TM Owner Amneal Pharmaceuticals
Releuko 300mcg/0.5mL Injection
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Indications & Clinical Uses
- Releuko 300 mcg/0.5 mL (filgrastim-ayow) is a recombinant granulocyte colony-stimulating factor (G-CSF) biosimilar to Neupogen (filgrastim) - not to the long-acting, pegylated product Neulasta (pegfilgrastim), which is a different formulation given far less often.
- It is FDA-approved to reduce infection risk in patients with non-myeloid cancers receiving myelosuppressive chemotherapy, to shorten neutrophil recovery and fever duration after induction/consolidation chemotherapy for acute myeloid leukaemia, to reduce neutropenia after bone marrow transplant, to mobilise blood stem cells for collection before transplant, to reduce infection complications in severe chronic neutropenia, and to increase survival after acute exposure to myelosuppressive doses of radiation.
- It is given by subcutaneous injection or intravenous infusion, typically starting under specialist supervision and often continued by self-injection at home.
Side Effects
- The most common effects, in more than 5% of patients, are bone pain, headache, fever, injection-site reactions, rash, cough, breathlessness, low-grade musculoskeletal pain, and low platelets or anaemia in chronic neutropenia.
- There is no boxed warning on the current label, but several serious reactions must be recognised promptly: splenic rupture (report any left upper abdominal or left shoulder pain at once), acute respiratory distress syndrome (fever with breathlessness and lung infiltrates), serious allergic reactions including anaphylaxis, sickling crises in people with sickle cell disease, capillary leak syndrome (sudden swelling and low blood pressure), and kidney inflammation (glomerulonephritis).
- Seek urgent care for any of these while on treatment.
Precautions & Warnings
- Releuko is contraindicated in anyone with a history of serious allergic reaction to filgrastim products or other G-CSFs.
- Do not give a dose within 24 hours before or after cytotoxic chemotherapy, since G-CSF-stimulated cells are sensitive to chemotherapy.
- Regular full blood counts are required throughout treatment to guide dosing and detect thrombocytopenia or excessive white cell rise.
- Use with caution in sickle cell disease, as Releuko can trigger sickling crises, and monitor for splenomegaly, especially in peripheral blood progenitor cell donors.
- Aortitis has been reported rarely and usually resolves after stopping treatment.
- Long-term use in severe chronic neutropenia requires monitoring for myelodysplastic syndrome and acute myeloid leukaemia and for bone density loss.
Avoid Interactions
- No specific pharmacokinetic drug-interaction studies are described for filgrastim-ayow.
- Because of the potential for both increased sensitivity of rapidly dividing myeloid cells and additive effects on blood counts, Releuko should not be given in the 24 hours immediately before or after chemotherapy or radiotherapy, and its safety when combined with other drugs that affect the bone marrow has not been fully established.
- Tell your healthcare provider about all other medicines and supplements you take, particularly other treatments that affect white blood cells, before starting Releuko, and about any history of sickle cell disease before the first dose.
References
Frequently Asked Questions
Releuko (filgrastim-ayow) is a biosimilar to Neupogen that raises white blood cell counts. It reduces infection risk after chemotherapy, speeds neutrophil recovery in leukaemia and transplant patients, helps mobilise stem cells for collection, and treats severe chronic neutropenia.
Releuko is given by subcutaneous injection or, in hospital, by intravenous infusion, usually once daily. Many patients are trained to self-inject at home after chemotherapy, starting the day after treatment and continuing until the blood count recovers, as directed by your care team.
Bone pain, headache, fever and injection-site reactions are the most common. Rare but serious effects include splenic rupture, breathing problems (ARDS), severe allergic reactions, and sickling crises in sickle cell disease. Report sudden left-sided abdominal or shoulder pain, or breathing difficulty, urgently.
Do not have a Releuko injection within 24 hours before or after chemotherapy. Tell your care team if you have sickle cell disease, since Releuko can trigger a sickling crisis. Regular blood tests are needed throughout treatment to check your response.
Releuko is an FDA-approved biosimilar to Neupogen (filgrastim), given daily, not to Neulasta (pegfilgrastim), which is a longer-acting, once-per-cycle version. The two are not interchangeable, and Releuko has shown no clinically meaningful differences from Neupogen in effectiveness or safety.
Duration depends on why it's prescribed: typically until your neutrophil count recovers after chemotherapy (often 1-2 weeks per cycle), longer after bone marrow transplant, or long-term for severe chronic neutropenia, with regular blood counts guiding when to stop or continue.
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