NEUPOGEN/GRASTOFIL/ NIVESTYM (Filgrastim)
NEUPOGEN/GRASTOFIL/ NIVESTYM (Filgrastim)
NEUPOGEN/GRASTOFIL/ NIVESTYM (Filgrastim)
NEUPOGEN/GRASTOFIL/ NIVESTYM (Filgrastim)
NEUPOGEN/GRASTOFIL/ NIVESTYM (Filgrastim)
NEUPOGEN/GRASTOFIL/ NIVESTYM (Filgrastim)
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NEUPOGEN/GRASTOFIL/ NIVESTYM (Filgrastim)

Vendor
AMGEN/APOTEX/PFIZER
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$3,959.99 USD
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$3,959.99 USD
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prescription refrigerated

What is this medication?

NEUPOGEN/GRASTOFIL/NIVESTYM (Filgrastim)
Colony Stimulating Factor, Hematopoietic Agent

NEUPOGEN and biosimilars GRASTOFIL and NIVESTYM are leukocyte growth factors indicated for the treatment of chemotherapy-induced myelosuppression in nonmyeloid malignancies, acute myeloid leukemia (AML) following induction or consolidation chemotherapy.  Filgrastim is used to reduce the duration of neutropenia in nonmyeloid malignancies, undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT).  Filgrastim is used to help mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis.  NEUPOGEN can also reduce the incidence and duration of sequelae of severe neutropenia (e.g.‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia.

What is a biosimilar biologic drug?

Manufacturers have found cost-efficient ways to recreate the molecules used in the original or “reference” biologic drug.  Biosimilars are highly “similar” to a reference biological drug despite differing in their chemical composition.  

The FDA approval of biosimilar drugs is based on a totality of evidence which is used by regulators in the approval of reference and biological drugs.  The FDA uses the same approach in evaluating biosimilars to confirm that there are no clinically meaningful differences in safety and efficacy between the reference biologic drug and the biosimilar.  The rigorous standard for authorization means that you can have confidence knowing that the quality, safety, and efficacy of a biosimilar is the same as any other biologic drug.

NEUPOGEN is a biologic
GRASTOFIL is a biosimilar to NEUPOGEN (Filgrastim)
NIVESTYM is a biosimilar to NEUPOGEN (Filgrastim)

How does this medication work? 

NEUPOGEN/GRASTOFIL/NIVESTYM (Filgrastim) is a granulocyte colony-stimulating factor (G-CSF) produced by recombinant DNA technology. G-CSFs stimulate the production, maturation, and activation of neutrophils to increase both their migration and cytotoxicity.

How should I take this medication? 

Dose varies with procedure, indication, tolerated toxicity and condition of patient:
SQ:
As a staring dose, inject 5 mcg/kg/day subcutaneously.

IV:
 Administer by short intravenous infusion (15 to 30 minutes), or continuous intravenous infusion.

Note:  Do not administer in the period 24 hours before to 24 hours after cytotoxic chemotherapy. 

How to Take:  May be administered subcutaneously (chemotherapy-induced neutropenia, peripheral blood progenitor cell collection, severe chronic neutropenia, hematopoietic radiation injury syndrome). Administer into the outer upper arm, abdomen (except within 2 inches of navel), front middle thigh, or the upper outer buttocks area. Rotate injection site.

What should I watch for while using this medication? 

Before starting NEUPOGEN/GRASTOFIL/NIVESTYM (Filgrastim), make sure your physician is aware of any allergies or medications you currently take, and current medical conditions. Filgrastim has been associated with alveolar hemorrhage, aortitis, capillary leak syndrome, cutaneous vasculitis, myelodysplastic syndrome, nephrotoxicity, acute respiratory distress syndrome, and rarely splenic rupture.  Filgrastim should be used with caution in patients with severe chronic neutropenia and sickle cell disorders.  Watch for signs and symptoms of left upper abdominal or shoulder pain suggestive of an enlarged spleen or splenic rupture.  Evaluate for signs and symptoms of fever, lung infiltrates or respiratory distress suggestive of acute respiratory distress syndrome (ARDS). 

What size needle does this medication use?

NEUPOGEN
Prefilled syringe: 27-gauge, ½ inch needle

What if I miss a dose?

This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

How should I store this medication?

Store in the refrigerator at 2° to 8°C (36° to 46°F) in the container it came in, tightly closed, and out of reach of children. Avoid shaking. Prior to injection‚ Filgrastim may be allowed to reach room temperature for a maximum of 24 hours, discard medication left at room temperature for greater than 24 hours.

What are the possible side effects of using this medication?

Chest pain, hypertension, skin rash, nausea, thrombocytopenia, dizziness, fatigue, pain, back pain, headache, ostealgia, cough, dyspnea, urinary tract infection, antibody development, sepsis, fever.

Note this is not a complete list of side effects for NEUPOGEN/GRASTOFIL/NIVESTYM (Filgrastim), only common ones.