Filgrastim-aafi: Difference between revisions

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== '''What is Filgrastim-aafi?''' ==
#REDIRECT [[Filgrastim]]


* Filgrastim-aafi ('''Nivestym''') is '''a leukocyte growth factor''' used  to treat low [[neutrophil]] count.
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[[File:Filgrastim.jpg|thumb|Filgrastim]]
 
 
== '''What are the uses of this medicine?''' ==
 
* Filgrastim-aafi ('''Nivestym''') is a man-made form of [[granulocyte colony-stimulating factor]] (G-CSF). G-CSF is a substance produced by the body. It stimulates the growth of [[neutrophils]], a type of [[white blood cell]] important in the body's fight against infection.
 
Filgrastim-aafi (Nivestym) 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 with a significant incidence of severe neutropenia with fever.
* Reduce the time to neutrophil recovery and the duration of fever, following [[induction]] or [[consolidation]] chemotherapy treatment of patients with [[acute myeloid leukemia]] (AML). 
* Reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g.‚ febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by [[bone marrow transplantation]] (BMT). 
* Mobilize autologous hematopoietic progenitor cells into the peripheral blood for collection by [[leukapheresis]]. 
* 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.
 
 
== '''How does this medicine work?''' ==
 
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* Filgrastim-aafi ('''Nivestym''') is '''a man-made form of [[granulocyte colony-stimulating factor]] (G-CSF)'''.
* Colony-stimulating factors are glycoproteins '''which act on hematopoietic cells by binding to specific cell surface receptors and stimulating proliferation‚ differentiation commitment‚ and some end-cell functional activation'''.
* '''G-CSF regulates the production of neutrophils within the bone marrow and affects neutrophil progenitor proliferation‚ differentiation, and selected end-cell functions.'''
 
 
== '''Who Should Not Use this medicine ?''' ==
 
This medicine cannot be used in patients who:
* have had a serious allergic reaction to human G-CSFs such as filgrastim products or pegfilgrastim products.
 
 
== '''What drug interactions can this medicine cause?''' ==
 
* Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
 
 
== '''Is this medicine FDA approved?''' ==
 
* Filgrastim was approved for medical use in the United States in 1991.
 
 
== '''How should this medicine be used?''' ==
 
'''Recommended dosage:'''
'''Patients with cancer receiving myelosuppressive chemotherapy or induction and/or consolidation chemotherapy for AML:'''
* Recommended starting dose is 5 mcg/kg/day subcutaneous injection, short intravenous infusion (15 to 30 minutes), or continuous intravenous infusion.
 
'''Patients with cancer undergoing bone marrow transplantation:'''
* 10 mcg/kg/day given as an intravenous infusion no longer than 24 hours. See Full Prescribing Information for recommended dosage adjustments and timing of administration.
 
'''Patients undergoing autologous peripheral blood progenitor cell collection and therapy:'''
* 10 mcg/kg/day subcutaneous injection.
* Administer for at least 4 days before first leukapheresis procedure and continue until last leukapheresis.
 
'''Patients with congenital neutropenia:'''
* Recommended starting dose is 6 mcg/kg subcutaneous injection twice daily.
 
'''Patients with cyclic or idiopathic neutropenia:'''
* Recommended starting dose is 5 mcg/kg subcutaneous injection daily.
 
'''Administration:'''
* Nivestym injections can be given by a healthcare provider by intravenous (IV) infusion or under your skin (subcutaneous injection).
* Your healthcare provider may decide subcutaneous injections can be given at home by you or your caregiver.
* You should not try to inject a dose of Nivestym less than 0.3 mL (180 mcg) from a Nivestym prefilled syringe.
* A dose less than 0.3 mL cannot be accurately measured using the Nivestym prefilled syringe.
* If you are receiving Nivestym because you are also receiving chemotherapy, your dose of Nivestym should be injected at least 24 hours before or 24 hours after your dose of chemotherapy. Your healthcare provider will do blood tests to monitor your white blood cell count, and if necessary, adjust your Nivestym dose.
* If you miss a dose of Nivestym, talk to your healthcare provider about when you should give your next dose.
 
