2015 May 9;385(9980):1853-62. doi: 10.1016/S0140-6736(15)60165-9. . Avoid coadministration with sensitive CYP3A4 substrates with a narrow therapeutic index. . Diphenhydramine (50 mg) was administered intravenously (IV), along with 20 mg of IV famotidine. (A) Frequency of CRS event grades by the Penn, Lee, and ASTCT grading scales (N = 111). If you already have diabetes, check your blood sugar regularly as directed and share the results with your doctor. Avoid or Use Alternate Drug. PRECAUTIONS: Before using brentuximab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. . 8600 Rockville Pike 0000000676 00000 n Before Consider increasing CYP3A substrate dose if needed. ketoconazole increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. . Vital signs were stable, with a temperature of 36.9C, pulse 84, respirations of 20, and blood pressure of 107/67 mm Hg. Cancers | Free Full-Text | Brentuximab-Induced Peripheral Neurotoxicity Ms. R is a 30-year-old woman who presented with stage IV Hodgkin lymphoma at the age of 29. Consider dose reduction of the sensitive CYP3A4 substrate(s) if unable to avoid. FOIA It works by slowing or stopping the growth of cancer cells. and transmitted securely. . Monitor patients for adverse reactions. <>>>/Rotate 180/MediaBox[0 0 612 792]>> Use Caution/Monitor. Istradefylline 40 mg/day increased peak levels and AUC of P-gp substrates in clinical trials. Monitor patients for adverse reactions. The CARTOX-10 questionnaire is a new tool proposed to prospectively assess overall cognitive function that could not be used in this retrospective study. Monitor CYP3A4 substrates coadministered with stiripentol for increased or decreased effects. rifampin decreases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Monitor Closely (1)oxcarbazepine decreases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. If unavoidable, reduce CYP3A substrate dose according to product labeling. Individual plans may vary Monitor patients for adverse reactions. 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. Use Caution/Monitor. . Evaluate for loss of therapeutic effect if medication must be coadministered. Monitor Closely (1)rifabutin decreases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Monitor Closely (1)enzalutamide will decrease the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. <>stream to8Tc#Y9AR~ ;YAv,qiHJ0Nu"d` Furthermore, the medical experts in this study identified fewer cases of clinically relevant CAR-T cell therapy-related NT by CTCAE criteria compared with those listed in the FDA label. 1 b. Adjust dose according to prescribing information if needed. MISSED DOSE: It is important to get each dose of this medication as scheduled. Monitor Closely (1)trastuzumab, brentuximab vedotin. Gradings by independent experts were compiled along with the investigators initial grading. 8600 Rockville Pike This strategy was based upon the results of the AETHERA phase III clinical trial (Moskowitz et al., 2015), showing improvement in progression-free survival with brentuximab vedotin consolidation therapy, post autologous transplant. We report a case of a grade 3 (Common Terminology Criteria for Adverse Events [CTCAE]) infusion reaction to brentuximab vedotin (Adcetris), in a patient with refractory Hodgkin lymphoma, at a large National Cancer Institute-designated cancer center in the Midwest (National Cancer Institute, 2010). HHS Vulnerability Disclosure, Help Lancet Oncol. Serious - Use Alternative (1)erdafitinib will increase the level or effect of brentuximab vedotin by P-glycoprotein (MDR1) efflux transporter. 2015 Mar;16(3):284-92. doi: 10.1016/S1470-2045(15)70013-6. Increase dose of CYP3A4 substrate, as needed, when coadministered with cenobamate. K^gs Serious - Use Alternative (1)voxelotor will increase the level or effect of brentuximab vedotin by 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. In the JULIET trial, NT was identified and graded per protocol according to the Common Terminology Criteria for Adverse Events (CTCAE) v4.03.10 Because it was not designed specifically for CAR-T cell therapy trials, the CTCAE scale has shortcomings in accurately capturing the severity, timing, and spectrum of NT. The CTCAE contain a grading scale for each adverse event term representing the severity of the event. Avoid coadministration with sensitive CYP3A substrates. Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners. 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. 2014;24:53575363. 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. tecovirimat will decrease the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Initial staging revealed lymphadenopathy above and below the diaphragm, as well as fluorodeoxyglucose (FDG)-avid lung lesions, splenic lesions, and multiple sites of bony involvement. Epub 2002 Apr 12. Monitor patients for adverse reactions. 