Federal Register/Vol. 83, No. 31/Wednesday, February 14, 2018
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Prescribing Information: Gazyvaro® (Obinutuzumab)
Prescribing information: Gazyvaro®▼ (obinutuzumab) PRESCRIBING INFORMATION Gazyvaro maintenance as a single agent, 1000 mg 70 mL/min are more at risk of IRRs, including severe Gazyvaro® (obinutuzumab) 1000 mg once every 2 months for 2 years or until disease IRRs. Do not administer further infusions if patient concentrate for solution for infusion progression (whichever occurs first). Administration: experiences acute life-threatening respiratory Refer to Gazyvaro Summary of Product Monitor closely for infusion related reactions (IRRs). symptoms, a Grade 4 (life threatening) IRR or, a Characteristics (SmPC) for full prescribing CLL: Cycle 1: Day 1(100 mg): Administer at 25 mg/hr second occurrence of a Grade 3 (prolonged/recurrent) information. over 4 hours. Do not increase the infusion rate. Day 2 IRR (after resuming the first infusion or during a (or Day 1 continued) (900 mg): If no IRR occurred subsequent infusion). Carefully monitor patients who Indications: Previously-untreated chronic lymphocytic during prior infusion administer at 50 mg/hr. Infusion have pre-existing cardiac or pulmonary conditions leukaemia (CLL), in combination with chlorambucil, in rate can be escalated in 50 mg/hr increments every 30 throughout the infusion and post-infusion period. For patients with co-morbidities making them unsuitable for minutes to 400 mg/hr. – All subsequent infusions: If no patients at acute risk of hypertensive crisis evaluate full-dose fludarabine-based therapy. Follicular IRR occurred during prior infusion when final rate was the benefit and risks of withholding anti-hypertensive lymphoma (FL), in combination with bendamustine 100 mg/hr or faster, start at 100 mg/hr and increase by medicine. -
Assessment of Overall Survival, Quality of Life, And
Supplementary Online Content Salas-Vega S, Iliopoulos O, Mossialos E. Assesment of overall survival, quality of life, and safety benefits associated with new cancer medicines [published online December 29, 2016]. JAMA Oncol. doi:10.1001/jamaoncol.2016.4166 eTable 1. Therapeutic profile of all cancer medicines approved by the FDA between 2003- 2013 eTable 2. Regulatory evidence in support of classification of drug clinical benefits eFigure 1. Number of cancer drugs that were evaluated by all three HTA agencies, sorted by magnitude of clinical benefits eTable 3. Interagency agreement–Krippendorff’s alpha coefficients eMethods This supplementary material has been provided by the authors to give readers additional information about their work. Online-Only Supplement © 2016 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 09/25/2021 Clinical value of cancer medicines Contents eExhibits ......................................................................................................................................................... 3 eTable 1. Therapeutic profile of all cancer medicines approved by the FDA between 2003- 2013 (Summary of eTable 2) ................................................................................................................... 3 eTable 2. Regulatory evidence in support of classification of drug clinical benefits ....................... 6 eFigure 1. Number of cancer drugs that were evaluated by all three HTA agencies, sorted by magnitude of clinical benefits -
Advances in the Treatment of Hematologic Malignancies a Review of Newly Approved Drugs
Advances in the Treatment of Hematologic Malignancies A Review of Newly Approved Drugs Katherine Shah, PharmD, BCOP Clinical Pharmacy Specialist, Hematology/Oncology Emory University Hospital / Winship Cancer Institute Disclosures • I do not (nor does any immediate family member have) a vested interest in or affiliation with any corporate organization offering financial support or grant monies for this continuing education activity or any affiliation with an organization whose philosophy could potentially bias my presentation • There was no financial support obtained for this CPE activity 1 Objectives • Discuss the pharmacologic principles of several new agents approved for use in hematologic malignancies – Drug class – Mechanism of action – Clinical trial highlights • Review approved dosing and recommend appropriate clinical monitoring and management of toxicities of new agents covered – Dosing recommendations for new agents – Side effect profile – Clinical management Approvals 1980‐2014 http://innovation.org/images/dmImage/SourceImage/lg_FDA_Approval.jpg 2 2014 Novel Drug Approvals Nature Reviews Drug Discovery 14, 77–81(2015) doi:10.1038/nrd4545 Select 2014 Novel Oncology Drugs Drug Indication Approval Date Siltuximab (Sylvant) Multicentric Castleman’s April 2014 Disease Belinostat (Beleodaq) Peripheral T‐cell Lymphoma July 2014 Idelalisib (Zydelig) CLL, Follicular NHL, SLL July 2014 Netupitant and Nausea/vomiting October 2014 palonosetron (Akynzeo) Blinatumomab Acute Lymphoblastic December 2014 (Blincyto) Leukemia, Ph‐ Ph-= Philadelphia -
Common Derm Conditions and Treatments
4/10/17 Classes of Dermatologic Medications What is that?! Common Dermatologic Conditions and ● Topical Immune Suppressants ● Immune Suppressants How to Treat Them ● Vitamin D Derivatives ● Antibiotics, Antivirals, Antiparasitic Matthew Fox, MD ● Retinoids ● Antimalarials Assistant Professor, Division of Dermatology ● Biologic Agents Dell Medical School, University of Texas at Austin Director of Dermatologic Surgery, Seton Healthcare Family ● Chemotherapeutic agents Learning Objectives Approach to Dermatologic Conditions • Know the clinical subtypes of acne *Know the mechanism and recommended dosing of topical retinoids, oral antibiotics and oral retinoids in the management of acne Acne • Understand the clinical presentation cutaneous dermatophyte infection Infectious diseases of the Skin *Know the classes and recommended dosing of antifungal treatments • Recognize the clinical manifestations of dermatitis Eczema *Know the relative potencies, side effects and indications of topical steroids Psoriasis • Describe the classic clinical findings for psoriasis *Know the mechanism of action and side effects of systemic antipsoriatic medications Sun Damage / Actinic Keratoses • Know the pertinent history and physical exam findings associated with a diagnosis of skin cancer, including the ABCDEs of melanoma Fundamentals Words to the wise… • All medications have side effects If you advise the patients of side effects ahead of time, you are informing the • Always consider drug interactions, patient. including with food and supplements If you did not tell the patient about a known • Always consider pregnancy and lactation side effect until after they experience status that side effect, it is an excuse 1 4/10/17 Reference: Approach to Dermatologic Conditions • Wolverton SE, ed. Acne Comprehensive Infectious diseases of the Skin Dermatologic Drug Eczema nd Therapy, 2 Ed. -
SYLVANT (Siltuximab) for Injection, for Intravenous Infusion Institute Prompt Anti-Infective Therapy and Do Not Administer Initial U.S
------------------------WARNINGS AND PRECAUTIONS----------------------- HIGHLIGHTS OF PRESCRIBING INFORMATION • Concurrent Active Severe Infections These highlights do not include all the information needed to use o Do not administer SYLVANT to patients with severe infections SYLVANT™ safely and effectively. See full prescribing information for until the infection resolves. (2) SYLVANT. o Monitor patients receiving SYLVANT closely for infections. SYLVANT (siltuximab) for Injection, for Intravenous infusion Institute prompt anti-infective therapy and do not administer Initial U.S. Approval: [yyyy] SYLVANT until the infection resolves. (2) ----------------------------INDICATIONS AND USAGE---------------------------- • Vaccinations: Do not administer live vaccines because IL-6 inhibition SYLVANT is an interleukin-6 (IL-6) antagonist indicated for the treatment of may interfere with the normal immune response to new antigens. (5.2) patients with multicentric Castleman’s disease (MCD) who are human • Infusion Related Reactions: Administer SYLVANT in a setting that immunodeficiency virus (HIV) negative and human herpesvirus-8 (HHV-8) provides resuscitation equipment, medication, and personnel trained to negative. (1) provide resuscitation. (6.1) • Gastrointestinal (GI) perforation: Use with caution in patients who may Limitation