White blood cell disorders:

Indications for: ROLVEDON

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.

Adult Dosage:

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 Dosage:

Not established.

ROLVEDON Contraindications:

History of serious allergic reactions, including anaphylaxis, to eflapegrastim, pegfilgrastim, or filgrastim products.

ROLVEDON 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 Classification:

Granulocyte colony stimulating factor.

Adverse Reactions:

Fatigue, nausea, diarrhea, bone pain, headache, pyrexia, anemia, rash, myalgia, arthralgia, back pain; ARDS, splenic rupture, glomerulonephritis, leukocytosis, capillary leak syndrome, thrombocytopenia.

Generic Drug Availability:


How Supplied:

Single-dose prefilled syringe—1 (w. supplies)