Version October 2024
Monitor patients for prolonged severe cytopenia and monitor for internal organ hemorrhage. Administer filgrastim or a biosimilar product to patients beginning Day 1 after lifileucel and continuing daily until the ANC is >1,000 per mm3 for 3 consecutive days, or per institutional standard. Treat severe infections. Monitor cardiopulmonary and renal functions throughout the treatment course. Administer in an inpatient hospital setting. An intensive care facility and specialists skilled in cardiopulmonary or intensive care medicine must be available.
Dosage guidance:
Safety: For autologous use only; confirm patient identity matches patient identifiers on the lifileucel cassette(s) and infusion bag(s). Lifileucel is provided as a single dose containing a suspension of tumor-derived T-cells provided in 1 to 4 infusion bag(s) (100 to 125 mL per bag) in individual protective metal cassettes. Administer in an inpatient setting with an intensive care unit staffed with specialists (intensive care or cardiopulmonary) available. Premedicate with acetaminophen and diphenhydramine (or another H1-antihistamine) ~30 to 60 minutes prior to lifileucel infusion. Avoid the use of systemic corticosteroids (may interfere with lifileucel activity).
Clinical considerations: A treatment course consists of multiple phases: 1) lymphodepleting chemotherapy (with cyclophosphamide and fludarabine) for 7 days, 2) lifileucel administration, and 3) aldesleukin (IL-2) administration. Administer prophylactic antimicrobials according to institutional guidelines. Do not administer lifileucel to patients with clinically significant systemic infections.
Lymphodepleting chemotherapy: Confirm availability of lifileucel and aldesleukin prior to initiation of lymphodepleting regimen.
Aldesleukin: Begin 3 to 24 hours after lifileucel administration to support in vivo cell expansion for up to a maximum of 6 doses. Aldesleukin should be administered in an inpatient setting under the supervision of a physician experienced in the use of anticancer agents.
Melanoma, unresectable or metastatic: IV: 7.5 × 109 to 72 × 109 viable cells; administer as soon as possible once 24 hours have elapsed following the last fludarabine dose, but no later than 4 days after the last dose of fludarabine.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Altered kidney function impairment prior to treatment initiation: There are no dosage adjustments provided in the manufacturer’s labeling.
Acute kidney injury related to lifileucel treatment: Withhold or discontinue lifileucel with indications of severe acute kidney injury, or if patient becomes ineligible to receive aldesleukin (IL-2) infusion.
There are no dosage adjustments provided in the manufacturer’s labeling.
Cardiac disorder, severe: Withhold or discontinue lifileucel infusion for severe cardiac disorders or if patient becomes ineligible to receive aldesleukin (IL-2).
Febrile neutropenia: Evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care as clinically indicated.
Hypersensitivity: Manage promptly.
Internal organ hemorrhage: Withhold or discontinue lifileucel infusion if internal organ hemorrhage occurs or patient becomes ineligible to receive aldesleukin (IL-2).
Infections: Manage appropriately.
Respiratory failure, severe, acute: Withhold or discontinue lifileucel infusion for severe acute respiratory failure, or if patient becomes ineligible to receive aldesleukin (IL-2).
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adults on concomitant therapy.
>10%:
Cardiovascular: Capillary leak syndrome (14%), edema (42%; including brain edema, lymphedema, macular edema, periorbital edema, pulmonary edema), hypertension (14%), hypotension (37%; including orthostatic hypotension), tachycardia (47%; including atrial fibrillation, sinus tachycardia, supraventricular tachycardia)
Dermatologic: Alopecia (31%), pruritus (14%), skin rash (37%)
Endocrine & metabolic: Hypophosphatemia (grades 3/4: 26%), weight gain (19%)
Gastrointestinal: Decreased appetite (31%), diarrhea (47%; grades ≥3: 2%), nausea (69%; grades ≥3: 3%), vomiting (44%; grades ≥3: 1%)
Genitourinary: Hematuria (14%)
Hematologic & oncologic: Anemia (grades 3/4: 58%), febrile neutropenia (47%; grades ≥3: 47%), leukopenia (grades 3/4: 47%), lymphocytopenia (grades 3/4: 42%), neutropenia (grades 3/4: 69%), thrombocytopenia (grades 3/4: 78%)
Infection: Infection (27%; including Clostridioides difficile colitis, meningitis, neutropenic sepsis, pneumonia, sepsis, severe infection, tuberculosis)
Nervous system: Chills (76%), encephalopathy (17%; including impaired consciousness, leukoencephalopathy, paranoid ideation), fatigue (56%; including asthenia, malaise), headache (21%)
Renal: Acute kidney injury (20%; including kidney failure)
Respiratory: Dyspnea (22%; including respiratory distress, respiratory failure), hypoxia (24%)
Miscellaneous: Fever (61%)
1% to 10%:
Cardiovascular: Cardiac disorder (grades ≥3: 9%; including acute myocardial infarction, cardiac arrhythmia, cardiac ventricular thrombosis, cardiomyopathy, prolonged QT interval on ECG)
Dermatologic: Vitiligo (7%)
Hypersensitivity: Anaphylaxis (1%), cytokine release syndrome (3%), infusion-related reaction (6%)
Ophthalmic: Uveitis (5%)
Frequency not defined:
Hematologic & oncologic: Hemorrhage (internal organ), pancytopenia
Ophthalmic: Blurred vision, decreased visual acuity, retinal detachment, retinal hemorrhage, visual impairment
There are no contraindications listed in the manufacturer's labeling.
