Regramostim
Also known as: glycosylated GM-CSF, Regramostim, rGM‑CSF, rhu GM-CSF (CHO-derived), Sargramostim
Source Regramostim at Peptiology
Save 10% with code PEPTI-BOSSRABBIT-10
Affiliate link: we earn a commission on purchases made through this link, at no extra cost to you.
Tapping Shop Now & Save 10% copies your 10% off code PEPTI-BOSSRABBIT-10 to your clipboard. Paste it at the Peptiology checkout to claim the discount.
Summary
Regramostim is a prescription, recombinant human granulocyte‑macrophage colony‑stimulating factor (GM‑CSF) produced in Chinese hamster ovary cells. It is used clinically to boost white‑blood‑cell production, particularly neutrophils, in patients whose bone‑marrow function is suppressed by chemotherapy, radiation, or transplantation, and to mobilise progenitor cells for autologous bone‑marrow support.
Mechanism of Action
Regramostim binds the GM‑CSF receptor on hematopoietic stem and progenitor cells, activating intracellular JAK/STAT signaling pathways. This promotes proliferation, differentiation and survival of myeloid lineages, especially neutrophils and macrophages, and enhances the release of CD34+ progenitor cells into peripheral blood, facilitating stem‑cell collection for transplant.
What the Research Shows
A 1993 review reported that regramostim, together with filgrastim and sargramostim, reduced neutropenic‑associated hospitalisations and infections in patients receiving myelosuppressive chemotherapy or bone‑marrow transplants. A 1991 case report described its use to accelerate marrow recovery after drug‑induced pancytopenia, shortening hospital stay. Comparative trials in 1995 showed that regramostim increased peripheral white‑cell counts 2.2‑2.7‑fold and mobilised CD34+ cells, but yielded lower total nucleated cells and colony‑forming units than molgramostim or sargramostim, and required more red‑cell transfusions. Overall, evidence supports its role in mitigating neutropenia and aiding progenitor‑cell collection, though it appears less potent than other GM‑CSF preparations.
Reported Benefits
Clinical data indicate that regramostim can lower the incidence of neutropenic fevers and infections in patients undergoing intensive chemotherapy or transplantation, and can speed hematopoietic recovery after severe marrow suppression. It also enables collection of peripheral blood progenitor cells for autologous bone‑marrow support, facilitating earlier engraftment after high‑dose chemotherapy.
Limitations of the Evidence
Comparative studies suggest regramostim is less effective at mobilising large numbers of progenitor cells than molgramostim or sargramostim. High‑dose use may provoke life‑threatening leukocytosis because it stimulates a broad range of leukocytes. Evidence is limited to relatively small oncology and transplant cohorts; broader efficacy and safety data are lacking.
Safety Considerations
Regramostim is generally tolerated, but high doses have been linked to severe adverse events due to excessive stimulation of multiple leukocyte lineages. Reported risks include fever, bone‑pain, capillary leak, and, rarely, life‑threatening systemic reactions. Monitoring of blood counts is advised, especially when used in patients with pre‑existing marrow compromise.
How It Is Administered
Regramostim is administered as an injectable protein via inhalation, intravenous infusion, or subcutaneous injection, depending on the clinical indication and formulation. Dosing regimens are determined by the prescribing clinician and are tailored to the severity of neutropenia or the needs of progenitor‑cell mobilisation.
Routes of Administration
Goals & Uses
- Pulmonary alveolar proteinosisRespiratoryModerate
- Accelerated hematopoietic recovery after stem‑cell transplantTransplantHigh
- Chemotherapy‑induced neutropeniaHematologyHigh
- Acceleration of myeloid engraftment post bone marrow transplantationHematology/transplantationModerate
- Reduction of chemotherapy-induced neutropeniaHematology/oncologyModerate
- Mobilization of hematopoietic progenitor cellsHematologyLow
Contraindications
- Hypersensitivity to GM-CSF or CHO-derived productsImmunologicHigh
- Active acute leukemiaHematologic MalignancyModerate
- Autoimmune conditions with risk of cytokine-driven flareImmunologicModerate
- Excessive leukemic myeloid blasts in bone marrow or peripheral bloodOncologicHigh
- Known hypersensitivity to GM‑CSF or any excipientAllergyHigh
Adverse Effects
- Bone painMusculoskeletalCommon
- Fever and flu-like symptomsConstitutionalCommon
- Injection site reactionsLocalCommon
- Capillary leak syndromeVascularRareLeakage of fluid from blood vessels into tissues
- Thromboembolic eventsCardiovascularRare
- Pleural/pericardial effusionsCardiovascular/respiratoryUncommon
- FeverSystemicCommonElevated body temperature
- Injection‑site reactionLocalCommon
- Bone pain / musculoskeletal painMusculoskeletalCommon
Drug Interactions
- Cytotoxic chemotherapy agentsLow
- CorticosteroidsModerate
- LithiumModerate
Population Constraints
- PregnancyReproductive SafetyRelative
- Pediatric patientsAgeRelative
- Pediatric patients (<2 years)AgeRelative
- Renal or hepatic impairmentOrgan DysfunctionRelative
Regulatory Status
- European UnionApprovedApproved: Neutropenia, Bone‑marrow transplantAuthorized under the same active substance as sargramostim.
