Omalizumab: Pediatric drug information

For additional information see "Omalizumab: Drug information" and "Omalizumab: Patient drug information"

For abbreviations, symbols, and age group definitions show table

ALERT: US Boxed Warning

Anaphylaxis:

Anaphylaxis, presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of omalizumab. Anaphylaxis has occurred as early as after the first dose of omalizumab but also has occurred beyond 1 year after beginning regularly administered treatment. Because of the risk of anaphylaxis, initiate omalizumab therapy in a health care setting and closely observe patients for an appropriate period of time after omalizumab administration. Health care providers administering omalizumab should be prepared to manage anaphylaxis, which can be life-threatening. Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care if symptoms occur. Selection of patients for self-administration of omalizumab should be based on criteria to mitigate risk from anaphylaxis.

Brand Names: US

Xolair

Brand Names: Canada

Xolair

Therapeutic Category

Monoclonal Antibody, Anti-Asthmatic

Dosing: Pediatric

Dosage guidance:

Safety: Due to risk of anaphylaxis, initiate therapy in a health care setting; health care provider will determine if self-administration by the patient or caregiver is appropriate based on risk for anaphylaxis and mitigation strategies.

Dosage form information: Omalizumab prefilled syringes and reconstituted lyophilized powder are different concentrations; use extra precaution during product selection and during dose volume calculations.

Asthma

Asthma: Dose and frequency based on actual body weight and pretreatment total IgE serum concentrations. Dosing should be adjusted during therapy for significant changes in body weight. Dosing should not be adjusted based on total IgE concentrations taken during treatment or if there is an interruption of therapy <1 year in duration as total IgE concentrations are elevated during treatment and remain elevated for up to 1 year after discontinuation of treatment. If therapy has been interrupted for ≥1 year, total IgE levels may be reevaluated for dosage determination.

Children ≥6 to <12 years: Note: Prefilled syringe may be used in ages ≥6 years; autoinjector is only for use in ages ≥12 years. SUBQ:

**Omalizumab Asthma Dosing for Children 6 to <12 Years of Age**
Pretreatment serum IgE	Patient weight (kg)	Dose (mg) SUBQ	Frequency (weeks)
≥30 to 100 units/mL	20 to 40 kg	75 mg	every 4 weeks
	>40 to 90 kg	150 mg
	>90 to 150 kg	300 mg
>100 to 200 units/mL	20 to 40 kg	150 mg	every 4 weeks
	>40 to 90 kg	300 mg	every 4 weeks
	>90 to 125 kg	225 mg	every 2 weeks
	>125 to 150 kg	300 mg	every 2 weeks
>200 to 300 units/mL	20 to 30 kg	150 mg	every 4 weeks
	>30 to 40 kg	225 mg
	>40 to 60 kg	300 mg
	>60 to 90 kg	225 mg	every 2 weeks
	>90 to 125 kg	300 mg
	>125 to 150 kg	375 mg
>300 to 400 units/mL	20 to 30 kg	225 mg	every 4 weeks
	>30 to 40 kg	300 mg	every 4 weeks
	>40 to 70 kg	225 mg	every 2 weeks
	>70 to 90 kg	300 mg	every 2 weeks
	>90 kg	No dose recommendation provided; data insufficient
>400 to 500 units/mL	20 to 25 kg	225 mg	every 4 weeks
	>25 to 30 kg	300 mg	every 4 weeks
	>30 to 50 kg	225 mg	every 2 weeks
	>50 to 70 kg	300 mg
	>70 to 90 kg	375 mg
	>90 kg	No dose recommendation provided; data insufficient
>500 to 600 units/mL	20 to 30 kg	300 mg	every 4 weeks
	>30 to 40 kg	225 mg	every 2 weeks
	>40 to 60 kg	300 mg
	>60 to 70 kg	375 mg
	>70 kg	No dose recommendation provided; data insufficient
>600 to 700 units/mL	20 to 25 kg	300 mg	every 4 weeks
	>25 to 40 kg	225 mg	every 2 weeks
	>40 to 50 kg	300 mg
	>50 to 60 kg	375 mg
	>60 kg	No dose recommendation provided; data insufficient
>700 to 900 units/mL	20 to 30 kg	225 mg	every 2 weeks
	>30 to 40 kg	300 mg
	>40 to 50 kg	375 mg
	>50 kg	No dose recommendation provided; data insufficient
>900 to 1,100 units/mL	20 to 25 kg	225 mg	every 2 weeks
	>25 to 30 kg	300 mg
	>30 to 40 kg	375 mg
	>40 kg	No dose recommendation provided; data insufficient
>1,100 to 1,200 units/mL	20 to 30 kg	300 mg	every 2 weeks
>1,100 to 1,200 units/mL	>30 kg	No dose recommendation provided; data insufficient
>1,200 to 1,300 units/mL	20 to 25 kg	300 mg	every 2 weeks
	>25 to 30 kg	375 mg	every 2 weeks
	>30 kg	No dose recommendation provided; data insufficient

