Approved by the FDA
Ryzneuta® is contraindicated in patients with a history of serious allergic reactions to granulocyte stimulating factors such as efbemalenograstim alfa-vuxw, pegfilgrastim, or filgrastim products.
See moreRyzneuta® is contraindicated in patients with a history of serious allergic reactions to granulocyte stimulating factors such as efbemalenograstim alfa-vuxw, pegfilgrastim, or filgrastim products.
Splenic rupture, including fatal cases, can occur following the administration of recombinant human granulocyte colony stimulating factor (rhG-CSF) products. Evaluate patients who report left upper abdominal or shoulder pain for an enlarged spleen or splenic rupture.
ARDS can occur in patients receiving rhG-CSF products. Evaluate patients who develop fever and lung infiltrates or respiratory distress. Discontinue Ryzneuta® in patients with ARDS.
Serious allergic reactions, including anaphylaxis, can occur in patients receiving rhG-CSF products. Permanently discontinue Ryzneuta® in patients with serious allergic reactions. Ryzneuta® is contraindicated in patients with a history of serious allergic reactions to Ryzneuta® or other rhG-CSF products such as pegfilgrastim, eflapegrastim or filgrastim products.
Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving rhG-CSF products. Discontinue Ryzneuta® if sickle cell crisis occurs.
Glomerulonephritis has occurred in patients receiving rhG-CSF products. The diagnoses were based upon azotemia, hematuria (microscopic and macroscopic), proteinuria, and renal biopsy. Generally, events of glomerulonephritis resolved after dose-reduction or discontinuation. Evaluate and consider dose-reduction or interruption of Ryzneuta® if causality is likely.
White blood cell (WBC) counts of 100 × 109/L or greater have been observed in patients receiving rhG-CSF products. Monitor complete blood count (CBC) during Ryzneuta® therapy. Discontinue Ryzneuta® treatment if WBC count of 100 × 109/L or greater occurs.
Thrombocytopenia has been reported in patients receiving rhG-CSF products. Thrombocytopenia occurred in 11% of Ryzneuta®-treated patients. One patient (0.4%) experienced severe thrombocytopenia. Monitor platelet counts.
Capillary leak syndrome has been reported after administration of rhG-CSF products and is characterized by hypotension, hypoalbuminemia, edema and hemoconcentration. Episodes vary in frequency and severity, and may be life-threatening if treatment is delayed. If symptoms develop, closely monitor, and give standard symptomatic treatment, which may include a need for intensive care.
The granulocyte colony-stimulating factor (G-CSF) receptor through which Ryzneuta® acts has been found on tumor cell lines. The possibility that Ryzneuta® acts as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which Ryzneuta® is not approved, cannot be excluded.
MDS and AML have been associated with the use of rhG-CSF products in conjunction with chemotherapy and/or radiotherapy in patients with breast and lung cancer. Monitor patients for signs and symptoms of MDS/AML in these settings.
Aortitis has been reported in patients receiving rhG-CSF products. It may occur as early as the first week after start of therapy. Consider aortitis in patients who develop generalized signs and symptoms such as fever, abdominal pain, malaise, back pain, and increased inflammatory markers (e.g., c-reactive protein and white blood cell count) without known etiology. Discontinue Ryzneuta® if aortitis is suspected.
Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes. This should be considered when interpreting bone imaging results.
In study GC-627-04, the most common adverse reactions (≥10%) through cycle 1 were nausea (51%), anemia (15%), and thrombocytopenia (12%). Other adverse reactions reported by ≥ 20% of Ryzneuta®-treated patients with breast cancer receiving myelosuppressive chemotherapy in study GC-627-05 were fatigue and bone pain.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088 (1-800-332-1088). You also may contact Acrotech Biopharma Inc. at 1-888-292-9617.