Regramostim
Also known as: glycosylated GM-CSF, Regramostim, rGM‑CSF, rhu GM-CSF (CHO-derived), Sargramostim
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Summary
Regramostim is a recombinant human GM‑CSF produced in yeast. It is used to accelerate bone‑marrow recovery after chemotherapy or stem‑cell transplantation and to treat pulmonary alveolar proteinosis.
Mechanism of Action
Binds the GM‑CSF receptor on hematopoietic progenitors, activating JAK2/STAT5 signaling to stimulate proliferation and differentiation of granulocyte and macrophage lineages and enhance functional activity of mature neutrophils and macrophages.
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
No sources recorded yet.
Frequently Asked Questions
What is Regramostim?
Regramostim is a recombinant human GM‑CSF produced in yeast. It is used to accelerate bone‑marrow recovery after chemotherapy or stem‑cell transplantation and to treat pulmonary alveolar proteinosis.
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.