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761075s004lbl.pdf
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Summary

Fulphila (pegfilgrastim-jmdb) is a biosimilar to Neulasta (pegfilgrastim) used to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs. The recommended dosage is a single subcutaneous injection of 6 mg administered once per chemotherapy cycle, with weight-based dosing for pediatric patients weighing less than 45 kg. Fulphila is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. Contraindications include a history of serious allergic reactions to human granulocyte colony-stimulating factors. Warnings and precautions include fatal splenic rupture, acute respiratory distress syndrome, serious allergic reactions, fatal sickle cell crises, and glomerulonephritis. The most common adverse reactions are bone pain and pain in extremity.

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Fulphila (pegfilgrastim-jmdb) is a biosimilar to Neulasta (pegfilgrastim) used to decrease the incidence of infection, as manifested by febrile neutropenia, in...

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  • File Size: 802 KB
  • Pages: 20
  • Language: EN
  • Author: fda/cder
  • Total Downloads: 87
  • Last Updated: 1 month ago

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