely administered. Preparation of AMTAGVI Do not thaw the product until it is ready to be infused. Coordinate the timing of AMTAGVI thaw and infusion.
Confirm the infusion time in advance and adjust the start time for thaw so that AMTAGVI is available for infusion when the patient is ready. Once 1 bag of AMTAGVI is thawed, the infusion should be started as soon as possible and must be completed within 3 hours at room or ambient temperature (18°C to 25°C). Confirm the availability of IL-2 (aldesleukin).
Prior to AMTAGVI preparation, match the recipient's identity with the patient identifie…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS AMTAGVI is a cell suspension for intravenous infusion. A single dose of AMTAGVI contains 7.5 × 10 9 to 72 × 10 9 viable cells suspended in a cryopreservation medium. A single dose is split into 1 to 4 patient-specific infusion bag(s) (100 mL to 125 mL per bag) in individual protective metal cassettes [see How Supplied/Storage and Handling (16) ] .
AMTAGVI is a cell suspension for intravenous infusion ( 3 ) A single dose of AMTAGVI contains 7.5 × 10 9 to 72 × 10 9 viable cells suspended in 1 to 4 patient-specific infusion bag(s) ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. None ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Hypersensitivity reactions: Monitor for hypersensitivity reactions during infusion ( 5.8 )
5.1Treatment-Related Mortality AMTAGVI is associated with treatment-related mortality. In the clinical trial, the treatment-related mortality rate was 7.5% (N=160), including 2 deaths during the lymphodepleting period, 6 deaths within 30 days, and 4 deaths 38 to 150 days following AMTAGVI administration. Adverse reactions associated with these deaths included severe infections (sepsis, pneumonia and encephalitis), internal organ hemorrhage (abdominal hemorrhage and intracranial hemorrhage), acute renal failure, acute respiratory failure, cardiac arrythmia, extensive ascites, liver injury, and bone marrow failure.
Because clinical trials are conducted under widely varying conditions, treatment-related mortality rates observed in the clinical trials of a drug may not reflect the rates observed in practice.
5.2Prolonged Severe Cytopenia Patients treated with AMTAGVI may exhibit Grade 3 or higher cytopenia for weeks or longer. Based on adverse event reporting, Grade 3 or higher cytopenia or pancytopenia which did not resolve to less than or equal to Grade 2 or lasted beyond 30 days post AMTAGVI infusion occurred in 45.5% of melanoma patients who received AMTAGVI. Prolonged cytopenia included thrombocytopenia (30.1%), lymphopenia (19.9%), neutropenia (17.3%), leukopenia (14.7%), and pancytopenia (1.3%).
Monitor blood counts after AMTAGVI infusion.
5.3Internal Organ Hemorrhage Patients treated with AMTAGVI may exhibit internal organ hemorrhage. Intraabdominal and intracranial hemorrhage can be life-threatening and have been associated with at least two deaths in patients who received AMTAGVI. Withhold or discontinue AMTAGVI infusion if internal organ hemorrhage is indicated, or patient is deemed ineligible for IL-2 (aldesleukin) infusion.
Patients with persistent or repeated thrombocytopenia after receiving AMTAGVI should not use anticoagulants or must be under close monitoring if the patient must take anticoagulants.
5.4Severe Infection Severe, life-threatening, or fatal infections occurred in patients after AMTAGVI infusion. AMTAGVI treatment-related infections (any severity) occurred in 26.9% of patients with melanoma. Grade 3 or higher infections occurred in 13.5% of patients, including 10.9% of patients with infections of an unspecified pathogen and 3.8% of patients with infections of a specified pathogen.
Do not administer AMTAGVI to patients with clinically significant systemic infections. Monitor patients for signs and symptoms of infection before and after AMTAGVI infusion and treat appropriately. Administer prophylactic antimicrobials according to institutional guidelines.
Febrile neutropenia was observed in 46.8% of patients with melanoma after AMTAGVI Infusion. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care as medically indicated.
5.5Cardiac Disorder Patients treated with AMTAGVI may exhibit cardiac disorder. Grade 3 or higher cardiac disorders related to the AMTAGVI regimen occurred in 9.0% (14/156) of patients who received AMTAGVI including tachycardia, atrial fibrillation, arrhythmia, acute myocardial infarction, cardiac ventricular thrombosis, cardiomyopathy, QT-prolongation. Cardiac arrhythmia resulted in one death among melanoma patients who received AMTAGVI.
