Comprehensive medication guide to Releuko including estimated pricing, availability information, side effects, and how to find it in stock at your local pharmacy.
Estimated Insurance Pricing
$0–$200 copay per injection depending on plan. Covered under Medicare Part B (buy-and-bill, Q5125) at 80% after deductible. Commercial plans vary; prior authorization typically required. Specialty tier copays may apply for home-dispensed prescriptions.
Estimated Cash Pricing
$490–$625 per injection at retail; as low as $179.74 (300 mcg) or $281.58 (480 mcg) with Drugs.com discount programs. GoodRx pricing as low as $489.87 with coupon as of April 2026.
Medfinder Findability Score
55/100
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Releuko (filgrastim-ayow) is a biosimilar to Neupogen (filgrastim), a granulocyte colony-stimulating factor (G-CSF) medication used to stimulate the production of white blood cells (neutrophils) in the bone marrow. It was FDA-approved on February 25, 2022, developed by Kashiv Biosciences and marketed by Amneal Pharmaceuticals, making it the third filgrastim biosimilar available in the United States.
Releuko is a recombinant human G-CSF protein produced through recombinant DNA technology. It is structurally highly similar to the natural G-CSF protein produced by the human body and has been shown to have no clinically meaningful differences in safety, purity, or potency from the reference product Neupogen.
Releuko is administered as a subcutaneous injection or intravenous infusion. It is available in single-dose vials and single-dose prefilled syringes in 300 mcg/0.5 mL and 480 mcg/0.8 mL strengths. It must be stored refrigerated at 2°C to 8°C and can only be kept at room temperature for up to 24 hours.
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Releuko works by mimicking the body's natural granulocyte colony-stimulating factor (G-CSF) protein. When injected, filgrastim-ayow binds to specific G-CSF receptors on the surface of neutrophil precursor cells (myeloid progenitors) in the bone marrow. This activates intracellular signaling pathways — including the JAK/STAT pathway — that instruct the progenitor cells to proliferate, differentiate into mature neutrophils, and survive longer than they normally would.
The result is a rapid increase in the absolute neutrophil count (ANC) in the bloodstream. White blood cell counts typically begin rising within 24–48 hours of the first dose, reaching a peak around day 5–8 of daily therapy. Once the stimulating dose of Releuko is discontinued, neutrophil counts return to baseline within 1–7 days.
This mechanism is critical for cancer patients receiving myelosuppressive chemotherapy, which depletes white blood cell precursors in the bone marrow. By accelerating neutrophil recovery, Releuko reduces the window of vulnerability to bacterial and fungal infections that would otherwise make chemotherapy too dangerous to administer on schedule.
300 mcg/0.5 mL — prefilled syringe
Single-dose prefilled syringe with 27-gauge 1/2 inch needle with UltraSafe Plus Needle Guard
480 mcg/0.8 mL — prefilled syringe
Single-dose prefilled syringe with 27-gauge 1/2 inch needle with UltraSafe Plus Needle Guard
300 mcg/mL — vial
Single-dose vial for subcutaneous or intravenous use
480 mcg/1.6 mL — vial
Single-dose vial for subcutaneous or intravenous use
Releuko is not listed on the FDA's Drug Shortage Database as an active national shortage as of 2026. However, it receives a findability score of 55 out of 100 on medfinder, reflecting that it is challenging to locate at retail pharmacies due to its specialty distribution model. Releuko is primarily distributed through specialty pharmacy channels and oncology clinic buy-and-bill programs — not through standard retail pharmacy wholesale networks.
Patients filling Releuko at retail pharmacies often encounter difficulty finding it in stock, especially at chain pharmacies like CVS and Walgreens. Specialty pharmacies such as Accredo, CVS Specialty, and Walgreens Specialty are more reliable sources. Cold-chain requirements (refrigeration at 2–8°C), prior authorization requirements from most insurers, and the inability to automatically substitute other filgrastim products all contribute to access challenges.
If you're having trouble locating Releuko, medfinder calls pharmacies near you to check which ones have it in stock and can fill your prescription. Results are texted to your phone, saving you hours of calling on hold.
Releuko is not a controlled substance and therefore has no DEA-specific prescribing restrictions. Any licensed prescriber — physician (MD/DO), nurse practitioner (NP), or physician assistant (PA) — can prescribe it in states where their scope of practice allows. In practice, Releuko is almost exclusively prescribed by specialists who manage the conditions requiring G-CSF therapy.
Medical Oncologists — Primary prescribers for cancer patients receiving myelosuppressive chemotherapy
Hematologists — For blood disorders including AML, severe chronic neutropenia, and bone marrow failure
Pediatric Oncologists/Hematologists — For children with congenital, cyclic, or idiopathic neutropenia
Bone Marrow Transplant Specialists — For myeloablative chemotherapy and BMT support
Primary Care Physicians — May manage ongoing therapy for patients with established chronic neutropenia diagnoses
Telehealth options are expanding but limited for new Releuko initiations, which typically require in-person evaluation, CBC lab results, and imaging. Established patients with chronic neutropenia on stable home-administered Releuko therapy may be able to manage follow-up and dose adjustments through telehealth appointments with their hematologist.
