Muplestim

Summary

Muplestim (rhIL-3) is a recombinant human interleukin-3 analog investigated for stimulating multi-lineage hematopoiesis. It was studied in clinical trials for conditions such as chemotherapy-induced myelosuppression, aplastic anemia, and HIV-related cytopenias. Development was not advanced to regulatory approval.

Mechanism of Action

Binds to the interleukin-3 receptor (IL-3R) on hematopoietic progenitor cells, stimulating proliferation and differentiation of multiple blood cell lineages including granulocytes, monocytes, erythrocytes, and megakaryocytes.

Routes of Administration

Goals & Uses

• HIV-associated cytopeniaInfectious Disease / HematologyLow
• Chemotherapy-induced myelosuppression mitigationHematopoietic SupportModerate
• Stem cell mobilizationHematopoietic Stem Cell TransplantationModerate
• Aplastic anemia treatmentHematologyLow

Contraindications

• Myeloid malignancyOncologyHigh
• Hypersensitivity to muplestim or excipientsAllergyHigh

Adverse Effects

• Fever and flu-like symptomsConstitutionalCommon
• EosinophiliaHematologicUncommon
• Injection site reactionsLocalCommon
• HeadacheNeurologicCommonPain in the head or upper neck
• HypotensionCardiovascularUncommonLow blood pressure
• ThrombocytosisHematologyUncommon

Drug Interactions

• GM-CSF (sargramostim)Low
• G-CSF (filgrastim)Low

Population Constraints

• Pediatric patientsAgeRelative
• Pregnant or lactating womenReproductiveRelative
• Patients with active myeloid malignancyOncologyRelative

Regulatory Status

• European UnionUnapprovedNo marketing authorization granted by EMA or predecessor bodies.
• United StatesInvestigationalInvestigated in Phase II/III trials; never received FDA approval. Development discontinued.

Muplestim was investigated in Phase II/III clinical trials primarily in the 1990s but was never approved by the FDA or other major regulatory agencies. Development was largely discontinued.

Evidence & Sources

No sources recorded yet.