Epub 2015 May 12. NT by ASTCT criteria provided concordance for 34 patients, a lower grade for 31 patients, and a higher grade for 3 patients compared with the CTCAE scale (Figure 1B). %%EOF An electrocardiogram (ECG) was obtained, which was unremarkable, showing normal sinus rhythm. doi: https://doi.org/10.1182/bloodadvances.2019001305. Severe Acute Pulmonary Toxicity Associated with Brentuximab in a Patient with Refractory Hodgkin's Lymphoma Severe Acute Pulmonary Toxicity Associated with Brentuximab in a Patient with Refractory Hodgkin's Lymphoma Case Rep Pulmonol. . This drug is available at a higher level co-pay. phenytoin decreases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. fosamprenavir increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. . Thus, the CTCAE scale identified 31 more patients as having NT than did either the mCRES system or the ASTCT system. 0000006704 00000 n Monitor Closely (1)oxcarbazepine decreases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Monitor Closely (1)brentuximab vedotin decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Upon the emergence of these symptoms, the brentuximab vedotin infusion was held. stiripentol, brentuximab vedotin. MEDICAL ALERT: Your condition can cause complications in a medical emergency. A grading (severity) scale is provided for each AE term. 0000003265 00000 n brentuximab vedotin and bleomycin both increase Other (see comment). The sponsor is expected to provide the name of the scale and version used to map the terms, Clinical Cancer Research. Modify Therapy/Monitor Closely. Monitor patients for adverse reactions. This page contains brief information about brentuximab vedotin As expected, especially when introducing new grading methods, some variance was observed among the 4 experts independent and blinded grading assessments. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Finally, based on the individual examples given here, evaluating NT using the CTCAE system is highly subjective when used by practitioners to capture CAR-T-associated encephalopathy. Consider increasing CYP3A substrate dose if needed. Monitor patients for adverse reactions. tipranavir increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Monitor Closely (1)phenytoin decreases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown. %PDF-1.5 % at the National Institutes of Health, An official website of the United States government, Drugs Approved for Different Types of Cancer, Drugs Approved for Conditions Related to Cancer, Complementary & Alternative Medicine (CAM), Find Clinical Trials for Brentuximab Vedotin, U.S. Department of Health and Human Services, Adults whose cancer has not been treated. Modify Therapy/Monitor Closely. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Consider dose reduction of sensitive CYP3A4 substrates.istradefylline will increase the level or effect of brentuximab vedotin by P-glycoprotein (MDR1) efflux transporter. nK doi: 10.1016/S2352-3026(21)00170-8. Fexinidazole inhibits CYP3A4. Use Caution/Monitor. If unavoidable, reduce CYP3A substrate dose according to product labeling. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid concomitant use of tucatinib with CYP3A substrates, where minimal concentration changes may lead to serious or life-threatening toxicities. Monitor Closely (1)nicardipine increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Salvage chemotherapy was administered with ifosfamide carboplatin, and etoposide (ICE). 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. stream 1 b. tazemetostat will decrease the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. brentuximab vedotin decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. It uses a range of grades from 1 to 5. HHS Vulnerability Disclosure, Help Use Caution/Monitor. If coadministration is unavoidable, monitor patients for loss of therapeutic effect of these drugs. Contraindicated. Increase dose of CYP3A4 substrate, as needed, when coadministered with cenobamate. Use Caution/Monitor. Use Caution/Monitor. Unable to load your collection due to an error, Unable to load your delegates due to an error. Most Manage and view all your plans together even plans in different states. informational and educational purposes only. . mitotane decreases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. . Use Caution/Monitor. Four medical experts with experience treating patients with 3 different CD19-targeted CAR-T cell constructs retrospectively