of Use be at increased risk. Promptly evaluate patients presenting with SYLVANT was not studied in patients with MCD who are HIV positive or symptoms that may be associated or suggestive of GI perforation. (5.4) HHV-8 positive because SYLVANT did not bind to virally produced IL-6 in a nonclinical study. ------------------------------ADVERSE REACTIONS------------------------------- The most common adverse reactions (>10% compared to placebo) during -----------------------DOSAGE AND ADMINISTRATION----------------------- treatment with SYLVANT in the MCD clinical trial were pruritus, increased For intravenous infusion only. weight, rash, hyperuricemia, and upper respiratory tract infection. -
Therapeutic Class Overview Antifungals, Topical
Therapeutic Class Overview Antifungals, Topical INTRODUCTION The topical antifungals are available in multiple dosage forms and are indicated for a number of fungal infections and related conditions. In general, these agents are Food and Drug Administration (FDA)-approved for the treatment of cutaneous candidiasis, onychomycosis, seborrheic dermatitis, tinea corporis, tinea cruris, tinea pedis, and tinea versicolor (Clinical Pharmacology 2018). The antifungals may be further classified into the following categories based upon their chemical structures: allylamines (naftifine, terbinafine [only available over the counter (OTC)]), azoles (clotrimazole, econazole, efinaconazole, ketoconazole, luliconazole, miconazole, oxiconazole, sertaconazole, sulconazole), benzylamines (butenafine), hydroxypyridones (ciclopirox), oxaborole (tavaborole), polyenes (nystatin), thiocarbamates (tolnaftate [no FDA-approved formulations]), and miscellaneous (undecylenic acid [no FDA-approved formulations]) (Micromedex 2018). The topical antifungals are available as single entity and/or combination products. Two combination products, nystatin/triamcinolone and Lotrisone (clotrimazole/betamethasone), contain an antifungal and a corticosteroid preparation. The corticosteroid helps to decrease inflammation and indirectly hasten healing time. The other combination product, Vusion (miconazole/zinc oxide/white petrolatum), contains an antifungal and zinc oxide. Zinc oxide acts as a skin protectant and mild astringent with weak antiseptic properties and helps to -
Whither Radioimmunotherapy: to Be Or Not to Be? Damian J
Published OnlineFirst April 20, 2017; DOI: 10.1158/0008-5472.CAN-16-2523 Cancer Perspective Research Whither Radioimmunotherapy: To Be or Not To Be? Damian J. Green1,2 and Oliver W. Press1,2,3 Abstract Therapy of cancer with radiolabeled monoclonal antibodies employing multistep "pretargeting" methods, particularly those has produced impressive results in preclinical experiments and in utilizing bispecific antibodies, have greatly enhanced the thera- clinical trials conducted in radiosensitive malignancies, particu- peutic efficacy of radioimmunotherapy and diminished its toxi- larly B-cell lymphomas. Two "first-generation," directly radiola- cities. The dramatically improved therapeutic index of bispecific beled anti-CD20 antibodies, 131iodine-tositumomab and 90yttri- antibody pretargeting appears to be sufficiently compelling to um-ibritumomab tiuxetan, were FDA-approved more than a justify human clinical trials and reinvigorate enthusiasm for decade ago but have been little utilized because of a variety of radioimmunotherapy in the treatment of malignancies, particu- medical, financial, and logistic obstacles. Newer technologies larly lymphomas. Cancer Res; 77(9); 1–6. Ó2017 AACR. "To be, or not to be, that is the question: Whether 'tis nobler in the pembrolizumab (anti-PD-1), which are not directly cytotoxic mind to suffer the slings and arrows of outrageous fortune, or to take for cancer cells but "release the brakes" on the immune system, arms against a sea of troubles, And by opposing end them." Hamlet. allowing cytotoxic T cells to be more effective at recognizing –William Shakespeare. and killing cancer cells. Outstanding results have already been demonstrated with checkpoint inhibiting antibodies even in far Introduction advanced refractory solid tumors including melanoma, lung cancer, Hodgkin lymphoma and are under study for a multi- Impact of monoclonal antibodies on the field of clinical tude of other malignancies (4–6). -
