nyuuzyou/wikis huggingface dataset:
Ibandronate (Boniva)

==General information==
Class/mechanism: Bisphosphonate, inhibits osteoclast activity, dissolution of hydroxyapatite crystals, and bone resorption/turnover.Ibandronate (Boniva) package insert Ibandronate (Boniva) package insert (locally hosted backup)Ibandronate injection (Boniva injection) package insert Ibandronate injection (Boniva injection) package insert (locally hosted backup)Boniva manufacturer's website
Route: PO, IV
Extravasation: no information
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias or the prescribing information. 
==Patient drug information==
*Patient counseling information can be found on page 17-21 of the Ibandronate (Boniva) package insert
*Patient counseling information can be found on page 18-21 of the Ibandronate injection (Boniva injection) package insert
*Ibandronate (Boniva) patient drug information (UpToDate)Ibandronate (Boniva) patient drug information (UpToDate)
==Also known as==
*Generic names: ibandronate sodium, ibandronic acid
*Brand names: Bandrobon, Bandrone, Bondenza, Bondronat, Boniva, Bonviva, Femorel
==References==
Category:Drugs
Category:Intravenous medications
Category:Oral medications
Category:Bisphosphonates
Category:FDA approved in 2003
Icotinib (Conmana)

==General information==
Class/mechanism from the NCI Drug Dictionary: An orally available quinazoline-based inhibitor of epidermal growth factor receptor (EGFR), with potential antineoplastic activity. Icotinib selectively inhibits the wild-type and several mutated forms of EGFR tyrosine kinase.
Route: PO
Extravasation: n/a
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias or the prescribing information. 
==Diseases for which it is used==
*EGFR-mutant NSCLC and multiple brain metastases
*Non-small cell lung cancer
==History of changes in NMPA indication==
*2011-06-07: Initial approval for non-small cell lung cancer. (Based on ICOGEN)
*2021-06: Approved for the postoperative adjuvant treatment of early-stage lung cancer with EGFR mutation. (Based on EVIDENCE)
==Also known as==
*Code name: BPI-2009H
*Brand name: Conmana
==References==
Category:Drugs
Category:Oral medications
Category:EGFR inhibitors
Category:Non-small cell lung cancer medications
Category:NMPA approved in 2011
Idarubicin (Idamycin)

==General information==
Class/mechanism: Anthracycline analog of Daunorubicin (Cerubidine), binds and intercalates between DNA base pairs. Inhibits topoisomerase II activity by stabilizing the DNA-topoisomerase II complex, resulting in single and double strand DNA breaks. May also inhibit polymerase activity and trigger free radical damage to DNA. In comparison to other anthracyclines, idarubicin lacks a methoxy group at position 4 of the anthracycline structure, which results in it having high lipophilicity and an increased rate of cellular uptake compared with other anthracyclines.Idarubicin (Idamycin) package insertIdarubicin Preservative-Free Solution (Idamycin PFS) package insertIdarubicin (Idamycin) package insert (locally hosted backup)Idarubicin Preservative-Free Solution (Idamycin PFS) (locally hosted backup)
Route: IV
Extravasation: vesicant
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias or the prescribing information. 
==Diseases for which it is used==
*Acute lymphocytic leukemia
*Acute myeloid leukemia
*Acute promyelocytic leukemia
==Patient drug information==
*Idarubicin (Idamycin) package insert
*Idarubicin (Idamycin) patient drug information (Chemocare)Idarubicin (Idamycin) patient drug information (Chemocare)
*Idarubicin (Idamycin) patient drug information (UpToDate)Idarubicin (Idamycin) patient drug information (UpToDate)
==History of changes in FDA indication==
* 1990-09-27: Initial FDA approval in combination with other approved antileukemic drugs for the treatment of acute myeloid leukemia (AML) in adults. (Based on L-19 Protocol, Mandelli et al. 1991, Vogler et al. 1992, Wiernik et al. 1992)
* 2014-12-04 (most recent label available on Drugs @ FDA): "in combination with other approved antileukemic drugs is indicated for the treatment of acute myeloid leukemia (AML) in adults. This includes French-American- British (FAB) classifications M1 through M7."
==History of changes in EMA indication==
*1989-11-29: EURD
==Also known as==
*Generic names: idarubicin comp, idarubicin hydrochloride
*Brand names: Idamycin, Idaru, Ondarubin, Zavedos, Zavedose
==References==
Category:Drugs
Category:Intravenous medications
Category:Vesicant
Category:Anthracyclines
Category:Topoisomerase II inhibitors
Category:B-cell acute lymphoblastic leukemia medications
Category:Acute myeloid leukemia medications
Category:Acute promyelocytic leukemia medications
Category:FDA approved in 1990
Category:EMA approved in 1989
Idarucizumab (Praxbind)