assessed and regraded NT after tisagenlecleucel treatment in patients with r/r DLBCL or r/r transformed follicular lymphoma in the JULIET trial, as reported in the US Food and Drug Administration (FDA) prescribing label. Antibody-drug conjugatesa new wave of cancer drugs. . Intracranial hemorrhage with or without associated edema is not considered a NT feature and is excluded from ICANS grading. Use Caution/Monitor. nelfinavir increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. lFsA For 39 regraded patients with CRS, 22 (56.4%) were graded the same across all 3 scales. Among 106 patients receiving tisagenlecleucel included in the FDA label, 62 (58.5%) patients were reported as having NT, including 43 (40.6%) with grade 1/2 and 19 (17.9%) with grade 3 or higher NT. Specific conditions and symptoms may have values or descriptive comment for each level, but the general guideline is: 1 - Mild 2 - Moderate 3 - Severe 4 - Life-threatening 5 - Death Grade 1: is defined as mild, asymptomatic symptoms. 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. Thus, as done in real-world practice, complex patient cases went through an adjudication discussion by the 4 experts, similar to a clinical tumor board, referring back to the source documents when necessary. Monitor Closely (1)nefazodone increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Delayed onset bleomycin-induced pneumonitis. Monitor patients for adverse reactions. For the present retrospective analysis, NT patient-level data from case report forms were collected for the JULIET trial for the 9-month data cutoff of December 2017. rucaparib will increase the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. abametapir will increase the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. 2022 May 20;12:879391. doi: 10.3389/fonc.2022.879391. Monitor Closely (2)stiripentol, brentuximab vedotin. -. 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. tepotinib will increase the level or effect of brentuximab vedotin by P-glycoprotein (MDR1) efflux transporter. Minor (1)anastrozole will increase the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Event occurred at least once in a patient with severe (grade 3-4) CRS per Penn grade. Use Caution/Monitor. Minor/Significance Unknown. Many people using this medication do not have serious side effects.This medication may rarely make your blood sugar rise, which can cause or worsen diabetes. 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. levoketoconazole increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Get medical help right away if you have any signs of infection (such as sore throat that doesn't go away, fever, swollen lymph nodes, chills, cough).Brentuximab sometimes causes side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). tucatinib will increase the level or effect of brentuximab vedotin by P-glycoprotein (MDR1) efflux transporter. Serious - Use Alternative (1)palifermin increases toxicity of brentuximab vedotin by Other (see comment). Coadministration of apalutamide, a strong CYP3A4 inducer, with drugs that are CYP3A4 substrates can result in lower exposure to these medications. Avoid or Use Alternate Drug. ritonavir increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Only 2 of the 31 patients who had NT per CTCAE, but grade 0 NT by mCRES and ASTCT, had received corticosteroids (Table 4). First, NT was regraded by CTCAE criteria retrospectively, giving one overarching CTCAE grade to each patient (eg, overarching CTCAE grade 3 was given for a patient who had the following individual neurological events: grade 3 encephalopathy, grade 2 paresthesia, and grade 1 dyskinesia), and compared with the FDA label. Use Caution/Monitor. Lencapavir (a moderate CYP3A4 inhibitor) may increase CYP3A4 substrates initiated within 9 months after last SC dose of lenacapavir, which may increase potential risk of adverse reactions of CYP3A4 substrates. % trailer Modify Therapy/Monitor Closely. 2013 Dec;14(13):1348-56. doi: 10.1016/S1470-2045(13)70501-1. saquinavir increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Treatment repeats every 28 days for 3 cycles in the absence of disease progression or unacceptable toxicity. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Last, NT grading using all 3 systems was summarized for all patients, and all patients were stratified according to presence of CRS by the Penn scale. Monitor patients for adverse reactions. Patients were randomly assigned in a 1:1 ratio to receive A+AVD (1.2 mg of brentuximab vedotin per kilogram of body weight, 25 mg of doxorubicin per square meter of body-surface area . US residents can call their local poison control center at 1-800-222-1222. Modify Therapy/Monitor Closely. Monitor Closely (1)eslicarbazepine acetate will decrease the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. . Avoid or Use Alternate Drug. 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 Closely (1)enzalutamide will decrease the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. CYP3A4 substrates may require dosage adjustment.stiripentol will increase the level or effect of brentuximab vedotin by P-glycoprotein (MDR1) efflux transporter. Avoid taking selinexor with other medications that may cause dizziness or confusion. Adjust dose according to prescribing information if needed. Controlled studies in pregnant women show no evidence of fetal risk. Mitotane is a strong inducer of cytochrome P-4503A4; monitor when coadministered with CYP3A4 substrates for possible dosage adjustments. Therefore, an mCRES scale was used for this analysis, wherein grades 1 and 2 (distinguished by the CARTOX-10 score) were combined. Tell your doctor right away if you have symptoms of high blood sugar, such as increased thirst/urination. Voxelotor increases systemic exposure of sensitive CYP3A4 substrates. R.T.M. This site needs JavaScript to work properly. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. Avoid or Use Alternate Drug. Trial Design. Epub 2013 Nov 15. Assessed using Balis scale; Grade 2. Brentuximab Approved for High-Risk Hodgkin Lymphoma in Children and Adolescents, Brentuximab May Mean Less Radiation for Children, Teens with Hodgkin Lymphoma. 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: maziarzr@ohsu.edu. Contraindicated (1)brentuximab vedotin and bleomycin both increase Other (see comment). hSmO0+1d^obPFtb>y2c X!p Aq@ld, Lancet Oncol. The CARTOX-10 questionnaire is a new tool proposed to prospectively assess overall cognitive function that could not be used in this retrospective study. Use Caution/Monitor. Monitor patients for adverse reactions. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). In the JULIET trial, NT was graded, per protocol, using CTCAE v4.03 criteria (Table 1). Patients with primary mediastinal B-cell lymphoma were not eligible for enrollment. 0000001368 00000 n Avoid or Use Alternate Drug. NT by ASTCT criteria provided concordance for 66 patients, a lower grade for 2 patients, and a higher grade for no patients compared with the mCRES scale (Figure 1B). Monitor Closely (1)isoniazid increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Before A New First-line Regimen for Advanced Hodgkin Lymphoma? Modify Therapy/Monitor Closely. 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. The first dose of brentuximab vedotin was administered without difficulty, at full dose (1.8 mg/kg) at a standard infusion time of 30 minutes. elagolix will decrease the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Poster presented at the 22nd Congress of the European Hematology Association. National Cancer Institute what this drug is used for and how it is used. :+fO_??:Rrc3CiDv=*s>#z #=5Wi[ Use Caution/Monitor. Most %PDF-1.4 Vital signs were stable, with a temperature of 36.9C, pulse 84, respirations of 20, and blood pressure of 107/67 mm Hg. fosphenytoin decreases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. All discrepancies were resolved during the adjudication conference that followed group meetings and discussions. indinavir increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. Epub 2002 Apr 12. Use Caution/Monitor. 0000004470 00000 n View the full answer Step 2/2 Monitor for toxicities of P-gp substrates that may require dosage reduction when coadministered with P-gp inhibitors. High-Dose Bendamustine Plus Brentuximab Combination Is Effective and Has a Favourable Toxicity Profile in the Treatment of Refractory and Relapsed Hodgkin Lymphoma . endstream endobj 1187 0 obj <>/Metadata 39 0 R/OCProperties<>/Outlines 66 0 R/PageLabels 1182 0 R/PageLayout/OneColumn/Pages 1184 0 R/PieceInfo<>>>/StructTreeRoot 79 0 R/Type/Catalog>> endobj 1188 0 obj <>/Font<>/ProcSet[/PDF/Text]>>/Rotate 0/StructParents 0/Type/Page>> endobj 1189 0 obj <>stream Monitor patients for adverse reactions. Only NT with at least temporal association with CAR-T cell therapy was considered for regrading.
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