SYLVANT® (Siltuximab): a Targeted Therapy That's PREFERRED for The
SYLVANT® (siltuximab): A Targeted Therapy That’s PREFERRED for the Treatment of iMCD NCCN CDCN Guidelines®1 Treatment Guidelines2 To access the clinical To access the treatment guidelines, scan the QR guidelines, scan the QR code or visit: code or visit: http://promail.nicelines.com/ https://ashpublications. v5fmsnet/OeCart/OEFrame. org/blood/article- asp?Action=NEWORDER&cme lookup/doi/10.1182/ nunodseq=&FromFav=&PmSe blood-2018-07-862334 ss1=3512&pos=NCCN01&v=9 The only FDA-approved therapy for the treatment of patients with MCD who are negative for HIV and HHV-8.3 Limitations of use: SYLVANT® was not studied in patients with MCD who are HIV positive or HHV-8 positive because SYLVANT did not bind to virally produced IL-6 in a nonclinical study.3 Please see Important Safety Information on back and accompanying Full Prescribing Information. Abbreviations: CDCN, Castleman Disease Collaborative Network; FDA, US Food and Drug Administration; HHV-8, human herpesvirus 8; HIV, human immunodeficiency virus; IL-6, interleukin-6; iMCD, idiopathic multicentric Castleman disease; MCD, multicentric Castleman disease; NCCN, National Comprehensive Cancer Network. NCCN Guidelines® Updates in Version 1.2020 of the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for B-Cell Lymphomas include new recommendations for the management of patients with iMCD.1 Primary Treatment Relapsed Disease HIV-1(-) PREFERRED MCD d HHV-8(-) Response If siltuximab, (criteria for Siltuximab (for Treat with alternate (idiopathic MCD)b continue until active disease -
Monitoring Multiple Myeloma Patients Treated with Daratumumab: Teasing out Monoclonal Antibody Interference
Clin Chem Lab Med 2016; 54(6): 1095–1104 Open Access Christopher McCuddena, Amy E. Axela, Dominique Slaets, Thomas Dejoie, Pamela L. Clemens, Sandy Frans, Jaime Bald, Torben Plesner, Joannes F.M. Jacobs, Niels W.C.J. van de Donk, Philippe Moreau, Jordan M. Schecter, Tahamtan Ahmadi and A. Kate Sasser* Monitoring multiple myeloma patients treated with daratumumab: teasing out monoclonal antibody interference DOI 10.1515/cclm-2015-1031 developed using a mouse anti-daratumumab antibody. To Received October 21, 2015; accepted February 10, 2016; previously evaluate whether anti-daratumumab bound to and shifted published online March 30, 2016 the migration pattern of daratumumab, it was spiked into Abstract daratumumab-containing serum and resolved by IFE/SPE. The presence (DIRA positive) or absence (DIRA negative) Background: Monoclonal antibodies are promising anti- of residual M-protein in daratumumab-treated patient myeloma treatments. As immunoglobulins, monoclonal samples was evaluated using predetermined assessment antibodies have the potential to be identified by serum criteria. DIRA was evaluated for specificity, limit of sensi- protein electrophoresis (SPE) and immunofixation elec- tivity, and reproducibility. trophoresis (IFE). Therapeutic antibody interference with Results: In all of the tested samples, DIRA distinguished standard clinical SPE and IFE can confound the use of between daratumumab and residual M-protein in com- these tests for response assessment in clinical trials and mercial serum samples spiked with daratumumab and disease monitoring. in daratumumab-treated patient samples. The DIRA Methods: To discriminate between endogenous myeloma limit of sensitivity was 0.2 g/L daratumumab, using protein and daratumumab, a daratumumab-specific spiking experiments. Results from DIRA were repro- immunofixation electrophoresis reflex assay (DIRA) was ducible over multiple days, operators, and assays. -
Ehealth DSI [Ehdsi V2.2.2-OR] Ehealth DSI – Master Value Set
