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Clinical Data in Support of BiosimilarityMultiple-dose, crossover study to assess PD/PK similarity in healthy volunteers (N=60)NIVESTYM PD/PK Study Description1
  • This was a randomized, open-label, multiple-dose crossover study evaluating the PD and PK equivalence following SC administration of NIVESTYM® (filgrastim-aafi) and Neupogen® (filgrastim) in healthy volunteers

  • The study was conducted at a single phase 1 unit in the United States

Primary PD endpoint: All subjects who completed the study and had sufficient data to calculate the primary PD variables (AUECCD34+ and CD34+max) were included in the PD population. Sufficient data were defined as having more than 3 measurable values in addition to the pre-dose samples and 120-hour sample, such that the primary endpoints could be reliably calculated. The PD population was the primary analysis set for the primary PD analyses.

Secondary PD endpoint: The secondary PD variable was the time to maximum observed CD34+ count. ReferencesAUECCD34+=area under the effect curve for CD34+ count; CD34+max=maximum observed CD34+ count; PD=pharmacodynamic; PK=pharmacokinetic; SC=subcutaneous.

Subjects were administered study medication for 5 consecutive days at a dose of 5 mcg/kg/day.

 NIVESTYM PD/PK Study Results

PD analysis established equivalence to Neupogen in support of biosimilarity1

Primary PD endpoint of CD34+ cells for PD population was similar across treatment groups.

PD population: n=56 (NIVESTYM); n=56 (Neupogen).
PD equivalence was concluded if the 90% confidence intervals for both AUECCD34+ and CD34+max were completely contained within the prespecified acceptance limits of 0.80-1.25.

 NIVESTYM showed a similar safety profile to Neupogen across adverse event categories1

Studies in support of biosimilarity in healthy volunteers

 Review Safety DataLoading
Reference:Data on file. Pfizer Inc.; New York, NY.
NIVESTYM® (filgrastim-aafi) is a registered trademark of Pfizer Inc.Neupogen® (filgrastim) is a registered trademark of Amgen Inc.

