NDC 0078-0958 Kymriah
Tisagenlecleucel Injection, Suspension Intravenous - View Dosage, Usage, Ingredients, Routes, UNII
Product Information
- 0078 - Novartis Pharmaceuticals Corporation
- 0078-0958 - Kymriah
Product Packages
NDC Code 0078-0958-19
Package Description: 1 INJECTION, SUSPENSION in 1 BAG
Product Details
What is NDC 0078-0958?
What are the uses for Kymriah?
What are Kymriah Active Ingredients?
What is the NDC to RxNorm Crosswalk for Kymriah?
- RxCUI: 1986442 - tisagenlecleucel 250000000 CELLS Injection
- RxCUI: 1986442 - tisagenlecleucel-T 250,000,000 CELLS Injection
- RxCUI: 1986447 - KYMRIAH 250,000,000 CELLS Injection
- RxCUI: 1986447 - tisagenlecleucel 250000000 CELLS Injection [Kymriah]
- RxCUI: 1986447 - Kymriah 250000000 CELLS Injection
Which are the Pharmacologic Classes for Kymriah?
- CD19 Receptor Interactions - [MoA] (Mechanism of Action)
- CD19-directed Chimeric Antigen Receptor - [EPC] (Established Pharmacologic Class)
- CD19-specific Chimeric Antigen Receptor - [CS]
- Genetically-modified Autologous T Cells - [EPC] (Established Pharmacologic Class)
- Increased T Lymphocyte Activation - [PE] (Physiologic Effect)
- T Lymphocytes, Cultured, Autologous, Genetically-modified - [EXT]
* Please review the disclaimer below.
Patient Education
Tisagenlecleucel Injection
Tisagenlecleucel injection is used to treat certain acute lymphoblastic leukemia (ALL; also called acute lymphoblastic leukemia and acute lymphatic leukemia; a type of cancer that begins in the white blood cells) in people 25 years of age or younger that has returned or is unresponsive to other treatment(s). It is also used to treat a certain type of non-Hodgkin's lymphoma (type of cancer that begins in a type of white blood cells that normally fights infection) and follicular lymphoma (FL; a slow-growing cancer that begins in the white blood cells) in adults that has returned or is unresponsive after treatment with at least two other medications. Tisagenlecleucel injection is in a class of medications called autologous cellular immunotherapy, a type of medication prepared using cells from the patient's own blood. It works by causing the body's immune system (a group of cells, tissues, and organs that protects the body from attack by bacteria, viruses, cancer cells, and other substances that cause disease) to fight the cancer cells.
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Cancer Chemotherapy
What is cancer chemotherapy?
Cancer chemotherapy is a type of cancer treatment. It uses medicines to destroy cancer cells.
Normally, the cells in your body grow and die in a controlled way. Cancer cells keep growing without control. Chemotherapy works by killing the cancer cells, stopping them from spreading, or slowing their growth.
Chemotherapy is used to:
- Treat cancer by curing the cancer, lessening the chance it will return, or stopping or slowing its growth.
- Ease cancer symptoms by shrinking tumors that are causing pain and other problems.
What are the side effects of chemotherapy?
Chemotherapy does not just destroy cancer cells. It can also harm some healthy cells, which causes side effects.
You may have a lot of side effects, some side effects, or none at all. It depends on the type and amount of chemotherapy you get and how your body reacts.
Some common side effects are:
- Mouth sores
- Fatigue
- Nausea and vomiting
- Pain
- Hair loss
There are ways to prevent or control some side effects. Talk with your health care provider about how to manage them. Healthy cells usually recover after chemotherapy is over, so most side effects gradually go away.
What can I expect when getting chemotherapy?
You may get chemotherapy in a hospital or at home, a doctor's office, or a medical clinic. You might be given the medicines by mouth, in a shot, as a cream, through a catheter, or intravenously (by IV).
Your treatment plan will depend on the type of cancer you have, which chemotherapy medicines are used, the treatment goals, and how your body responds to the medicines.
Chemotherapy may be given alone or with other treatments. You may get treatment every day, every week, or every month. You may have breaks between treatments so that your body has a chance to build new healthy cells.
NIH: National Cancer Institute
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* Please review the disclaimer below.
[1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
[2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
[3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
[4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.
[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.
[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.
[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.
[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".