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NYVEPRIA (pegfilgrastim-apgf)
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NYVEPRIA Quick Finder
Highlights
Indications and Usage
1 INDICATIONS AND USAGE
NYVEPRIA 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...
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy
The recommended dosage of NYVEPRIA is a single subcutaneous injection of...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
NYVEPRIA is a clear, colorless, preservative-free solution available as:
- •
- Injection: 6 mg/0.6 mL in a single-dose prefilled syringe for manual use only.
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Contraindications
4 CONTRAINDICATIONS
NYVEPRIA is contraindicated in patients with a history of serious allergic reactions to pegfilgrastim products or filgrastim products. Reactions have included anaphylaxis [see...
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Splenic Rupture
Splenic rupture, including fatal cases, can occur following the administration of pegfilgrastim products. Evaluate for...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Although available...
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Overdosage
10 OVERDOSAGE
Overdosage of pegfilgrastim products may result in leukocytosis and bone pain. Events of edema, dyspnea, and pleural effusion have been reported in a single patient who administered pegfilgrastim on 8...
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Description
11 DESCRIPTION
Pegfilgrastim-apgf is a covalent conjugate of recombinant methionyl human G-CSF and monomethoxypolyethylene glycol. Recombinant methionyl human G-CSF is a water-soluble 175 amino acid protein with a molecular...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Pegfilgrastim products are colony-stimulating factors that act on hematopoietic cells by binding to specific cell...
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
No carcinogenicity or mutagenesis studies have been performed with pegfilgrastim...
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Clinical Studies
14 CLINICAL STUDIES
Pegfilgrastim was evaluated in three randomized, double-blind, controlled studies. Studies 1 and 2 were active-controlled studies that employed doxorubicin 60 mg/m2 and docetaxel...
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
NYVEPRIA (pegfilgrastim-apgf) injection is a clear, colorless solution supplied in a prefilled single-dose syringe for manual use containing 6 mg pegfilgrastim-apgf, supplied with a 27-...
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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).
Advise patients of the following risks and potential risks with NYVEPRIA:...
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Instructions For Use
Instructions for Use | |||
NYVEPRIA (Nigh-VEP ree-ah) |
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