Use Caution/Monitor. . Typically, CTCAE grading is directly collected from the site on the adverse experience case report form. See this image and copyright information in PMC. For 2 weeks after abametapir application, avoid taking drugs that are CYP3A4 substrates. rifabutin decreases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Serious - Use Alternative (1)palifermin increases toxicity of brentuximab vedotin by Other (see comment). Moskowitz AJ, Schder H, Yahalom J, McCall SJ, Fox SY, Gerecitano J, Grewal R, Hamlin PA, Horwitz S, Kobos R, Kumar A, Matasar M, Noy A, Palomba ML, Perales MA, Portlock CS, Sauter C, Shukla N, Steinherz P, Straus D, Trippett T, Younes A, Zelenetz A, Moskowitz CH. Tell your doctor right away if you have symptoms such as: low back/side pain (flank pain), signs of kidney problems (such as painful urination, pink/bloody urine, change in the amount of urine), muscle spasms/weakness.A very serious allergic reaction to this drug is rare. Consider reducing the dosage of P-gp substrates, where minimal concentration changes may lead to serious or life-threatening toxicities. Disclaimer. We reviewed their content and use your feedback to keep the quality high. Monitor patients for adverse reactions. -, Uzel I., Ozguroglu M., Uzel B., et al. tucatinib will increase the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Vital signs were checked every 15 minutes during the infusion reaction and remained stable throughout. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine. Use Caution/Monitor. saquinavir increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. K^gs 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. Monitor Closely (1)fedratinib will increase the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Patients with primary mediastinal B-cell lymphoma were not eligible for enrollment. Any adverse event occurred was recorded and classified for type and grade using NCI-CTCAE criteria (v 4.0). Tremors and myoclonus associated with immune effector cell therapies may be graded according to CTCAE v5.0, but they do not influence ICANS grading. Expert Rev Hematol. Monitor Closely (1)trastuzumab, brentuximab vedotin. Monitor CYP3A4 substrates coadministered with stiripentol for increased or decreased effects. according to the NCI toxicity grading scale , this reaction is grade a. This site needs JavaScript to work properly. Use Caution/Monitor. Please enable it to take advantage of the complete set of features! Contraindicated because of increased risk of pulmonary toxicity. Avoid coadministration with sensitive CYP3A substrates. The .gov means its official. Use Caution/Monitor. palifermin increases toxicity of brentuximab vedotin by Other (see comment). atazanavir increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. (A) Frequency of CRS event grades by the Penn, Lee, and ASTCT grading scales (N = 111). The CRES and ASTCT scales, which measure immune effector cell-associated neurotoxicity syndrome, offer more accurate assessments of NT after CAR-T cell therapy. FOIA Avoid coadministration of sensitive CYP3A4 substrates with ivosidenib or replace with alternate therapies. Brentuximab Vedotin Infusion Reaction Management: A Case Study PMC mifepristone will increase the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Either increases toxicity of the other by immunosuppressive effects; risk of infection. 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. Novartis Pharmaceuticals Corporation Web site. For example, if an event could not be reconciled by the 4 experts and was graded as 2, 3, 3, and 4, then grade 4 was the final grading. enzalutamide will decrease the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. C- Treatment Strategies to Optimize Outcomes With Brentuximab Vedotin stiripentol, brentuximab vedotin. 1199 0 obj <>stream Use Caution/Monitor. 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. In contrast, as originally graded in the trial and included in the FDA label, NT by CTCAE includes numerous nervous system or psychiatric events not indicative of neurotoxic effects of CAR-T cell therapies (eg, anxiety, late-onset dizziness, headache with onset up to 2 months after CAR-T cell infusion, peripheral neuropathy, and sleep disorder). Always ask your health care professional for complete information about this product and your specific health needs. Guidance for Industry - Food and Drug Administration Controlled studies in pregnant women show no evidence of fetal risk. R.T.M. Use Caution/Monitor. Individual patient-level NT data from the phase 2, single-group, global, pivotal JULIET trial (NCT02445248) were retrospectively and independently graded, using CTCAE, ASTCT, and mCRES, by 4 medical experts with experience managing patients with 3 different CD19-targeted CAR constructs. %%EOF Use Caution/Monitor. The Lancet. Either increases toxicity of the other by immunosuppressive effects; risk of infection. 