Romurtide

Summary

Romurtide (muroctasin) is a synthetic MDP derivative approved in Japan for the treatment of leukopenia associated with anticancer therapy. It stimulates hematopoietic recovery by inducing endogenous production of colony-stimulating factors and activating macrophage-mediated immune responses.

Mechanism of Action

Romurtide is a synthetic muramyl dipeptide (MDP) analogue that activates innate immune responses by stimulating macrophages and monocytes, enhancing hematopoiesis, and promoting production of colony-stimulating factors (CSFs) including G-CSF and M-CSF, thereby accelerating recovery of neutrophils and platelets after myelosuppressive chemotherapy or radiation.

Routes of Administration

Goals & Uses

• ImmunostimulationImmunomodulationModerate
• Platelet recoveryHematopoietic SupportModerate
• Hematopoietic recovery after radiotherapyHematopoietic SupportModerate
• Treatment of chemotherapy-induced leukopeniaHematopoietic SupportHigh

Contraindications

• Severe hepatic or renal impairmentOrgan ImpairmentModerate
• Hypersensitivity to romurtide or MDP analoguesAllergyHigh
• Autoimmune disordersImmuneModerate

Adverse Effects

• Fever / PyrexiaSystemicCommon
• Hypersensitivity reactionsImmunologicRare
• Injection site reactionsLocalCommon
• Malaise / fatigueSystemicUncommon
• Chills / rigorsSystemicCommon
• Elevated liver enzymesHepaticUncommonIncrease in AST/ALT or other hepatic markers

Drug Interactions

• Cytotoxic chemotherapy agentsLow
• Immunosuppressants (e.g., corticosteroids)Moderate

Population Constraints

• Pediatric patientsAgeRelative
• Elderly patientsAgeRelative
• Pregnant womenReproductiveRelative

Regulatory Status

• European UnionUnapprovedNot approved by the EMA; not commercially available in the EU.
• United StatesUnapprovedNot approved by the FDA; not commercially available in the United States.
• United KingdomUnapprovedNot approved by the MHRA.

Approved in Japan for clinical use to treat leukopenia induced by chemotherapy or radiotherapy. Not approved by the US FDA or EMA. Limited regulatory recognition outside Japan.

Evidence & Sources

No sources recorded yet.