Children ≥12 years and Adolescents: SUBQ:

**Omalizumab Asthma Dosing for Patients ≥12 Years of Age**
Pretreatment serum IgE	Patient weight (kg)	Dose (mg) SUBQ	Frequency (weeks)
≥30 to 100 units/mL	30 to 90 kg	150 mg	every 4 weeks
≥30 to 100 units/mL	>90 to 150 kg	300 mg	every 4 weeks
>100 to 200 units/mL	30 to 90 kg	300 mg	every 4 weeks
>100 to 200 units/mL	>90 to 150 kg	225 mg	every 2 weeks
>200 to 300 units/mL	30 to 60 kg	300 mg	every 4 weeks
	>60 to 90 kg	225 mg	every 2 weeks
	>90 to 150 kg	300 mg	every 2 weeks
>300 to 400 units/mL	30 to 70 kg	225 mg	every 2 weeks
	>70 to 90 kg	300 mg	every 2 weeks
	>90 kg	No dose recommendation provided; data insufficient
>400 to 500 units/mL	30 to 70 kg	300 mg	every 2 weeks
	>70 to 90 kg	375 mg	every 2 weeks
	>90 kg	No dose recommendation provided; data insufficient
>500 to 600 units/mL	30 to 60 kg	300 mg	every 2 weeks
	>60 to 70 kg	375 mg	every 2 weeks
	>70 kg	No dose recommendation provided; data insufficient
>600 to 700 units/mL	30 to 60 kg	375 mg	every 2 weeks
>600 to 700 units/mL	>60 kg	No dose recommendation provided; data insufficient

Food allergy

Food allergy:

Note : Only for reduction of Type 1 (IgE-mediated) allergic reactions (including anaphylaxis) that may occur with accidental exposure; should be used in conjunction with food avoidance.

Dose and frequency based on actual body weight; dosing should be adjusted during therapy for significant changes in body weight. Dosing should not be adjusted based on total IgE concentrations taken during treatment or if there is an interruption of therapy <1 year in duration as total IgE concentrations are elevated during treatment and remain elevated for up to 1 year after discontinuation of treatment. If therapy has been interrupted for ≥1 year, total IgE levels may be reevaluated for dosage determination. The duration of therapy has not been determined; continued need for therapy should be periodically evaluated.

Children and Adolescents: Note : Prefilled syringes may be used in ages ≥1 year; autoinjector is only for use in ages ≥12 years. SUBQ:

