granulocyte colony stimulating factor


Also found in: Dictionary, Acronyms, Wikipedia.
Related to granulocyte colony stimulating factor: dysostosis multiplex, Neupogen, G-CSF, CSF3

filgrastim

(fil-gra-stim) ,

Neupogen

(trade name),

G-CSF

(trade name),

granulocyte colony stimulating factor

(trade name)

Classification

Therapeutic: colony stimulating factors
Pregnancy Category: C

Indications

Prevention of febrile neutropenia and associated infection in patients who have received bone marrow–depressing antineoplastics for the treatment of nonmyeloid malignancies.Reduction of time for neutrophil recovery and duration of fever in patients undergoing induction and consolidation chemotherapy for acute myelogenous leukemia.Reduction of time to neutrophil recovery and sequelae of neutropenia in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation.Mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis.Management of severe chronic neutropenia.Neutropenia associated with HIV infection.Neonatal neutropenia.

Action

A glycoprotein, filgrastim binds to and stimulates immature neutrophils to divide and differentiate. Also activates mature neutrophils.

Therapeutic effects

Decreased incidence of infection in patients who are neutropenic from chemotherapy or other causes.
Improved harvest of progenitor cells for bone marrow transplantation.

Pharmacokinetics

Absorption: Well absorbed after subcut administration.
Distribution: Unknown.
Metabolism and Excretion: Unknown.
Half-life: Adults—3.5 hr; Neonates—4.4 hr.

Time/action profile

ROUTEONSETPEAKDURATION
IV, subcutunknownunknown4 days†
†Return of neutrophil count to baseline

Contraindications/Precautions

Contraindicated in: Hypersensitivity to filgrastim or Escherichia coli-derived proteins.
Use Cautiously in: Malignancy with myeloid characteristics;Pre-existing cardiac disease; Obstetric: Use only if potential benefit justifies potential risk to fetus; Lactation: Unlikely to adversely affect breast-fed infant.

Adverse Reactions/Side Effects

Gastrointestinal

  • splenic rupture (life-threatening)
  • splenomegaly

Ear, Eye, Nose, Throat

  • hemoptysis

Hematologic

  • excessive leukocytosis
  • sickle cell crises
  • thrombocytopenia

Respiratory

  • acute respiratory distress syndrome (life-threatening)
  • pulmonary infiltrates

Local

  • allergic reactions (life-threatening)
  • pain, redness at subcut site

Musculoskeletal

  • medullary bone pain (most frequent)

Interactions

Drug-Drug interaction

Simultaneous use with antineoplastics may have adverse effects on rapidly proliferating neutrophils—avoid use for 24 hr before and 24 hr after chemotherapy.Lithium may potentiate the release of neutrophils; concurrent use should be undertaken cautiously.

Route/Dosage

After Myelosuppressive Chemotherapy
Intravenous Subcutaneous (Adults and Children) 5 mcg/kg/day as a single injection daily for up to 2 wk. Dosage may be increased by 5 mcg/kg during each cycle of chemotherapy, depending on blood counts.
After Bone Marrow Transplantation
Intravenous Subcutaneous (Adults) 10 mcg/kg/day as a 4- or 24-hr IV infusion or as a continuous subcut infusion; initiate at least 24 hr after chemotherapy and at least 24 hr after bone marrow transplantation. Subsequent dosage is adjusted according to blood counts.
Peripheral Blood Progenitor Cell Collection and Therapy
Subcutaneous (Adults) 10 mcg/kg/day as a bolus or continuous infusion for at least 4 days before first leukapheresis and continued until last leukapheresis; dosage modification suggested if WBC >100,000 cells/mm3.
Severe Chronic Neutropenia
Subcutaneous (Adults) Congenital neutropenia—6 mcg/kg twice daily. Idiopathic/cyclical neutropenia—5 mcg/kg daily (decrease if ANC remains >10,000/mm3).
Neonatal neutropenia
Intravenous Subcutaneous (Neonates) 5–10 mcg/kg/day once daily for 3–5 days.

