Modify Therapy/Monitor Closely. Modify Therapy/Monitor Closely. Avoid concomitant use of tucatinib with CYP3A substrates, where minimal concentration changes may lead to serious or life-threatening toxicities. Use Caution/Monitor. siponimod and brentuximab vedotin both increase immunosuppressive effects; risk of infection. Bethesda, MD 20894, Web Policies 0000001503 00000 n lenacapavir will increase the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Monitor patients for adverse reactions. what you should tell your doctor before using this drug. Monitor CYP3A4 substrates coadministered with stiripentol for increased or decreased effects. If long-term use of such medications is essential, consider discontinuing efgartigimod and using alternative therapies. Brentuximab Vedotin: A Review in CD30-Positive Hodgkin Lymphoma. Hydrocortisone (50 mg) was administered intravenously, and Ms. R's condition improved, with resolution of her symptoms within 30 minutes of the second hydrocortisone dose. Owing to potential additive immunosuppressive effects, consider duration of effect and mechanism of action of these therapies if coadministered. Use Caution/Monitor. Use Caution/Monitor. Use Caution/Monitor. larotrectinib will increase the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Important: The drug information on this page is meant to be educational. Limitations of this analysis include its retrospective nature and the consequent insufficient detail for full implementation of the CARTOX grading system (eg, the prospective part of the CARTOX-10 score questionnaire), thus requiring the grouping of grade 1/2 NT events together. Use Caution/Monitor. If use is unavoidable, refer to the prescribing information of the P-gp substrate for dosage modifications. Monitor Closely (1)cenobamate will decrease the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Talk to your doctor if you have been exposed to an infection or for more details.Tell your health care professional that you are using brentuximab before having any immunizations/vaccinations. Use Caution/Monitor. Depressed level of consciousness should be attributable to no other cause (eD180X X gD181X X, no sedating medication). E.S.R. Monitor patients for adverse reactions. With these simplistic criteria, deriving the toxicity grades was a simple task. Q4|o<9RIG"q\b1JEK["O|{Qt2{GgW5HRN~qk+#G$+ Iyao"s7]pUBj" Our data indicate that the CRES/mCRES and ASTCT criteria both offer more accurate assessments of the occurrence and severity of CAR-T cell-related NT events. Would you like email updates of new search results? hbbd``b`"\35`= This scale was then grouped with gradation of signs of increased intracranial pressure and presence of seizures, whereby the greatest level of toxicity in any given domain would also be captured as the overall CRES grade. darunavir increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. - Febrile neutropenia - - ANC <1000/mm3 with a single temperature of >38.3 degrees C (101 degrees F) or a sustained temperature of >=38 degrees C (100.4 degrees F) for more than one hour Life-threatening consequences; urgent intervention indicated Death Definition: If unable to avoid coadministration of belzutifan with sensitive CYP3A4 substrates, consider increasing the sensitive CYP3A4 substrate dose in accordance with its prescribing information. what this drug is used for and how it is used. Use Caution/Monitor. Bioorganic & medicinal chemistry letters. Monitor Closely (1)nelfinavir increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Monitor Closely (1)clarithromycin increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. European journal of haematology. istradefylline will increase the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Novartis is committed to sharing with qualified external researchers access to patient-level data and supporting clinical documents from eligible studies. Use Caution/Monitor. Stupor or coma, Any clinical seizure focal or generalized that resolves rapidly or nonconvulsive seizures on EEG that resolve with intervention, Life-threatening prolonged seizure (>5 minutes); or repetitive clinical or electrical seizures without return to baseline in between; deep focal motor weakness such as hemiparesis or paraparesis, Diffuse cerebral edema on neuroimaging; decerebrate or decorticate posturing; or cranial nerve VI palsy; or papilledema; or Cushings triad, 1, 1, 1, 2, 2, 2, 2, 3, 3, 4, 5, 5, 6, 7, 8, 9, 18, 28, 63, 195. This study is the first to retrospectively apply a modified version of the CARTOX Working Groups CRES grading system and the ASTCT consensus ICANS criteria to the same CAR-T cell-related NT data set from a registrational trial. palifermin increases toxicity of brentuximab vedotin by Other (see comment). Monitor Closely (1)ofatumumab SC, brentuximab vedotin. <>/ProcSet [/PDF /Text /ImageB /ImageC /ImageI]>>/Rotate 180/MediaBox[0 0 612 792]>> For 39 regraded patients with CRS, 22 (56.4%) were graded the same across all 3 scales. Modify Therapy/Monitor Closely. |n9>S[JRpN}O%N^W`kV7b]v:!E"}e"7-3h8B5Sp?ZA %ET89" baH& You are being redirected to Patients with primary mediastinal B-cell lymphoma were not eligible for enrollment. Coadministration of apalutamide, a strong CYP3A4 inducer, with drugs that are CYP3A4 substrates can result in lower exposure to these medications. Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners. sharing sensitive information, make sure youre on a federal Monitor patients for adverse reactions. Brentuximab vedotin Monitor Closely (1)enzalutamide will decrease the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. primidone will decrease the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. The CRES and ASTCT scales, which measure immune effector cell-associated neurotoxicity syndrome, offer more accurate assessments of NT after CAR-T cell therapy. Mitotane is a strong inducer of cytochrome P-4503A4; monitor when coadministered with CYP3A4 substrates for possible dosage adjustments. received honoraria, membership on the board of directors or advisory committees, and research funding from Celgene; consultancy and honoraria from Dava Oncology; honoraria and research funding from Genentech; membership on the board of directors or advisory committees for Gilead; consultancy, honoraria, and research funding from Merck; honoraria, membership on the board of directors or advisory committees, and research funding from Novartis; and consultancy, honoraria, and membership on the board of directors or advisory committees for Nordic Nanovector. In the majority of patients who had higher-grade NT per the CTCAE scale than the mCRES and ASTCT scales, the less specialized CTCAE scale identified NT not considered relevant for CRES or ICANS, resulting in grades of 0 by mCRES and ASTCT. receives research funding from Kite Pharma, a Gilead Company, and Celgene; he also receives research funding from and has patents licensed or pending with Juno Therapeutics, a Celgene/Bristol-Myers Squibb company; has participated in advisory board and/or data monitoring committee meetings for which he receives honoraria for BioLine RX, Kite Pharma, Gilead, Pharmacyclics, Novartis, Juno Therapeutics, and Celgene; and is a scientific advisory board member for which he receives honoraria from and has stock options in A2 Biotherapeutics. Use Caution/Monitor. Minor/Significance Unknown. Contraindicated because of increased risk of pulmonary toxicity. Among 111 patients infused with tisagenlecleucel (as of December 2017), the 4 experts identified 50 patients (45%) who had any-grade NT per CTCAE, 19 (17%) per mCRES, and 19 (17%) per ASTCT. Monitor patients for adverse reactions. HOW TO USE: This medication is given by injection into a vein over 30 minutes by a health care professional. Use Caution/Monitor. Monitor patients for adverse reactions. 0000001096 00000 n For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada). 2010;16(3):888897. Share cases and questions with Physicians on Medscape consult. K^gs Brentuximab vedotin combined with ABVD or AVD for patients with newly diagnosed Hodgkin's lymphoma: a phase 1, open-label, dose-escalation study. Richard T. Maziarz, Stephen J. Schuster, Vadim V. Romanov, Elisha S. Rusch, Junlong Li, James E. Signorovitch, David G. Maloney, Frederick L. Locke; Grading of neurological toxicity in patients treated with tisagenlecleucel in the JULIET trial. Use Caution/Monitor. endobj J.E.S. Modify Therapy/Monitor Closely. This document does not contain all possible drug interactions. 0000007690 00000 n If coadministration unavoidable, monitor for adverse reactions and reduce CYP3A substrate dose in accordance with product labeling. :+fO_??:Rrc3CiDv=*s>#z #=5Wi[ Monitor sensitive CYP3A4 substrates for effectiveness if coadministered. Eligible patients were at least 18 years old, with 2 or more prior lines of therapy (including rituximab and an anthracycline), and were ineligible for or had relapsed after autologous hematopoietic stem cell transplantation. Monitor Closely (1)belzutifan will decrease the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. After reconstitution (see section 6.6), each mL contains 5 mg of brentuximab vedotin. Monitor patients for adverse reactions. . ketoconazole increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Consider dose reduction of sensitive P-gp substrates. Acute pulmonary toxicity