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. Monitor CYP3A4 substrates coadministered with stiripentol for increased or decreased effects. anastrozole will increase the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. PDF ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS - European Medicines Agency By clicking send, you acknowledge that you have permission to email the recipient with this information. Delayed onset bleomycin-induced pneumonitis. It is not a substitute for medical advice. Use Caution/Monitor. -. this drug, research results, and ongoing clinical trials. 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. Monitor patients for adverse reactions. Overall, fewer cases of CAR-T cell therapy-related NT were identified by both the mCRES system and the ASTCT criteria compared with the CTCAE scale. Version 1.2019. voriconazole increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. Avoid or Use Alternate Drug. Avoid or Use Alternate Drug. z**5p`'_O%4TUX^\O. This regimen was chosen based on the clinical rationale for H1 and H2 blockade, as well as corticosteroid and antipyretic coverage, in the prevention of hypersensitivity reactions, not classified as anaphylaxis. official website and that any information you provide is encrypted Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.This drug may make you dizzy. (a) Computed tomography (CT) of the chest showing patchy, nodular ground glass opacities along a bronchovascular distribution throughout both lungs. You'll get a detailed solution from a subject matter expert that helps you learn core concepts. Avoid or Use Alternate Drug. :+fO_??:Rrc3CiDv=*s>#z #=5Wi[ Owing to potential additive immunosuppressive effects, consider duration of effect and mechanism of action of these therapies if coadministered. Avoid or Use Alternate Drug. Use Caution/Monitor. Toxicity grading for laboratory results began in 1999 with CTCAE version 2.0. Men and women using this medication should ask about reliable forms of birth control during treatment and for 6 months after the last dose. Hematology-Oncology Guidelines: 2017 Midyear Review. NCI CTCAE v5.0 hematologic toxicity Neutropenia, thrombocytopenia, anemia, and lymphocytopenia are determined from the complete blood count. The second dose of brentuximab vedotin was complicated by nausea, chest pain, and dysphagia within 10 minutes of medication initiation. Journal of Clinical Oncology. To view formulary information first create a list of plans. Q4|o<9RIG"q\b1JEK["O|{Qt2{GgW5HRN~qk+#G$+ Iyao"s7]pUBj" Monitor patients for adverse reactions. Idelalisib is a strong CYP3A inhibitor; avoid coadministration with sensitive CYP3A substrates. 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. 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 . This suggests that the CTCAE scale would pose difficulties in reliable clinician training outcomes as well as consistent global institutional implementation. To lower your risk, your doctor may add a medication and tell you to drink plenty of fluids. Compare formulary status to other drugs in the same class. Monitor patients for adverse reactions. 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. Vital signs were checked every 15 minutes during the infusion reaction and remained stable throughout. Encorafenib both inhibits and induces CYP3A4 at clinically relevant plasma concentrations. Assessed using Balis scale; Grade 2. Consult your doctor for more details. Avoid or substitute another drug for these medications when possible. Bioorganic & medicinal chemistry letters. Presented at 15th International Conference on Malignant Lymphoma; 18-22 June 2019; Lugano, Switzerland. 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. Standard epinephrine and methylprednisolone were available at the bedside in the event of any anaphylactic reaction. Monitor patients for adverse reactions. Modify Therapy/Monitor Closely. stiripentol, brentuximab vedotin. xZcj!"a]R76 l .]Y 4hf)ceA$Oq5SiG $Ulq9g'"7rED_quXlqq4x Use Caution/Monitor. 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. Monitor sensitive CYP3A4 substrates for effectiveness if coadministered. Monitor Closely (1)siponimod and brentuximab vedotin both increase immunosuppressive effects; risk of infection. 1 0 obj Use Caution/Monitor. nicardipine 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. provider for the most current information. Modify Therapy/Monitor Closely. Evaluate for loss of therapeutic effect if medication must be coadministered. is employed by the Analysis Group, which received research funding from Novartis. Search for other works by this author on: Chimeric antigen receptor-T cell therapy: Practical considerations for implementation in Europe, CAR T cell immunotherapy for human cancer, Long-term safety and activity of axicabtagene ciloleucel in refractory large B-cell lymphoma (ZUMA-1): a single-arm, multicentre, phase 1-2 trial, Analysis of safety data from 2 multicenter trials of CTL019 in pediatric and young adult patients with relapsed/refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL). erdafitinib will increase the level or effect of brentuximab vedotin by P-glycoprotein (MDR1) efflux transporter. First, BVIN is highly frequent. endobj PMC . Avoid or Use Alternate Drug. Yescarta [package insert]. Prevention and Treatment of Side Effects of Immunotherapy for Bladder Cancer. With these simplistic criteria, deriving the toxicity grades was a simple task. affecting hepatic/intestinal enzyme CYP3A4 metabolism. apalutamide will decrease the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Careers. . 