Avoid or Use Alternate Drug. saquinavir increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. . tecovirimat will decrease the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. 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. Mitotane is a strong inducer of cytochrome P-4503A4; monitor when coadministered with CYP3A4 substrates for possible dosage adjustments. Patients treated with selinexor may experience neurological toxicities. Brentuximab vedotin combined with ABVD or AVD for patients with newly diagnosed Hodgkin's lymphoma: a phase 1, open-label, dose-escalation study. Diphenhydramine (50 mg) was administered intravenously (IV), along with 20 mg of IV famotidine. Antibody-drug conjugatesa new wave of cancer drugs. Federal government websites often end in .gov or .mil. brentuximab vedotin decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. 2013;33(1):93104. Therefore, an mCRES scale was used for this analysis, wherein grades 1 and 2 (distinguished by the CARTOX-10 score) were combined. Modify Therapy/Monitor Closely. Monitor Closely (1)trastuzumab, brentuximab vedotin. 1186 0 obj <> endobj When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects. -, DeVita Michael D, Evens Andrew M, Rosen Steven T, Greenberger Paul A, Petrich Adam M. Multiple successful desensitizations to brentuximab vedotin: a case report and literature review. Use Caution/Monitor. If not feasible, avoid use of abametapir. hiM!JE%Y}>0G2dh&b5"?f` 1M\'`('PD,)*+Z{-784qZS5'fh [o=]^'W1 2L_:o0aHIX :#HoZl&]{j%jO Upon the emergence of these symptoms, the brentuximab vedotin infusion was held. provider for the most current information. 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. Use Caution/Monitor. Guidance for Industry - Food and Drug Administration The infusion was discontinued with 40 mg of drug remaining, due to the prolonged infusion time. Modify Therapy/Monitor Closely. trailer Would you like email updates of new search results? Ms. R is a 30-year-old woman who presented with stage IV Hodgkin lymphoma at the age of 29. Indicated for primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30 expressing mycosis fungoides (MF) who have received prior systemic therapy, 1.8 mg/kg IV q3Weeks; not to exceed 180 mg/dose, Continue until a maximum of 16 cycles, disease progression, or unacceptable toxicity, Indicated in previously untreated CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone (CHP), 1.8 mg/kg IV q3Weeks for 6-8 doses; not to exceed 180 mg/dose, Patients weighing >100 kg should be calculated based on a weight of 100 kg, Indicated in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide (AVEPC), for previously untreated high risk classical Hodgkin lymphoma (cHL) in pediatric patients aged 2 years, Day 1: Brentuximab 1.8 mg/mg (not to exceed 180 mg/dose) IV with each cycle of chemotherapy for up to 5 doses, Calculate patients weighing >100 kg based on a weight of 100 kg. 2021 Aug;8(8):e562-e571. Only NT with at least temporal association with CAR-T cell therapy was considered for regrading. CYP3A4 substrates may require dosage adjustment. Avoid or Use Alternate Drug. Epub 2015 May 12. Your list will be saved and can be edited at any time. 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. CTCAE stands for Common Terminology Criteria for Adverse Events; these criteria are also called "common toxicity criteria." In CTCAE, an adverse event (AE) is defined as any abnormal clinical finding temporally associated with the use of a therapy for cancer; causality is not required. High-Dose Bendamustine Plus Brentuximab Combination Is Effective and affecting hepatic/intestinal enzyme CYP3A4 metabolism. 2005;66(1):p. 195. doi: 10.1016/j.urology.2005.01.038. Use Caution/Monitor. Monitor patients for adverse reactions. This suggests that the CTCAE scale would pose difficulties in reliable clinician training outcomes as well as consistent global institutional implementation. Consider increasing CYP3A substrate dose if needed. Avoid or Use Alternate Drug. darunavir increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Monitor Closely (1)voriconazole increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. 0000005575 00000 n berotralstat will increase the level or effect of brentuximab vedotin by P-glycoprotein (MDR1) efflux transporter. efavirenz will decrease the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Comment: Palifermin should not be administered within 24 hr before, during infusion of, or within 24 hr after administration of antineoplastic agents. CRS was also regraded according to the Lee and ASTCT scales (S.J.S., R.T.M., E.S.R., J.L., J.E.S., V.V.R., F.L.L., D.G.M., manuscript in preparation). Monitor Closely (1)atazanavir increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. 