Kymriah Package Insert

SPECIALTY GUIDELINE MANAGEMENT - Provider.carefirst.com
Kymriah SGM P2017a CVS Caremark is an independent company that provides pharmacy benefit management services to CareFirst BlueCross BlueShield and CareFirst BlueChoice, Inc. members. Kymriah [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; May 2018. ... Fetch Document

HIGHLIGHTS OF PRESCRIBING INFORMATION With A Fluoropyrimidine ...
3 FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE 1.1 Melanoma KEYTRUDA®(pembrolizumab) is indicated for the treatment of patients with unresectable or metastatic melanoma [see Clinical Studies (14.1)]. 1.2 Non-Small Cell Lung Cancer ... Retrieve Document

5.21.101 Kymriah (tisagenlecleucel) 3 16 18 EA
Kymriah [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corp.; August 2017. Policy History Date Action September 2017 Addition to PA December 2017 Annual editorial review Change in the age requirement from 2 through 25 to 25 yrs. of age and ... View Doc

An Overview Of Chimeric Antigen Receptor T-cells
KYMRIAH (tisagenlecleucel) •FDA Approval: treatment of patients up to 25 years of age with relapsed or refractory B-cell precursor acute lymphoblastic leukemia •Autologous CAR-T cell product targeting CD19 YESCARTA (axicabtagene ciloleucel suspension) [package insert]. KYMRIAH (tisagenlecleucel) [package insert]. ... Visit Document

Last Review Status/Date - Media.fepblue.org
Kymriah may also be used to treat adult relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Kymriah may cause cytokine release syndrome (CRS) and neurological toxicities. Kymriah should not be administered in patients with an active infection or any inflammatory disorders (1). References 1. Kymriah [package insert]. ... View Document

PHARMACY POLICY STATEMENT - Caresource.com
CareSource considers Kymriah (tisagenlecleucel) not medically necessary for the treatment of the diseases that are not listed in this document. DATE ACTION/DESCRIPTION 10/24/2017 New policy for Kymriah created. 12/21/2017 Member’s age requirement adjusted to 25 years of age or younger. References: 1. Kymriah [package insert]. ... View This Document

KYMRIAH™ (tisagenlecleucel - AZBlue
Kymriah Package Insert: -FDA-approved indication and dosage: Indication Recommended Dose For the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse ... Fetch Document

STATE OF WEST VIRGINIA DEPARTMENT OF HEALTH AND HUMAN ...
KYMRIAH is a CD19-directed modified autologous T-cell immunotherapy indicated for the treatment of: 1) Patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) ... Retrieve Content

Reference ID: 4132874
Differentiation Syndrome . In the clinical trial, 14% of patients treated with IDHIFA experienced differentiation syndrome, which may be life-threatening or fatal if not treated. ... Access Content

Engineering An Immunity To Cancer: A New Era Of Adoptive ...
A New Era of Adoptive Cellular Therapy with Tisagenlecleucel (Kymriah) in Pediatric ALL Diana Schreier, Pharm.D., M.B.A. Pharmacy Grand Rounds October 17, 2017 Kymriah® [package insert]. Novartis Pharmac euticals Corporation. New Hanover, NJ; 2017. ... Return Document

HIGHLIGHTS OF PRESCRIBING INFORMATION Total CAR- These ...
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use KYMRIAH safely and effectively. See full prescribing information for ... Access Full Source

New Drug Update - Ncop.memberlodge.org
Tisagenlecleucel (Kymriah®) Approved in August 2017 for treatment of patients up to age 25 with B cell acute lymphoblastic leukemia (ALL) that is refractory or in a second or later relapse In May 2018, second indication added for treatment of relapsed or refractory large B cell lymphoma after 2 or ... Read Content

Package Insert - YESCARTA
YESCARTA is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more ... Fetch Doc

Kymriah (tisagenlecleucel) - Moda Health
Kymriah [package insert]. East Hanover, NJ; Novartis Pharmaceuticals Corp., May 2018. Accessed May 2018. 2. Porter DL, Hwang WT, Frey NV, et al. Chimeric antigen receptor T cells persist and induce sustained remissions in relapsed refractory chronic lymphocytic leukemia. Sci Transl Med. ... Retrieve Content

UnitedHealthcare·
The efficacy of Kymriah for the treatment of relapsed or refractory B-cell ALL was demonstrated in a phase 2 open-label trial in 63 patients. Among the 63 patients who received Kymriah, 52 (83%) achieved remission with MRD as determined by an independent review committee. ... Fetch Full Source

PHARMACY POLICY STATEMENT - Caresource.com
New policy for Kymriah created. 05/01/2018 . Carve out information added—No longer paid for by CareSource. CareSource will review authorization requests and final decision on coverage and payment with be made by IN Medicaid. References: 1. Kymriah [package insert]. East Hanover, NJ; Novartis Pharmaceuticals Corp., May 2018. 2. ... Retrieve Document

D (S) Kymriah (tisagenlecleucel) - Connecticare.com
Kymriah [package insert]. East Hanover, NJ; Novartis Pharmaceuticals Corp., August 2017. 2. Grupp S, Laetsch T, Buechner J, et al. Analysis of a global registration trial of the efficacy and safety of CTL019 in pediatric and young Adults with relapsed/refractory acute lymphoblastic ... Access This Document

Clinical Policy: Tisagenlecleucel (Kymriah) - Health Net
In patients receiving Kymriah. Do not administer Kymriah to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab. Neurological toxicities, which may be severe or life-threatening, can occur following treatment with Kymriah, including concurrently with CRS. Monitor for neurological ... Access Content

Kymriah (tisagenlecleucel) Document Number: FDA
Kymriah (tisagenlecleucel) Document Number: Kymriah is indicated for the treatment of patients up to 25 years of age with B‐cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. 1. Kymriah [package insert]. East Hanover, NJ: ... Read Here