Neulasta (pegfilgrastim)

NEULASTA (pegfilgrastim) – a leukocyte growth factor that is commonly used to decrease the incidence of infection in patients receiving myelosuppressive anti-cancer drugs.

FDA approved uses: 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. Neulasta is NOT indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

Available dosage forms:

Prefilled Syringe – 0.6 mL solution with 6 mg of pegfilgrastim.

Usual dosage:  For subcutaneous injection only. Recommended dose is 6 mg once per chemotherapy cycle. Do not administer between 14 days before and 24 hours after administration of cytotoxic chemotherapy.

Contraindications:  Do not administer to patients with a history of serious allergic reactions to pegfilgrastim or filgrastim.

Special Warnings: Fatal splenic rupture can occur. Evaluate for splenomegaly or splenic rupture in patients with left upper abdominal or shoulder pain. Acute respiratory distress syndrome (ARDS) can occur. Evaluate for ARDS in patients who develop fever, lung infiltrates, or respiratory distress. Discontinue Neulasta in patients with ARDS. Serious allergic reactions, including anaphylaxis, can occur. Permanently discontinue Neulasta in patients with serious allergic reactions. Severe and sometimes fatal sickle cell crises can occur.

Adverse reactions (side effects) of these medications: The most common side effects of Neulasta include bone pain and pain in extremity. Other adverse reactions seen in clinical trials or post-marketing include: Leukocytosis, splenomegaly, splenic rupture, sickle cell crisis, allergic reactions, anaphylaxis, skin rash, urticaria, generalized erythema/flushing, ARDS, injection site reactions, Sweet’s syndrome, and cutaneous vasculitis.

Common drug interactions: None reported. However, one database recommends that lithium be used with caution during Neulasta therapy because of lithium’s potential to stimulate the release of neutrophils.

Special instructions for patients: Tell doctor if you have any of the following conditions: sickle cell disease, allergic reactions to pegfilgrastim, filgrastim, E. coli protein, other medicines, foods, dyes, or preservatives, pregnant or trying to get pregnant, or breastfeeding. Call doctor right away if any of the following symptoms are experienced: aches, pains, headache, loss of appetite, nausea and vomiting or unusual tiredness.

Full prescribing information may be found at the manufacturer’s official website Neulasta.com        or at the U.S. Food and Drug Administration’s website at Neulasta Info at Drugs@FDA

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