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Anwendungsgebiete

GRANIX is indicated to reduce the duration of severe neutropenia in adult and pediatric patients 1 month and older with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia. GRANIX (tbo-filgrastim) is a leukocyte growth factor indicated in adult and pediatric patients 1 month and older for reduction in the duration of severe neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.

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Warnhinweise und Vorsichtsmaßnahmen

Splenic Rupture: Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture ( 5.1 ) Acute Respiratory Distress Syndrome (ARDS): Monitor for and manage immediately. Discontinue GRANIX if suspected ( 5.2 ) Serious Allergic Reactions Including Anaphylaxis: Permanently discontinue GRANIX in patients with serious allergic reactions ( 5.3 ) Sickle Cell Disorders: Severe and sometimes fatal crisis can occur.

Discontinue GRANIX if suspected ( 5.4 ) Glomerulonephritis: Evaluate and consider dose reduction or interruption of GRANIX if causality is likely ( 5.5 ) Capillary Leak Syndrome: Monitor if symptoms develop and administer standard symptomatic treatment ( 5.6 ) Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML): Monitor patients with breast and lung cancer using GRANIX in conjunction with chemotherapy and/or radiotherapy for signs and symptoms of MDS/AML.

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5.1

Anwendungsgebiete

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Warnhinweise und Vorsichtsmaßnahmen

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5.1

Nebenwirkungen

The following potential serious adverse reactions are discussed in greater detail in other sections of the labeling: Splenic Rupture [see Warnings and Precautions (5.1) ] Acute Respiratory Distress Syndrome [see Warnings and Precautions (5.2) ] Serious Allergic Reactions [see Warnings and Precautions (5.3) ] Sickle Cell Disorders [see Warnings and Precautions (5.4) ] Glomerulonephritis [see Warnings and Precautions (5.5) ] Capillary Leak Syndrome [see Warnings and Precautions (5.6) ] Potential for Tumor Growth Stimulatory Effects on Malignant Cells [see Warnings and Precautions (5.7) ] Myelodysplastic Syndrome and Acute Myeloid Leukemia [see Warnings and Precautions (5.8) ] Leukocytosis [ see Warnings and Precautions ( 5.9 ) ] Simultaneous Use with Chemotherapy and Radiation Therapy Not Recommended [see Warnings and Precautions ( 5.10 ) ] Aortitis [see Warnings and Precautions ( 5.12 ) ] Alveolar Hemorrhage [see Warnings and Precautions (5.13) ] Most common adverse reaction (≥1%) to GRANIX is bone pain ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals at 1 ‑ 866-832-8537 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Adverse Reactions in Adult Patients GRANIX clinical trials safety data are based upon the results of three randomized clinical trials in patients receiving myeloablative chemotherapy for breast cancer (N=348), lung cancer (N=240) and non-Hodgkin’s lymphoma (N=92).

In the breast cancer study, 99% of patients were female, the median age was 50 years, and 86% of patients were Caucasian. In the lung cancer study, 80% of patients were male, the median age was 58 years, and 95% of patients were Caucasian. In the non-Hodgkin’s lymphoma study, 52% of patients were male, the median age was 55 years, and 88% of patients were Caucasian. In all three studies a placebo (Cycle 1 of the breast cancer study only) or a non-U.S.-approved filgrastim product were used as controls.

Both GRANIX and the non-U.S.-approved filgrastim product were administered at 5 mcg/kg subcutaneously once daily beginning one day after chemotherapy for at least five days and continued to a maximum of 14 days or until an ANC of ≥10,000 x 10 6 /L after nadir was reached. Bone pain was the most frequent treatment-emergent adverse reaction that occurred in at least 1% or greater in patients treated with GRANIX at the recommended dose and was numerically two times more frequent than in the placebo group.

The overall incidence of bone pain in Cycle 1 of treatment was 3.4% (3.4% GRANIX, 1.4% placebo, 7.5% non-U.S.-approved filgrastim product). Leukocytosis In clinical studies, leukocytosis (WBC counts > 100,000 x 10 6 /L) was observed in less than 1% patients with non-myeloid malignancies receiving GRANIX. No complications attributable to leukocytosis were reported in clinical studies. Additional Adverse Reactions Other adverse reactions known to occur following administration of filgrastim products include myalgia, headache, vomiting, cutaneous vasculitis and thrombocytopenia.

Adverse Reactions in Pediatric Patients GRANIX clinical trials safety data in pediatric patients are based upon the results of one single-arm clinical trial in 50 pediatric patients who received myelosuppressive chemotherapy for treatment of solid tumors without marrow involvement [see Use in Special Populations ( 8.4 )] . In this study, GRANIX was administered at 5 mcg/kg subcutaneously once daily beginning one day after chemotherapy.

The most common (>5%) adverse reactions included thrombocytopenia (34%), pyrexia (8%), pain in extremity (6%), headache (6%) and diarrhea (6%).

6.2Postmarketing Experience

The following adverse reactions have been identified during post-approval use of GRANIX. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Sweet’s syndrome (acute febrile neutrophilic dermatosis), asthenia, diarrhea, and fatigue

Packung	Code	Status
TBO-FILGRASTIM 300MCG/0.5ML	BLA125294-001	Prescription
TBO-FILGRASTIM 480MCG/0.8ML	BLA125294-002	Prescription

Granix

Anwendungsgebiete

Gegenanzeigen

Warnhinweise und Vorsichtsmaßnahmen

5.1

Zwei Arzneimittel in einer Frage?

Granix

Anwendungsgebiete

Gegenanzeigen

Warnhinweise und Vorsichtsmaßnahmen

5.1

Zwei Arzneimittel in einer Frage?

5.2Acute Respiratory Distress Syndrome

5.3Serious Allergic Reactions

5.4Sickle Cell Disorders Severe

5.5Glomerulonephritis

5.6Capillary Leak Syndrome

5.7Potential for Tumor Growth Stimulatory Effects on Malignant Cells

5.9Leukocytosis

5.10Simultaneous Use with Chemotherapy and Radiation Therapy Not Recommended

5.11Nuclear Imaging

5.12Aortitis

5.13Alveolar Hemorrhage

Schwangerschaft und Stillzeit

8.1Pregnancy Risk Summary

Nebenwirkungen

6.1Clinical Trials Experience

6.2Postmarketing Experience

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