Omalizumab Dosage

Medically reviewed by Drugs.com. Last updated on Jun 3, 2024.

Applies to the following strengths: 150 mg; 75 mg/0.5 mL; 150 mg/mL; 300 mg/2 mL

Usual Adult Dose for Asthma - Maintenance

Injectable:
Dose preparation is based on weight and pre-treatment IgE levels:

30 to 60 kg:

IgE 30 to 100 international units/mL: 150 mg subcutaneously every 4 weeks
IgE 100 to 300 international units/mL: 300 mg subcutaneously every 4 weeks
IgE 300 to 400 international units/mL: 225 mg subcutaneously every 2 weeks
IgE 400 to 600 international units/mL: 300 mg subcutaneously every 2 weeks
IgE 600 to 700 international units/mL: 375 mg subcutaneously every 2 weeks

60 to 70 kg:

IgE 30 to 100 international units/mL: 150 mg subcutaneously every 4 weeks
IgE 100 to 200 international units/mL: 300 mg subcutaneously every 4 weeks
IgE 200 to 400 international units/mL: 225 mg subcutaneously every 2 weeks
IgE 400 to 500 international units/mL: 300 mg subcutaneously every 2 weeks
IgE 500 to 600 international units/mL: 375 mg subcutaneously every 2 weeks
IgE greater than 600 international units/mL: Do not dose

70 to 90 kg:

IgE 30 to 100 international units/mL: 150 mg subcutaneously every 4 weeks
IgE 100 to 200 international units/mL: 300 mg subcutaneously every 4 weeks
IgE 200 to 300 international units/mL: 225 mg subcutaneously every 2 weeks
IgE 300 to 400 international units/mL: 300 mg subcutaneously every 2 weeks
IgE 400 to 500 international units/mL: 375 mg subcutaneously every 2 weeks
IgE greater than 500 international units/mL: Do not dose

90 to 150 kg:

IgE 30 to 100 international units/mL: 300 mg subcutaneously every 4 weeks
IgE 100 to 200 international units/mL: 225 mg subcutaneously every 2 weeks
IgE 200 to 300 international units/mL: 300 mg subcutaneously every 2 weeks
IgE greater than 300 international units/mL: Do not dose

Comments:

Interruptions lasting less than 1 year: Dose based on serum IgE levels obtained at the initial dose determination.
Interruptions lasting 1 year or more: Retest total serum IgE levels for dose determination.
Periodically reassess the need for continued therapy based on the patient's disease severity and level of asthma control.

Use: Management of moderate to severe persistent asthma in patients inadequately controlled with inhaled corticosteroids and with a positive skin test or in vitro reactivity to a perennial aeroallergen

Usual Adult Dose for Urticaria

Injectable: 150 to 300 mg subcutaneously every 4 weeks

Comments:

Dosing not dependent on IgE levels or body weight.
Avoid administering more than 150 mg per injection site.

Use: Chronic idiopathic urticaria in patients remaining symptomatic after H1 antihistamine treatment

Usual Pediatric Dose for Asthma - Maintenance

Less than 12 years: Not recommended.
12 years and older:
Injectable: Dose preparation is based on weight and pre-treatment IgE levels:

30 to 60 kg:

IgE 30 to 100 international units/mL: 150 mg subcutaneously every 4 weeks
IgE 100 to 300 international units/mL: 300 mg subcutaneously every 4 weeks
IgE 300 to 400 international units/mL: 225 mg subcutaneously every 2 weeks
IgE 400 to 600 international units/mL: 300 mg subcutaneously every 2 weeks
IgE 600 to 700 international units/mL: 375 mg subcutaneously every 2 weeks

60 to 70 kg:

IgE 30 to 100 international units/mL: 150 mg subcutaneously every 4 weeks
IgE 100 to 200 international units/mL: 300 mg subcutaneously every 4 weeks
IgE 200 to 400 international units/mL: 225 mg subcutaneously every 2 weeks
IgE 400 to 500 international units/mL: 300 mg subcutaneously every 2 weeks
IgE 500 to 600 international units/mL: 375 mg subcutaneously every 2 weeks
IgE greater than 600 international units/mL: Do not dose

70 to 90 kg:

IgE 30 to 100 international units/mL: 150 mg subcutaneously every 4 weeks
IgE 100 to 200 international units/mL: 300 mg subcutaneously every 4 weeks
IgE 200 to 300 international units/mL: 225 mg subcutaneously every 2 weeks
IgE 300 to 400 international units/mL: 300 mg subcutaneously every 2 weeks
IgE 400 to 500 international units/mL: 375 mg subcutaneously every 2 weeks
IgE greater than 500 international units/mL: Do not dose

90 to 150 kg:

IgE 30 to 100 international units/mL: 300 mg subcutaneously every 4 weeks
IgE 100 to 200 international units/mL: 225 mg subcutaneously every 2 weeks
IgE 200 to 300 international units/mL: 300 mg subcutaneously every 2 weeks
IgE greater than 300 international units/mL: Do not dose

Comments:

Interruptions lasting less than 1 year: Dose based on serum IgE levels obtained at the initial dose determination.
Interruptions lasting 1 year or more: Retest total serum IgE levels for dose determination.
Periodically reassess the need for continued therapy based upon the patient's disease severity and level of asthma control.

Usual Pediatric Dose for Urticaria

Less than 12 years: Not recommended.
12 years and older:
Injectable: 150 to 300 mg subcutaneously every 4 weeks

Comments:

Dosing not dependent on IgE levels or body weight.
Avoid administering more than 150 mg per injection site.

Use: Chronic idiopathic urticaria in patients remaining symptomatic after H1 antihistamine treatment

Renal Dose Adjustments

Data not available; use with caution.

Liver Dose Adjustments

Data not available; use with caution.

Dose Adjustments

Dose adjustments may be required based on significant changes in weight. The manufacturer product information should be consulted.

Precautions

US BOXED WARNING:

ANAPHYLAXIS: Bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat of tongue have been reported in patients administered this drug and may occur beyond 1 year after beginning treatment.
Patients should be monitored after administration and anaphylaxis treatments should be available for use in the event of occurrence.
Inform patients of signs/symptoms of anaphylaxis and advise them to seek immediate medical care in the event of a reaction.

Safety and efficacy have not been established in patients younger than 12 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

Avoid administering more than 150 mg per injection site. Divide doses of greater than 150 mg among at least 2 injection sites.
Adjust dosing if patient weight significantly changes.
May take 5 to 10 seconds to inject.

Storage requirements:

Refrigerate, protect from light.
Once reconstituted, use within 8 hours (refrigerated) or 4 hours (room temperature).

Reconstitution/preparation techniques: The manufacturer product information should be consulted.

General:

This drug is not indicated for the treatment of acute bronchospasm, status asthmaticus, other forms of urticaria, and other allergic conditions.
This drug should be administered by a health care provider experienced in treating severe asthma or chronic spontaneous urticaria.

Monitoring:

Retest serum IgE levels for dosing if this drug is interrupted for 1 year or longer
Signs and symptoms of anaphylaxis or anaphylactoid reactions
Assess asthma control or urticaria symptoms periodically

Patient advice:

Do not discontinue current asthma or chronic urticaria therapy when beginning this drug.
Instruct patients to notify their healthcare provider upon signs and symptoms of worsening asthma or allergic reaction.
Advise patient to speak to healthcare provider if pregnant, intend to become pregnant, or are breastfeeding.