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Rolvedon Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Single-dose prefilled syringe—1 (w. supplies)
Manufacturer
Generic Availability
NO
Rolvedon Indications
Indications
To decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with clinically significant incidence of febrile neutropenia.
Limitations of Use
Not for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.
Rolvedon Dosage and Administration
Adult
Give 13.2mg by SC inj once per chemotherapy cycle. Administer ~24 hours after cytotoxic chemotherapy. Do not give within the period from 14 days before to 24 hours after administration of cytotoxic chemotherapy.
Children
Not established.
Rolvedon Contraindications
Contraindications
History of serious allergic reactions, including anaphylaxis, to eflapegrastim, pegfilgrastim, or filgrastim products.
Rolvedon Boxed Warnings
Not Applicable
Rolvedon Warnings/Precautions
Warnings/Precautions
Monitor for enlarged spleen or splenic rupture, and for acute respiratory distress syndrome (ARDS); evaluate if symptoms occur; discontinue if ARDS is diagnosed. Permanently discontinue if serious allergic reactions occur. Sickle cell disorders; discontinue if sickle cell crisis occurs. Evaluate if glomerulonephritis is suspected; consider dose reduction or interruption if treatment-related. Monitor CBCs, platelets during therapy; discontinue if WBC count ≥100x109/L occurs. Monitor closely if symptoms of capillary leak syndrome develop. Discontinue if aortitis is suspected. Tumor growth factor (eg, myeloid malignancies, myelodysplasia). Monitor for MDS/AML in those with breast or lung cancer. Possible transient (+) bone imaging changes in nuclear imaging. Pregnancy. Nursing mothers.
Rolvedon Pharmacokinetics
See Literature
Rolvedon Interactions
Not Applicable
Rolvedon Adverse Reactions
Adverse Reactions
Fatigue, nausea, diarrhea, bone pain, headache, pyrexia, anemia, rash, myalgia, arthralgia, back pain; ARDS, splenic rupture, glomerulonephritis, leukocytosis, capillary leak syndrome, thrombocytopenia.
Rolvedon Clinical Trials
See Literature
Rolvedon Note
Not Applicable
Rolvedon Patient Counseling
See Literature
