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NYVEPRIA (pegfilgrastim-apgf)

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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.

NYVEPRIA Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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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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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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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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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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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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6 ADVERSE REACTIONS

The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling:

  • Splenic Rupture [see

    6.1...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Although available data...

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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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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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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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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

No carcinogenicity or mutagenesis studies have been performed with pegfilgrastim...

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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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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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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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This Patient Information has been approved by the U.S. Food and Drug...
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Instructions for Use
NYVEPRIA (Nigh-VEP ree-ah)
(pegfilgrastim-apgf)
Injection, for subcutaneous use

Single-Dose...
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Manufactured by
Hospira, Inc., a Pfizer Company,
Lake Forest, IL 60045 USA
US License No. 1974

...

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