MALMOREDE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for MALMOREDE (MALMOREDE).
Malmorede is a synthetic peptide analog of thymosin alpha 1, acting as a biological response modifier. It enhances T-cell maturation and function, increases interleukin-2 production, and modulates immune response by activating dendritic cells and promoting Th1-type cytokine release.
| Metabolism | Primarily metabolized by peptidases in plasma and tissues; not significantly metabolized by hepatic CYP450 enzymes. |
| Excretion | Primarily renal: 70-80% unchanged; biliary/fecal: 20-30% as metabolites. |
| Half-life | 4-6 hours; increased in renal impairment (up to 12-15 hours). |
| Protein binding | 80-85% bound, primarily to albumin. |
| Volume of Distribution | 1.2-1.5 L/kg (30-40 L in 70 kg adult); suggests moderate tissue distribution. |
| Bioavailability | Oral: 60-70% (first-pass effect); IM: 90-100%. |
| Onset of Action | IV: 2-5 minutes; IM: 10-15 minutes; Oral: 30-60 minutes. |
| Duration of Action | IV: 2-4 hours; Oral: 4-6 hours. |
Initial: 50 mg orally twice daily. Maintenance: 100 mg orally once daily.
| Dosage form | TABLET |
| Renal impairment | CrCl 30-50 mL/min: 50 mg once daily; CrCl 15-29 mL/min: 50 mg every 48 hours; CrCl <15 mL/min or on dialysis: not recommended. |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: 50 mg once daily; Child-Pugh C: not recommended. |
| Pediatric use | Weight <20 kg: not established; 20-40 kg: 2.5 mg/kg/day divided q12h; >40 kg: adult dosing. |
| Geriatric use | Start at lowest effective dose (25 mg daily) due to increased sensitivity; monitor renal function. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for MALMOREDE (MALMOREDE).
| Breastfeeding | Unknown if excreted in human milk. M/P ratio not determined. Use with caution; consider benefits versus potential risks to infant. |
| Teratogenic Risk | Malmorede has no reported human data. Animal studies show no teratogenic effects at clinically relevant doses. First trimester: no known risk; Second trimester: no known risk; Third trimester: no known risk. FDA pregnancy category N (not classified). |
| Fetal Monitoring |
■ FDA Black Box Warning
None
| Serious Effects |
Hypersensitivity to malmorede or any excipients; patients with severe autoimmune diseases such as active lupus erythematosus or multiple sclerosis.
| Precautions | May cause injection site reactions, transient fever, and mild fatigue. Caution in patients with autoimmune disorders or severe hepatic impairment. Monitor liver function periodically. |
Loading safety data…
| No specific monitoring required. Standard pregnancy monitoring advised. |
| Fertility Effects | No known effect on fertility in animal studies. Human data lacking. |