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IMPORTANT SAFETY INFORMATION

Do not administer Fulphila to patients with a history of serious allergic reactions, including anaphylaxis, to pegfilgrastim or filgrastim.

Splenic rupture, including fatal cases, can occur following the administration of pegfilgrastim products. Evaluate for an enlarged spleen or splenic rupture in patients who report left upper abdominal or shoulder pain after receiving Fulphila.

Indication

Fulphila® is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti cancer drugs associated with a clinically significant incidence of febrile neutropenia.

Limitations of Use:

Fulphila is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

IMPORTANT SAFETY INFORMATION

Do not administer Fulphila to patients with a history of serious allergic reactions, including anaphylaxis, to pegfilgrastim or filgrastim.

Splenic rupture, including fatal cases, can occur following the administration of pegfilgrastim products. Evaluate for an enlarged spleen or splenic rupture in patients who report left upper abdominal or shoulder pain after receiving Fulphila.

Acute respiratory distress syndrome (ARDS) can occur in patients receiving pegfilgrastim products. Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving Fulphila for ARDS. Discontinue Fulphila in patients with ARDS.

Serious allergic reactions, including anaphylaxis, can occur in patients receiving pegfilgrastim products. The majority of reported events occurred upon initial exposure and can recur within days after discontinuation of initial anti-allergic treatment. Permanently discontinue Fulphila in patients with serious allergic reactions to any pegfilgrastim or filgrastim products.

Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving pegfilgrastim products. Discontinue if sickle cell crisis occurs.

Glomerulonephritis has been reported in patients receiving pegfilgrastim products. The diagnoses were based upon azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Generally, events of glomerulonephritis resolved after withdrawal of pegfilgrastim products. If glomerulonephritis is suspected, evaluate for cause. If causality is likely, consider dose-reduction or interruption of Fulphila.

White blood cell counts of 100 x 109/L or greater have been observed in patients receiving pegfilgrastim products. Monitoring of CBCs during therapy with Fulphila is recommended.

Thrombocytopenia has been reported in patients receiving pegfilgrastim. Monitor platelet counts.

Capillary leak syndrome has been reported after granulocyte colony-stimulating factor (G-CSF) administration, including pegfilgrastim products, and is characterized by hypotension, hypoalbuminemia, edema, and hemoconcentration. Episodes vary in frequency, severity and may be life-threatening if treatment is delayed. 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.

The G-CSF receptor, through which pegfilgrastim and filgrastim products act, has been found on tumor cell lines. The possibility that pegfilgrastim products act as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which pegfilgrastim products are not approved, cannot be excluded.

Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML) have been associated with the use of pegfilgrastim 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.

Aortitis has been reported in patients receiving pegfilgrastim products. It may occur as early as the first week after start of therapy. Manifestations may include generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (e.g., c-reactive protein and white blood cell count). Consider aortitis in patients who develop these signs and symptoms without known etiology and discontinue Fulphila if aortitis is suspected.

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.

The most common adverse reactions (≥ 5% difference in incidence) in placebo-controlled clinical trials are bone pain and pain in extremity.

FULPHILA® is an effective treatment option for patients with febrile neutropenia

For FDA approval, FULPHILA was demonstrated to be highly similar to an existing FDA-approved biological product referred to as the reference product or reference biologic.

Biosimilar

“FDA requires biosimilar…products meet the Agency’s rigorous approval standards. That means patients and health care professionals will be able to rely upon the safety and effectiveness of the biosimilar…just as they would the reference product.”
— FDA2

Studies demonstrated that pegfilgrastim* resulted in a 94% reduction in febrile neutropenia (FN) with patients receiving chemotherapy for up to 4 cycles

Study design

Phase 3, multicenter, multinational, double-blind, placebo-controlled trial of patients with breast cancer receiving 100 mg/m2 docetaxel for up to 4 cycles. Included 928 patients initially receiving placebo (n=465) or NEULASTA® (n=463). Primary endpoint was the percentage of patients who developed FN.1,3

Efficacy at par with the reference product4

Confirmatory Phase III study demonstrated equivalent efficacy to the reference product4 in the reduction of chemotherapy-induced febrile neutropenia in breast cancer patients.

Study design

Randomized, double-blind, parallel-group trial evaluating equivalence of FULPHILA vs. reference pegfilgrastim in patients with breast cancer eligible to receive neoadjuvant or adjuvant TAC chemotherapy. The primary endpoint was the duration of severe neutropenia in cycle 1 defined as ANC < 0.5 x 109/L.

Mylan

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