- GRANIX is a leukocyte growth factor indicated for reduction in the duration
of severe neutropenia in patients with nonmyeloid malignancies receiving myelosuppressive
anticancer drugs associated with a clinically significant incidence of febrile
- Splenic rupture: Splenic rupture, including fatal cases, can occur following the administration of
human granulocyte colony-stimulating factors (hG-CSFs). Discontinue GRANIX
and evaluate for an enlarged spleen or splenic rupture in patients who report upper
abdominal or shoulder pain after receiving GRANIX.
- Acute respiratory distress syndrome (ARDS): ARDS can occur in patients receiving hG-CSFs.
Evaluate patients who develop fever and lung infiltrates or respiratory distress
after receiving GRANIX, for ARDS. Discontinue GRANIX in patients
- Allergic reactions: Serious allergic reactions, including anaphylaxis, can occur in patients receiving
hG-CSFs. Reactions can occur on initial exposure.
Permanently discontinue GRANIX in patients with serious allergic reactions.
Do not administer GRANIX to patients with a history of serious allergic
reactions to filgrastim or pegfilgrastim.
- Use in patients with sickle cell disease: Severe and sometimes fatal sickle cell crises can occur in patients with sickle
cell disease receiving hG-CSFs. Consider the potential risks and benefits prior
to the administration of GRANIX in patients with sickle cell disease. Discontinue
GRANIX in patients undergoing a sickle cell crisis.
- Potential for tumor growth stimulatory effects on malignant cells: The granulocyte colony-stimulating factor (G-CSF) receptor, through which GRANIX
acts, has been found on tumor cell lines. The possibility that GRANIX acts
as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia,
diseases for which GRANIX is not approved, cannot be excluded.
- Most common treatment-emergent adverse reaction: The most common treatment-emergent adverse reaction that occurred in patients treated
with GRANIX at the recommended dose with an incidence of at least 1% or
greater and two times more frequent than in the placebo group was bone pain.
Please see Full Prescribing Information.