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You are now leaving PfizerPro You are now leaving www.pfizerpro.co.uk. Links to external websites are provided as a resource to the viewer. This website is neither owned nor controlled by Pfizer Ltd. Pfizer accepts no responsibility for the content or services of the linked site other than the information or other materials relating to Pfizer medicines or business which it has provided or reviewed. PP-PFE-GBR-3859. November 2021
INDICATIONSPatients With Cancer Receiving Myelosuppressive Chemotherapy
  • NIVESTYM® 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 significant incidence of severe neutropenia with fever
Patients With Acute Myeloid Leukemia Receiving Induction or Consolidation Chemotherapy
  • NIVESTYM® is indicated for reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML)
Patients With Cancer Undergoing Bone Marrow Transplantation
  • NIVESTYM® is indicated to reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ eg, febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by BMT
Patients Undergoing Autologous Peripheral Blood Progenitor Cell Collection and Therapy
  • NIVESTYM® is indicated for the mobilization of autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis
Patients With Severe Chronic Neutropenia
  • NIVESTYM® is indicated for chronic administration to reduce the incidence and duration of sequelae of neutropenia (eg‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia
Please see full Prescribing Information, including Patient Information, and Instructions for Use, for NIVESTYM.
Important Safety Information CONTRAINDICATIONSNIVESTYM® is contraindicated in patients with a history of serious allergic reactions to human granulocyte-colony stimulating factors (G-CSF), such as filgrastim products or pegfilgrastim products.WARNINGS AND PRECAUTIONSSplenic RuptureSplenic 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 SyndromeAcute 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 NIVESTYM® in patients with ARDS.Serious Allergic ReactionsSerious allergic reactions, including anaphylaxis, have been reported in patients receiving filgrastim products. The majority of reported events occurred upon initial exposure. Provide symptomatic treatment for allergic reactions. Allergic reactions, including anaphylaxis, in patients receiving filgrastim products can recur within days after the discontinuation of initial anti-allergic treatment. Permanently discontinue NIVESTYM® in patients with serious allergic reactions. NIVESTYM® is contraindicated in patients with a history of serious allergic reactions to human G-CSF such as filgrastim products or pegfilgrastim products.Sickle Cell DisordersSevere and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving filgrastim products. Discontinue NIVESTYM® if sickle cell crisis occurs.GlomerulonephritisGlomerulonephritis has occurred in patients receiving filgrastim products. The diagnoses were based upon azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Generally, events of glomerulonephritis resolved after dose reduction or discontinuation of filgrastim products. If glomerulonephritis is suspected, evaluate for cause. If causality is likely, consider dose-reduction or interruption of NIVESTYM®.Alveolar Hemorrhage and HemoptysisAlveolar hemorrhage manifesting as pulmonary infiltrates and hemoptysis requiring hospitalization has been reported in healthy donors treated with filgrastim products undergoing peripheral blood progenitor cell (PBPC) collection mobilization. Hemoptysis resolved with discontinuation of filgrastim products. The use of NIVESTYM® for PBPC mobilization in healthy donors is not an approved indication.Capillary Leak SyndromeCapillary leak syndrome (CLS) has been reported after G-CSF administration, including filgrastim products, and is characterized by hypotension, hypoalbuminemia, edema, and hemoconcentration. Episodes vary in frequency and severity and may be life-threatening if treatment is delayed. Patients who develop symptoms of CLS should be closely monitored and receive standard symptomatic treatment, which may include the need for intensive care.Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML)Patients With Severe Chronic Neutropenia (SCN)Confirm the diagnosis of SCN before initiating NIVESTYM® therapy. MDS and AML have been reported to occur in the natural history of congenital neutropenia without cytokine therapy. Cytogenetic abnormalities, transformation to MDS, and AML have also been observed in patients treated with filgrastim products for SCN. Based on available data including a post-marketing surveillance study, the risk of developing MDS and AML appears to be confined to the subset of patients with congenital neutropenia. Abnormal cytogenetics and MDS have been associated with the eventual development of myeloid leukemia. The effect of filgrastim products on the development of abnormal cytogenetics and the effect of continued filgrastim product administration in patients with abnormal cytogenetics or MDS are unknown. Monitor patients for signs and symptoms of MDS/AML in these settings. If a patient with SCN develops abnormal cytogenetics or myelodysplasia‚ the risks and benefits of continuing NIVESTYM® should be carefully considered.Patients with Breast and Lung CancerMDS 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.ThrombocytopeniaThrombocytopenia has been reported in patients receiving filgrastim products. Monitor platelet counts.LeukocytosisPatients With Cancer