Rolvedon 13.2 mg/.6mL
eflapegrastim-xnst · INJECTION, SOLUTION · Spectrum Pharmaceuticals, Inc.
Rolvedon is a injection, solution containing eflapegrastim-xnst at 13.2 mg/.6mL, taken subcutaneous. Manufactured by Spectrum Pharmaceuticals, Inc..
Key Facts
- Brand Name
- Rolvedon
- Generic Name
- eflapegrastim-xnst
- NDC Code (Product)
76961-101- Manufacturer
- Spectrum Pharmaceuticals, Inc.
- Strength
- 13.2 mg/.6mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- BLA761148
- Drug Class
- Leukocyte Growth Factor [EPC]
- Marketing Start
- 10/18/2022
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Rolvedon is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia. Limitations of Use Rolvedon is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. Rolvedon is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia. ( 1 ) Limitations of Use Rolvedon is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • Recommended Dose: 13.2 mg administered subcutaneously once per chemotherapy cycle. ( 2.1 ) • Administer approximately 24 hours after cytotoxic chemotherapy. Do not administer within the period from 14 days before to 24 hours after administration of cytotoxic chemotherapy. ( 2.1 ) 2.1 Recommended Dosage The recommended dosage of Rolvedon is a single subcutaneous injection of 13.2 mg administered once per chemotherapy cycle. Administer approximately 24 hours after cytotoxic chemotherapy. Do not administer within the period from 14 days before to 24 hours after administration of cytotoxic chemotherapy. 2.2 Administration Rolvedon is administered subcutaneously via a single-dose prefilled syringe. Prior to use‚ take the carton out of the refrigerator and place the sealed blister tray on a clean flat surface for a minimum of 30 minutes to allow the product to reach room temperature. Do not warm up the prefilled syringe in any other way. Discard any prefilled syringe left at room temperature for greater than 72 hours. Do not shake. If Rolvedon is accidentally frozen, do not use. Remove the tray from box and carefully remove the prefilled syringe from the tra…
Contraindications
4 CONTRAINDICATIONS Rolvedon is contraindicated in patients with a history of serious allergic reactions to eflapegrastim, pegfilgrastim, or filgrastim products. Reactions may include anaphylaxis [see Warnings and Precautions ( 5.3 )] . Patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as eflapegrastim, pegfilgrastim 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 )] • Sickle cell crisis 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 (MDS) and Acute Myeloid Leukemia (AML) in Patients with Breast and Lung Cancer [see Warnings and Precautions ( 5.10 )] • Aortitis [see Warnings and Precautions ( 5.11 )] • Nuclear Imaging [see Warnings and Precautions ( 5.12 )] The most common adverse reactions (≥20%) are fatigue, nausea, diarrhea, bone pain, headache, pyrexia, anemia, rash, myalgia, arthralgia, and back pain. ( 6.1 …
Frequently Asked Questions
What is Rolvedon used for?
Rolvedon contains eflapegrastim-xnst. It is a injection, solution taken subcutaneous. Consult your doctor for specific uses.
Is Rolvedon a controlled substance?
Rolvedon is not classified as a controlled substance by the DEA.
What is the generic name for Rolvedon?
The generic name for Rolvedon is eflapegrastim-xnst. There are no other listed brand versions of eflapegrastim-xnst.
What is the NDC code for Rolvedon 13.2 mg/.6mL?
The NDC (National Drug Code) for Rolvedon 13.2 mg/.6mL is 76961-101, listed by Spectrum Pharmaceuticals, Inc..
Other Rolvedon Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)