- United StatesApprovedApproved: Bone‑marrow transplant recovery, Chemotherapy‑induced neutropenia, Pulmonary alveolar proteinosis (inhaled)Marketed as Leukine® (sargramostim); Regramostim is a biosimilar formulation.
- United KingdomUnapprovedNo MHRA approval on record for regramostim.
Regramostim was investigated in clinical trials but did not receive broad regulatory approval in major jurisdictions. It is distinct from sargramostim (Leukine, FDA-approved) and molgramostim. No current approved indications are on record in the US, EU, or UK.
Evidence & Sources
- Journal ArticleModerateLouie SG, Jung B1993-01-01T00:00:00.000000Z
- Journal ArticleLowKennedy DT, Hayney MS, Lake KD1996-01-01T00:00:00.000000Z
- Journal ArticleModerateHussein AM, et al.1995-01-01T00:00:00.000000Z
- Journal ArticleModerateHussein AM, et al.1995-01-01T00:00:00.000000Z
Frequently Asked Questions
When is regramostim typically prescribed?
It is used to prevent or treat neutropenia in patients receiving myelosuppressive chemotherapy, radiation, or undergoing bone‑marrow transplantation, and to mobilise stem cells for autologous transplant procedures.
How does regramostim differ from filgrastim?
Both are colony‑stimulating factors, but filgrastim (G‑CSF) primarily stimulates neutrophil production, whereas regramostim (GM‑CSF) stimulates a broader range of myeloid cells, which can increase efficacy but also raises the risk of systemic side effects at high doses.
Can regramostim be used in patients with existing infections?
It is often given to reduce infection risk by raising neutrophil counts, but clinicians monitor closely because rapid leukocyte expansion can exacerbate inflammatory responses in some infections.
Is regramostim effective for stem‑cell collection?
Studies show it can mobilise CD34+ progenitor cells, though it yields fewer cells than some other GM‑CSF products, so it may be chosen when other agents are unavailable or contraindicated.
What are common side effects?
Patients may experience fever, bone or muscle pain, injection‑site reactions, and, rarely, severe systemic reactions such as capillary leak syndrome; blood‑count monitoring is recommended.
What is Regramostim?
Regramostim is a prescription, recombinant human granulocyte‑macrophage colony‑stimulating factor (GM‑CSF) produced in Chinese hamster ovary cells. It is used clinically to boost white‑blood‑cell production, particularly neutrophils, in patients whose bone‑marrow function is suppressed by chemotherapy, radiation, or transplantation, and to mobilise progenitor cells for autologous bone‑marrow support.
What is Regramostim used for?
Regramostim is educationally associated with: Pulmonary alveolar proteinosis, Accelerated hematopoietic recovery after stem‑cell transplant, Chemotherapy‑induced neutropenia, Acceleration of myeloid engraftment post bone marrow transplantation, Reduction of chemotherapy-induced neutropenia, Mobilization of hematopoietic progenitor cells. Educational only — not medical advice.
How is Regramostim administered?
Recorded routes of administration: Inhalation, Intravenous, Subcutaneous.
What are the potential side effects of Regramostim?
Reported adverse effects include: Bone pain, Fever and flu-like symptoms, Injection site reactions, Capillary leak syndrome, Thromboembolic events, Pleural/pericardial effusions, Fever, Injection‑site reaction, Bone pain / musculoskeletal pain. This list is not exhaustive — consult a qualified clinician.
Who should avoid Regramostim?
Recorded contraindications: Hypersensitivity to GM-CSF or CHO-derived products, Active acute leukemia, Autoimmune conditions with risk of cytokine-driven flare, Excessive leukemic myeloid blasts in bone marrow or peripheral blood, Known hypersensitivity to GM‑CSF or any excipient. Consult a qualified clinician before use.