OMLYCLO

Clinical safety rating: caution

Comprehensive clinical and safety monograph for OMLYCLO (OMLYCLO).

How it works

OMLYCLO (omalizumab) is a recombinant humanized monoclonal antibody that selectively binds to human immunoglobulin E (IgE). It inhibits the binding of IgE to the high-affinity FcεRI receptor on mast cells and basophils, thereby reducing the release of mediators of the allergic response.

What the body does with it

Metabolism	Omalizumab is a monoclonal antibody that undergoes degradation via the reticuloendothelial system (RES) and is catabolized to small peptides and amino acids. It is not metabolized by cytochrome P450 enzymes or excreted renally.
Excretion	Primarily renal excretion (70-80% as unchanged drug) and fecal/biliary elimination (20-30%).
Half-life	Terminal elimination half-life: 2-4 hours in healthy adults; prolonged to 4-8 hours in renal impairment (CrCl <30 mL/min).
Protein binding	Approximately 90% bound, primarily to albumin and alpha-1-acid glycoprotein.
Volume of Distribution	Vd: 0.5-1.0 L/kg, indicating moderate tissue distribution.
Bioavailability	Oral: 80-90% (first-pass metabolism minimal).
Onset of Action	Oral: 30-60 minutes; Intravenous: immediate (within 5 minutes).
Duration of Action	Oral: 6-8 hours; Intravenous: 4-6 hours; duration may be extended in hepatic or renal dysfunction.

Classification & Brands

Dosing & administration

For seasonal trivalent inactivated influenza vaccine (IIV3): 0.5 mL intramuscularly as a single dose.

Dosage form	INJECTABLE
Renal impairment	No dose adjustment required for any degree of renal impairment.
Liver impairment	No dose adjustment required for any degree of hepatic impairment.
Pediatric use	Children 6 months through 8 years: 0.5 mL intramuscularly; if receiving influenza vaccine for the first time, administer 2 doses at least 4 weeks apart. Children 9 years and older: 0.5 mL intramuscularly as a single dose.
Geriatric use	Adults 65 years and older: 0.5 mL intramuscularly as a single dose; no specific dose adjustment needed, but consider age-related immune response and comorbidities.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for OMLYCLO (OMLYCLO).

Breastfeeding	OMLYCLO is excreted into breast milk. Milk-to-plasma ratio approximately 0.5-1.0. Potential for accumulation in infants due to long half-life. Monitor infant for drowsiness, poor feeding, and respiratory depression. Use only if essential.
Teratogenic Risk	OMLYCLO (clobazam) is a benzodiazepine. First trimester: Associated with oral clefts and congenital malformations in some studies. Second and third trimesters: Risk of CNS depression, hypotonia, respiratory depression, and withdrawal symptoms in neonates. Avoid use unless benefit clearly outweighs risk.

Warnings & precautions

■ FDA Black Box Warning

Anaphylaxis, presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema, has been reported after administration of OMALYZE (omalizumab). Anaphylaxis has occurred as early as after the first dose, but also after months and years of treatment. Patients should be observed for a period of time after administration and be educated about the signs and symptoms of anaphylaxis.

Side Effect Profile

Serious Effects

Absolute Contraindications

["History of anaphylaxis to omalizumab or any of its excipients","Acute bronchospasm or status asthmaticus (not for acute rescue)"]

Clinical Precautions

Precautions

["Anaphylaxis risk: observe patients for at least 2 hours after injection","Malignancy: rare reports of malignancies; monitor for signs","Eosinophilic conditions: Churg-Strauss syndrome or eosinophilic pneumonia may present upon steroid withdrawal","Arthralgia, rash, and serum sickness-like reactions","Helminth infection risk: patients at high risk may reactivate or acquire new infections"]

Clinical Tips & Counseling

Drug interactions

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OMLYCLO

Clinical safety rating: caution

Comprehensive clinical and safety monograph for OMLYCLO (OMLYCLO).

How it works

What the body does with it

Metabolism	Omalizumab is a monoclonal antibody that undergoes degradation via the reticuloendothelial system (RES) and is catabolized to small peptides and amino acids. It is not metabolized by cytochrome P450 enzymes or excreted renally.
Excretion	Primarily renal excretion (70-80% as unchanged drug) and fecal/biliary elimination (20-30%).
Half-life	Terminal elimination half-life: 2-4 hours in healthy adults; prolonged to 4-8 hours in renal impairment (CrCl <30 mL/min).
Protein binding	Approximately 90% bound, primarily to albumin and alpha-1-acid glycoprotein.
Volume of Distribution	Vd: 0.5-1.0 L/kg, indicating moderate tissue distribution.
Bioavailability	Oral: 80-90% (first-pass metabolism minimal).
Onset of Action	Oral: 30-60 minutes; Intravenous: immediate (within 5 minutes).
Duration of Action	Oral: 6-8 hours; Intravenous: 4-6 hours; duration may be extended in hepatic or renal dysfunction.

Classification & Brands

Dosing & administration

For seasonal trivalent inactivated influenza vaccine (IIV3): 0.5 mL intramuscularly as a single dose.

Dosage form	INJECTABLE
Renal impairment	No dose adjustment required for any degree of renal impairment.
Liver impairment	No dose adjustment required for any degree of hepatic impairment.
Pediatric use	Children 6 months through 8 years: 0.5 mL intramuscularly; if receiving influenza vaccine for the first time, administer 2 doses at least 4 weeks apart. Children 9 years and older: 0.5 mL intramuscularly as a single dose.
Geriatric use	Adults 65 years and older: 0.5 mL intramuscularly as a single dose; no specific dose adjustment needed, but consider age-related immune response and comorbidities.

Use during pregnancy

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

Clinical note

Comprehensive clinical and safety monograph for OMLYCLO (OMLYCLO).

Breastfeeding	OMLYCLO is excreted into breast milk. Milk-to-plasma ratio approximately 0.5-1.0. Potential for accumulation in infants due to long half-life. Monitor infant for drowsiness, poor feeding, and respiratory depression. Use only if essential.
Teratogenic Risk	OMLYCLO (clobazam) is a benzodiazepine. First trimester: Associated with oral clefts and congenital malformations in some studies. Second and third trimesters: Risk of CNS depression, hypotonia, respiratory depression, and withdrawal symptoms in neonates. Avoid use unless benefit clearly outweighs risk.

Warnings & precautions

■ FDA Black Box Warning

Side Effect Profile

Serious Effects

Absolute Contraindications

["History of anaphylaxis to omalizumab or any of its excipients","Acute bronchospasm or status asthmaticus (not for acute rescue)"]