Brentuximab vedotin desensitization in a patient with refractory Hodgkin's lymphoma. Drugs. . startxref CRS grade and use of anticytokine therapy or corticosteroids were also obtained. Use Caution/Monitor. View the formulary and any restrictions for each plan. indinavir increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. 2 0 obj Monitor patients for adverse reactions. ivosidenib will decrease the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. First-line therapy for previously untreated Stage III or IV cHL in combination with doxorubicin, vinblastine, and dacarbazine (AVD), 1.2 mg/kg IV q2Weeks (in combination with AVD); not to exceed 120 mg/dose, Continue until a maximum of 12 doses, disease progression, or unacceptable toxicity, Indicated for cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation, Initiate within 46 weeks post-auto-HSCT or upon recovery from auto-HSCT, Indicated for cHL after failure of auto-HSCT or after failure of at least 2 prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates, Continue until disease progression or unacceptable toxicity, Indicated for treatment of previously-untreated sALCL, Indicated for treatment of systemic anaplastic large cell lymphoma (sALCL) after failure of at least 1 prior multiagent chemotherapy regimen, Mild or moderate (CrCl 30-80 mL/min): No dosage adjustment required, 1.2 mg/kg q2Weeks: 0.9 mg/kg q2Weeks; not to exceed 90 mg/dose, 1.8 mg/kg q3Weeks: 1.2 mg/kg q3Weeks; not to exceed 120 mg/dose, Moderate or severe (Child-Pugh B or C): Avoid use, New or worsening Grade 2 or 3: Hold dose until neuropathy improves to Grade 1 or baseline; restart at 1.2 mg/kg (not to exceed 120 mg/dose), Grade 2: Reduce dose to 0.9 mg/kg/dose q2Weeks; not to exceed 90 mg/dose, Grade 3: Hold dose until neuropathy improves to Grade 2; restart at 0.9 mg/kg q2Weeks (not to exceed 90 mg/dose); consider modifying dose of other neurotoxic chemotherapy, Grade 2 sensory neuropathy: No dosage adjustment required, Grade 2 motor neuropathy or Grade 3 sensory neuropathy: Reduce to 1.2 mg/kg q3Weeks (not to exceed 120 mg/dose), Grade 3 motor neuropathy or Grade 4 peripheral neuropathy: Discontinue brentuximab, Grade 3: Administer G-CSF prophylaxis for subsequent cycles for patients not receiving primary G-CSF prophylaxis, Grade 3 neutropenia: Hold dose until resolution to baseline or Grade 2 ; consider G-CSF prophylaxis for subsequent cycles, Recurrent Grade 4 (despite use of G-CSF prophylaxis): Consider discontinuing brentuximab or reduce to 1.2 mg/kg q3Weeks (not to exceed 120 mg/dose), Seattle Genetics, Inc; 21823 30th Drive Southeast, Bothell, WA 98021, Reduce dose of vincristine {monograph link} based in prescribing information, If neuropathy resolves to Grade 1 by day 8 of next cycle, then resume vincristine at full dose, First occurrence: Hold until resolves to Grade 2, then restart at 1.2 mg/kg (not to exceed 120 mg/dose) IV q3Weeks, Second occurrence: Hold until resolves to Grade 2, then restart at 0.8 mg/kg (not to exceed 80 mg/dose) IV q3Weeks, Third occurrence of Grade 3 peripheral neuropathy, Grade 3 or 4: Reduce to 1.2 mg/kg (not to exceed 120 mg/dose) q3Weeks if unable to start a cycle >5 weeks after start of previous cycle (>2-week delay), Mild-to-moderate (CrCl 30-80 mL/min): No dosage adjustment necessary, Mild (Child-Pugh A): Reduce dose to 1.2 mg/kg (not to exceed 120 mg/dose) IV q3Weeks, JC virus infection resulting in PML and death can occur; cases of progressive multifocal leukoencephalopathy (PML) reported, PML is a rare, but serious brain infection that can result in death, Signs and symptoms of PML may develop over several weeks or months and may include mood changes, unusual behavior, confusion, thinking problems, memory loss, changes in vision, speech, or walking, and a unilateral decrease in strength or weakness, Infusion-related reactions (eg, anaphylaxis), may occur, If anaphylaxis occurs, immediately and permanently discontinue treatment, If an infusion-related reaction occurs, interrupt infusion, After interrupting or discontinuing treatment, institute appropriate medical