Concerns related to adverse effects:
• Cardiac disorder: Patients treated with lifileucel may experience cardiac disorders, including a case of fatal cardiac arrhythmia in a patient with melanoma. Grade 3 or higher cardiac disorders (including tachycardia, atrial fibrillation, arrhythmia, acute myocardial infarction, cardiac ventricular thrombosis, cardiomyopathy, and/or QT prolongation) related to the lifileucel treatment regimen have occurred.
• Hematologic toxicity: Patients treated with lifileucel may experience ≥ grade 3 cytopenias; may be prolonged (for weeks or longer). Grade 3 or higher cytopenia or pancytopenia that did not resolve to ≤ grade 2 or lasted beyond 30 days following lifileucel infusion occurred in nearly half of patients with melanoma treated with lifileucel. Prolonged cytopenias included thrombocytopenia, lymphopenia, neutropenia, leukopenia, and pancytopenia. Febrile neutropenia was observed in nearly half of patients with melanoma following lifileucel infusion. Patients with persistent or recurrent thrombocytopenia following lifileucel should avoid anticoagulant use or must be closely monitored if anticoagulants cannot be avoided.
• Hypersensitivity: Allergic reactions, including serious hypersensitivity (eg, anaphylaxis), may occur with lifileucel. Acute infusion reactions (which are defined as occurring within 1 day of infusion) may occur and include fever, rigors/chills, tachycardia, rash, hypotension, dyspnea, cough, chest tightness, and wheezing. Acute infusion reactions usually resolve on the same day of infusion.
• Infection: Severe, life-threatening, or fatal infections have occurred following lifileucel infusion. Lifileucel-related infections of any severity occurred in over one-fourth of patients with melanoma. Grade 3 or higher infections have occurred, including both specified and unspecified pathogens.
• Internal organ hemorrhage: Internal organ hemorrhage may occur in patients treated with lifileucel. Intraabdominal and intracranial hemorrhage may be life-threatening and have been associated with fatal cases.
• Kidney failure: Lifileucel-treated patients may develop worsened kidney function, which has been associated with fatalities.
• Respiratory failure: Patients treated with lifileucel may develop worsened respiratory function, which has been associated with fatalities.
• Treatment-related mortality: Lifileucel is associated with treatment-related mortality. In the clinical trial, treatment-related mortality occurred in 7.5% of patients, including rare cases that occurred during lymphodepleting chemotherapy. Mortality was associated with severe infections (sepsis, pneumonia, and encephalitis), internal organ hemorrhage (abdominal or intracranial hemorrhage), acute kidney 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 rates that may be observed in practice.
Dosage form specific issues:
• Albumin: Lifileucel contains albumin (a product of human plasma), which may confer a theoretical risk of disease transmission.
• Dimethyl sulfoxide: Lifileucel contains dimethyl sulfoxide, which has been associated with serious hypersensitivity reactions, including anaphylaxis.
• Universal precautions: Lifileucel contains human tissue cells; follow universal precautions and facility biosafety guidelines for handling and disposal to avoid potential transmission of infectious diseases.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension, Intravenous:
Amtagvi: 72000000000 CELLS (1 ea) [contains albumin human, aldesleukin]
No
Suspension (Amtagvi Intravenous)
72000000000CELLS (per each): $0.00
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Lifileucel must be administered at qualified treatment centers; information is available from the manufacturer at https://amtagvi.com/#find-a-treatment-center.
