HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use NIVESTYM safely and effectively. See full prescribing information for NIVESTYM.
NIVESTYM™ (filgrastim-aafi) injection, for subcutaneous or intravenous use
Initial U.S. Approval: 2018
NIVESTYM (filgrastim-aafi) is biosimilar1 to NEUPOGEN (filgrastim).
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
NIVESTYM is a leukocyte growth factor indicated to
DOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHS
Patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as filgrastim products or pegfilgrastim products. (4)
WARNINGS AND PRECAUTIONS
Most common adverse reactions in patients:
To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
NIVESTYM™ Highlights (filgrastim-aafi)
Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine.
*Contact Medical Information.
Submit a medical question for Pfizer prescription products.
To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at