Filgrastim-aafi

What is Filgrastim-aafi?

• Filgrastim-aafi (Nivestym) is a leukocyte growth factor used to treat low neutrophil count.

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?

• 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 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 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?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

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., 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.

• Dailymed label info on Filgrastim-aafi
• FDA Filgrastim-aafi