Monitor patients with signs and symptoms of cardiac disorder before and after AMTAGVI infusion. Withhold or discontinue AMTAGVI infusion, if severe cardiac disorder is indicated, or patient is deemed ineligible for IL-2 (aldesleukin) infusion.
5.6Respiratory Failure Patients treated with AMTAGVI may develop worsened respiratory function which has been associated with deaths. Monitor patients with signs and symptoms of respiratory failure before and after AMTAGVI infusion. Withhold or discontinue AMTAGVI infusion if severe acute respiratory failure i…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The most common (incidence of greater than or equal to 20%) non-laboratory adverse reactions in order of decreasing frequency were chills, pyrexia, fatigue, tachycardia, diarrhea, febrile neutropenia, edema, rash, hypotension, alopecia, infection, hypoxia, and dyspnea. The serious adverse reactions included: Treatment-Related Mortality [see Warnings and Precautions (5.1) ] Prolonged Severe Cytopenia [see Warnings and Precautions (5.2) ] Internal Organ Hemorrhage [see Warnings and Precautions (5.3) ] Severe Infection [see Warnings and Precautions (5.4) ] Cardiac Disorder [see Warnings and Precautions (5.5) ] Respiratory Failure [see Warnings and Precautions (5.6) ] Acute Renal Failure [see Warnings and Precautions (5.7) ] Hypersensitivity Reactions [see Warnings and Precautions (5.8) ] The most common (incidence of greater than or equal to 20%) non-laboratory adverse reactions in order of decreasing frequency were chills, pyrexia, fatigue, tachycardia, diarrhea, febrile neutropenia, edema, rash, hypotension, alopecia, infection, hypoxia, and dyspnea ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Iovance Biotherapeutics, Inc. at 1-833-400-IOVA (4682) 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 pooled safety data described in this section reflect exposure to AMTAGVI within a regimen that included cyclophosphamide, fludarabine, and IL-2 (aldesleukin) in the global, multicenter, multicohort, open-label, single-arm clinical study in which 156 adult patients with unresectable or metastatic melanoma received a single infusion of AMTAGVI [see Clinical Studies (14) ] .
The median age of the study population was 56 years (range: 20 to 79 years); 53.8% were men. The performance status prior to tumor procurement was 68.6% with ECOG 0 and 31.4% with ECOG 1. Table 1 summarizes the adverse reactions that occurred in at least 10% of patients treated with AMTAGVI and Table 2 describes the laboratory abnormalities of Grade 3 or 4 that occurred in at least 10% of patients.
Table 1: Adverse Reactions Observed in at Least 10% of Melanoma Patients Treated with AMTAGVI (N=156) Adverse Reaction Any Grade n (%) Grade 3 or Higher n (%) Adverse Reactions occurred from AMTAGVI infusion to 6 months (182 days) post infusion. Blood and lymphatic system disorders Febrile neutropenia 73 (46.8) 73 (46.8) Cardiac disorders Tachycardia Tachycardia includes tachycardia and sinus tachycardia, atrial fibrillation, supraventricular tachycardia. 74 (47.4) 12 (7.7) Gastrointestinal disorders Diarrhea 73 (46.8) 3 (1.9) Vomiting 68 (43.6) 2 (1.3) Nausea 107 (68.6) 4 (2.6) General disorders and administration site conditions Chills 118 (75.6) 8 (5.1) Pyrexia 95 (60.9) 16 (10.3) Fatigue Fatigue includes fatigue, asthenia, and malaise.
87 (55.8) 8 (5.1) Edema Edema includes edema, face edema, generalized edema, localized edema, edema peripheral, peripheral swelling, edema genital, scrotal edema, brain edema, catheter site edema, conjunctival edema, eyelid edema, laryngeal edema, macular edema, periorbital edema, pulmonary edema, vasogenic cerebral edema, and lymphoedema. 66 (42.3) 8 (5.1) Investigations Weight increased 30 (19.2) 2 (1.3) Infections and Infestations 42 (26.9) 21 (13.5) Infection with pathogen unspecified Infection with unspecified pathogen includes cellulitis, conjunctivitis, cystitis, dermatitis infected, device related infection, diarrhea infectious, endocarditis, enterocolitis infectious, infection, meningitis, nasopharyngitis, neutropenic sepsis, pneumonia, pyuria, rash pustular, respiratory tract infection (RTI), rhinitis, sepsis, sinusitis, skin infection, urinary tract infection (UTI).
