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Tisagenlecleucel (Kymriah)

Trade Name : KYMRIAH

Novartis Pharmaceuticals Corporation

INJECTION, SUSPENSION, CELLULAR THERAPY

Strength 2000000 1-Jan

TISAGENLECLEUCEL

Delivery Process

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Tisagenlecleucel (Kymriah) which is also known as KYMRIAH and Manufactured by Novartis Pharmaceuticals Corporation. It is available in strength of 2000000 1-Jan per ml. Read more

Tisagenlecleucel (Kymriah) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • No data
  • See full prescribing information for complete boxed warning.
  • KYMRIAH is a CD19-directed geneticallyu00a0modified autologous Tu00a0cell immunotherapyu00a0indicated for the treatment of:
  • KYMRIAH is au00a0CD19-directed geneticallyu00a0modified autologous T-cell immunotherapy indicated for the treatment of:
  • Patients up to 25 years of ageu00a0with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. ()u00a0n
  • Adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma.n : KYMRIAH is not indicated for treatment of patients with primary central nervous system lymphoma ()
  • For autologous use only. For intravenous use only.
  • For autologous use only. For intravenous use only.
  • Administer a lymphodepleting regimen if needed before infusion of KYMRIAH u00a0(n n
  • Do NOT use a leukodepleting filter.
  • Verify the patientu2019s identity prior to infusion.u00a0()n
  • Premedicate with acetaminophen and an H1-antihistamine. ()n
  • Confirm availability of tocilizumab prior to infusion. (, )n
  • Dosing of KYMRIAH is based on the number ofu00a0chimeric antigen receptor (CAR)-positive viableu00a0T cells.n
  • Pediatric and n- Yn- oung n- An- dult B-cell ALLn- (up to 25 years of age)
  • Arrayn- Arrayn- Array
  • 6n- u00a0n- 8
  • 2.1n- 2.1
  • Adult Relapsed or Refractory n- Diffuse Large B-cell Lyn- mn- pn- hn- oma
  • Administer 0.6 to 6.0 x 10 CAR-positive viable T cells intravenously. ()
  • Pediatric n- and n- Yn- oung n- An- dultn- r/rn- B-n- cn- ell ALLn- (up to 25 years of age)n- :n- [see How Supplied/Storage and Handling (16)]
  • Adult r/r DLBCL:n- [see How Supplied/Storage and Handling (16)]
  • ntttttttSee the CoA for actual cell count.u00a0The volume in theu00a0infusion bag ranges from 10 mL to 50 mL.
  • Au00a0single dose of KYMRIAH contains 0.2 to 5.0 x 10u00a0CAR-positive viable T cells per kg of body weight for patients 50 kg or less, or 0.1 to 2.5 x 10u00a0CAR-positive viable T cells for patients more than 50 kg, suspended in a patient-specific infusion bag for i.v. infusion. ()
  • A single dose of KYMRIAH contains 0.6 to 6.0 x 10 CAR-positive viable T cells suspended in one or more patient-specific infusion bag(s) for i.v. infusion.u00a0()
  • None.
  • None. ()
  • No data
  • Hypersensitivity Reactions:
  • Serious Infections:
  • Prolonged Cytopenias:
  • Hypogammaglobulinemia:
  • Secondary Malignancies:
  • Effects on Ability to Drive and Use Machines:
  • The following serious adverse reactions are discussed in greater detail in another section of the label:
  • 6
  • 6
  • HIV and the lentivirus used to make KYMRIAH have limited, short spans of identical genetic material (RNA). Therefore, some commercial HIV nucleic acid test (NATs) tests may yield false-positive results in patients who have received KYMRIAH.
  • No data
  • KYMRIAHu2122 (tisagenlecleucel)u00a0is a CD19-directed geneticallyu00a0modified autologous T cell immunotherapy comprised of autologous T cells that are genetically modified using a lentiviral vector to encode an anti-CD19 chimeric antigen receptor (CAR).u00a0The CAR isu00a0comprised of a murine single-chain antibody fragment (scFv) specific for CD19, followed by a CD8 hinge and transmembrane region that is fused to the intracellular signaling domains for 4-1BB (CD137) and CD3u00a0zeta.