Note: Prior to infusion, assess patient health status and confirm acceptable for lifileucel and aldesleukin (IL-2) administration. Confirm patient identity matches with the identifiers on the infusion bag. Coordinate the timing of administration with thawing. If more than 1 infusion bag is required, administer the contents of each infusion bag completely before proceeding to thaw and infusing the contents of the next bag. Infuse as soon as possible after thawing; must be administered within 3 hours after thawing. Inspect the contents of the thawed infusion bag. If cell clumps are visible, gently mix the contents of the bag by inverting the bag prior to infusion. If needed, gently massage the bag to disperse cell clumps. Do not infuse the contents of an infusion bag if it is damaged or leaking, or otherwise appears to be compromised. For IV use only. Do NOT use a leukocyte-depleting filter.
IV: Prime tubing with NS prior to infusion, then initiate lifileucel infusion. Infuse lifileucel at a rate of ~1 mL/minute for the initial 5 minutes, then infuse at 5 to 10 mL/minute thereafter. The entire contents of all bags must be infused to complete a single dose. After the last bag is infused, rinse the tubing with NS at the same infusion rate to ensure all product is delivered.
Follow universal precautions and facility biosafety guidelines for handling and disposal.
Melanoma, unresectable or metastatic: Treatment of unresectable or metastatic melanoma in adults previously treated with a PD-1 blocking antibody, and, if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.
Amtagvi may be confused with Atgam.
Lifileucel may be confused with lifitegrast, lisocabtagene maraleucel, lovotibeglogene autotemcel, sipuleucel-T, tisagenlecleucel.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
5-Aminosalicylic Acid Derivatives: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy
Abrocitinib: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination
Antithymocyte Globulin (Equine): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of immunosuppressive therapy is reduced. Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor therapy
Antithyroid Agents: Myelosuppressive Agents may enhance the neutropenic effect of Antithyroid Agents. Risk C: Monitor therapy
Baricitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Baricitinib. Risk X: Avoid combination
BCG Products: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of BCG Products. Risk X: Avoid combination
Brincidofovir: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Brincidofovir. Risk C: Monitor therapy
Brivudine: May enhance the adverse/toxic effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination
Chikungunya Vaccine (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Chikungunya Vaccine (Live). Risk X: Avoid combination
Chloramphenicol (Ophthalmic): May enhance the adverse/toxic effect of Myelosuppressive Agents. Risk C: Monitor therapy
Chloramphenicol (Systemic): Myelosuppressive Agents may enhance the myelosuppressive effect of Chloramphenicol (Systemic). Risk X: Avoid combination
Cladribine: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Cladribine. Risk X: Avoid combination
CloZAPine: Myelosuppressive Agents may enhance the adverse/toxic effect of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor therapy
Coccidioides immitis Skin Test: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the diagnostic effect of Coccidioides immitis Skin Test. Management: Consider discontinuing these oncologic agents several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider therapy modification
COVID-19 Vaccine (Adenovirus Vector): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Adenovirus Vector). Management: Administer a 2nd dose using an mRNA COVID-19 vaccine (at least 4 weeks after the primary vaccine dose) and a bivalent booster dose (at least 2 months after the additional mRNA dose or any other boosters). Risk D: Consider therapy modification
COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor therapy
COVID-19 Vaccine (mRNA): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider therapy modification
COVID-19 Vaccine (Subunit): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Subunit). Risk C: Monitor therapy
COVID-19 Vaccine (Virus-like Particles): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Virus-like Particles). Risk C: Monitor therapy
Deferiprone: Myelosuppressive Agents may enhance the neutropenic effect of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Risk D: Consider therapy modification
Dengue Tetravalent Vaccine (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Dengue Tetravalent Vaccine (Live). Risk X: Avoid combination
Denosumab: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and immunosuppressants. If combined, monitor patients for signs/symptoms of serious infections. Risk D: Consider therapy modification
Deucravacitinib: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination
Etrasimod: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination
Fexinidazole: Myelosuppressive Agents may enhance the myelosuppressive effect of Fexinidazole. Risk X: Avoid combination
Filgotinib: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination
Inebilizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Inebilizumab. Risk C: Monitor therapy
Influenza Virus Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating immunosuppressants if possible. If vaccination occurs less than 2 weeks prior to or during therapy, revaccinate at least 3 months after therapy discontinued if immune competence restored. Risk D: Consider therapy modification
