Molgramostim
Also known as: CSF2 recombinant, GM-CSF, Leucomax, Molgradex, recombinant human GM‑CSF, rhGM‑CSF, rhu GM-CSF (E. coli)
Source Molgramostim at Peptiology
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Summary
Molgramostim is a recombinant human GM‑CSF produced in E. coli, investigated for treatment of chemotherapy‑induced neutropenia, acute respiratory distress syndrome, and pulmonary alveolar proteinosis.
Mechanism of Action
Binds the GM‑CSF receptor on hematopoietic progenitors and mature myeloid cells, stimulating proliferation, differentiation and functional activation of neutrophils, monocytes and macrophages.
Routes of Administration
Goals & Uses
- Pulmonary alveolar proteinosisRespiratoryModerate
- Treatment of aplastic anemiaHematologyLow
- Bone marrow transplant supportHematology/OncologyModerate
- Chemotherapy‑induced neutropeniaHematologyModerate
- Treatment of chemotherapy-induced neutropeniaHematologyHigh
- Infectious disease adjunct (COVID-19)Infectious DiseaseLow
- Acute Respiratory Distress Syndrome (ARDS)RespiratoryLow
- Treatment of autoimmune pulmonary alveolar proteinosis (aPAP)PulmonologyModerate
Contraindications
- Concurrent myeloid malignancyOncologyHigh
- Known hypersensitivity to molgramostim or any excipientAllergyHigh
- Hypersensitivity to GM-CSF or E. coli-derived proteinsAllergy/ImmunologyHigh
- Active autoimmune conditions (non-PAP) without monitoringImmunologyModerate
- Excessive myeloid blast count (>10%) or leukemiaOncologyHigh
- Active myeloid malignancy (e.g., AML)OncologyModerate
Adverse Effects
- Bone painMusculoskeletalCommon
- Fever and flu-like symptomsConstitutionalCommon
- Cough/bronchospasm (inhaled route)PulmonaryCommon
- Injection site reactionsLocalCommon
- Capillary leak syndromeVascularRareLeakage of fluid from blood vessels into tissues
- Pleural/pericardial effusionCardiovascular/PulmonaryUncommon
- FeverSystemicCommonElevated body temperature
- Injection‑site reactionLocalCommon
- Bone pain / musculoskeletal painMusculoskeletalCommon
Drug Interactions
- Other myeloid growth factors (e.g., filgrastim)Low
- Myelosuppressive chemotherapy agentsModerate
- CorticosteroidsModerate
- LithiumLow
Population Constraints
- PregnancyReproductive SafetyRelative
- Pediatric patientsAgeRelative
- Pediatric patients (<1 year)AgeRelative
- Pregnant womenReproductiveRelative
- Patients with autoimmune disease historyImmunologyRelative
- Renal or hepatic impairmentOrgan DysfunctionRelative
Regulatory Status
- European UnionInvestigationalEMA has not granted marketing authorization.
- United StatesInvestigationalNot FDA‑approved; used in clinical trials.
- United KingdomInvestigationalMHRA classifies as Clinical Trial Material.
Approved in some European and other countries historically for chemotherapy-induced neutropenia; sargramostim (yeast-derived, glycosylated) is the FDA-approved GM-CSF in the US. Molgramostim (inhaled) is under active investigation in the EU and US for autoimmune pulmonary alveolar proteinosis (IMPALA trials).
Evidence & Sources
No sources recorded yet.
Frequently Asked Questions
What is Molgramostim?
Molgramostim is a recombinant human GM‑CSF produced in E. coli, investigated for treatment of chemotherapy‑induced neutropenia, acute respiratory distress syndrome, and pulmonary alveolar proteinosis.
What is Molgramostim used for?
Molgramostim is educationally associated with: Pulmonary alveolar proteinosis, Treatment of aplastic anemia, Bone marrow transplant support, Chemotherapy‑induced neutropenia, Treatment of chemotherapy-induced neutropenia, Infectious disease adjunct (COVID-19), Acute Respiratory Distress Syndrome (ARDS), Treatment of autoimmune pulmonary alveolar proteinosis (aPAP). Educational only — not medical advice.
How is Molgramostim administered?
Recorded routes of administration: Inhalation, Inhaled, Intravenous, Subcutaneous.
What are the potential side effects of Molgramostim?
Reported adverse effects include: Bone pain, Fever and flu-like symptoms, Cough/bronchospasm (inhaled route), Injection site reactions, Capillary leak syndrome, Pleural/pericardial effusion, Fever, Injection‑site reaction, Bone pain / musculoskeletal pain. This list is not exhaustive — consult a qualified clinician.
Who should avoid Molgramostim?
Recorded contraindications: Concurrent myeloid malignancy, Known hypersensitivity to molgramostim or any excipient, Hypersensitivity to GM-CSF or E. coli-derived proteins, Active autoimmune conditions (non-PAP) without monitoring, Excessive myeloid blast count (>10%) or leukemia, Active myeloid malignancy (e.g., AML). Consult a qualified clinician before use.