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. We conclude that the CTCAE system is suboptimal for the grading of CAR-T cell therapy-associated NT, as it captures a high number of nonattributable and nonspecific nervous system and psychiatric events. Monitor Closely (1)mifepristone will increase the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada). Brentuximab vedotin (BV) is an anti-CD30 antibody-drug conjugate approved to treat classical Hodgkin lymphoma (HL). Use Caution/Monitor. . Owing to potential additive immunosuppressive effects, consider duration of effect and mechanism of action of these therapies if coadministered. Only 2 of the 31 patients who had NT per CTCAE, but grade 0 NT by mCRES and ASTCT, had received corticosteroids (Table 4). . The most current release files are in order of appearance: CTCAE_5.0; CTCAE v5.0 in the NCI Thesaurus .xlsx format; CTCAE v5.0 in the NCI Thesaurus .xls format; CTCAE v5.0 in the original CTEP .xlsx format . According to the NCI's. primidone will decrease the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Monitor Closely (1)phenobarbital decreases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. 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 brentuximab vedotin and isavuconazonium sulfate both decrease immunosuppressive effects; risk of infection. Avoid coadministration with sensitive CYP3A4 substrates with a narrow therapeutic index. Lancet. enzalutamide will decrease the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. belzutifan will decrease the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. phenobarbital decreases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.It is unknown if this medication passes into breast milk. All material on this website is protected by copyright, Copyright 1994-2023 by WebMD LLC. . Contraindicated (1)brentuximab vedotin and bleomycin both increase Other (see comment). . Use Caution/Monitor. Epub 2016 Apr 17. and a collection of links to more information about the use of Use Caution/Monitor. fexinidazole will increase the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. 0000000016 00000 n Monitor patients for adverse reactions. Use Caution/Monitor. Prevention and Treatment of Side Effects of Immunotherapy for Bladder Cancer. 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. Either increases toxicity of the other by immunosuppressive effects; risk of infection. MedlinePlus Information on Brentuximab Vedotin - A lay language summary of important information about this drug that may include the following: Drugs are often studied to find out if they can help treat or prevent conditions other than the ones they are approved for. Use Caution/Monitor. Modify Therapy/Monitor Closely. is employed by Novartis. Adding plans allows you to compare formulary status to other drugs in the same class. Adjust dosage of CYP3A4 substrates, if clinically indicated. Younes A, Connors JM, Park SI, Fanale M, O'Meara MM, Hunder NN, Huebner D, Ansell SM. Keep all medical and lab appointments. Avoid or Use Alternate Drug. Urology. Use Caution/Monitor. Minor (1)cyclophosphamide will increase the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Serious - Use Alternative (1)lonafarnib will increase the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. 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 site is secure. Poster presented at the 22nd Congress of the European Hematology Association. Nivolumab is an antibody that enhances the immune system to better fight Hodgkin lymphoma cells. Q4|o<9RIG"q\b1JEK["O|{Qt2{GgW5HRN~qk+#G$+ Iyao"s7]pUBj" Monitor Closely (1)cenobamate will decrease the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. The ASTCT grading scale for ICANS is similarly domain-based and uses a modified version of the CARTOX-10 screening tool, called the Immune Effector Cell-Associated Encephalopathy (ICE) score. Brentuximab vedotin combined with ABVD or AVD for patients with newly diagnosed Hodgkin's lymphoma: a phase 1, open-label, dose-escalation study. Monitor Closely (1)cobicistat will increase the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown. In this version, toxicity grading was based on absolute ranges relative to the upper and lower limits of normal. government site. 2017 Mar;77(4):435-445. doi: 10.1007/s40265-017-0705-5. cobicistat will increase the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. This drug is available at a higher level co-pay. stiripentol, brentuximab vedotin. affecting hepatic/intestinal enzyme CYP3A4 metabolism. A patient receiving an initial brentuximab infusion experiences severe respiratory distress requiring inthubation. This is the first study to retrospectively apply CTCAE, mCRES, and ASTCT criteria to the same patient data set. . If not feasible, avoid use of abametapir. Avoid taking selinexor with other medications that may cause dizziness or confusion. Patients with PET-positive then receive brentuximab vedotin IV over 30 minutes and nivolumab IV over 30 minutes on day 1. 