ARMLUPEG 6 mg/.6mL
pegfilgrastim-unne · INJECTION · Lupin Pharmaceuticals, Inc.
ARMLUPEG is a injection containing pegfilgrastim-unne at 6 mg/.6mL, taken subcutaneous. Manufactured by Lupin Pharmaceuticals, Inc..
Key Facts
- Brand Name
- ARMLUPEG
- Generic Name
- pegfilgrastim-unne
- NDC Code (Product)
70748-273- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Strength
- 6 mg/.6mL
- Dosage Form
- INJECTION
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- BLA761212
- Drug Class
- Leukocyte Growth Factor [EPC]
- Marketing Start
- 04/01/2026
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Armlupeg 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 Armlupeg is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy Armlupeg is indicated in adults and pediatric patients aged newborn and older 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 Armlupeg is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 1.2 Patients with Hematop…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Patients with cancer receiving myelosuppressive chemotherapy For adult patients of any weight and pediatric patients weighing 45 kg and greater, the recommended dosage is 6 mg subcutaneously once per chemotherapy cycle. (2.1) Do not administer between 14 days before and 24 hours after administration of chemotherapy. (2.1) Patients acutely exposed to myelosuppressive doses of radiation For adults of any weight and pediatric patients weighing 45 kg and greater, the recommended dosage is two doses, 6 mg each, 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) 2.1 Patients with Cancer Receiving Myelosuppressive Chemotherapy The recommended dosage of Armlupeg for adults of any weight and pediatric patients weighing at least 45 kg with cancer receiving myelosuppressive chemotherapy is a single subcutaneous injection of 6 mg administered once per chemotherapy cycle. Do not administer Armlupeg between 14 days before and 24 hours after administration of chemotherapy. 2.2 Patients with Hematopoietic Subsyndrome of Acute Ra…
Contraindications
4 CONTRAINDICATIONS Armlupeg is contraindicated in patients with a history of a serious hypersensitivity reaction to pegfilgrastim products or filgrastim products. Reactions have included anaphylaxis [see Warnings and Precautions (5.3)]. In patients with a history of serious hypersensitivity reaction to pegfilgrastim products or filgrastim products.
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 Hypersensitivity 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. To report SUSPECTED ADVERSE REACTIONS, contact Valorum Biologics, LLC at 1-844-576-2709 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. *Biosimilar means that th…
Frequently Asked Questions
What is ARMLUPEG used for?
ARMLUPEG contains pegfilgrastim-unne. It is a injection taken subcutaneous. Consult your doctor for specific uses.
Is ARMLUPEG a controlled substance?
ARMLUPEG is not classified as a controlled substance by the DEA.
What is the generic name for ARMLUPEG?
The generic name for ARMLUPEG is pegfilgrastim-unne. There are no other listed brand versions of pegfilgrastim-unne.
What is the NDC code for ARMLUPEG 6 mg/.6mL?
The NDC (National Drug Code) for ARMLUPEG 6 mg/.6mL is 70748-273, listed by Lupin Pharmaceuticals, Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)