Pegfilgrastim is a leukocyte growth factor used to reduce the incidence of febrile neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer therapy that is associated with a clinically significant risk of neutropenia.

The recommended dosage of Pegfilgrastim is a single subcutaneous injection of 6 mg, administered once per chemotherapy cycle in adults. Do not administer Pegfilgrastim between 14 days before and 24 hours after administration of cytotoxic chemotherapy. Visually inspect the solution for particulate matter or discoloration before administration. Do not administer Pegfilgrastim if the solution is discolored or contains particles.
Note: The needle cover on the pre-filled syringe contains natural rubber (latex), which may cause allergic reactions in individuals with latex sensitivity.

Pegfilgrastim should not be administered to patients with a history of serious allergic reactions to pegfilgrastim or filgrastim.

Fatal splenic rupture: Splenic rupture, including fatal cases, has been reported following pegfilgrastim administration. Evaluate for splenomegaly or splenic rupture in patients experiencing left upper abdominal pain or shoulder pain.
Acute Respiratory Distress Syndrome (ARDS): ARDS may occur. Monitor for symptoms such as fever, lung infiltrates, or respiratory distress. Discontinue Pegfilgrastim in patients developing ARDS.
Serious allergic reactions: Reactions such as anaphylaxis may occur. Some cases have been delayed and occurred days after initial exposure. Permanently discontinue Pegfilgrastim in patients with serious allergic reactions. Do not administer Pegfilgrastim to patients with a history of allergic reactions to the drug.
Patients with sickle cell disorders: Severe and sometimes fatal sickle cell crises have been reported in patients with sickle cell disease receiving Pegfilgrastim or its parent compound (filgrastim).

Splenic Rupture: Splenic rupture, including fatal cases, has been reported following Pegfilgrastim administration. Evaluate for an enlarged spleen or rupture in patients experiencing upper abdominal or shoulder pain.
Acute Respiratory Distress Syndrome (ARDS): ARDS may develop in patients receiving Pegfilgrastim. Monitor for symptoms such as fever, respiratory distress, and lung infiltrates. Discontinue Pegfilgrastim in patients diagnosed with ARDS.
Serious Allergic Reactions: Serious allergic reactions, including anaphylaxis, have been reported. Most cases occurred upon initial exposure, but allergic reactions may also recur days after drug administration. Discontinue Pegfilgrastim permanently in patients with severe allergic reactions.
Patients with Sickle Cell Disorders: Severe sickle cell crises, including fatal cases, have been reported in patients with sickle cell disease receiving Pegfilgrastim.

Pregnancy – Category C: There are no adequate and well-controlled studies of Pegfilgrastim use in pregnant women. In animal studies, Pegfilgrastim was embryotoxic and increased pregnancy loss at doses approximately 4 times the recommended human dose based on body surface area. Pegfilgrastim should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers: It is not known whether Pegfilgrastim is excreted in human breast milk. Other recombinant G-CSF products are poorly excreted in breast milk and are not orally absorbed by neonates. Caution should be exercised when administering Pegfilgrastim to nursing mothers.
Pediatric Use: The safety and effectiveness of Pegfilgrastim in pediatric patients have not been established.
Geriatric Use: Of the 932 cancer patients who received Pegfilgrastim in clinical studies, 150 (16%) were aged 65 and over, and 24 (3%) were aged 75 and over. No overall differences in safety or effectiveness were observed between older and younger patients.
Renal Impairment: In a study of 30 subjects with varying degrees of renal impairment, including end-stage renal disease, renal dysfunction had no effect on the pharmacokinetics of Pegfilgrastim. Therefore, no dose adjustment is necessary in patients with renal impairment.

No formal drug interaction studies have been performed with Pegfilgrastim. However, the increased bone marrow activity in response to growth factors may result in temporary positive bone imaging changes. Consider these findings when interpreting bone-imaging results. This product must not be mixed with other medications, particularly sodium chloride solutions.

The maximum dose of Pegfilgrastim that can be safely administered has not been determined. Single subcutaneous doses of 300 mcg/kg have been administered to healthy volunteers and cancer patients with non-small cell lung cancer without serious adverse effects. In these patients, the mean peak absolute neutrophil count (ANC) was 58 × 10⁹/L, with a corresponding mean peak white blood cell (WBC) count of 67 × 10⁹/L. The highest observed ANC was 95 × 10⁹/L, with a corresponding WBC count of 120 × 10⁹/L.

Store in a refrigerator (2–8°C).
Do not freeze.
Do not shake.
Protect from light.
