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Drug: Pegfilgrastim-fpgk
Brand: Stimufend 6mg/0.6mL
Manufacturer /
TM Owner
Fresenius Kabi
Origin: Germany

Stimufend 6mg/0.6mL Injection

Stimufend is a granulocyte colony-stimulating factor containing Pegfilgrastim-fpgk. It stimulates the bone marrow to produce neutrophils, reducing the risk of infection during chemotherapy. It is used in the treatment of blood disorders. It is supplied as an injection (6mg/0.6mL). It supports better disease control and quality of life when used as directed.
Strength: 6mg/0.6mL
Pack Size: 1s
Storage: 2°C to 8°C
Form: Injection

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Indications & Clinical Uses

  • Stimufend 6 mg/0.6 mL is a prefilled syringe containing pegfilgrastim-fpgk, a biosimilar to the originator pegfilgrastim (Neulasta) made by Fresenius Kabi and FDA-approved in 2022.
  • It is a long-acting granulocyte colony-stimulating factor that stimulates the bone marrow to make more infection-fighting white blood cells.
  • Stimufend is indicated to lower the risk of infection, including febrile neutropenia, in adults with non-myeloid cancers who receive bone-marrow-suppressing chemotherapy associated with a clinically significant rate of severe neutropenia with fever, and separately to improve survival in adults and children acutely exposed to harmful doses of radiation.
  • It is not approved to mobilise blood stem cells for transplant.
  • Stimufend is given once per chemotherapy cycle, not daily.

Side Effects

  • The most common side effect of Stimufend, reported in about 3 in 10 patients, is bone pain, which is usually manageable with standard painkillers; pain in the arms or legs is also common.
  • The current label carries no boxed warning, but serious reactions can occur: rupture of the spleen (reported as sudden left-sided abdominal or shoulder-tip pain), acute respiratory distress syndrome with breathing difficulty, sickle cell crisis in patients with sickle cell disease, and capillary leak syndrome causing swelling and low blood pressure.
  • Serious allergic reactions, including anaphylaxis, have also been reported.
  • Seek urgent medical attention for severe abdominal or shoulder pain, breathing problems, or swelling with dizziness after a Stimufend injection.

Precautions & Warnings

  • Stimufend must not be given to anyone who has had a serious allergic reaction to pegfilgrastim or filgrastim products.
  • Tell your healthcare provider immediately about sudden left upper abdominal or shoulder-tip pain, which may signal splenic enlargement or rupture, or about new shortness of breath, fever and cough, which may signal acute respiratory distress syndrome.
  • People with sickle cell disorders should be monitored closely, and Stimufend should be stopped at once if a sickle cell crisis occurs.
  • Rare capillary leak syndrome can cause rapid swelling and low blood pressure requiring urgent care.
  • Stimufend is given the day after chemotherapy, not on the same day, and should not be given in the 14 days before or 24 hours after cytotoxic chemotherapy, because rapidly dividing marrow cells are more sensitive to chemotherapy during that window.

Avoid Interactions

  • Stimufend should not be given within 14 days before or 24 hours after myelosuppressive chemotherapy, because the newly stimulated bone marrow cells are especially sensitive to chemotherapy and radiation during that window; your oncology team will time each injection carefully around your chemotherapy cycle.
  • No other clinically significant drug interactions are established on the current label.
  • Lithium may increase the release of neutrophils from the bone marrow, so tell your provider if you take it, as closer monitoring of blood counts may be needed.
  • As with any injectable biologic, tell your healthcare provider about all other medicines, herbal products and supplements you use.

References

Frequently Asked Questions

Stimufend (pegfilgrastim-fpgk) is a biosimilar to Neulasta that helps prevent infections, including febrile neutropenia, in adults having chemotherapy for cancer that lowers white blood cell counts. It is also used to improve survival in adults and children after harmful radiation exposure, but not for collecting stem cells before a transplant.

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