Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Review the steps for direct patient administration with patients and caregivers. Training by the healthcare provider should aim to ensure that patients and caregivers can successfully perform all of the steps in the Instructions for Use of NIVESTYM vial and prefilled syringe, including showing the patient or caregiver how to measure the required dose, particularly if a patient is on a dose other than the entire prefilled syringe. If a patient or caregiver is not able to demonstrate that they can measure the dose and administer the product successfully, you should consider whether the patient is an appropriate candidate for self-administration of NIVESTYM or whether the patient would benefit from a different NIVESTYM presentation. Advise patients of the following risks and potential risks with NIVESTYM:
Instruct patients who self-administer NIVESTYM using the prefilled syringe or single-dose vial of the:
This Patient Information has been approved by the U.S. Food and Drug Administration
Revised: March 2023
Patient InformationNIVESTYM (Neye-ves-tim)(filgrastim-aafi)injection
What is NIVESTYM?
NIVESTYM is a man-made form of granulocyte colony-stimulating factor (G-CSF). G-CSF is a substance produced by the body. It stimulates the growth of neutrophils, a type of white blood cell important in the body's fight against infection.
Do not take NIVESTYM if you have had a serious allergic reaction to human G-CSFs such as filgrastim products or pegfilgrastim products.
Before you take NIVESTYM, tell your healthcare provider about all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How will I receive NIVESTYM?
What are the possible side effects of NIVESTYM?
NIVESTYM may cause serious side effects, including:
The most common side effects experienced in patients receiving NIVESTYM include:
These are not all the possible side effects of NIVESTYM. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store NIVESTYM?
Keep NIVESTYM out of the reach of children.
General information about the safe and effective use of NIVESTYM.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use NIVESTYM for a condition for which it was not prescribed. Do not give NIVESTYM to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about NIVESTYM that is written for healthcare professionals.
What are the ingredients in NIVESTYM?
Active ingredient: (filgrastim-aafi)
Inactive ingredients: acetate, polysorbate 80, sodium, sorbitol, and water for Injection
Manufactured by Hospira, Inc., a Pfizer Company, Lake Forest, IL 60045 USAUS License No. 1974
Distributed by Pfizer Labs, division of Pfizer Inc., New York, NY 10001 USA
LAB-0935-5.0For more information go to www.pfizer.com or call 1-800-438-1985.
Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine.
*Contact Medical Information. 8AM-9PM ET Monday to Friday; excluding holidays.
Submit a medical question for Pfizer prescription products.
To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, and you are
not part of a clinical trial* for this product, click the link below to submit your
*If you are involved in a clinical trial for this 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
You may also contact the U.S. Food and Drug Administration (FDA) directly to report
adverse events or product quality concerns either online at