MTC eHealth DSI [eHDSI v2.2.2-OR] eHealth DSI – Master Value Set Catalogue Responsible : eHDSI Solution Provider PublishDate : Wed Nov 08 16:16:10 CET 2017 © eHealth DSI eHDSI Solution Provider v2.2.2-OR Wed Nov 08 16:16:10 CET 2017 Page 1 of 490 MTC Table of Contents epSOSActiveIngredient 4 epSOSAdministrativeGender 148 epSOSAdverseEventType 149 epSOSAllergenNoDrugs 150 epSOSBloodGroup 155 epSOSBloodPressure 156 epSOSCodeNoMedication 157 epSOSCodeProb 158 epSOSConfidentiality 159 epSOSCountry 160 epSOSDisplayLabel 167 epSOSDocumentCode 170 epSOSDoseForm 171 epSOSHealthcareProfessionalRoles 184 epSOSIllnessesandDisorders 186 epSOSLanguage 448 epSOSMedicalDevices 458 epSOSNullFavor 461 epSOSPackage 462 © eHealth DSI eHDSI Solution Provider v2.2.2-OR Wed Nov 08 16:16:10 CET 2017 Page 2 of 490 MTC epSOSPersonalRelationship 464 epSOSPregnancyInformation 466 epSOSProcedures 467 epSOSReactionAllergy 470 epSOSResolutionOutcome 472 epSOSRoleClass 473 epSOSRouteofAdministration 474 epSOSSections 477 epSOSSeverity 478 epSOSSocialHistory 479 epSOSStatusCode 480 epSOSSubstitutionCode 481 epSOSTelecomAddress 482 epSOSTimingEvent 483 epSOSUnits 484 epSOSUnknownInformation 487 epSOSVaccine 488 © eHealth DSI eHDSI Solution Provider v2.2.2-OR Wed Nov 08 16:16:10 CET 2017 Page 3 of 490 MTC epSOSActiveIngredient epSOSActiveIngredient Value Set ID 1.3.6.1.4.1.12559.11.10.1.3.1.42.24 TRANSLATIONS Code System ID Code System Version Concept Code Description (FSN) 2.16.840.1.113883.6.73 2017-01 A ALIMENTARY TRACT AND METABOLISM 2.16.840.1.113883.6.73 2017-01 -
Gazyva (Obinutuzumab)
Gazyva (obinutuzumab) (Intravenous) Document Number: IC-0184 Last Review Date: 06/03/2019 Date of Origin: 01/02/2014 Dates Reviewed: 8/2014, 3/2015, 5/2015, 8/2015, 11/2015, 2/2016, 3/2016, 5/2016, 8/2016, 11/2016, 2/2017, 5/2017, 8/2017, 11/2017, 2/2018, 5/2018, 9/2018, 12/2018, 03/2019, 06/2019 I. Length of Authorization Chronic lymphocytic leukemia/Small Lymphocytic Lymphoma (CLL/SLL): Coverage is provided for six months (6 cycles) and may NOT be renewed. All other indications: Coverage is provided for six months and may be renewed up to a max of two years therapy. II. Dosing Limits A. Quantity Limit (max daily dose) [Pharmacy Benefit]: Gazyva 1000 mg/40 mL vial: 1 vial every 28 days (3 vials the initial 28-day cycle only) B. Max Units (per dose and over time) [Medical Benefit]: Chronic lymphocytic leukemia/Small Lymphocytic Lymphoma (CLL/SLL): Loading Dose: 10 billable units day 1, 90 billable units day 2, 100 billable units days 8, 15 of Cycle 1 (28 days) Maintenance Dose: 100 billable units every 28 days All other indications: Loading Dose: 100 billable units days 1, 8, 15 of Cycle 1 (28 days) Maintenance Dose: 100 billable units every 21 days for 8 cycles; then every 2 months for 2 years III. Initial Approval Criteria Patient aged 18 years or older; AND Patient does not have an active infection; AND Patient has not received a live vaccine in the preceding 28 days; AND Patient does not have positive hepatitis B or hepatitis C serology; AND Proprietary & Confidential © 2019 Magellan Health, Inc. -
Medical Drug Benefit Clinical Criteria Updates
UniCare Health Plan of West Virginia, Inc. Medicaid Managed Care Provider Bulletin April 2020 Medical drug benefit Clinical Criteria updates On November 15, 2019, and February 21, 2020, the Pharmacy and Therapeutics (P&T) Committee approved the following Clinical Criteria applicable to the medical drug benefit for UniCare Health Plan of West Virginia, Inc. These policies were developed, revised or reviewed to support clinical coding edits. Visit Clinical Criteria to search for specific policies. For questions or additional information, use this email. Please see the explanation/definition for each category of Clinical Criteria below: New: newly published criteria Revised: addition or removal of medical necessity requirements, new document number Annual Review: minor wording and formatting updates, new document number Updates marked with an asterisk (*): criteria may be perceived as more restrictive Please share this notice with other members of your practice and office staff. Please note: The clinical criteria listed below applies only to the medical drug benefits contained within the member’s medical policy. This does not apply to pharmacy services. Effective date Document number Clinical Criteria title New, revised, annual review 06/01/2020 ING-CC-0002* Colony Stimulating Factor Agents Revised 06/01/2020 ING-CC-0124 Keytruda (pembrolizumab) Revised 06/01/2020 ING-CC-0125* Opdivo (nivolumab) Revised 06/01/2020 ING-CC-0119* Yervoy (ipilimumab) Revised 06/01/2020 Abraxane (paclitaxel, protein ING-CC-0099* Revised bound) 06/01/2020