Receiving Myelosuppressive Chemotherapy:White blood cell counts of 100,000/mm3 or greater were observed in approximately 2% of patients who received filgrastim at dosages above 5 mcg/kg/day. In patients with cancer receiving NIVESTYM® as an adjunct to myelosuppressive chemotherapy, to avoid the potential risks of excessive leukocytosis, it is recommended that NIVESTYM® therapy be discontinued if the absolute neutrophil count (ANC) surpasses 10,000/mm3 after the chemotherapy-induced ANC nadir has occurred. Monitor CBCs at least twice weekly during therapy. Dosages of NIVESTYM® that increase the ANC beyond 10,000/mm3 may not result in any additional clinical benefit. In patients with cancer receiving myelosuppressive chemotherapy, discontinuation of filgrastim therapy usually resulted in a 50% decrease in circulating neutrophils within 1 to 2 days, with a return to pretreatment levels in 1 to 7 days.Peripheral Blood Progenitor Cell Collection and Therapy:During the period of administration of NIVESTYM® for PBPC mobilization in patients with cancer, discontinue NIVESTYM® if the leukocyte count rises to >100,000/mm3.Cutaneous VasculitisCutaneous vasculitis has been reported in patients treated with filgrastim products. In most cases, the severity of cutaneous vasculitis was moderate or severe. Most of the reports involved patients with SCN receiving long-term filgrastim therapy. Hold NIVESTYM® therapy in patients with cutaneous vasculitis. NIVESTYM® may be started at a reduced dose when the symptoms resolve and the ANC has decreased.Potential Effect on Malignant CellsNIVESTYM® is a growth factor that primarily stimulates neutrophils. The G-CSF receptor through which NIVESTYM® acts has also been found on tumor cell lines. The possibility that NIVESTYM® acts as a growth factor for any tumor type cannot be excluded. The safety of filgrastim products in chronic myeloid leukemia (CML) and myelodysplasia has not been established.When NIVESTYM® is used to mobilize PBPC, tumor cells may be released from the marrow and subsequently collected in the leukapheresis product. The effect of reinfusion of tumor cells has not been well studied, and the limited data available are inconclusive.Simultaneous Use With Chemotherapy and Radiation Not RecommendedThe safety and efficacy of NIVESTYM® given simultaneously with cytotoxic chemotherapy have not been established. Because of the potential sensitivity of rapidly dividing myeloid cells to cytotoxic chemotherapy, do not use NIVESTYM® in the period 24 hours before through 24 hours after the administration of cytotoxic chemotherapy.The safety and efficacy of NIVESTYM® have not been evaluated in patients receiving concurrent radiation therapy. Avoid the simultaneous use of NIVESTYM® with chemotherapy and radiation therapy.Nuclear ImagingIncreased 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.AortitisAortitis has been reported in patients receiving filgrastim 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 (eg, c-reactive protein and white blood cell count). Consider aortitis in patients who develop these signs and symptoms without known etiology. Discontinue NIVESTYM® if aortitis is suspected.ADVERSE REACTIONS
The most common adverse reactions in patients:
  • with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs (≥5% difference in incidence compared to placebo) are anemia, constipation, diarrhea, oral pain, vomiting, asthenia, malaise, peripheral edema, decreased hemoglobin, decreased appetite, oropharyngeal pain, and alopecia
  • with AML (≥2% difference in incidence) are epistaxis, back pain, pain in extremity, erythema, maculopapular rash, diarrhea, constipation, and transfusion reaction
  • with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT) (≥5% difference in incidence) are rash, hypersensitivity, thrombocytopenia, anemia, hypertension, sepsis, bronchitis, and insomnia
  • undergoing peripheral blood progenitor cell mobilization and collection (≥5% incidence) are bone pain, pyrexia, increased blood alkaline phosphatase, and headache
  • with severe chronic neutropenia (≥5% difference in incidence) are arthralgia, bone pain, back pain, muscle spasms, musculoskeletal pain, pain in extremity, splenomegaly, anemia, upper respiratory tract infection, urinary tract infection, epistaxis, chest pain, diarrhea, hypoesthesia, and alopecia
This product’s labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.IndicationsPatients With Cancer Receiving Myelosuppressive Chemotherapy
  • NIVESTYM® 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 significant incidence of severe neutropenia with fever
Patients With Acute Myeloid Leukemia Receiving Induction or Consolidation Chemotherapy
  • NIVESTYM® is indicated for reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML)
Patients With Cancer Undergoing Bone Marrow Transplantation
  • NIVESTYM® is indicated to reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ eg, febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by BMT
Patients Undergoing Autologous Peripheral Blood Progenitor Cell Collection and Therapy
  • NIVESTYM® is indicated for the mobilization of autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis
Patients With Severe Chronic Neutropenia
  • NIVESTYM® is indicated for chronic administration to reduce the incidence and duration of sequelae of neutropenia (eg‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia
Please see full Prescribing Information, including Patient Information, and Instructions for Use, for NIVESTYM.