- 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 neutropenia.
- 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
- 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 with ARDS.
- 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.
- Capillary leak syndrome (CLS): CLS can occur
in patients receiving hG-CSFs and is characterized by hypotension, hypoalbuminemia,
edema and hemoconcentration. Episodes vary in frequency, severity and may be life-threatening
if treatment is delayed. Patients who develop symptoms of CLS should be closely
monitored and receive standard symptomatic treatment, which may include a need for
- 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.
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