Availability

Injection: 300 mcg/mL in 1- and 1.6-mL vials

Nursing implications

Nursing assessment

  • Monitor heart rate, BP, and respiratory status before and periodically during therapy.
  • Assess bone pain throughout therapy. Pain is usually mild to moderate and controllable with nonopioid analgesics, but may require treatment with opioid analgesics, especially in patients receiving high-dose IV therapy.
  • Monitor for signs and symptoms of allergic reactions (rash‚ urticaria‚ facial edema, wheezing‚ dyspnea, (hypotension‚ tachycardia). Usually occur within 30 min of administration. Treatment includes antihistamines‚ steroids‚ bronchodilators‚ and/or epinephrine; may recur with rechallenge.
  • Assess for signs and symptoms of acute respiratory distress syndrome (fever, lung infiltrates, or respiratory distress). If symptoms occur, withhold filgrastim until symptoms resolve or discontinue.
  • Lab Test Considerations: After chemotherapy, obtain a CBC with differential, including examination for the presence of blast cells, and platelet count before chemotherapy and twice weekly during therapy to avoid leukocytosis. Monitor ANC. A transient rise is seen 1–2 days after initiation of therapy, but therapy should not be discontinued until ANC >10,000/mm3.
    • After bone marrow transplant, the daily dose is titrated by the neutrophil response. When the ANC is >1000/mm3 for 3 consecutive days, the dose should be reduced by 5 mcg/kg/day. If the ANC remains >1000/mm3 for 3 or more consecutive days, filgrastim is discontinued. If the ANC decreases to <1000/mm3, filgrastim should be resumed at 5 mcg/kg/day.
    • For chronic severe neutropenia, monitor CBC with differential and platelet count twice weekly during initial 4 wk of therapy and during 2 wk after any dose adjustment.
    • May cause ↓ platelet count and transient ↑ in uric acid, LDH, and alkaline phosphatase concentrations.

Potential Nursing Diagnoses

Risk for infection (Indications)
Acute pain (Side Effects)

Implementation

  • Do not confuse Neupogen with Neumega (oprelvekin).
  • Administer no earlier than 24 hr after cytotoxic chemotherapy, at least 24 hr after bone marrow infusion, and not during the 24 hr before administration of chemotherapy.
    • Refrigerate; do not freeze. Do not shake. May warm to room temperature for up to 6 hr before injection. Discard if left at room temperature for >6 hr. Vial is for 1-time use only.
  • Subcutaneous: If dose requires >1 mL of solution, may be divided into 2 injection sites.
    • May also be administered as a continuous subcut infusion over 24 hr after bone marrow transplantation.
  • Intravenous Administration
  • Continuous Infusion: Diluent: Dilute in D5W. Refrigerate; do not freeze. Do not shake. May warm to room temperature for up to 6 hr before injection. Vial is for 1-time use only.Concentration: Dilute to a final concentration of at least 15 mcg/mL. If the final concentration is <15 mcg/mL, human albumin in a concentration of 2 mg/mL must be added to D5W before filgrastim to prevent adsorption of the components of the drug delivery system.
  • Rate: After chemotherapy dose is administered via infusion over 15–60 min.
    • After chemotherapy dose may also be administered as a continuous infusion.
    • After bone marrow transplant, dose should be administered as an infusion over 4 or 24 hr.
  • Y-Site Compatibility: acyclovir, allopurinol, amikacin, aminophylline, ampicillin, ampicillin/sulbactam, aztreonam, bleomycin, bumetanide, buprenorphine, butorphanol, calcium gluconate, carboplatin, carmustine, cefazolin, cefotetan, ceftazidime, chlorpromazine, cisplatin, cyclophosphamide, cytarabine, dacarbazine, daunorubicin, dexamethasone, diphenhydramine, doxorubicin, doxycycline, droperidol, enalaprilat, famotidine, floxuridine, fluconazole, fludarabine, ganciclovir, granisetron, haloperidol, hydrocortisone, hydromorphone, idarubicin, ifosfamide, leucovorin calcium, levofloxacin, lorazepam, mechlorethamine, melphalan, meperidine, mesna, methotrexate, metoclopramide, mitoxantrone, morphine, nalbuphine, ondansetron, potassium chloride, promethazine, ranitidine, sodium acetate, sodium bicarbonate, streptozocin, ticarcillin/clavulanate, tobramycin, trastuzumab, trimethoprim/sulfamethoxazole, vancomycin, vinblastine, vincristine, vinorelbine, zidovudine
  • Y-Site Incompatibility: aminocaproic acid, amphotericin B colloidal, cefepime, cefoperazone, cefotaxime, cefoxitin, ceftaroline, ceftriaxone, cefuroxime, clindamycin, dactinomycin, etoposide, fluorouracil, furosemide, heparin, mannitol, methylprednisolone sodium succinate, metronidazole, mitomycin, prochlorperazine, thiotepa