Leflunomide: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents. Risk D: Consider therapy modification
Linezolid: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy
Mumps- Rubella- or Varicella-Containing Live Vaccines: May enhance the adverse/toxic effect of Immunosuppressants (Miscellaneous Oncologic Agents). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Risk X: Avoid combination
Nadofaragene Firadenovec: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid combination
Natalizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Natalizumab. Risk X: Avoid combination
Ocrelizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ocrelizumab. Risk C: Monitor therapy
Ofatumumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ofatumumab. Risk C: Monitor therapy
Olaparib: Myelosuppressive Agents may enhance the myelosuppressive effect of Olaparib. Risk C: Monitor therapy
Pidotimod: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Pidotimod. Risk C: Monitor therapy
Pimecrolimus: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination
Pneumococcal Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Pneumococcal Vaccines. Risk C: Monitor therapy
Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Risk X: Avoid combination
Polymethylmethacrylate: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the potential for allergic or hypersensitivity reactions to Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider therapy modification
Promazine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy
Rabies Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider therapy modification
Ritlecitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ritlecitinib. Risk X: Avoid combination
Ropeginterferon Alfa-2b: Myelosuppressive Agents may enhance the myelosuppressive effect of Ropeginterferon Alfa-2b. Management: Avoid coadministration of ropeginterferon alfa-2b and other myelosuppressive agents. If this combination cannot be avoided, monitor patients for excessive myelosuppressive effects. Risk D: Consider therapy modification
Ruxolitinib (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ruxolitinib (Topical). Risk X: Avoid combination
Sipuleucel-T: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants prior to initiating sipuleucel-T therapy. Risk D: Consider therapy modification
Sphingosine 1-Phosphate (S1P) Receptor Modulator: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk C: Monitor therapy
Tacrolimus (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Tacrolimus (Topical). Risk X: Avoid combination
Talimogene Laherparepvec: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid combination
Tertomotide: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Tertomotide. Risk X: Avoid combination
Tofacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Tofacitinib. Risk X: Avoid combination
Typhoid Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Typhoid Vaccine. Risk X: Avoid combination
Ublituximab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ublituximab. Risk C: Monitor therapy
Upadacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Upadacitinib. Risk X: Avoid combination
Vaccines (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
Vaccines (Non-Live/Inactivated/Non-Replicating): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Give non-live/inactivated/non-replicating vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before or during therapy should be revaccinated at least 3 after therapy is complete. Risk D: Consider therapy modification
Yellow Fever Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Yellow Fever Vaccine. Risk X: Avoid combination
Verify pregnancy status prior to treatment initiation. Pregnancy testing is recommended prior to treatment in sexually active patients who could become pregnant.
Animal reproduction studies have not been conducted.
Report any pregnancies that may occur during treatment to the manufacturer (Iovance Biotherapeutics 1-833-400-IOVA).
It is not known if lifileucel is present in breast milk.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
Assess patient health status and confirm acceptable for lifileucel and aldesleukin (IL-2) administration prior to lifileucel infusion. Monitor blood counts following lifileucel infusion. Verify pregnancy status prior to treatment initiation; pregnancy testing is recommended prior to treatment in sexually active patients who could become pregnant. Monitor before and after lifileucel infusion for signs/symptoms of cardiac disorders, infections, acute kidney failure, and respiratory failure. Monitor for signs/symptoms of hypersensitivity and internal organ hemorrhage. Monitor during and after infusion for signs/symptoms of infusion reactions.
Lifileucel is a tumor-derived autologous tumor-infiltrating lymphocyte (TIL) therapy, composed primarily of CD4+ and CD8+ T-cells, manufactured using resected tumor tissue from the eligible patient, and then expanded ex-vivo. Resection of the tumor tissue, followed by ex-vivo expansion, allows for reinvigoration of T-cell functionality outside of the immunosuppressive tumor microenvironment. Following lymphodepleting therapy, re-infusion, and in vivo T-cell expansion with high-dose aldesleukin (IL-2), TILs migrate to tumor sites, target tumor-associated antigens, and facilitate immune-mediated tumor cell lysis and overall tumor regression (Ref).
Onset: Median time to initial response: 1.5 months (range: 1.3 to 4.2 months).
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