Pegstim Warnings

Splenic Rupture: Rare cases of splenic rupture resulting in deaths, have been reported following administration of Pegfilgrastim (Pegstim) for peripheral blood progenitor cell (PBPC) mobilization in both healthy donors and patients with cancer. A diagnosis of splenic rupture or splenomegaly should be considered in patients receiving Pegfilgrastim (Pegstim) and experiencing left upper abdominal pain and/or shoulder tip pain.
Respiratory Effects: Adult respiratory distress syndrome (ARDS) has been reported in neutropenic patients with sepsis receiving Pegfilgrastim (Pegstim). It has been postulated that an influx of neutrophils into sites of inflammation in the lungs may have caused such disease. The onset of pulmonary signs such as cough, fever and dyspnea in association with radiological signs of pulmonary infiltrates, and deterioration in pulmonary function manifesting as respiratory distress along with increased neutrophil count in neutropenic patients receiving Pegfilgrastim (Pegstim) may warrant evaluation for the presence of ARDS. In such circumstances Pegfilgrastim (Pegstim) should be discontinued and for withheld until ARDS has resolved, and the patients should receive appropriate treatment.
Sickle Cell Disease: Severe sickle cell crisis, resulting in deaths has been reported in patients with sickle cell disease (specifically, homozygous sickle cell anemia, sickle cell-hemoglobin C disease, and sickle cell-β+- thalassemia disease) who received Pegfilgrastim (Pegstim). Patients with sickle cell disease who receive Pegfilgrastim (Pegstim) should be well hydrated and monitored for the occurrence of sickle cell crisis. If severe sickle cell crisis occurs supportive care should be initiated, and interventions to ameliorate the underlying event (e.g., therapeutic red blood cell exchange transfusion) should be considered.
Allergic Reactions: Allergic reactions like skin rash, urticaria can occur in patients receiving Pegfilgrastim (Pegstim). The majority of reported events occurred upon initial exposure. In some cases, symptoms recurred with a rechallenge, suggesting a casual relationship.
Serious allergic reactions, including angioedema or anaphylaxis, can recur within days after the discontinuation of initial anti-allergic treatment. Permanently discontinue Pegfilgrastim (Pegstim) in patients with serious allergic reactions. Do not administer Pegfilgrastim (Pegstim) to patients with a history of serious allergic reactions to Pegfilgrastim or Filgrastim. Close follow up of the patients along with antihistamines should be the treatment of choice.