Is Neulasta FDA approved?
Amgen has been granted approval in the USA for Neulasta(pegfilgrastim), a new version of Neupogen (filgrastim), its blockbuster treatment for low white blood cell counts in patients undergoing chemotherapy for cancer.
What is pegfilgrastim used for?
Pegfilgrastim injection products are used to reduce the chance of infection in people who have certain types of cancer and are receiving chemotherapy medications that may decrease the number of neutrophils (a type of blood cell needed to fight infection).
What is Neulasta indicated for?
Neulasta is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia [see Clinical Studies (14.1)].
When was Neulasta FDA approved?
Approval Date: 1/31/2002.
How long has Neulasta been on the market?
Although Neulasta has been available for 12 years, some patients still do not receive their Neulasta at least 24 hours after cytotoxic chemotherapy as specified in the Neulasta PI.
What are side effects of pegfilgrastim?
Incidence not known
- Black, tarry stools.
- bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site.
How much does pegfilgrastim cost?
As of 08/18/2021 the list price for Neulasta® is $6,417.99* per dose. Neulasta® is a single dose administered once per chemotherapy cycle. Most patients do not pay the list price.
Is Neulasta a chemotherapy drug?
What Neulasta Onpro Is Used For. This medicine is used to stimulate the growth of “healthy” white blood cells in the bone marrow, once chemotherapy is given. White blood cells help the body to fight infection. This is not a chemotherapy drug.
What is the cost of Neulasta?
As of 08/18/2021 the list price for Neulasta® is $6,417.99† per dose. Neulasta® is a single dose administered once per chemotherapy cycle. Most patients do not pay the list price. Actual cost will vary.