==General information==
Class/mechanism: Monoclonal antibody fragment (Fab) that binds to Dabigatran (Pradaxa) and its metabolites with higher affinity than dabigatran binds to thrombin, which neutralizes the anticoagulant effect of dabigatran.Idarucizumab (Praxbind) package insert Idarucizumab (Praxbind) package insert (locally hosted backup)Praxbind manufacturer's website
Route: IV
Extravasation: no information
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias or the prescribing information.
==Diseases for which it is used==
*Bleeding with anticoagulation
==Patient drug information==
*Idarucizumab (Praxbind) package insert
==History of changes in FDA indication==
*2015-10-16: Approved in patients treated with Pradaxa when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery/urgent procedures or in life-threatening or uncontrolled bleeding. 
==History of changes in PMDA indication==
*2016-09-28: New approval for the reversal of anticoagulant effect of dabigatran under the following situations: life-threatening or uncontrolled bleeding; and when performing emergency surgery or procedures in which serious bleeding is expected.
==Also known as==
*Code name: BI-655075
*Brand name: Praxbind
==References==
Category:Drugs
Category:Intravenous medications
Category:Anti-dabigatran antibody fragments
Category:Hematology medications
Category:Hemostasis medications
Category:FDA approved in 2015
Category:PMDA approved in 2016
Idecabtagene vicleucel (Abecma)

==Mechanism of action==
From the NCI Drug Dictionary: A preparation of autologous peripheral blood T lymphocytes (PBTLs) that have been genetically modified to express a chimeric antigen receptor (CAR) specific for the B-cell maturation antigen (BCMA), with potential immunostimulating and antineoplastic activities. Upon administration, idecabtagene vicleucel specifically recognizes and kills BCMA-expressing tumor cells.
==Toxicity management==
*Link to REMS program
==Diseases for which it is used==
*Multiple myeloma
==History of changes in FDA indication==
*2021-03-26: Approved for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. (Based on KarMMa)
==History of changes in EMA indication==
*2021-08-25: Initial conditional authorization for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti CD38 antibody and have demonstrated disease progression on the last therapy. (Based on KarMMa)
==History of changes in Health Canada indication==
*2021-05-26: Initial notice of compliance with conditions for the treatment of adult patients with multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and who are refractory to their last treatment.
==History of changes in PMDA indication==
*2022-01-20: Initial approval
==Patient Drug Information==
*idecabtagene vicleucel (Abecma) Package Insertidecabtagene vicleucel (Abecma) Package Insert
==Also known as==
*Code name: bb2121
*Generic name: ide-cel
*Brand name: Abecma
==References==
Category:Anti-BCMA CAR T-cells
Category:Anti-BCMA cellular therapy
Category:Intravenous medications
Category:Multiple myeloma medications
Category:REMS program
Category:EMA approved in 2021
Category:FDA approved in 2021
Category:Health Canada approved in 2021
Category:PMDA approved in 2022
Imetelstat (Rytelo)