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. The https:// ensures that you are connecting to the Brentuximab vedotin 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. Minor/Significance Unknown. Monitor patients for adverse reactions. Use Caution/Monitor. ADL, activities of daily living; CSF, cerebrospinal fluid; EEG, electroencephalogram; ICP, intracranial pressure. NT regrading of the JULIET trial by CTCAE, modified CRES, and ASTCT criteria highlighted the need for standardized NT grading practices. Brentuximab attaches to CD30 positive cancer cells in a targeted way and delivers vedotin to kill them. Minor (1)acetazolamide will increase the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Treatment of relapsed aggressive lymphomas: regimens with and without high-dose therapy and stem cell rescue. A toxicity grading scale is provided for each AE term, it varies from 1 (mild) to 5 (death). Serious - Use Alternative (1)palifermin increases toxicity of brentuximab vedotin by Other (see comment). };wN:iyUFYg,Wyi^dgvBMu9L> {Ij{>i JS8Lk6P&adAQWEPN_aKe7+S|O[u/_>v~?W I}yr>T%D$D5fqYsms xp `sv@K4([MhT3O idelalisib will increase the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. A patient receiving an initial brentuximab infusion experiences severe respiratory distress requiring inthubation. Brentuximab vedotin for paediatric relapsed or refractory Hodgkin's lymphoma and anaplastic large-cell lymphoma: a multicentre, open-label, phase 1/2 study. PDF Grading Lab Toxicities using NCI- Common Terminology Criteria for 0000010614 00000 n Istradefylline 40 mg/day increased peak levels and AUC of CYP3A4 substrates in clinical trials. . Adjust dosage of CYP3A4 substrates, if clinically indicated. Intracranial hemorrhage with or without associated edema is not considered a NT feature and is excluded from ICANS grading. (A) Classification of NT by CTCAE, mCRES, and ASTCT grading systems (N = 111). 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. Use Caution/Monitor. commonly, these are "non-preferred" brand drugs or specialty doi: 10.1016/S2352-3026(21)00170-8. Disclaimer. Use Caution/Monitor. Coadministration of efgartigimod with medications that bind to the human neonatal Fc receptor may lower systemic exposures and effectiveness of such medications. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine. This potential conflict of interest has been reviewed and managed by Oregon Health & Science University. Use Caution/Monitor. Event was observed at least once in a patient with CRS per Penn grade. siponimod and brentuximab vedotin both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Use Caution/Monitor. doi: 10.1002/phar.1170. This effect was not observed with istradefylline 20 mg/day. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. If not feasible, avoid use of abametapir. Monitor Closely (1)nicardipine increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. 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. Use Caution/Monitor. 113 0 obj <> endobj 0000003265 00000 n %%EOF Monitor patients for adverse reactions. -, Uzel I., Ozguroglu M., Uzel B., et al. Use Caution/Monitor. We conclude that CTCAE v4.03 was not designed for, and is suboptimal for, grading CAR-T cell therapy-associated NT. Brentuximab may harm an unborn baby. Use Caution/Monitor. - 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: Drugs. Use Caution/Monitor. Stiripentol is a CYP3A4 inhibitor and inducer. Coadministration may increase risk for adverse effects of CYP3A4 substrates. CYP3A4 substrates may require dosage adjustment.stiripentol will increase the level or effect of brentuximab vedotin by P-glycoprotein (MDR1) efflux transporter. Before Monitor Closely (1)ofatumumab SC, brentuximab vedotin. Either increases toxicity of the other by immunosuppressive effects; risk of infection. SIDE EFFECTS: See also Warning and How to Use sections.Nausea, vomiting, diarrhea, dizziness, headache, or unusual tiredness may occur. Abstract 254, Kite announces two-year data for Yescarta, Juno Therapeutics reports clinical hold on the JCAR015 phase II ROCKET trial [press release]. 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. For 2 weeks after abametapir application, avoid taking drugs that are CYP3A4 substrates. 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. 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. . 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.
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