0000001503 00000 n 0000001684 00000 n The brentuximab vedotin infusion was again held, and 100 mg of IV methylprednisolone was administered. Individual plans may vary %PDF-1.6 % Monitor Closely (1)nefazodone increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Monitor Closely (1)sarecycline will increase the level or effect of brentuximab vedotin by P-glycoprotein (MDR1) efflux transporter. provided study materials or patients; V.V.R. Use Caution/Monitor. . JULIET (NCT02445248) was the first global, phase 2, single-group, pivotal trial of centrally manufactured tisagenlecleucel for adult patients with r/r DLBCL and r/r transformed follicular lymphoma. 0000004401 00000 n |n9>S[JRpN}O%N^W`kV7b]v:!E"}e"7-3h8B5Sp?ZA %ET89" baH& Use Caution/Monitor. Use Caution/Monitor. . mitotane decreases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Unable to load your collection due to an error, Unable to load your delegates due to an error. 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. It works by slowing or stopping the growth of cancer cells. If unavoidable, reduce CYP3A substrate dose according to product labeling. F.L.L. primidone will decrease the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Coadministration of palifermin within 24 hr of chemotherapy resulted in increased severity and duration of oral mucositis. commonly, these are "preferred" (on formulary) brand drugs. Brentuximab vedotin desensitization in a patient with refractory Hodgkin's lymphoma. Newland A. M., Li J. X., Wasco L. E., Aziz M. T., Lowe D. K. Brentuximab vedotin: a CD30-Directed antibody-cytotoxic drug conjugate. CYP3A4 substrates may require dosage adjustment. Consider increasing CYP3A substrate dose if needed. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC. abametapir will increase the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Bethesda, MD 20894, Web Policies Stiripentol is a CYP3A4 inhibitor and inducer. PDF Lab CTCAE - the Perl Way - PharmaSUG Use Caution/Monitor. CTCAE Files - National Institutes of Health nelfinavir increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. National Cancer Institute Brentuximab vedotin is given with cyclophosphamide, doxorubicin hydrochloride, and prednisone in adults. National Library of Medicine IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. Most doi: 10.1016/s0140-6736(15)60165-9. Monitor patients for adverse reactions. Use Caution/Monitor. %PDF-1.4 . Monitor patients for adverse reactions. Use Caution/Monitor. Novartis is committed to sharing with qualified external researchers access to patient-level data and supporting clinical documents from eligible studies. If a rare but severe allergic reaction occurs, the infusion will be stopped and you should never receive brentuximab again. Avoid or Use Alternate Drug. Epub 2002 Apr 12. 2013 Dec;14(13):1348-56. doi: 10.1016/S1470-2045(13)70501-1. . This effect was not observed with istradefylline 20 mg/day. . Use Caution/Monitor. Monitor Closely (1)fosamprenavir increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Absent Adverse Event: 1 . 113 19 Avoid or Use Alternate Drug. Monitor Closely (1)brentuximab vedotin and isavuconazonium sulfate both decrease immunosuppressive effects; risk of infection. 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. Monitor Closely (1)voriconazole increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. tipranavir increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Find Clinical Trials for Brentuximab Vedotin - Check for trials from NCI's list of cancer clinical trials now accepting patients. S.J.S. Coadministration of apalutamide, a strong CYP3A4 inducer, with drugs that are CYP3A4 substrates can result in lower exposure to these medications. . Use Caution/Monitor. The information may not cover all possible uses, actions, interactions, or side effects of this drug, or precautions to be taken while using it. prescription products. Cancers | Free Full-Text | Brentuximab-Induced Peripheral Neurotoxicity Federal government websites often end in .gov or .mil. Avoid concomitant use of tucatinib with CYP3A substrates, where minimal concentration changes may lead to serious or life-threatening toxicities. Avoid or Use Alternate Drug. 0000000016 00000 n Monitor patients for adverse reactions. ! Epub 2013 Nov 15. Please confirm that you would like to log out of Medscape. Istradefylline 40 mg/day increased peak levels and AUC of CYP3A4 substrates in clinical trials. Avoid or Use Alternate Drug. For 39 regraded patients with CRS, 22 (56.4%) were graded the same across all 3 scales. You should not become pregnant while using brentuximab. Tell your doctor right away if you have symptoms of high blood sugar, such as increased thirst/urination. This drug is available at a middle level co-pay. Epub 2013 Nov 15. Consult your doctor for more details. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. Monitor Closely (1)lenacapavir will increase the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. brentuximab vedotin decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. 0000001368 00000 n You are being redirected to and transmitted securely. View the formulary and any restrictions for each plan. and a collection of links to more information about the use of affecting hepatic/intestinal enzyme CYP3A4 metabolism. . Most Contact the applicable plan Because of the possible risk to a nursing infant, breast-feeding while using this drug is not recommended. Thirty minutes later, however, Ms. R developed tingling and numbness in her feet and tongue. Modify Therapy/Monitor Closely. larotrectinib will increase the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Median follow-up from time of infusion was 14 months; 93 patients had at least 3 months of follow-up and made up the efficacy analysis set. Serious - Use Alternative (1)tepotinib will increase the level or effect of brentuximab vedotin by P-glycoprotein (MDR1) efflux transporter. Clipboard, Search History, and several other advanced features are temporarily unavailable. x=nIHVcLmlY(H IyYQUV,-Sbq_sz?nnc/g|qZNv^x\^m5xfzmIpuEDqQXAeaVW/_D~$}r$DtbGp/zda%MilTQiglpq Information last revised March 2023. Talk to your doctor if you are using marijuana (cannabis).Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Older adults may be more sensitive to the side effects of this drug.Tell your doctor if you are pregnant or plan to become pregnant. Monitor Closely (1)carbamazepine decreases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. 5 0 obj Monitor patients for adverse reactions. lopinavir increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. received honoraria, membership on the board of directors or advisory committees, and research funding from Novartis; consultancy and honoraria from CRSPR Therapeutics, Incyte, and Juno Therapeutics; honoraria from Kite Therapeutics; patents and royalties from Athersys, Inc.; and is employed by Oregon Health & Science University. 113 0 obj <> endobj Brentuximab vedotin desensitization in a patient with refractory Hodgkin's lymphoma. This patient information sheet applies only to approved uses of the drug. Men and women using this medication should ask about reliable forms of birth control during treatment and for 6 months after the last dose. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. Patients treated with selinexor may experience neurological toxicities. unspecified interaction mechanism. . Bookshelf xZcj!"a]R76 l .]Y 4hf)ceA$Oq5SiG $Ulq9g'"7rED_quXlqq4x -. endstream European journal of haematology. Use Caution/Monitor. Use Caution/Monitor. . Monitor sensitive CYP3A4 substrates for effectiveness if coadministered. Monitor Closely (1)rifabutin decreases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. voxelotor will increase the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Depressed level of consciousness should be attributable to no other cause (eD180X X gD181X X, no sedating medication). Monitor Closely (1)atazanavir increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Compare formulary status to other drugs in the same class. Clipboard, Search History, and several other advanced features are temporarily unavailable. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. Definition from the NCI Drug Dictionary - Detailed scientific definition and other names for this drug. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Consider increasing CYP3A substrate dose if needed. Components and Organization CATEGORY A CATEGORY is a broad classification of AEs based on anatomy and/or pathophysiology. Editorial assistance was provided by Marie Louise Edwards, Lei Yin, and Yichen Lu from Analysis Group, Inc., and was supported by Novartis Pharmaceuticals Corporation. to8Tc#Y9AR~ ;YAv,qiHJ0Nu"d` HHS Vulnerability Disclosure, Help Cytokine release syndrome and neurotoxicity by baseline tumor burden in adults with relapsed or refractory diffuse large B-cell lymphoma treated with tisagenlecleucel [abstract], Analyses of cytokine release syndrome and neurotoxicity by age and lymphodepleting chemotherapy use in adults with relapsed or refractory diffuse large B-cell lymphoma treated with