==Mechanism of action==
From NCI Drug Dictionary: The sodium salt of imetelstat, a synthetic lipid-conjugated, 13-mer oligonucleotide N3' P5'-thio-phosphoramidate with potential antineoplastic activity. Complementary to the template region of telomerase RNA (hTR), imetelstat acts as a competitive enzyme inhibitor that binds and blocks the active site of the enzyme (a "telomerase template antagonist"), a mechanism of action which differs from that for the antisense oligonucleotide-mediated inhibition of telomerase activity through telomerase mRNA binding. Inhibition of telomerase activity in tumor cells by imetelstat results in telomere shortening, which leads to cell cycle arrest or apoptosis. Link to company website
==Diseases for which it is established==
*Myelodysplastic syndrome
==Diseases for which it is used==
*Essential thrombocythemia
*Myelofibrosis
==History of changes in FDA indication==
*2024-06-06: Approved for adults with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia requiring four or more red blood cell units over 8 weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESAs). (Based on IMerge)
==Also known as==
*Code name: GRN-163L
*Brand name: Rytelo
Category:Drugs
Category:Intravenous medications
Category:Telomerase inhibitors
Category:Essential thrombocythemia medications
Category:Myelodysplastic syndrome medications
Category:Myelofibrosis medications
Category:FDA approved in 2024
Immune effector cells toxicity management

Page co-editor	Page co-editor 	Page co-editor	Page co-editor
 	Leyre Zubiri, MD, PhDMassachusetts General HospitalBoston, MA	 	Matthew Hadfield, DOLifespan/Brown UniversityProvidence, RILinkedIn
The purpose of this page is to address the management of toxicity from bispecific T-cell engager and immune effector cell (IEC) therapy, notably CAR-T. There is a separate page for the management of immune checkpoint inhibitor (ICI) toxicities, available here.
*We have moved How I Treat articles to a dedicated page.
=Guidelines=
Given the rapid change in evidence in many areas of hematology/oncology, readers are encouraged to consider any guideline published 5+ years ago to be for historical purposes, only.
==ASCO==
*2021: Santomasso et al. Management of Immune-Related Adverse Events in Patients Treated With Chimeric Antigen Receptor T-Cell Therapy: ASCO Guideline EuroPMC
==ASTCT==
*2019: Lee et al. ASTCT Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells EuroPMC
==Consensus recommendations==
*2024: Crombie et al. Consensus recommendations on the management of toxicity associated with CD3xCD20 bispecific antibody therapy EuroPMC
==EBMT/JACIE/EHA==
*2023: Rejeski et al. Immune effector cell-associated hematotoxicity: EHA/EBMT consensus grading and best practice recommendations EuroPMC
*2022: Hayden et al. Management of adults and children receiving CAR T-cell therapy: 2021 best practice recommendations of the European Society for Blood and Marrow Transplantation (EBMT) and the Joint Accreditation Committee of ISCT and EBMT (JACIE) and the European Haematology Association (EHA) EuroPMC
==SITC==
*2020: Maus et al. Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immune effector cell-related adverse events EuroPMC
=REMS programs for CAR T-cells=
*Axicabtagene ciloleucel (Yescarta)
*Brexucabtagene autoleucel (Tecartus)
*Ciltacabtagene autoleucel (Carvykti)
*Idecabtagene vicleucel (Abecma)
*Lisocabtagene maraleucel (Breyanzi)
*Tisagenlecleucel (Kymriah)
Category:Immunotherapy regimens
Category:Supportive oncology
Inavolisib (Itovebi)

==Mechanism of action==
From NCI Drug Dictionary: An orally available inhibitor of phosphatidylinositol 3-kinase (PI3K), with potential antineoplastic activity. Inavolisib binds to and inhibits various members of the PI3K family, including activating mutations in the catalytic alpha isoform PIK3CA. PI3K inhibition prevents the activation of the PI3K-mediated signaling pathway and results in the inhibition of growth and survival of PI3K-overexpressing tumor cells.
==Diseases for which it is used==
*PIK3CA-mutated breast cancer
==History of changes in FDA indication==
*2024-10-10: Approved with palbociclib and fulvestrant for adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth-factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy. (Based on INAVO120)
==Also known as==
*Code names: GDC-0077, RG-6114, RO-7113755
*Brand name: Itovebi
==References==
Category:Drugs
Category:Oral medications
Category:Protein expression-specific medications
Category:Mutation-specific medications
Category:PI3K alpha inhibitors
Category:Breast cancer medications
Category:FDA approved in 2024
Indomethacin (Indocin)

