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IMPORTANT SAFETY INFORMATION

Contraindication

Stimufend (pegfilgrastim-fpgk) is contraindicated in patients with a history of serious allergic reactions to pegfilgrastim products or filgrastim products
Reactions have included anaphylaxis

Splenic Rupture

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

Acute Respiratory Distress Syndrome (ARDS)

ARDS can occur in patients receiving pegfilgrastim products
Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving STIMUFEND
Discontinue STIMUFEND in patients with ARDS

Serious Allergic Reactions

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 the discontinuation of initial anti-allergic treatment
Permanently discontinue STIMUFEND in patients with serious allergic reactions

Use in Patients with Sickle Cell Disorders

In patients with sickle cell trait or disease, severe and sometimes fatal sickle cell crises can occur in patients receiving pegfilgrastim products
Discontinue STIMUFEND if sickle cell crisis occurs

Glomerulonephritis

Has occurred in patients receiving pegfilgrastim products
Diagnoses based on azotemia, hematuria, proteinuria, and renal biopsy
Generally, events resolved after dose-reduction or discontinuation of pegfilgrastim products
If suspected, evaluate for cause and if cause is likely, consider dose-reduction or interruption of STIMUFEND

Leukocytosis

Increased white blood cell counts of 100 x 10⁹/L have been observed
Monitoring of complete blood count (CBC) during STIMUFEND therapy is recommended

Thrombocytopenia

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

Capillary Leak Syndrome (CLS)

CLS has been reported after G-CSF administration, including pegfilgrastim products
Characterized by hypotension, hypoalbuminemia, edema and hemoconcentration
Episodes vary in frequency, severity and may be life-threatening if treatment is delayed
Patients with symptoms should be closely monitored and receive standard symptomatic treatment, which may include a need for intensive care

Potential for Tumor Growth Stimulatory Effects on Malignant Cells

G-CSF receptor 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) in Patients with Breast and Lung Cancer

MDS and AML have been associated with the use of pegfilgrastim 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

Aortitis

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. Discontinue STIMUFEND if aortitis is suspected

Nuclear Imaging

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

Most common adverse reactions

Bone pain
Pain in extremity

Indications and Usage

Stimufend 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 clinically significant incidence of febrile neutropenia.

Stimufend is indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome).

Limitations of Use

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

Please see Stimufend full Prescribing Information

Stimufend Injection: 6 mg/0.6 mL in a single-dose prefilled syringe for manual use only.

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IMPORTANT SAFETY INFORMATION

INDICATION

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IMPORTANT SAFETY INFORMATION

INDICATION