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NIVESTYM™ (filgrastim-aafi)

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NIVESTYM™ Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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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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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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3 DOSAGE FORMS AND STRENGTHS

Vial:

  • Injection: 300 mcg/mL of a clear, colorless solution in a single-dose vial
  • ...
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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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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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6 ADVERSE REACTIONS

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

  • Splenic Rupture [see

    6.1 Clinical Trials...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Available data from...

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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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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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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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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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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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16 HOW SUPPLIED/STORAGE AND HANDLING

Vials

Injection: Single-dose vials containing 300 mcg/mL of a sterile, clear, colorless, preservative-free...

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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
NIVESTYM (Neye-ves-tim)
(filgrastim-aafi)
injection
Single-Dose Prefilled Syringe

Important

Read the Patient Information for...

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This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.

...

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Resources

Pfizer enCompass™
Pfizer enCompass™ is a resource available to patients on NIVESTYM therapy. Support includes assistance for eligible uninsured and insured patients who cannot afford their out-of-pocket costs. To learn more, call Pfizer enCompass to talk to an Access Counselor at (844) 722-6672 or visit the Pfizer enCompass website.
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