NSAID
==Also known as==
*Brand names: Ductaclose, Elmetacin, Indocid, Indocin, Indocrom, Indoga, Inmecin, Tivorbex, Welldom
Category:Drugs
Category:Oral medications
Category:Rectal medications
Category:Intravenous medications
Category:Topical medications
Category:COX-1 inhibitors
Category:COX-2 inhibitors
Category:Antipyretics
Category:FDA approved in 1965
Infigratinib (Truseltiq)

==Mechanism of action==
From the NCI Drug Dictionary: An orally bioavailable pan inhibitor of human fibroblast growth factor receptors (FGFRs) with potential antiangiogenic and antineoplastic activities. Infigratinib selectively binds to and inhibits the activities of FGFRs, which may result in the inhibition of tumor angiogenesis and tumor cell proliferation, and the induction of tumor cell death.
==Diseases for which it is used==
*Cholangiocarcinoma
==History of changes in FDA indication==
*2021-05-28: Accelerated approval for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. (Based on CBGJ398X2204)
==History of changes in Health Canada indication==
*2021-09-27: Initial notice of compliance with conditions for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 fusion or other rearrangement.
==Also known as==
*Code name: BGJ-398
*Brand name: Truseltiq
Category:Drugs
Category:Oral medications
Category:Mutation-specific medications
Category:FGFR inhibitors
Category:Cholangiocarcinoma medications
Category:FDA approved in 2021
Category:Health Canada approved in 2021
Inflammatory myofibroblastic tumor

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Note: this is a rare cancer, see this page for more information. These are regimens tested in subtype-specific populations, please see the main soft tissue sarcoma page for other regimens.
Last updated on 2024-07-23:1 regimens on this page
1 variants on this page
=Guidelines=
Given the rapid change in evidence in many areas of hematology/oncology, readers are encouraged to consider any guideline published 5+ years ago to be for historical purposes, only.
==NCCN==
*NCCN does not currently have guidelines at this granular level; please see NCCN Guidelines - Soft Tissue Sarcoma.
=All lines of therapy=
==Crizotinib monotherapy==
===Regimen===
Study 	Dates of enrollment	Evidence
Gambacorti-Passerini et al. 2018 (PROFILE 1013)	2011-03 to 2013-10 	Phase 1b, fewer than 20 pts in this subgroup (RT)
====Biomarker eligibility criteria====
*ALK+
====Targeted therapy====
*Crizotinib (Xalkori) 250 mg PO twice per day on days 1 to 21
21-day cycles
===References===
#PROFILE 1013: Gambacorti-Passerini C, Orlov S, Zhang L, Braiteh F, Huang H, Esaki T, Horibe K, Ahn JS, Beck JT, Edenfield WJ, Shi Y, Taylor M, Tamura K, Van Tine BA, Wu SJ, Paolini J, Selaru P, Kim TM. Long-term effects of crizotinib in ALK-positive tumors (excluding NSCLC): A phase 1b open-label study. Am J Hematol. 2018 May;93(5):607-614. Epub 2018 Feb 8. link to original article link to PMC article dosing details in manuscript have been reviewed by our editors EuroPMC NCT01121588
Category:Inflammatory myofibroblastic tumor regimens
Category:Disease-specific pages
Category:Soft tissue sarcomas
Inherited coagulopathy - null regimens