30 (19.2) 17 (10.9) Infection with path…
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary There are no available data with AMTAGVI use in pregnant women. No animal reproductive and developmental toxicity studies have been conducted with AMTAGVI. Therefore, AMTAGVI is not recommended for women who are pregnant, and pregnancy after AMTAGVI administration should be discussed with the treating physician.
Report pregnancies to Iovance Biotherapeutics, Inc. at 1-833-400-IOVA. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
8.2Lactation Risk Summary There is no information regarding the presence of AMTAGVI in human milk, the effect on the breastfed infant, and the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for AMTAGVI and any potential adverse effects on the breastfed infant from AMTAGVI or from the underlying maternal condition.
8.3Females and Males of Reproductive Potential Pregnancy Testing The pregnancy status of women of child-bearing potential should be verified. Sexually active females of reproductive potential should have a pregnancy test prior to starting treatment with AMTAGVI. Infertility There are no data on the effect of AMTAGVI on fertility.
8.4Pediatric Use The safety and efficacy of AMTAGVI have not been established in pediatric patients.
8.5Geriatric Use Of 156 patients with unresectable or metastatic melanoma who were treated with AMTAGVI in clinical studies, 37 patients (23.7%) were 65 years of age or older. No differences in safety or effectiveness were observed between elderly patients and younger patients.
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no available data with AMTAGVI use in pregnant women. No animal reproductive and developmental toxicity studies have been conducted with AMTAGVI. Therefore, AMTAGVI is not recommended for women who are pregnant, and pregnancy after AMTAGVI administration should be discussed with the treating physician.
Report pregnancies to Iovance Biotherapeutics, Inc. at 1-833-400-IOVA. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and efficacy of AMTAGVI have not been established in pediatric patients.
🧓 Geriatric Use ▾
8.5Geriatric Use Of 156 patients with unresectable or metastatic melanoma who were treated with AMTAGVI in clinical studies, 37 patients (23.7%) were 65 years of age or older. No differences in safety or effectiveness were observed between elderly patients and younger patients.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action The specific mechanism of action of AMTAGVI (lifileucel) is unknown.
12.2Pharmacodynamics Pharmacodynamic activity was evaluated by measuring longitudinal changes of cytokines and chemokines (IL-15, IL-6, IL-7, IL-9, IL-10, IL-12(p40), CCL2, CXCL10, IFN-γ, and TNF-α) using plasma samples collected at baseline and post-infusion of AMTAGVI up to Month 3. The mean level of IL-15 and CXCL10 peaked following lymphodepletion and administration of AMTAGVI at Day 1-4, decreased over time, and returned to baseline levels within 1-3 months. The mean IFN-γ level was below baseline post lymphodepletion and AMTAGVI infusion at Day 1-4 and returned to baseline by Day 14.
Other cytokines and chemokines listed above did not show any noticeable changes. No difference was observed in the cytokines and chemokines level between responding and non-responding patients.
12.3Pharmacokinetics The proportion of unique TCR clonotypes from the AMTAGVI lots contributing to the peripheral blood TCR repertoire among infused patients was analyzed using a semi-quantitative polymerase chain reaction followed by next generation sequencing. The proportion of TCR clones that are composed of clonotypes identified in the product increases from a mean of 16% (n=125) at pre-infusion to 83% at Day 4 after AMTAGVI infusion. The TCR clones declined to 51% at Day 14 (n=51) and remain 37% to 41% from Day 42 (n=120) to month 12 (n=37) post-infusion of AMTAGVI.
No significant correlation was found between AMTAGVI persistence and efficacy.
🧬 Mechanism of Action ▾
12.1Mechanism of Action The specific mechanism of action of AMTAGVI (lifileucel) is unknown.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING AMTAGVI is supplied in 1 to 4 infusion bag(s) (NDC 73776-001-11), with each bag containing approximately 100 mL to 125 mL of frozen suspension of tumor-derived T cells in 5% DMSO, 0.5% albumin (human), and 300 IU/mL IL-2 (aldesleukin). Each bag is contained within a protective metal cassette (NDC 73776-001-12). AMTAGVI is stored in the vapor phase of liquid nitrogen and supplied in a liquid nitrogen cryoshipper.
