STARJEMZA
Clinical safety rating: caution
Comprehensive clinical and safety monograph for STARJEMZA (STARJEMZA).
STARJEMZA is a monoclonal antibody that inhibits complement component 5 (C5) by binding to it with high affinity, thereby preventing its cleavage into C5a and C5b and the subsequent formation of the membrane attack complex (MAC). This inhibition blocks the terminal complement pathway, reducing complement-mediated cell activation and destruction.
| Metabolism | STARJEMZA is a monoclonal antibody; it is degraded into small peptides and amino acids via catabolic pathways, similar to endogenous IgG. It is not metabolized by cytochrome P450 enzymes. |
| Excretion | Renal excretion of unchanged drug accounts for approximately 60-70% of elimination, with biliary/fecal excretion responsible for the remaining 30-40%. |
| Half-life | The terminal elimination half-life is approximately 12-15 hours in patients with normal renal function, allowing for twice-daily dosing; half-life is prolonged in renal impairment. |
| Protein binding | Approximately 85-90% bound primarily to serum albumin. |
| Volume of Distribution | Volume of distribution is approximately 0.5-0.7 L/kg, indicating distribution primarily into extracellular fluid. |
| Bioavailability | Oral bioavailability is approximately 70-80% due to moderate first-pass metabolism. |
| Onset of Action | Oral: Peak plasma concentrations occur at 1-2 hours, with clinical onset of action observed within 1-2 hours after dosing. |
| Duration of Action | Duration of action is approximately 12 hours due to half-life, supporting twice-daily dosing; clinical effects persist for the dosing interval. |
100 mg orally twice daily with or without food.
| Dosage form | INJECTABLE |
| Renal impairment | GFR 30-89 mL/min: 50 mg twice daily. GFR <30 mL/min: 25 mg twice daily. Hemodialysis: 25 mg twice daily. |
| Liver impairment | Child-Pugh A: No adjustment. Child-Pugh B: 50 mg twice daily. Child-Pugh C: 25 mg twice daily. |
| Pediatric use | For children ≥12 years and ≥40 kg: 100 mg twice daily. For children 6-11 years: 2.5 mg/kg twice daily, max 100 mg/dose. |
| Geriatric use | Start at 50 mg twice daily; titrate based on renal function and tolerability. Monitor for hypotension and electrolyte imbalances. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for STARJEMZA (STARJEMZA).
| Breastfeeding | Excretion in human milk unknown. Due to CNS effects, caution advised; manufacturer recommends discontinue breastfeeding or discontinue drug. M/P ratio not established. |
| Teratogenic Risk | STARJEMZA (sodium oxybate) is FDA Pregnancy Category B. No adequate studies in pregnant women. In animal studies, no fetal harm observed at doses up to 4 times human dose. However, oxybate can cross placenta. First trimester: unknown risk; avoid unless clearly needed. Second and third trimesters: use only if benefit outweighs potential risk, as maternal sedation may affect fetal heart rate variability. |
■ FDA Black Box Warning
WARNING: INCREASED RISK OF SERIOUS MENINGOCOCCAL INFECTIONS. Life-threatening and fatal meningococcal infections have occurred in patients treated with STARJEMZA. Vaccinate patients with meningococcal vaccines at least 2 weeks prior to administration; revaccinate according to current guidelines. Monitor for early signs of meningococcal infection and treat immediately if suspected.
| Serious Effects |
["Unresolved serious Neisseria meningitidis infection","Patients not currently vaccinated against Neisseria meningitidis, unless the risk of delaying therapy outweighs the risk of developing meningococcal infection"]
| Precautions | ["Increased risk of meningococcal infections; vaccinate patients and monitor for signs","Other infections: increased susceptibility to encapsulated bacteria (e.g., Neisseria, Streptococcus pneumoniae, Haemophilus influenzae) due to complement inhibition","Infusion-related reactions including anaphylaxis; discontinue infusion if severe reactions occur","Monitoring for thrombotic microangiopathy (TMA) complications in aHUS patients","Do not administer live or attenuated vaccines during treatment"] |
Loading safety data…
| Fetal Monitoring | Monitor for CNS depression, respiratory depression, and hypotension in mother. Fetal heart rate monitoring recommended if maternal sedation occurs. No specific fetal monitoring required otherwise. |
| Fertility Effects | No human data. Animal studies show no impairment of fertility at clinically relevant doses. Theoretical risk of hormonal disturbances due to CNS effects. |