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The purpose of this page is to provide references to "null therapy" such as placebo and observation. These references provide further insight into the historical development of the treatment landscape. See the main inherited coagulopathy page for regimens that include active treatment.
=Factor VIII deficiency (Hemophilia A), without inhibitors, all lines of therapy=
==Observation==
===Regimen===
Study 	Dates of enrollment 	Evidence 	Comparator	Comparative Efficacy
Mahlangu et al. 2018 (HAVEN 3)	2016-09 to not reported	Phase 3 (C)	Emicizumab	Higher bleeding rate (primary endpoint)
No active treatment.
===References===
# HAVEN 3: Mahlangu J, Oldenburg J, Paz-Priel I, Negrier C, Niggli M, Mancuso ME, Schmitt C, Jiménez-Yuste V, Kempton C, Dhalluin C, Callaghan MU, Bujan W, Shima M, Adamkewicz JI, Asikanius E, Levy GG, Kruse-Jarres R. Emicizumab prophylaxis in patients who have hemophilia A without inhibitors. N Engl J Med. 2018 Aug 30;379(9):811-822. link to original article EuroPMC NCT02847637
=Factor VIII deficiency (Hemophilia A), with inhibitors, all lines of therapy=
==Observation==
===Regimen===
Study 	Dates of enrollment 	Evidence 	Comparator	Comparative Efficacy
Oldenburg et al. 2017 (HAVEN 1)	2015-11-17 to not reported	Phase 3 (C)	Emicizumab	Higher bleeding rate (primary endpoint)
No active treatment.
===References===
# HAVEN 1: Oldenburg J, Mahlangu JN, Kim B, Schmitt C, Callaghan MU, Young G, Santagostino E, Kruse-Jarres R, Negrier C, Kessler C, Valente N, Asikanius E, Levy GG, Windyga J, Shima M. Emicizumab prophylaxis in hemophilia A with inhibitors. N Engl J Med. 2017 Aug 31;377(9):809-818. Epub 2017 Jul 10. link to original article EuroPMC
Category:Inherited coagulopathy regimens
Category:Disease-specific pages
Category:Null regimens
Inotuzumab ozogamicin (Besponsa)

==General information==
Class/mechanism: Antibody targeting CD22, conjugated with a cytotoxic, antitumor antibiotic (calicheamicin). Inotuzumab demonstrates a dose-dependent cytotoxicity both in vitro and in vivo. Inotuzumab ozogamicin (Besponsa) package insert Inotuzumab ozogamicin (Besponsa) package insert (locally hosted backup)Besponsa manufacturer's websiteNCT01363297 ClinicalTrials.Gov website]
Route: IV
Extravasation: No information
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias or the prescribing information.
==Diseases for which it is established==
*B-cell acute lymphoblastic leukemia (FDA)
**B-cell acute lymphoblastic leukemia, pediatric (FDA)
==Diseases for which it is used==
*Indolent lymphoma
==Diseases for which it was used==
*Diffuse large B-cell lymphoma
==Patient drug information==
*Inotuzumab ozogamicin (Besponsa) package insert
*Inotuzumab ozogamicin (Besponsa) patient drug information (Chemocare)Inotuzumab ozogamicin (Besponsa) patient drug information (Chemocare)
==History of changes in FDA indication==
*2017-08-17: Approved for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). (Based on INO-VATE ALL)
*2024-03-06: Approved for pediatric patients 1 year and older with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL).
==History of changes in EMA indication==
*2017-06-28: Initial authorization
==History of changes in Health Canada indication==
*2018-03-15: Initial notice of compliance as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL). 
==History of changes in PMDA indication==
*2018-01-19: New approval for the treatment of relapsed or refractory CD22-positive acute lymphoblastic leukemia.
==Also known as==
*Code name: CMC-544
*Brand name: Besponsa
==References==
Category:Drugs
Category:Intravenous medications
Category:Protein expression-specific medications
Category:Anti-CD22 antibody-drug conjugates
Category:Enediyne antibiotic
Category:B-cell acute lymphoblastic leukemia medications
Category:Indolent lymphoma medications
Category:Diffuse large B-cell lymphoma medications (historic)
Category:EMA approved in 2017
Category:FDA approved in 2017
Category:Health Canada approved in 2018
Category:PMDA approved in 2018
Category:Pfizer product