  • KYMRIAH is prepared from the patientu2019s peripheral blood mononuclear cells, which are obtained via a standard leukapheresis procedure. The mononuclear cells are enriched for T cells, then transduced with the lentiviral vector containing the anti-CD19 CAR transgene, and activated with anti-CD3/CD28 antibody coated beads. The transduced T cells are expanded in cell culture, washed, and formulated into a suspension, which then is cryopreserved.u00a0The product must pass a sterility test before release for shipping as a frozen suspension in a patient-specific infusion bag(s). The product is thawed prior to administrationu00a0. The thawed product is a colorless to slightly yellow suspension of cells.
  • In addition to T cells, other cell populations, including monocytes, NK cells, and B cells, may be present. The formulation contains 31.25% (v/v) ofu00a0Plasma-Lyte A, 31.25% (v/v) of 5% Dextrose/0.45% sodium chloride, 10 % Dextran 40 (LMD)/5% Dextrose, 20% (v/v) of 25%u00a0Human Serum Albumin (HSA), and 7.5% (v/v) Cryoserv dimethylsulfoxide (DMSO).
  • Pediatric and Young Adult r/r n- B-cell ALLn- :
  • Adult n- r/r n- DLBCL:
  • The actual number of CAR-positive T cells in the product is reported on the Certificate of Analysis (CoA) that is shipped with KYMRIAH.u00a0The volume of CAR-positive viable T cells in an infusion bag ranges from 10 mL to 50 mL.
  • No data
  • Genotoxicity assays and carcinogenicity assessment in rodent models were not performed for KYMRIAH. n expansion studies with transduced T cells (KYMRIAH) from healthy donors and patients showed no evidence for transformation and/or immortalization of T cells. n studies in immunocompromised mice did not show signs of abnormal cell growth or signs of clonal cell expansion for up to 7 monthsu00a0after cell injection. A genomic insertion site analysis was performed on KYMRIAH products from 14 individual donors (12 patients and 2 healthy volunteers). There was no evidence for preferential integration near genes of concern, or preferential outgrowth of cells harboring integration sites of concern
  • No studies on the effects of KYMRIAH on fertility have been conducted.
  • No data
  • 1. Porter, D. et al (2015). Chimeric antigen receptor T cells persist and induce sustained remissions in relapsed refractory chronic lymphocytic leukemia (Table S4A). Sci. Transl. Med., 303ra139. DOI: 10.1126/scitranslmed.aac5415
  • KYMRIAH is supplied as a frozen suspension of genetically modified autologous T cells in an infusion bag(s) labeled for the specific recipient.u00a0KYMRIAHu00a0is shipped directly to the cell lab associated with the infusion center in a liquid nitrogen Dewar. Product and patient-specific labels are located inside the Dewar.
  • Ped ALL: NDC 0078-0846-19
  • DLBCL:u00a0NDC 0078-0958-19
  • Advise the patient to read the FDA-approved patient labeling (Medication Guide).
  • Ensure that patients understand the risk of manufacturing failure. This has been reported in up to 9% of manufacturing attempts. In case of a manufacturing failure, a second manufacturing of KYMRIAH may be attempted. In addition, while the patient awaits the product, additional chemotherapy (not the lymphodepletion) may be necessary and may increase the risk of adverse events during the pre-infusion period.
  • Prior to infusion, advise patients of the following risks:
  • Patients should be instructed to contact Novartis Pharmaceuticals Corporation at 1-844-4KYMRIAH if they get secondary malignancies n
  • Distributed by:
  • Novartis Pharmaceuticals Corporation
  • East Hanover, New Jersey 07936
  • u00a9 Novartis
  • T2018-67
  • T2018-62
  • PRINCIPAL DISPLAY PANEL
  • tisagenlecleucel
  • KYMRIAHn
  • NDC 0078-0958-19
  • Human T cells
  • Rx only
  • Suspension for IV infusion
  • Cultured, genetically modified
  • For autologous use only
  • Dispense with Medication Guide
  • Novartis
  • PRINCIPAL DISPLAY PANEL
  • tisagenlecleucel
  • KYMRIAHn
  • NDC 0078-0846-19
  • Human T cells
  • Rx only
  • Suspension for IV infusion
  • Cultured, genetically modified
  • For autologous use only
  • Dispense with Medication Guide
  • Novartis

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