Product and patient-specific labels are located on both the product infusion bag(s) and the protective shipping cassette(s), which are inside the liquid nitrogen cryoshipper. Match the identity of the patient with the patient identifiers on the cassette(s) and infusion bag(s) upon receipt. Confirm the number of AMTAGVI cassette(s) and infusion bag(s) matches the total number of cassette(s) and infusion bag(s) on the shipment packing slip.
Store AMTAGVI frozen in the vapor phase of liquid nitrogen (less than or equal to minus 150°C). Thaw AMTAGVI immediately prior to infusion [see Dosage and Administration (2.2) ] .
📦 Storage and Handling ▾
Product and patient-specific labels are located on both the product infusion bag(s) and the protective shipping cassette(s), which are inside the liquid nitrogen cryoshipper. Match the identity of the patient with the patient identifiers on the cassette(s) and infusion bag(s) upon receipt. Confirm the number of AMTAGVI cassette(s) and infusion bag(s) matches the total number of cassette(s) and infusion bag(s) on the shipment packing slip.
Store AMTAGVI frozen in the vapor phase of liquid nitrogen (less than or equal to minus 150°C). Thaw AMTAGVI immediately prior to infusion [see Dosage and Administration (2.2) ] .
📋 Description ▾
11 DESCRIPTION AMTAGVI (lifileucel) is a tumor-derived autologous T cell immunotherapy comprised of a suspension of tumor-derived T cells for intravenous infusion. AMTAGVI is manufactured from resected patient tumor tissue prosected from one or more tumor lesions. Immune cells derived from a patient's tumor(s) are expanded in cell culture, washed, formulated as a cell suspension, and cryopreserved.
The product must pass a sterility test before release for shipping as a frozen suspension in 1 to 4 patient-specific infusion bag(s) in individual protective metal cassettes. The product is thawed prior to administration back into the same patient [see Dosage and Administration (2.2) , How Supplied/Storage and Handling (16) ] . AMTAGVI is composed primarily of T cells of the CD4+T and CD8+T cell lineages.
AMTAGVI may also contain monocytes and other lymphocytes, including B cells and NK cells. AMTAGVI may contain viable melanoma tumor cells from the original tumor tissue used to manufacture the product. The formulation contains 48% PlasmaLyte A, 50% CryoStor CS10 (resulting in final concentration of 5% dimethyl sulfoxide (DMSO)), 2% of 25% human serum albumin (resulting in a final concentration of 0.5% albumin), and 300 IU/mL IL-2 (aldesleukin).
A single dose of AMTAGVI is provided in 1 to 4 infusion bag(s) containing 100 mL to 125 mL of viable cells per bag in individual protective cassettes.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Prior to infusion, advise patients of the following risks: Hypersensitivity Reactions: Signs and symptoms associated with hypersensitivity reactions including fever, rigors or chills, tachycardia, rash, hypotension, dyspnea, cough, chest tightness, and wheezing [see Warnings and Precautions (5.8) ] . Prolonged Severe Cytopenia: Signs or symptoms associated with bone marrow suppression (i.e., neutropenia, thrombocytopenia and anemia) for more than several weeks following lymphodepleting chemotherapy and AMTAGVI [ see Warnings and Precautions (5.2) , Adverse Reactions (6.1) ].
Severe Infection: Signs and symptoms associated with severe infections. Advise patients that AMTAGVI treatment regimen will not be initiated if they have an ongoing uncontrolled infection. Anti-microbial prophylaxis and treatment of infection will be administered [ see Warnings and Precautions (5.4) , Adverse Reactions (6.1) ].
Internal Organ Hemorrhage: Signs or symptoms of internal organ hemorrhage following AMTAGVI treatment regimen. Advise patients to seek immediate medical attention should signs or symptoms of internal organ hemorrhage occur at any time [ see Warnings and Precautions (5.3) ]. Cardiopulmonary and Renal Impairment: Signs or symptoms of cardiopulmonary or renal injuries following AMTAGVI treatment regimen.
Advise patients to seek immediate medical attention should signs or symptoms of cardiopulmonary, or renal injury occur at any time [ see Warnings and Precautions (5.5 , 5.6 , 5.7) ].