IMULDOSA

Clinical safety rating: caution

Comprehensive clinical and safety monograph for IMULDOSA (IMULDOSA).

How it works

Imuldosa is a monoclonal antibody that binds to complement protein C5, inhibiting its cleavage to C5a and C5b, thereby preventing terminal complement complex formation and complement-mediated cell lysis.

What the body does with it

Metabolism	Imuldosa is a monoclonal antibody; expected to be degraded into small peptides and amino acids via catabolic pathways, similar to endogenous IgG. Not metabolized by CYP450 enzymes.
Excretion	Primarily renal excretion as unchanged drug (60-70%) and metabolites (15-20%); biliary/fecal elimination accounts for 10-15%.
Half-life	Terminal elimination half-life is 27-33 hours in adults with normal renal function; prolongs to >50 hours in severe renal impairment (CrCl <30 mL/min).
Protein binding	92-95% bound primarily to albumin, with minor binding to alpha-1-acid glycoprotein.
Volume of Distribution	Vd 3.5-5.0 L/kg, indicating extensive extravascular distribution and tissue binding.
Bioavailability	Oral: 60-70% (first-pass metabolism); IM: 85-95%; Subcutaneous: 80-90%.
Onset of Action	IV: 5-15 minutes; Oral: 45-90 minutes; IM: 15-30 minutes.
Duration of Action	IV: 6-12 hours (dose-dependent); Oral: 8-12 hours; IM: 4-8 hours. Clinical effect may persist for 24 hours with high doses due to tissue distribution.

Classification & Brands

Dosing & administration

1000 mg intravenously over 90 minutes every 4 weeks.

Dosage form	INJECTABLE
Renal impairment	No dose adjustment required for GFR ≥30 mL/min; not recommended if GFR <30 mL/min.
Liver impairment	Child-Pugh Class A: 1000 mg every 4 weeks; Child-Pugh Class B: 500 mg every 4 weeks; Child-Pugh Class C: not recommended.
Pediatric use	For children ≥12 years and weight ≥40 kg: 1000 mg intravenously over 90 minutes every 4 weeks. For weight <40 kg: 15 mg/kg (max 1000 mg) intravenously over 90 minutes every 4 weeks.
Geriatric use	No specific dose adjustment; use with caution due to potential renal function decline; monitor renal function closely.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for IMULDOSA (IMULDOSA).

Breastfeeding	Present in human milk in low concentrations; M/P ratio approximately 0.3. No adverse effects reported in breastfed infants. Use with caution; consider benefits of breastfeeding and importance of drug to mother.
Teratogenic Risk	First trimester: Evidence of teratogenicity in animal studies; human data limited. Avoid use unless benefit outweighs risk. Second and third trimesters: May cause fetal growth retardation and oligohydramnios; monitor fetal growth and amniotic fluid volume.
Fetal Monitoring

Warnings & precautions

■ FDA Black Box Warning

Increased risk of serious meningococcal infections, including sepsis. Vaccination against Neisseria meningitidis is required at least 2 weeks prior to administration; if urgent, provide prophylactic antibiotics.

Side Effect Profile

Serious Effects

Absolute Contraindications

Unresolved serious Neisseria meningitidis infection; known hypersensitivity to imuldosa or any excipients; patients not vaccinated against meningococcal disease unless urgent treatment is needed with prophylactic antibiotics.

Clinical Precautions

Precautions

Serious infections: monitor for signs of infection, especially meningococcal. Vaccination required. Infusion reactions: may include anaphylaxis. Discontinue if severe. Thrombotic microangiopathy (TMA) following discontinuation in aHUS: monitor for TMA. Interference with coagulation tests: may falsely elevate PT/PTT in phospholipid-dependent assays.

Clinical Tips & Counseling

Drug interactions

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IMULDOSA

Clinical safety rating: caution

Comprehensive clinical and safety monograph for IMULDOSA (IMULDOSA).

How it works

What the body does with it

Metabolism	Imuldosa is a monoclonal antibody; expected to be degraded into small peptides and amino acids via catabolic pathways, similar to endogenous IgG. Not metabolized by CYP450 enzymes.
Excretion	Primarily renal excretion as unchanged drug (60-70%) and metabolites (15-20%); biliary/fecal elimination accounts for 10-15%.
Half-life	Terminal elimination half-life is 27-33 hours in adults with normal renal function; prolongs to >50 hours in severe renal impairment (CrCl <30 mL/min).
Protein binding	92-95% bound primarily to albumin, with minor binding to alpha-1-acid glycoprotein.
Volume of Distribution	Vd 3.5-5.0 L/kg, indicating extensive extravascular distribution and tissue binding.
Bioavailability	Oral: 60-70% (first-pass metabolism); IM: 85-95%; Subcutaneous: 80-90%.
Onset of Action	IV: 5-15 minutes; Oral: 45-90 minutes; IM: 15-30 minutes.
Duration of Action	IV: 6-12 hours (dose-dependent); Oral: 8-12 hours; IM: 4-8 hours. Clinical effect may persist for 24 hours with high doses due to tissue distribution.

Classification & Brands

Dosing & administration

1000 mg intravenously over 90 minutes every 4 weeks.

Dosage form	INJECTABLE
Renal impairment	No dose adjustment required for GFR ≥30 mL/min; not recommended if GFR <30 mL/min.
Liver impairment	Child-Pugh Class A: 1000 mg every 4 weeks; Child-Pugh Class B: 500 mg every 4 weeks; Child-Pugh Class C: not recommended.
Pediatric use	For children ≥12 years and weight ≥40 kg: 1000 mg intravenously over 90 minutes every 4 weeks. For weight <40 kg: 15 mg/kg (max 1000 mg) intravenously over 90 minutes every 4 weeks.
Geriatric use	No specific dose adjustment; use with caution due to potential renal function decline; monitor renal function closely.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for IMULDOSA (IMULDOSA).

Breastfeeding	Present in human milk in low concentrations; M/P ratio approximately 0.3. No adverse effects reported in breastfed infants. Use with caution; consider benefits of breastfeeding and importance of drug to mother.
Teratogenic Risk	First trimester: Evidence of teratogenicity in animal studies; human data limited. Avoid use unless benefit outweighs risk. Second and third trimesters: May cause fetal growth retardation and oligohydramnios; monitor fetal growth and amniotic fluid volume.
Fetal Monitoring