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. 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. official website and that any information you provide is encrypted to8Tc#Y9AR~ ;YAv,qiHJ0Nu"d` Monitor Closely (1)ceritinib 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& Monitor patients for adverse reactions. fosphenytoin decreases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Monitor Closely (1)eslicarbazepine acetate will decrease the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor (1)acetazolamide will increase the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. nK Encorafenib both inhibits and induces CYP3A4 at clinically relevant plasma concentrations. NCI CTCAE v5.0 hematologic toxicity Neutropenia, thrombocytopenia, anemia, and lymphocytopenia are determined from the complete blood count. 2018 Oct;5(10):e450-e461. 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. 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. . Use Caution/Monitor. . Assessed using Balis scale; Grade 2. 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). F.L.L. 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. PDF Implementing Laboratory Toxicity Grading for CTCAE Version 5 Monitor patients for adverse reactions. . Epub 2002 Apr 12. To view formulary information first create a list of plans. Solved A patient receiving an initial brentuximab infusion - Chegg Other key exclusion criteria included prior anti-CD19 therapy, prior allogeneic hematopoietic stem cell transplant, and active central nervous system disease involvement. endobj PMC stiripentol will increase the level or effect of brentuximab vedotin by P-glycoprotein (MDR1) efflux transporter. 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). Consider increasing CYP3A substrate dose if needed. Avoid or Use Alternate Drug. J.L. After leukapheresis, manufacturing of tisagenlecleucel was carried out at centralized facilities in Morris Plains, New Jersey, and in Leipzig, Germany. a patient receiveing an initial brentuximab infusion experiences severe respiratory distress requiring intubation. V.V.R. Information last revised March 2023. 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). Dose-dense brentuximab vedotin plus ifosfamide, carboplatin, and etoposide for second-line treatment of relapsed or refractory classical Hodgkin lymphoma: a single centre, phase 1/2 study. PDF Get to the Bottom of Lab Toxicity Grading: Challenges and Ms. R's symptoms resolved within 40 minutes, and the brentuximab vedotin infusion was able to be continued over a prolonged period of more than 4 hours. Lancet (London, England) 2015;385:18531862. is employed by the Analysis Group, which received funding from Novartis. As of December 2017, 111 patients were infused with tisagenlecleucel in the JULIET trial. % and transmitted securely. 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. Coadministration of apalutamide, a strong CYP3A4 inducer, with drugs that are CYP3A4 substrates can result in lower exposure to these medications. Monitor Closely (1)enzalutamide will decrease the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Brentuximab Vedotin - NCI - National Cancer Institute 0000001178 00000 n 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 Grading and management of cytokine release syndrome in patients treated Modify Therapy/Monitor Closely. Coadministration may increase risk for adverse effects of CYP3A4 substrates. PDF ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS - European Medicines Agency Avoid or Use Alternate Drug. The recipient will receive more details and instructions to access this offer. Istradefylline 40 mg/day increased peak levels and AUC of CYP3A4 substrates in clinical trials. Reduce dose of vincristine {monograph link} based in prescribing information; Continue brentuximab dose; . 0000001820 00000 n Would you like email updates of new search results? ADL, activities of daily living; CSF, cerebrospinal fluid; EEG, electroencephalogram; ICP, intracranial pressure. Unauthorized use of these marks is strictly prohibited. phenytoin decreases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. . 