No. Releuko (filgrastim-ayow) is not a controlled substance. It is not scheduled by the Drug Enforcement Administration (DEA) and has no abuse potential. Releuko is a biologic medication — a recombinant protein — and is not a narcotic, stimulant, or sedative.
Because it is not a controlled substance, there are no DEA-mandated prescription restrictions such as limits on quantity dispensed, required in-person prescriber visits, or prohibition of electronic prescribing. Releuko can be prescribed electronically, called in to a pharmacy, or faxed — standard for any non-controlled prescription medication. However, it does require a valid prescription and is available only through specialty pharmacy channels due to its biologic nature and storage requirements.
The most commonly reported side effects of Releuko (filgrastim-ayow) include:
Bone pain (most common — caused by increased bone marrow activity)
Fever (pyrexia)
Rash and skin reactions
Cough and shortness of breath
Nosebleeds (epistaxis)
Diarrhea and nausea
Injection site reactions (redness, bruising, swelling)
Hair loss (alopecia) — primarily in long-term chronic neutropenia use
Splenic rupture (rare, potentially fatal — left upper abdominal or shoulder pain is a warning sign)
Acute respiratory distress syndrome (ARDS)
Anaphylaxis (serious allergic reaction — contraindicated if prior serious allergy to filgrastim or pegfilgrastim)
Glomerulonephritis (kidney inflammation — hematuria, proteinuria)
Sickle cell crisis (in patients with sickle cell disease — avoid use or use with extreme caution)
MDS/AML risk (long-term use in congenital neutropenia patients — requires ongoing CBC monitoring)
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Zarxio (filgrastim-sndz)
First FDA-approved filgrastim biosimilar (2015). Most widely stocked. Preferred by most insurers. Prefilled syringes stable at room temperature up to 4 days vs. 24 hours for Releuko.
Nivestym (filgrastim-aafi)
Second filgrastim biosimilar (2018), manufactured by Pfizer. Same indications as Zarxio except radiation exposure. Comparable pricing and storage to Releuko.
Neupogen (filgrastim)
Original reference product by Amgen (approved 1991). Broadest indication set including radiation exposure syndrome and stem cell mobilization. Higher cost but Amgen Safety Net Foundation offers patient assistance.
Neulasta / pegfilgrastim biosimilars
Longer-acting, pegylated G-CSF requiring only one injection per chemotherapy cycle. Multiple biosimilars available (Fulphila, Udenyca, Ziextenzo, Nyvepria, Fylnetra). Preferred in many chemotherapy regimens for convenience.
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Cytotoxic chemotherapy agents
majorMust NOT be administered within 24 hours before or after cytotoxic chemotherapy. Concurrent use can worsen bone marrow suppression by stimulating rapidly dividing myeloid cells that are then destroyed by chemotherapy.
Radiation therapy
majorAvoid simultaneous use. Concurrent radiation and G-CSF may amplify bone marrow toxicity. Coordinate timing carefully with radiation oncology team.
Lithium
moderateLithium potentiates neutrophil release from bone marrow. Combined with Releuko, may cause excessive leukocytosis (WBC > 100,000/mm³). Monitor CBC more frequently.
Bleomycin
moderateCase reports suggest possible increased pulmonary toxicity when G-CSF is combined with bleomycin-containing regimens. Monitor for respiratory symptoms.
Other G-CSF products (Zarxio, Nivestym, Neupogen, Neulasta)
majorDo not combine with other G-CSF agents. No clinical benefit; increased risk of severe leukocytosis.
Releuko (filgrastim-ayow) is a valuable filgrastim biosimilar that plays a critical role in oncology care. As the third filgrastim biosimilar approved by the FDA, it provides another option for patients and providers seeking alternatives to the more expensive brand Neupogen. For most standard indications — particularly chemotherapy-induced neutropenia — Releuko is clinically equivalent to Neupogen and other filgrastim biosimilars, with comparable safety and efficacy data.
The primary challenges with Releuko are practical rather than clinical: specialty-only distribution, cold-chain requirements, insurance step therapy protocols, and the inability to auto-substitute at the pharmacy. Patients and providers who understand these barriers and plan ahead — submitting PAs early, establishing specialty pharmacy relationships, and knowing when to switch to an available alternative — will have the best experience with Releuko.
If you're struggling to find Releuko in stock, medfinder can help. medfinder calls pharmacies near you to find which ones have Releuko available and can fill your prescription. Results are texted to you, so you can focus on your treatment — not the pharmacy search.
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