associated with brentuximab appears to be a rare but serious adverse effect that can be potentially fatal. All material on this website is protected by copyright, Copyright 1994-2023 by WebMD LLC. As of December 2017, 111 patients received tisagenlecleucel in JULIET. Comment: Palifermin should not be administered within 24 hr before, during infusion of, or . In addition, inpatient care, as mandated in the ZUMA-1 trial, may have allowed more opportunity to detect sensitive changes in low-grade ICANS, which may not be as clearly identifiable in the outpatient setting in which approximately 25% of CAR-T cell therapy infusions were performed in JULIET. encorafenib, brentuximab vedotin. Avoid taking selinexor with other medications that may cause dizziness or confusion. Owing to potential additive immunosuppressive effects, consider duration of effect and mechanism of action of these therapies if coadministered. 2018, Diffuse large B-cell lymphoma (DLBCL): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. This analysis had 2 objectives. Monitor patients for adverse reactions. hiM!JE%Y}>0G2dh&b5"?f` 1M\'`('PD,)*+Z{-784qZS5'fh [o=]^'W1 2L_:o0aHIX :#HoZl&]{j%jO Use Caution/Monitor. 2018 Oct;5(10):e450-e461. Avoid or Use Alternate Drug. Instrumental ADL refers to preparing meals, shopping for groceries or clothes, using the telephone, managing money, and so on. To view formulary information first create a list of plans. unspecified interaction mechanism. mitotane decreases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. endobj erdafitinib will increase the level or effect of brentuximab vedotin by P-glycoprotein (MDR1) efflux transporter. Serious - Use Alternative (1)idelalisib will increase the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown. Avoid or Use Alternate Drug. 0000004470 00000 n x=nIHVcLmlY(H IyYQUV,-Sbq_sz?nnc/g|qZNv^x\^m5xfzmIpuEDqQXAeaVW/_D~$}r$DtbGp/zda%MilTQiglpq ! Minor/Significance Unknown. <> Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature. Criteria for grading on the CTCAE scale vary by toxicity, however by convention, grade 1 typically refers to asymptomatic or mild symptoms not requiring intervention, grade 2 refers to moderate symptoms that interfere somewhat with daily function and where some intervention may be indicated, and grade 3 refers to severe symptoms that interfere . Avoid or Use Alternate Drug. Your doctor should order a pregnancy test before you start this medication. CTCAE 4.0 Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 U.S.DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health . endobj 2013 Dec;14(13):1348-56. doi: 10.1016/S1470-2045(13)70501-1. Care must be taken to compare the data generated here with NT results from other clinical trials using other CD19 CAR-T cell therapies for DLBCL. Use Caution/Monitor. Avoid or Use Alternate Drug. MISSED DOSE: It is important to get each dose of this medication as scheduled. The National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0, and the Total Neuropathy Score clinical version (TNSc) are both validated scores to quantify peripheral neuropathy (PN), with the TNSc being more sensitive to clinical changes. . Use Caution/Monitor. CYP3A4 substrates may require dosage adjustment.stiripentol will increase the level or effect of brentuximab vedotin by P-glycoprotein (MDR1) efflux transporter. By clicking send, you acknowledge that you have permission to email the recipient with this information. . Absent Adverse Event: 1 . 0000010614 00000 n doi: 10.1016/s0140-6736(15)60165-9. Authors Tecovirimat is a weak CYP3A4 inducer. Use Caution/Monitor. brentuximab vedotin and bleomycin both increase Other (see comment). Use Caution/Monitor. Use Caution/Monitor. Urology. Brentuximab vedotin as consolidation therapy after autologous stem-cell transplantation in patients with Hodgkin's lymphoma at risk of relapse or progression (AETHERA): a randomised, double-blind, placebo-controlled, phase 3 trial. endstream endobj 5316 0 obj <>stream All data provided are anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. Before Monitor patients for adverse reactions. Avoid or Use Alternate Drug. 0 Monitor patients for adverse reactions. . Monitor patients for adverse reactions. Use Caution/Monitor. . Journal of Clinical Oncology. The numbers inside of the columns refer to absolute number of patients. Monitor patients for adverse reactions. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Lancet Oncol. Only NT with at least temporal association with CAR-T cell therapy was considered for regrading. Lynch RC, Cassaday RD, Smith SD, Fromm JR, Cowan AJ, Warren EH, Shadman MS, Shustov A, Till BG, Ujjani CS, Libby EN 3rd, Philip M, Coye H, Martino CN, Bhark SL, Morris K, Rasmussen H, Behnia S, Voutsinas J, Gopal AK. With the institution of the outlined premedications, Ms. R tolerated subsequent infusions well, at full dose and at standard infusion rates, with no documented infusion reactions, and was able to complete a total of 16 cycles of consolidation therapy. Monitor patients for adverse reactions. Brentuximab vedotin consolidation therapy was prescribed in the post-transplant consolidation setting, beginning 45 days after stem cell reinfusion, given the patient's high risk for recurrence. Clipboard, Search History, and several other advanced features are temporarily unavailable. Definitions and Grading of Peripheral Sensory and Motor Neuropathy (reproduced from NCI Common Terminology Criteria for Adverse Events, Version 4.03) The peripheral neuropathy associated with brentuximab vedotin is generally reversible and may often be managed with modifications to dosing and schedule. The NCI Common Terminology Criteria for Adverse Events (CTCAE) is a descriptive terminology which is utilized for Adverse Event (AE) reporting. Correspondence: Richard T. Maziarz, Adult Blood and Marrow Stem Cell Transplant & Cellular Therapy Program, Knight Cancer Institute, Oregon Health and Science University, Mail code: OC14HO, 3181 SW Sam Jackson Park Rd, Portland, OR 97239; e-mail: [email protected]. Coadministration of encorafenib with sensitive CYP3A4 substrates may result in increased toxicity or decreased efficacy of these agents. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. Monitor sensitive CYP3A4 substrates for effectiveness if coadministered. hSmO0+1d^obPFtb>y2c X!p Aq@ld, brentuximab vedotin decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Fexinidazole inhibits CYP3A4. To gain a better understanding of tisagenlecleucels NT safety profile, NT-related data collected in the JULIET trial were assessed retrospectively by a panel of medical experts and regraded using the CTCAE criteria in parallel with the mCRES system and the ASTCT criteria. In addition, the mCRES scale used here may have underestimated the actual CRES grade 1/2 because the CARTOX-10 score might pick up subtle mental status changes not recognized or reported by the investigators using CTCAE. Tremors and myoclonus associated with immune effector cell therapies may be graded according to CTCAE v5.0, but they do not influence ICANS grading. The .gov means its official. After two cycles of salvage chemotherapy, a PET-CT confirmed a complete response, and she proceeded to an autologous stem cell transplant with a preparative regimen of carmustine, etoposide, cytosine arabinoside, and melphalan (BEAM). Modify Therapy/Monitor Closely. Epub 2015 Feb 13. F.L.L. Use Caution/Monitor. Use Caution/Monitor. Avoid or Use Alternate Drug. CYP3A4 substrates may require dosage adjustment. Evaluate for loss of therapeutic effect if medication must be coadministered. 1. 2013;33(1):93104. Use Caution/Monitor. This effect was not observed with istradefylline 20 mg/day. Monitor patients for adverse reactions. and transmitted securely. This potential conflict of interest has been reviewed and managed by Oregon Health & Science University. https://profreg.medscape.com/px/getpracticeprofile.do?method=getProfessionalProfile&urlCache=aHR0cHM6Ly9yZWZlcmVuY2UubWVkc2NhcGUuY29tL2RydWcvYWRjZXRyaXMtYnJlbnR1eGltYWItdmVkb3Rpbi05OTk2ODA=, View explanations for tiers and sotorasib will decrease the level or effect of brentuximab vedotin by P-glycoprotein (MDR1) efflux transporter. A patient receiving an initial brentuximab infusion experiences severe respiratory distress requiring inthubation. However, the CTCAE scale was not specifically developed to capture the scope and severity of the NT syndrome that can occur after CAR-T cell therapy, and new grading systems have since emerged that are more appropriate for this purpose. Use Caution/Monitor. stiripentol, brentuximab vedotin. Monitor Closely (1)isoniazid increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. In the JULIET trial, NT was graded, per protocol, using CTCAE v4.03 criteria (Table 1). It uses a range of grades from 1 to 5. Avoid or Use Alternate Drug. Blood and lymphatic system disorders: Febrile neutropenia, Gastrointestinal disorders: Acute pancreatitis and gastrointestinal complications (including fatal outcomes), Infections: PML, serious infections and opportunistic infections, Metabolism and nutrition disorders: Hyperglycemia, Respiratory, thoracic and mediastinal disorders: Noninfectious pulmonary toxicity including pneumonitis, interstitial lung disease, and ARDS (some with fatal outcomes), Skin and subcutaneous tissue disorders: Toxic epidermal necrolysis, including