Medical writing support was provided by Ina Nikolaeva (Healthcare Consultancy Group) and was funded by Novartis Pharmaceuticals Corporation. Event occurred at least once in a patient with severe (grade 3-4) CRS per Penn grade. Definition from the NCI Drug Dictionary - Detailed scientific definition and other names for this drug. 0000004470 00000 n erdafitinib will increase the level or effect of brentuximab vedotin by P-glycoprotein (MDR1) efflux transporter. Monitor patients for adverse reactions. Brentuximab Vedotin: A Review in CD30-Positive Hodgkin Lymphoma. Version 1.2019. Use Caution/Monitor. atazanavir increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Istradefylline 40 mg/day increased peak levels and AUC of CYP3A4 substrates in clinical trials. . This suggests that the CTCAE scale would pose difficulties in reliable clinician training outcomes as well as consistent global institutional implementation. cobicistat will increase the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. 2013 Dec;14(13):1348-56. doi: 10.1016/S1470-2045(13)70501-1. Comparison of criteria for NT grades between CTCAE, CARTOX-10 mCRES, and ASTCT scales. This document does not contain all possible drug interactions. 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. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). 2005;66(1):p. 195. doi: 10.1016/j.urology.2005.01.038. . . Consider reducing the dosage of P-gp substrates, where minimal concentration changes may lead to serious or life-threatening toxicities.Serious - Use Alternative (1)tucatinib will increase the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. |n9>S[JRpN}O%N^W`kV7b]v:!E"}e"7-3h8B5Sp?ZA %ET89" baH& 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 Owing to potential additive immunosuppressive effects, consider duration of effect and mechanism of action of these therapies if coadministered. 1199 0 obj <>stream endstream 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. Epub 2015 Feb 13. introduced the concept for this study for review; and all authors provided data analysis and interpretation, manuscript writing, and final approval of manuscript and are accountable for all aspects of the work. Pivotal safety and efficacy results from Transcend NHL 001, a multicenter phase 1 study of lisocabtagene maraleucel (liso-cel) in relapsed/refractory (R/R) large B cell lymphomas [abstract]. 5315 0 obj <>stream 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. Federal government websites often end in .gov or .mil. Modify Therapy/Monitor Closely. Use Caution/Monitor. what you should tell your doctor before using this drug. what this drug is used for and how it is used. Use Caution/Monitor. rucaparib will increase the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. hN0W7|sRC%*;gUg|Ib(I L!B$R,=$|=I[TbF[@z`H)n7}Q,iz8O/KZG. 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. official website and that any information you provide is encrypted trailer This potential conflict of interest has been reviewed and managed by Oregon Health & Science University. If coadministration unavoidable, monitor for adverse reactions and reduce CYP3A substrate dose in accordance with product labeling. Monitor or titrate P-gp substrate dose if coadministered. This is the first study to retrospectively apply CTCAE, mCRES, and ASTCT criteria to the same patient data set. z**5p`'_O%4TUX^\O. Brentuximab vedotin for paediatric relapsed or refractory Hodgkin's lymphoma and anaplastic large-cell lymphoma: a multicentre, open-label, phase 1/2 study. Coadministration of apalutamide, a strong CYP3A4 inducer, with drugs that are CYP3A4 substrates can result in lower exposure to these medications. Toxicity grading for laboratory results began in 1999 with CTCAE version 2.0. According to the NCI's. toxicity grading scale, this reaction is a grade: Question: A patient receiving an initial brentuximab infusion experiences severe respiratory distress requiring inthubation. Serious - Use Alternative (1)idelalisib will increase the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. commonly, these are "non-preferred" brand drugs. government site. If unable to avoid coadministration of belzutifan with sensitive CYP3A4 substrates, consider increasing the sensitive CYP3A4 substrate dose in accordance with its prescribing information. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. ADL, activities of daily living; CSF, cerebrospinal fluid; EEG, electroencephalogram; ICP, intracranial pressure. NCI Common Terminology Criteria for Adverse Events (CTCAE) data files and related documents are published here. th{U j06,`A & NW`c-D&2,s;H$2DD;IXDjzRirTz6>XjNHWa][+RpVR=} \ShV*IQ_O|YAiBXvlX5y,seqHi|@h(cg="b&XY"im|%{7s\fI5I5FMi^Zqickfk,;n+{!iv |z$85w~#e Instrumental ADL refers to preparing meals, shopping for groceries or clothes, using the telephone, managing money, and so on. This information is not individual medical advice and does not substitute for the advice of your health care professional. . Evaluate for loss of therapeutic effect if medication must be coadministered. . Avoid or Use Alternate Drug. Minor/Significance Unknown. Brentuximab may harm an unborn baby. Use Caution/Monitor. Modify Therapy/Monitor Closely. Z1ef-/N*"ho8'Xsc?