Patient/Family Teaching

  • Explain purpose of filgrastim to patient. Instruct patient and caregiver to read Instructions for Patients and Caregivers before starting therapy and with each Rx refill in case of changes.
  • Advise female patient to notify health care professional if pregnancy is planned or suspected or if breast feeding. Encourage patients that become pregnant during therapy to enroll in Amgen's Pregnancy Surveillance Program by calling 1-800-77AMGEN (1-800-772-6436). Encourage patients that breast feed during therapy to enroll in Amgen's Lactation Surveillance Program by calling 1-800-77AMGEN (1-800-772-6436).
  • Home Care Issues: Instruct patient on correct technique and proper disposal for home administration. Caution patient not to reuse needle, vial, or syringe. Provide patient with a puncture-proof container for needle and syringe disposal.

Evaluation/Desired Outcomes

  • Decreased incidence of infection in patients who receive bone marrow–depressing antineoplastics.
  • Reduction of duration and sequelae of neutropenia after bone marrow transplantation.
  • Reduction of the incidence and duration of sequelae of neutropenia in patients with severe chronic neutropenia.
  • Improved harvest of progenitor cells for bone marrow transplantation.

granulocyte colony stimulating factor

A circulating hormonal substance that controls the growth of some of the white cells of the blood. The human gene for this factor has been sequenced and the factor is produced by recombinant DNA techniques (genetic engineering) and sold under brand names such as Granocyte and Neupogen.
References in periodicals archive ?
Effects of stem-cell mobilization with recombinant human granulocyte colony stimulating factor in patients with per cutaneously revascularized acute anterior myocardial infarction.
Sweet syndrome following therapeutic use of granulocyte colony stimulating factor.
The picture is changing today and biotechnology feeds innovative ideas to the pharmaceutical industry to produce products such as recombinant human insulin, growth hormone, monoclonal antibodies, granulocyte colony stimulating factors, erythropoeitin and interferon vaccines.
Biotechnology products already in use on the market include erythropoietin (EPO), granulocyte colony stimulating factors, growth hormone (GH), human insulin, and tissue plasminogen activator (TPA).
Fitch anticipates leverage to be relatively stable despite demand pressure on Amgen's Aranesp product continuing into the first half of 2008, competition from biosimilars of erthythropoiesis-stimulating agents (ESA) and granulocyte colony stimulating factors (G-CSFs) in Europe, as well as an expectation that near-term debt maturities will be refinanced.
This study is focused on established segments in Europe including Erythropoietin, Granulocyte Colony Stimulating Factors, Human Growth Hormones and emerging segments including monoclonal antibodies, Insulin and interferon.
European Granulocyte Colony Stimulating Factors Biosimilars Market 109
Market Overview European Granulocyte Colony Stimulating Factors Biosimilars 110
Forecast and Trends European Granulocyte Colony Stimulating Factors Biosimilars Market 111
Market Share and Competitive Analysis European Granulocyte Colony Stimulating Factors Biosimilars Market 115
Competitive Landscape European Granulocyte Colony Stimulating Factors Biosimilars 119

Full browser ?