tisagenlecleucel. Your doctor should order a pregnancy test before you start this medication. More patients with CRS (per the Penn scale) had NT during the study than those without CRS (NT by ASTCT criteria: 15/64 [23.4%] vs 4/47 [8.5%], 2 test: P = .039). . Avoid or Use Alternate Drug. Epub 2015 Mar 19. Tecovirimat is a weak CYP3A4 inducer. Use Caution/Monitor.elagolix will decrease the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Brentuximab vedotin combined with ABVD or AVD for patients with newly diagnosed Hodgkin's lymphoma: a phase 1, open-label, dose-escalation study. Monitor patients for adverse reactions. istradefylline will increase the level or effect of brentuximab vedotin by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Monitor patients for adverse reactions. Nivolumab is an antibody that enhances the immune system to better fight Hodgkin lymphoma cells. Modify Therapy/Monitor Closely. BV-induced peripheral neurotoxicity (BVIN) is one of the greatest concerns for haematologists treating HL for several reasons. is a scientific advisor to Kite/Gilead, Novartis, Celgene/BMS, GammaDelta Therapeutics, and Wugen; and an allogene consultant with grant options for Cellular Biomedicine Group, Inc. phenobarbital decreases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Pharmacotherapy: The Journal of Human Pharmacology and Drug Therapy. Prevention and Treatment of Side Effects of Immunotherapy for Bladder Cancer. Monitor Closely (1)levoketoconazole increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Monitor Closely (1)mifepristone will increase 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. . Four medical experts with experience treating patients with different CAR-T cell therapy products independently reviewed patient-level data from the JULIET trial, using the broadly defined NT criteria (ie, any nervous system or psychiatric disorders) in the FDA label, and they regraded NT for each patient based on the case report forms. Use Caution/Monitor. lFsA Get medical help right away if you develop any signs of PML, including changes in mood, unusual behavior, confusion, difficulty concentrating, changes in vision/speech/walking, decreased strength or weakness on one side of the body. Intraveous granisetron was given for nausea. 0000004470 00000 n Monitor for toxicities of P-gp substrates that may require dosage reduction when coadministered with P-gp inhibitors. . NOTES: Lab and/or medical tests (such as complete blood counts, kidney/liver function, blood sugar) should be done while you are using this medication. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. 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. Use Caution/Monitor. Either increases effects of the other by immunosuppressive effects; risk of infection. Contraindicated. Contribution: R.T.M., S.J.S., D.G.M., and F.L.L. 1 b. 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. Use Caution/Monitor. <>/ProcSet [/PDF /Text /ImageB /ImageC /ImageI]>>/Rotate 180/MediaBox[0 0 612 792]>> 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. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. endobj A toxicity grading scale is provided for each AE term, it varies from 1 (mild) to 5 (death). The .gov means its official. Serious - Use Alternative (1)ivosidenib will decrease 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. is employed by Novartis. MEDICAL ALERT: Your condition can cause complications in a medical emergency. Consider reducing the dose of P-glycoprotein (P-gp) substrates, if adverse reactions are experienced when administered concomitantly with stiripentol. Self-care ADL refers to bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not being bedridden. Use Caution/Monitor. PMC doi: https://doi.org/10.1182/bloodadvances.2019001305. hiM!JE%Y}>0G2dh&b5"?f` 1M\'`('PD,)*+Z{-784qZS5'fh [o=]^'W1 2L_:o0aHIX :#HoZl&]{j%jO The brentuximab vedotin was restarted 30 minutes after symptom resolution at a decreased infusion rate to be administered over 60 minutes. 8600 Rockville Pike Monitor patients for adverse reactions. All material on this website is protected by copyright, Copyright 1994-2023 by WebMD LLC. Monitor Closely (1)mitotane decreases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. This product may contain inactive ingredients, which can cause allergic reactions or other problems. acetazolamide will increase the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Santa Monica, CA: Kite Pharma, Inc; 2019, Kymriah [package insert]. After reconstitution (see section 6.6), each mL contains 5 mg of brentuximab vedotin. 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.
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