Drug Detail:Omalizumab (Omalizumab [ oh-ma-liz-oo-mab ])
Drug Class: Selective immunosuppressants
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.
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 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.
Frequently asked questions
- What are the most common skin conditions? (with photos)
- Is Xolair an immunosuppressant?
- How long before Xolair starts working?
- How does Xolair work?
- Does Xolair cause weight gain?
- What is omalizumab's mechanism of action?
- Omalizumab and Covid-19 vaccine, what should I know?
- Can Xolair be self-administered at home?
- What is Xolair approved for?