management, Premedicate patients who previously experienced infusion-related reactions for subsequent infusions, Premedication may include acetaminophen, an antihistamine, and a corticosteroid, Coadministration with ketoconazole, a potent CYP3A4 inhibitor, increased exposure to MMAE which may increase the risk of adverse reaction, Closely monitor adverse reactions when concomitantly used with strong CYP3A4 inhibitors, In animal reproduction studies, administration of brentuximab vedotin to pregnant rats during organogenesis at doses similar to the clinical dose (1.8 mg/kg q3weeks) caused embryo-fetal toxicities, including congenital malformation, Verify pregnancy status of females of reproductive potential prior to initiation, Advise females of reproductive potential to avoid pregnancy during treatment and for at least 6 months after final dose; immediately report pregnancy, May damage spermatozoa and testicular tissue, resulting in possible genetic abnormalities, Use effective contraception in males with female sexual partners of reproductive potential during treatment and for at least 6 months after final dose, Based on findings in rats, male fertility may be compromised by brentuximab, Reconstitute with 10.5 mL sterile water for injection to yield 5 mg/mL, Direct stream toward vial wall and not directly at cake or powder to prevent foaming, Do not shake vial; gently swirl vial to aid dissolution, Reconstituted solution should be clear to slightly opalescent, colorless, and free of visible particulates, Calculate dosage volume (mL) and withdraw dose from vial(s), Patients weighing >100 kg should be calculated for 100 kg, Dilute reconstituted solution in at least 100 mL of 0.9% NaCl, D5W, or LR (final concentration: 0.4-1.8 mg/mL), Contains no bacteriostatic preservatives, use immediately or refrigerate solution and use within 24 hr, Adults with previously untreated Stage III or IV cHL who are treated with brentuximab + AVD, Adults with previously untreated PTCL who are treated with brentuximab + CHP, Pediatric patients with previously untreated high risk cHL who are treated with brentuximab + AVEPC. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2018, Cytokine release syndrome with the novel treatments of acute lymphoblastic leukemia: pathophysiology, prevention, and treatment, Axicabtagene ciloleucel CAR T-cell therapy in refractory large B-cell lymphoma, Efficacy and safety of bispecific T-cell engager (BiTE) antibody blinatumomab for the treatment of relapsed/refractory acute lymphoblastic leukemia and non-Hodgkins lymphoma: a systemic review and meta-analysis, Correlative analyses of cytokine release syndrome and neurological events in tisagenlecleucel-treated relapsed/refractory diffuse large B-cell lymphoma patients. 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. PDF Common Terminology Criteria for Adverse Events (CTCAE) Monitor patients for adverse reactions. J.E.S. Recognizing that the CAR-T-associated NT represents a unique syndrome that would benefit from a unified scale, the multiinstitution CAR-T cell-therapy-associated Toxicity (CARTOX) Working Group introduced the term CAR-T cell-Related Encephalopathy Syndrome (CRES).23 The CARTOX group created a CRES grading system that included a 10-point questionnaire (CARTOX-10), designed to capture subtle to severe cognitive and attentive dysfunction. 2015;95:361364. Serious - Use Alternative (1)abametapir will increase the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. This page contains brief information about brentuximab vedotin Monitor Closely (1)fosamprenavir increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Monitor Closely (1)atazanavir increases levels of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism. If concomitant use unavoidable, reduce the P-gp substrate dosage if recommended in its approved product labeling. Monitor patients for adverse reactions. 113 0 obj <> endobj ceritinib will increase the level or effect of brentuximab vedotin by affecting hepatic/intestinal enzyme CYP3A4 metabolism.
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