01). The incidence of hospitalizations (1% versus 14%) and IV anti-infective use (2% versus 10%) for the treatment of febrile neutropenia were also lower in the Neulasta®-treated patients compared with the placebo-treated patients.
INDICATIONS AND USAGE
Neulasta® is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non‑myeloid malignancies receiving myelosuppressive anti‑cancer drugs associated with a clinically significant incidence of febrile neutropenia (see CLINICAL STUDIES).
CONTRAINDICATIONS
Neulasta® is contraindicated in patients with known hypersensitivity to E coli‑derived proteins‚ pegfilgrastim‚ Filgrastim, or any other component of the product.
WARNINGS
General
The safety and efficacy of Neulasta® for peripheral blood progenitor cell (PBPC) mobilization has not been eva luated in adequate and well-controlled studies. Neulasta® should not be used for PBPC mobilization.
Splenic Rupture
RARE CASES OF SPLENIC RUPTURE HAVE BEEN REPORTED FOLLOWING THE ADMINISTRATION OF NEULASTA®. SPLENIC RUPTURE, IN SOME CASES RESULTING IN DEATH, HAS ALSO BEEN ASSOCIATED WITH FILGRASTIM, THE PARENT COMPOUND OF NEULASTA®. PATIENTS RECEIVING NEULASTA® WHO REPORT LEFT UPPER ABDOMINAL AND/OR SHOULDER TIP PAIN SHOULD BE eva lUATED FOR AN ENLARGED SPLEEN OR SPLENIC RUPTURE.
Adult Respiratory Distress Syndrome (ARDS)
Adult respiratory distress syndrome (ARDS) has been reported in neutropenic patients with sepsis receiving Filgrastim, the parent compound of Neulasta®, and is postulated to be secondary to an influx of neutrophils to sites of inflammation in the lungs. Neutropenic patients receiving Neulasta® who develop fever, lung infiltrates, or respiratory distress should be eva luated for the possibility of ARDS. In the event that ARDS occurs, Neulasta® should be discontinued and/or withheld until resolution of ARDS and patients should receive appropriate medical management for this condition.
Allergic Reactions
Allergic reactions to Neulasta®, including anaphylaxis, skin rash, and urticaria, have been reported in postmarketing experience. The majority of reported events occurred upon initial exposure. In some cases, symptoms recurred with rechallenge, suggesting a causal relationship. In rare cases, allergic reactions including anaphylaxis, recurred within days after initial anti-allergic treatment was discontinued. If a serious allergic reaction occurs, appropriate therapy should be administered, with close patient follow-up over several days. Neulasta® should be permanently discontinued in patients with serious allergic reactions.
Sickle Cell Disease
Severe sickle cell crises have been associated with the use of Neulasta® in patients with sickle cell disease. Severe sickle cell crises, in some cases resulting in death, have also been associated with Filgrastim, the parent compound of pegfilgrastim. Only physicians qualified by specialized training or experience in the treatment of patients with sickle cell disease should prescribe Neulasta® for such patients, and only after careful consideration of the potential risks and benefits.
PRECAUTIONS
General
Use With Chemotherapy and/or Radiation Therapy
Neulasta® should not be administered in the period between 14 days before and 24 hours after administration of cytotoxic chemothe |