0000001503 00000 n 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 Closely (1)fedratinib 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. Monitor Closely (1)ritonavir increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. <>>>/Rotate 180/MediaBox[0 0 612 792]>> Medical experts were able to achieve agreement regarding NT grading using all 3 grading systems applied to data extracted from the JULIET trial after discussions. Monitor patients for adverse reactions. Presented at 15th International Conference on Malignant Lymphoma; 18-22 June 2019; Lugano, Switzerland. endobj eCollection 2022. Monitor patients for adverse reactions. 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. !2$0f 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). istradefylline will increase the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. anastrozole will increase the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. For example, encephalopathy and delirium are the principal points of focus, or cognitive domains, of the more clinically sensitive mCRES and ASTCT systems. % After reconstitution (see section 6.6), each mL contains 5 mg of brentuximab vedotin. . Epub 2015 Mar 19. Use Caution/Monitor. Monitor Closely (1)tecovirimat will decrease the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Results: We selected 32 dermatological toxicities, including 12 created by our group, sorted into 7 categories: skin rash, dry skin/pruritus, hyperkeratotic papules, palmoplantar . Avoid or Use Alternate Drug. Monitor or titrate P-gp substrate dose if coadministered. Use Caution/Monitor. Encorafenib both inhibits and induces CYP3A4 at clinically relevant plasma concentrations. Monitor Closely (1)rifampin decreases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. lFsA Monitor Closely (1)sarecycline will increase the level or effect of brentuximab vedotin by P-glycoprotein (MDR1) efflux transporter. If unavoidable, reduce CYP3A substrate dose according to product labeling. Monitor patients for adverse reactions. Brentuximab may harm an unborn baby. affecting hepatic/intestinal enzyme CYP3A4 metabolism. A patient with an ICE score of 0 may be classified as grade 3 ICANS if awake with global aphasia, but a patient with an ICE score of 0 may be classified grade 4 ICANS if unarousable. Use Caution/Monitor. Mitotane is a strong inducer of cytochrome P-4503A4; monitor when coadministered with CYP3A4 substrates for possible dosage adjustments. Monitor Closely (1)ublituximab and brentuximab vedotin both increase immunosuppressive effects; risk of infection. USES: Brentuximab is used to treat certain types of cancers (Hodgkin's lymphoma, systemic anaplastic large cell lymphoma, peripheral T-cell lymphoma, primary cutaneous anaplastic large cell lymphoma, CD30-expressing mycosis fungoides). A toxicity grading scale is provided for each AE term, it varies from 1 (mild) to 5 (death). . Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. . (a) Computed tomography (CT) of the chest showing patchy, nodular ground glass opacities along a bronchovascular distribution throughout both lungs. Use Caution/Monitor. Event was observed at least once in a patient with CRS per Penn grade. xZcj!"a]R76 l .]Y 4hf)ceA$Oq5SiG $Ulq9g'"7rED_quXlqq4x is employed by Novartis. BV-induced peripheral neurotoxicity (BVIN) is one of the greatest concerns for haematologists treating HL for several reasons. Modify Therapy/Monitor Closely. Monitor Closely (1)darunavir increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. 0000001593 00000 n hbbd``b`"\35`= Monitor Closely (1)saquinavir increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Serious - Use Alternative (1)fexinidazole will increase the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. isoniazid increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. MISSED DOSE: It is important to get each dose of this medication as scheduled. . Avoid or Use Alternate Drug. Monitor patients for adverse reactions. PMC Men and women using this medication should ask about reliable forms of birth control during treatment and for 6 months after the last dose. Vital signs were checked every 15 minutes during the infusion reaction and remained stable throughout. 1199 0 obj <>stream cyclophosphamide will increase the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Modify Therapy/Monitor Closely. Consult your doctor for more details. Adjust dosage of CYP3A4 substrates, if clinically indicated. Results of a pivotal phase II study of brentuximab vedotin for patients with relapsed or refractory Hodgkin's lymphoma. Closely monitor for reduced effectiveness of medications that bind to the human neonatal Fc receptor. 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. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC. Bookshelf Delayed onset bleomycin-induced pneumonitis. . Either increases effects of the other by immunosuppressive effects; risk of infection.

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