_a;M5Jsk 1u4/O"EiJJXc@5G kncGW5_ fe 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. If a less serious reaction occurs, the infusion will be interrupted, you will be treated for the reaction, and the infusion will be continued. In the JULIET trial, NT was graded, per protocol, using CTCAE v4.03 criteria (Table 1). tucatinib will increase the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Monitor sensitive CYP3A4 substrates for effectiveness if coadministered. After reconstitution (see section 6.6), each mL contains 5 mg of brentuximab vedotin. It is possible that a similar process would also lead to decreased numbers of NT events attributable to CAR-T cell therapy for ZUMA-1 and TRANSCEND. Use Caution/Monitor. J.L. 2 0 obj doi: 10.1016/s0140-6736(15)60165-9. Use Caution/Monitor. endobj Front Oncol. tipranavir increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. The site is secure. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Thirty minutes after onset, the chest pain was persistent, and oxygen saturations were normal. In the subgroup analysis of patients with or without CRS, all 3 grading systems identified more patients with CRS as having NT compared with patients without CRS (Table 6). endobj Use Caution/Monitor. 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. This patient information sheet applies only to approved uses of the drug. 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. Newland A. M., Li J. X., Wasco L. E., Aziz M. T., Lowe D. K. Brentuximab vedotin: a CD30-Directed antibody-cytotoxic drug conjugate. These criteria are used for the management of chemotherapy . unspecified interaction mechanism. Use Caution/Monitor. . PMC National Library of Medicine Lancet Haematol. Monitor Closely (1)nicardipine increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. acetazolamide will increase the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. CTC Version 2.0 Publish Date: April 30, 1999 Cancer Therapy Evaluation Program 1 Revised March 23, 1998 Common Toxicity Criteria, Version 2.0 DCTD, NCI, NIH, DHHS March 1998 With this study, we showed that the first step in investigating the complex clinical syndrome of NT associated with CAR-T cell therapies is the accurate grading, which can then be used to investigate further associations of NT and clinically relevant markers (eg, age, tumor burden).27,28. Younes A, Connors JM, Park SI, Fanale M, O'Meara MM, Hunder NN, Huebner D, Ansell SM. istradefylline will increase the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Coadministration of apalutamide, a strong CYP3A4 inducer, with drugs that are CYP3A4 substrates can result in lower exposure to these medications. https://profreg.medscape.com/px/getpracticeprofile.do?method=getProfessionalProfile&urlCache=aHR0cHM6Ly9yZWZlcmVuY2UubWVkc2NhcGUuY29tL2RydWcvYWRjZXRyaXMtYnJlbnR1eGltYWItdmVkb3Rpbi05OTk2ODA=, View explanations for tiers and lonafarnib will increase 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. Event was observed at least once in a patient with CRS per Penn grade. Monitor patients for adverse reactions. Treatment repeats every 2 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Minor/Significance Unknown. xref clarithromycin increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. We compare the results of regrading by CTCAE to the original FDA data report, as well as regrading by CTCAE compared with a modified CRES (mCRES) score and the ASTCT ICANS score. Monitor patients for adverse reactions. doi: 10.1200/JCO.2011.38.0410. Contribution: R.T.M., S.J.S., D.G.M., and F.L.L. If unable to avoid coadministration of belzutifan with sensitive CYP3A4 substrates, consider increasing the sensitive CYP3A4 substrate dose in accordance with its prescribing information. Monitor Closely (1)brentuximab vedotin decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. 1 0 obj Severe infusion reactions to brentuximab vedotin in two patients with Hodgkin lymphoma previously treated with allogeneic stem cell transplantation. Editorial assistance was provided by Marie Louise Edwards, Lei Yin, and Yichen Lu from Analysis Group, Inc., and was supported by Novartis Pharmaceuticals Corporation. is employed by the Analysis Group, which received research funding from Novartis. official website and that any information you provide is encrypted affecting hepatic/intestinal enzyme CYP3A4 metabolism. hRo0W#Jl$$*h$[RdI%vdL,4CxG6oJ[$:l5K#KY8hDQH0 I@GQp'93BnESJK\ _!kXh3h@J(E[ G[ltceZuaP,{KMq0q.Rz^I!5HKrI1ui]~;hzELj.QUP{~^M D}-*C\4OQ#&2w8cHmQKQ+dp~WWI7OB=G''G'ap}(\;U;D_B^':o/oMjgRlr+rv#1}4s YXNTFIASyCm*5 ~}JW y./cA L6 Modify Therapy/Monitor Closely. Delayed onset bleomycin-induced pneumonitis. You should not become pregnant while using brentuximab. Avoid or Use Alternate Drug. 2015 Aug;8(4):403-12. doi: 10.1586/17474086.2015.1044432. brentuximab vedotin decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Minor/Significance Unknown. Vital signs were checked every 15 minutes during the infusion reaction and remained stable throughout. Each vial contains 50 mg of brentuximab vedotin. . The above information is provided for general j4UY=h2nlYzDG@.Sr {aI}khvU2%3fs+KFR3f. Use Caution/Monitor. -, Okeley N. M., Miyamoto J. Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature. %PDF-1.6 % Monitor Closely (1)St John's Wort decreases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Monitor Closely (1)primidone will decrease the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Elagolix is a weak-to-moderate CYP3A4 inducer. Use Caution/Monitor. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to cholera vaccine. These 31 patients generally presented with either nervous system disorders such as syncope, dizziness, peripheral neuropathy, and hypotonia that seemed distinct from and did not raise clinical suspicion of encephalopathy, or psychiatric disorders such as anxiety and insomnia (Table 2). Use Caution/Monitor. Lancet Oncol. Disclaimer. Epub 2013 Nov 15. Monitor Closely (1)isoniazid increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. (B) Cross-classification of NT by 3 grading scales: CTCAE, ASTCT, and mCRES. Locatelli F, Mauz-Koerholz C, Neville K, Llort A, Beishuizen A, Daw S, Pillon M, Aladjidi N, Klingebiel T, Landman-Parker J, Medina-Sanson A, August K, Sachs J, Hoffman K, Kinley J, Song S, Song G, Zhang S, Suri A, Gore L. Lancet Haematol. Therefore, an mCRES scale was used for this analysis, wherein grades 1 and 2 (distinguished by the CARTOX-10 score) were combined. Use Caution/Monitor. Minor/Significance Unknown. Thirty minutes later, however, Ms. R developed tingling and numbness in her feet and tongue. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. toxicity grading scale, this reaction is a grade: Based on the NCI's toxicity grading scale, a severe respiratory distr A patient receiving an initial brentuximab infusion experiences severe respiratory distress requiring intubation According to the NCi's toxicity grading scale, this reaction is a grade: A. According to the US Food and Drug Administration definition of NT using CTCAE, 62 of 106 patients infused with tisagenlecleucel had NT as of September 2017. Trial Design. In conclusion, this is the first study to retrospectively apply the CTCAE, mCRES, and ASTCT systems to the same patient data set. -, Uzel I., Ozguroglu M., Uzel B., et al. Hematology-Oncology Guidelines: 2017 Midyear Review. Avoid or Use Alternate Drug. To lower your risk, your doctor may add a medication and tell you to drink plenty of fluids. It is anticipated that future studies will have prospective data collected using more specific ICANS grading and allowing more precise comparisons of clinical trial adverse events. Clipboard, Search History, and several other advanced features are temporarily unavailable. Avoid or Use Alternate Drug. Presented at 24th Congress of the European Hematology Association; 13-16 June 2019; Amsterdam, The Netherlands. 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. (a) Computed tomography (CT) of the chest showing patchy, nodular ground glass opacities along a bronchovascular distribution throughout both lungs. Use Caution/Monitor. Your doctor may need to adjust your diabetes medication, exercise program, or diet.Tell your doctor right away if you have any serious side effects, including: numbness/tingling/weakness/pain of the hands/feet/arms/legs, muscle weakness, shortness of breath, easy bruising/bleeding, signs of liver disease (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine), severe diarrhea, severe constipation, black stools, vomit that looks like coffee grounds.This medication may lower your ability to fight infections. Urology. A: Generally acceptable. To view formulary information first create a list of plans. . Patients treated with selinexor may experience neurological toxicities. First, BVIN is highly frequent. Use Caution/Monitor. Monitor or titrate P-gp substrate dose if coadministered. Monitor patients for adverse reactions. Coadministration of palifermin within 24 hr of chemotherapy resulted in increased severity and duration of oral mucositis. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC. Monitor patients for adverse reactions. doi: 10.1007/s00280-002-0447-1. FDA label information for this drug is available at DailyMed. Use Caution/Monitor. Epub 2015 May 12. 0000006704 00000 n 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. - 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: Use Caution/Monitor. Use Caution/Monitor. For 47 patients without CRS, the CTCAE, mCRES, and ASTCT systems identified a rate of grade 3 or higher NT of 10.6%, 8.5%, and 8.5%, respectively (Table 6). commonly, these are generic drugs. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, diabetes.Brentuximab can make you more likely to get infections or may make current infections worse.
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