STIMUFEND 6 mg/.6mL
pegflilgrastim-fpgk · INJECTION, SOLUTION · Fresenius Kabi USA, LLC
STIMUFEND is a injection, solution containing pegflilgrastim-fpgk at 6 mg/.6mL, taken subcutaneous. Manufactured by Fresenius Kabi USA, LLC.
Key Facts
- Brand Name
- STIMUFEND
- Generic Name
- pegflilgrastim-fpgk
- NDC Code (Product)
65219-371- Manufacturer
- Fresenius Kabi USA, LLC
- Strength
- 6 mg/.6mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- BLA761173
- Drug Class
- Leukocyte Growth Factor [EPC]
- Marketing Start
- 10/06/2022
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Stimufend is a leukocyte growth factor 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. ( 1.1 ) Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome). ( 1.2 ) Limitations of Use Stimufend is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy 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 [see Clinical Studies ( 14.1 )] . Limitations of Use Stimufend is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.2 Patients with Hematopoietic Subsyndrome of Acute Radiation Syndrom…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Patients with cancer receiving myelosuppressive chemotherapy 6 mg administered subcutaneously once per chemotherapy cycle. ( 2.1 ) Do not administer between 14 days before and 24 hours after administration of cytotoxic chemotherapy. ( 2.1 ) Use weight-based dosing for pediatric patients weighing less than 45 kg; refer to Table 1 . ( 2.3 ) Patients acutely exposed to myelosuppressive doses of radiation Two doses, 6 mg each, administered subcutaneously one week apart. Administer the first dose as soon as possible after suspected or confirmed exposure to myelosuppressive doses of radiation, and a second dose one week after. ( 2.2 ) Use weight-based dosing for pediatric patients weighing less than 45 kg; refer to Table 1 . ( 2.3 ) 2.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy The recommended dosage of Stimufend is a single subcutaneous injection of 6 mg administered once per chemotherapy cycle. For dosing in pediatric patients weighing less than 45 kg, refer to Table 1 . Do not administer Stimufend between 14 days before and 24 hours after administration of cytotoxic chemotherapy. 2.2 Patients with Hematopoietic Subsyndrome of Acute Radiat…
Contraindications
4 CONTRAINDICATIONS Stimufend is contraindicated in patients with a history of serious allergic reactions to pegfilgrastim products or filgrastim products. Reactions have included anaphylaxis [see Warnings and Precautions ( 5.3 )] . Patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as pegfilgrastim products or filgrastim products. ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant 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 )] Use in Patients with Sickle Cell Disorders [see Warnings and Precautions ( 5.4 )] Glomerulonephritis [see Warnings and Precautions ( 5.5 )] Leukocytosis [see Warnings and Precautions ( 5.6 )] Thrombocytopenia [see Warnings and Precautions ( 5.7 )] Capillary Leak Syndrome [see Warnings and Precautions ( 5.8 )] Potential for Tumor Growth Stimulatory Effects on Malignant Cells [see Warnings and Precautions ( 5.9 )] Myelodysplastic syndrome [see Warnings and Precautions ( 5.10 )] Acute myeloid leukemia [see Warnings and Precautions ( 5.10 )] Aortitis [see Warnings and Precautions ( 5.11 )] Most common adverse reactions (≥ 5% difference in incidence compared to placebo) are bone pain and pain in extremity. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Northstar Rx LLC at 1-800-206-7821 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinica…
Frequently Asked Questions
What is STIMUFEND used for?
STIMUFEND contains pegflilgrastim-fpgk. It is a injection, solution taken subcutaneous. Consult your doctor for specific uses.
Is STIMUFEND a controlled substance?
STIMUFEND is not classified as a controlled substance by the DEA.
What is the generic name for STIMUFEND?
The generic name for STIMUFEND is pegflilgrastim-fpgk. There are no other listed brand versions of pegflilgrastim-fpgk.
What is the NDC code for STIMUFEND 6 mg/.6mL?
The NDC (National Drug Code) for STIMUFEND 6 mg/.6mL is 65219-371, listed by Fresenius Kabi USA, LLC.
Other STIMUFEND Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)