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NIVESTYM™ (filgrastim-aafi)
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
NIVESTYM™ Quick Finder
Highlights
Indications and Usage
1 INDICATIONS AND USAGE
1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy
NIVESTYM is indicated to decrease the incidence of infection‚ as manifested...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Dosage in Patients with Cancer Receiving Myelosuppressive Chemotherapy or Induction and/or Consolidation Chemotherapy for AML
The...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
Vial:
- •
- Injection: 300 mcg/mL of a clear, colorless solution in a single-dose vial
- •...
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Contraindications
4 CONTRAINDICATIONS
NIVESTYM is contraindicated in patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as filgrastim products or pegfilgrastim products...
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Splenic Rupture
Splenic rupture, including fatal cases, has been reported following the administration of filgrastim products. Evaluate...
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Adverse Reactions
6 ADVERSE REACTIONS
The following serious adverse reactions are discussed in greater detail in other sections of the labeling:
- •
- Splenic Rupture [see Warnings and...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Available data from...
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Overdosage
10 OVERDOSAGE
The maximum tolerated dose of filgrastim products has not been determined. In filgrastim clinical trials of patients with cancer receiving myelosuppressive chemotherapy‚ WBC counts > 100‚000/mm...
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Description
11 DESCRIPTION
Filgrastim-aafi is a 175 amino acid human granulocyte colony-stimulating factor (G-CSF) manufactured by recombinant DNA technology.
NIVESTYM is produced by Escherichia coli...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Colony-stimulating factors are glycoproteins which act on hematopoietic cells by binding to specific cell surface...
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
The carcinogenic potential of filgrastim products has not been studied. Filgrastim...
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Clinical Studies
14 CLINICAL STUDIES
14.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy
The safety and efficacy of filgrastim to decrease the incidence of infection‚ as...
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
Vials
Injection: Single-dose vials containing 300 mcg/mL of a sterile, clear, colorless,...
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Medication Guide
17 PATIENT COUNSELING INFORMATION
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....
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Instructions For Use
Instructions for Use
NIVESTYM (Neye-ves-tim)
(filgrastim-aafi)
injection
Single-Dose...
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Report Adverse Event
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(800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.