fatal outcomes, Concomitant use of brentuximab with bleomycin because of pulmonary toxicity, Peripheral neuropathy (predominately sensory neuropathy) and motor neuropathy reported; drug-induced peripheral neuropathy is cumulative; monitor for symptoms of neuropathy (eg, hypoesthesia, hyperesthesia, paresthesia, discomfort, a burning sensation, neuropathic pain, weakness), Fatal and serious cases of febrile neutropenia reported; monitor complete blood counts (CBC) prior to each dose; start primary prophylaxis with G-CSF beginning with Cycle 1 for patients who receive drug with chemotherapy for previously untreated Stage III or IV cHL or previously untreated PTCL and pediatric patients who receive this medication in combination with chemotherapy for previously untreated high risk cHL, Grade 3 or 4 thrombocytopenia or anemia can occur, Frequency of Grade 3 adverse reactions and deaths reported to be greater in patients with severe renal or hepatic impairment compared to patients with normal renal/hepatic function, Serious cases of hepatotoxicity, including fatal outcomes reported after first dose or after rechallenge; serious cases of hepatotoxicity, including fatal outcomes; preexisting liver disease, elevated baseline liver enzymes, and concomitant medications may increase risk; monitor liver enzymes and bilirubin; patients experiencing new, worsening, or recurrent hepatotoxicity may require a delay, change in dose, or discontinuation of therapy, JC virus infection resulting in progressive multifocal leukoencephalopathy (PML) and death reported (see Black Box Warnings), Closely monitor for emergence of bacterial, fungal or viral infections, Events of noninfectious pulmonary toxicity (eg, pneumonitis, interstitial lung disease, acute respiratory distress syndrome [ARDS]), some with fatal outcomes, reported, Fatal and serious cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) reported; if SJS or TEN occurs, discontinue treatment and administer appropriate medical therapy, Acute pancreatitis, including fatal outcomes, reported, Fatal and serious gastrointestinal (GI) complications (eg, perforation, hemorrhage, erosion, ulcer, intestinal obstruction, enterocolitis, neutropenic colitis, and ileus) reported; lymphoma with preexisting GI involvement may increase risk of perforation; promptly evaluate for any new or worsening GI symptoms, and treat appropriately, Patients with rapidly proliferating tumor and high tumor burden are at risk of tumor lysis syndrome; closely monitor and treat appropriately, Serious events of hyperglycemia (eg, new-onset hyperglycemia), exacerbation ofpreexisting diabetes mellitus, and ketoacidosis (including fatal outcomes) have beenreported; occurred more frequently in patients with high body mass index or diabetes;monitor serum glucose and if hyperglycemia develops, administer antihyperglycemicmedications as clinically indicated, Based on the findings from animal studies and mechanism of action, brentuximab may cause fetal harm, Available data from case reports in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes, There is no information related to the presence of brentuximab vedotin in human milk, the effects on the breastfed child, or the effects on milk production, Owing to the potential for serious adverse reactions in a breastfed child from brentuximab, including cytopenias and neurologic or gastrointestinal toxicities, breastfeeding is not recommended during treatment. Both the CRES/mCRES and ASTCT scales appear to suit clinicians needs, with small nuances separating them; however, ICANS scoring per ASTCT is now being adopted by most physicians and regulatory bodies, and we expect it to become the universal grading scale for CAR-T cell therapy-associated NT. . }? Monitor patients for adverse reactions. is employed by Novartis. Use Caution/Monitor. We report the case of a twenty-nine-year-old female with Hodgkin's lymphoma who was treated with brentuximab and later presented with severe acute pulmonary toxicity; she improved after the discontinuation of brentuximab and administration of antibiotics and glucocorticoid therapy. Intraveous granisetron was given for nausea. . voxelotor will increase the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. We conclude that CTCAE v4.03 was not designed for, and is suboptimal for, grading CAR-T cell therapy-associated NT. a patient receiveing an initial brentuximab infusion experiences severe respiratory distress requiring intubation. endstream Vital signs were checked every 15 minutes during the infusion reaction and remained stable throughout. Brentuximab vedotin desensitization in a patient with refractory Hodgkin's lymphoma. Avoid or Use Alternate Drug.