Filgrastim-sndz

What is Filgrastim-sndz

• Filgrastim-sndz (Zarxio) is a leukocyte growth factor, 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

What are the uses of this medicine?

Filgrastim-sndz (Zarxio) used to:

• Decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid 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-sndz (Zarxio) is a leukocyte growth factor, 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.
• Endogenous G-CSF is a lineage-specific colony-stimulating factor that is produced by monocytes‚ fibroblasts, and endothelial cells.
• 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 healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Is this medicine FDA approved?

• In 2015, Sandoz's filgrastim-sndz (trade name Zarxio), obtained the approval of the U.S. Food and Drug Administration (FDA) as a biosimilar.

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.

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

• Direct administration of less than 0.3 mL (180 mcg) is not recommended due to potential for dosing errors.

Administration:

• Inject Zarxio subcutaneously in the outer area of upper arms, abdomen, thighs, or upper outer areas of the buttock.
• Filgrastim injection products come as a solution (liquid) in vials and prefilled syringes to be injected subcutaneously (under the skin) or to be slowly or continuously injected intravenously (into a vein).

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 300 mcg/0.5 mL in a single-dose prefilled syringe with BD UltraSafe Passive® Needle Guard
• Injection: 480 mcg/0.8 mL in a single-dose prefilled syringe with BD UltraSafe Passive® Needle Guard

This medicine is available in fallowing brand namesː

• Zarxio

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

Zarxio may cause serious side effects, including:

• Spleen rupture
• Acute respiratory distress syndrome (ARDS)
• 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. Evaluate patients who develop fever and lung infiltrates or respiratory distress for ARDS. Discontinue Zarxio in patients with ARDS.
• Serious allergic reactions, including anaphylaxis, have been reported in patients receiving filgrastim products. Permanently discontinue Zarxio in patients with serious allergic reactions.
• Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving filgrastim products. Discontinue Zarxio if sickle cell crisis occurs.
• Glomerulonephritis has occurred in patients receiving filgrastim products. Evaluate and consider dose-reduction or interruption of Zarxio if causality is likely.
• Alveolar hemorrhage manifesting as pulmonary infiltrates and hemoptysis requiring hospitalization have been reported in healthy donors treated with filgrastim products undergoing peripheral blood progenitor cell (PBPC) collection mobilization.
• 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 with breast and lung cancer using Zarxio in conjunction with chemotherapy and/or radiotherapy for signs and symptoms of MDS/AML.
• Thrombocytopenia has been reported in patients receiving filgrastim products. Monitor platelet counts.
• Cutaneous vasculitis has been reported in patients treated with filgrastim products. Hold Zarxio therapy in patients with cutaneous vasculitis. Zarxio may be started at a reduced dose when the symptoms resolve and the ANC has decreased.
• The safety of filgrastim products in chronic myeloid leukemia (CML) and myelodysplasia has not been established.
• The safety and efficacy of Zarxio given simultaneously with cytotoxic chemotherapy have not been established. The safety and efficacy of Zarxio have not been evaluated in patients receiving concurrent radiation therapy. Avoid the simultaneous use of Zarxio with chemotherapy and radiation therapy.
• Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone-imaging changes. This should be considered when interpreting bone-imaging results.
• Aortitis has been reported in patients receiving filgrastim products. Consider aortitis in patients who develop these signs and symptoms without known etiology. Discontinue Zarxio 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 Zarxio 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-sndz
• Inactive ingredients: glutamic acid, polysorbate 80, sorbitol, sodium hydroxide, water for injection

Who manufactures and distributes this medicine?

Manufactured by:

• Sandoz Inc., Princeton, NJ , US License No. 2003

At:

• Sandoz GmbH, Langkampfen, Austria, Product of Austria

What should I know about storage and disposal of this medication?

• Store Zarxio in the refrigerator between 36°F to 46°F (2°C to 8°C).
• Do not freeze.
• Store Zarxio in the original pack to protect it from light.
• Do not shake Zarxio.
• Take Zarxio out of the refrigerator 30 minutes before use and allow it to reach room temperature before preparing an injection.
• Zarxio may be allowed to reach room temperature for up to 24 hours. Throw away (dispose of) any Zarxio that has been left at room temperature for longer than 24 hours.
• After you inject your dose, throw away (dispose of) any unused Zarxio left in the prefilled syringe. Do not save unused Zarxio in the prefilled syringe for later use.

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