 
== '''What are the  dosage forms and brand names of this medicine?''' ==
 
This medicine is available in fallowing doasage form:
'''As Vial'''
* Injection: 300 mcg/mL in a single-dose vial
* Injection: 480 mcg/1.6 mL in a single-dose vial
 
'''Prefilled Syringe'''
* Injection: 300 mcg/0.5 mL in a single-dose prefilled syringe
* Injection: 480 mcg/0.8 mL in a single-dose prefilled syringe
 
This medicine is available in fallowing brand namesː
* '''Nivestym'''
 
 
=='''What side effects can this medication cause?'''==
 
The most common side effects of this medicine include:
In Patients with cancer receiving chemotherapy:
* fever, pain, rash, cough, and shortness of breath
 
In Patients with acute myeloid leukemia receiving chemotherapy:
* pain, [[nose bleed]], and rash
 
In Patients with cancer receiving chemotherapy followed by bone marrow transplant:
* rash
 
In Patients who are having their own blood cells collected:
* bone pain, fever, and headache
 
In Patients with severe chronic neutropenia:
* pain, decreased red blood cells, nose bleed, [[diarrhea]], reduced sensation, and hair loss
 
Nivestym may cause serious side effects, including:
* [[Spleen]] rupture
* [[acute respiratory distress syndrome]]
* Serious allergic reactions
* [[Sickle cell crisis|Sickle cell crises]]
* [[glomerulonephritis]]
* [[Capillary leak syndrome]]
* [[Myelodysplastic syndrome]] (MDS) and [[acute myeloid leukemia]] (AML)
* [[thrombocytopenia]]
* [[leukocytosis]]
* cutaneous [[vasculitis]]
* [[aortitis]]
 
 
==''' What special precautions should I follow?''' ==
 
* Splenic rupture, including fatal cases, has been reported following the administration of filgrastim products. Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture.
* [[Acute respiratory distress syndrome]] (ARDS) has been reported in patients receiving filgrastim products. Discontinue Nivestym in patients with ARDS.
* Serious allergic reactions, including [[anaphylaxis]], have been reported in patients receiving filgrastim products. Nivestym is contraindicated in patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as filgrastim or pegfilgrastim.
* Severe and sometimes fatal [[Sickle cell crisis|sickle cell crises]] can occur in patients with sickle cell disorders receiving filgrastim products. Discontinue Nivestym if sickle cell crisis occurs.
* [[Glomerulonephritis ]]has occurred in patients receiving filgrastim products.  If glomerulonephritis is suspected, evaluate for cause.
* [[Capillary leak syndrome]] (CLS) has been reported after G-CSF administration, including filgrastim products, and is characterized by [[hypotension]], [[hypoalbuminemia]], [[edema]] and hemoconcentration.  Patients who develop symptoms of capillary leak syndrome should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care.
* MDS and AML have been associated with the use of filgrastim products in conjunction with [[chemotherapy]] and/or [[radiotherapy]] in patients with breast and lung cancer. Monitor patients for signs and symptoms of MDS/AML in these settings.
* [[Thrombocytopenia]] has been reported in patients receiving filgrastim products. Monitor platelet counts.
* Cutaneous [[vasculitis]] has been reported in patients treated with filgrastim products. Hold Nivestym therapy in patients with cutaneous vasculitis.
* [[Aortitis]] has been reported in patients receiving filgrastim products. Discontinue Nivestym if aortitis is suspected.
 
 
== '''What to do in case of emergency/overdose?''' ==
 
* {{overdose}}
 
 
== '''Can this medicine be used in pregnancy?''' ==
 
* It is not known if Nivestym will harm your unborn baby.
 
 
=='''Can this medicine be used in children?'''==
 
* The safety and effectiveness of filgrastim have been established in pediatric patients.
 
 
== '''What are the active and inactive ingredients in this medicine?''' ==
 
* '''Active ingredient:''' (filgrastim-aafi)
* '''Inactive ingredients:''' acetate, polysorbate 80, sodium, sorbitol, and water for Injection
 
 
== '''Who manufactures and distributes this medicine?''' ==
 
* Manufactured by [[Hospira, Inc.|Hospira, Inc]]., a Pfizer Company, Lake Forest, IL USA
 
 
== '''What should I know about storage and disposal of this medication?''' ==
 
* Store Nivestym in the refrigerator between 36°F to 46°F (2°C to 8°C).
* Do not freeze.
* Keep Nivestym in the original carton to protect from light or physical damage. Do not leave Nivestym in direct sunlight.
* Do not shake Nivestym.
* Take Nivestym out of the refrigerator 30 minutes before use and allow it to reach room temperature before preparing an injection.
* Throw away (dispose of) any Nivestym that has been left at room temperature for longer than 24 hours.
* After you inject your dose, throw away (dispose of) any unused Nivestym left in the vials or prefilled syringes. Do not save unused Nivestym in the vials or prefilled syringes for later use.
 
 
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[[Category:Amgen]]
[[Category:Hoffmann-La Roche brands]]
[[Category:Novartis brands]]
[[Category:AbbVie brands]]
[[Category:Pfizer brands]]
[[Category:Drugs acting on the blood and blood forming organs]]
[[Category:Growth factors]]
[[Category:Immunostimulants]]
[[Category:Recombinant proteins]]

Revision as of 04:24, 2 July 2024

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