**Omalizumab Food Allergy Dosing for Patients ≥1 Year of Age**
Pretreatment serum IgE	Patient weight (kg)	Dose (mg) SUBQ	Frequency (weeks)
≥30 to 100 units/mL	≥10 to 40 kg	75 mg	every 4 weeks
	>40 to 90 kg	150 mg
	>90 to 150 kg	300 mg
>100 to 200 units/mL	≥10 to 20 kg	75 mg	every 4 weeks
	>20 to 40 kg	150 mg
	>40 to 90 kg	300 mg
	>90 to 125 kg	450 mg
	>125 to 150 kg	600 mg
>200 to 300 units/mL	≥10 to 15 kg	75 mg	every 4 weeks
	>15 to 30 kg	150 mg
	>30 to 40 kg	225 mg
	>40 to 60 kg	300 mg
	>60 to 90 kg	450 mg
	>90 to 125 kg	600 mg
	>125 to 150 kg	375 mg	every 2 weeks
>300 to 400 units/mL	≥10 to 20 kg	150 mg	every 4 weeks
	>20 to 30 kg	225 mg
	>30 to 40 kg	300 mg
	>40 to 70 kg	450 mg
	>70 to 90 kg	600 mg
	>90 to 125 kg	450 mg	every 2 weeks
	>125 to 150 kg	525 mg	every 2 weeks
>400 to 500 units/mL	≥10 to 15 kg	150 mg	every 4 weeks
	>15 to 25 kg	225 mg
	>25 to 30 kg	300 mg
	>30 to 50 kg	450 mg
	>50 to 70 kg	600 mg
	>70 to 90 kg	375 mg	every 2 weeks
	>90 to 125 kg	525 mg
	>125 to 150 kg	600 mg
>500 to 600 units/mL	≥10 to 15 kg	150 mg	every 4 weeks
	>15 to 20 kg	225 mg
	>20 to 30 kg	300 mg
	>30 to 40 kg	450 mg
	>40 to 60 kg	600 mg
	>60 to 70 kg	375 mg	every 2 weeks
	>70 to 90 kg	450 mg
	>90 to 125 kg	600 mg
	>125 kg	No dose recommendation provided; data insufficient
>600 to 700 units/mL	≥10 to 15 kg	150 mg	every 2 weeks
	>15 to 20 kg	225 mg	every 4 weeks
	>20 to 25 kg	300 mg	every 4 weeks
	>25 to 30 kg	225 mg	every 2 weeks
	>30 to 40 kg	450 mg	every 4 weeks
	>40 to 50 kg	600 mg	every 4 weeks
	>50 to 60 kg	375 mg	every 2 weeks
	>60 to 80 kg	450 mg
	>80 to 90 kg	525 mg
	>90 kg	No dose recommendation provided; data insufficient
>700 to 800 units/mL	≥10 to 20 kg	150 mg	every 2 weeks
	>20 to 30 kg	225 mg
	>30 to 40 kg	300 mg
	>40 to 50 kg	375 mg
	>50 to 70 kg	450 mg
	>70 to 80 kg	525 mg
	>80 to 90 kg	600 mg
	>90 kg	No dose recommendation provided; data insufficient
>800 to 900 units/mL	≥10 to 20 kg	150 mg	every 2 weeks
	>20 to 30 kg	225 mg
	>30 to 40 kg	300 mg
	>40 to 50 kg	375 mg
	>50 to 60 kg	450 mg
	>60 to 70 kg	525 mg
	>70 to 80 kg	600 mg
	>80 kg	No dose recommendation provided; data insufficient
>900 to 1,000 units/mL	≥10 to 15 kg	150 mg	every 2 weeks
	>15 to 25 kg	225 mg
	>25 to 30 kg	300 mg
	>30 to 40 kg	375 mg
	>40 to 50 kg	450 mg
	>50 to 60 kg	525 mg
	>60 to 70 kg	600 mg
	>70 kg	No dose recommendation provided; data insufficient
>1,000 to 1,100 units/mL	≥10 to 15 kg	150 mg	every 2 weeks
	>15 to 25 kg	225 mg
	>25 to 30 kg	300 mg
	>30 to 40 kg	375 mg
	>40 to 50 kg	450 mg
	>50 to 60 kg	600 mg
	>60 kg	No dose recommendation provided; data insufficient
>1,100 to 1,200 units/mL	≥10 to 15 kg	150 mg	every 2 weeks
	>15 to 20 kg	225 mg
	>20 to 30 kg	300 mg
	>30 to 40 kg	450 mg
	>40 to 50 kg	525 mg
	>50 to 60 kg	600 mg
	>60 kg	No dose recommendation provided; data insufficient
>1,200 to 1,300 units/mL	≥10 to 12 kg	150 mg	every 2 weeks
	>12 to 20 kg	225 mg
	>20 to 25 kg	300 mg
	>25 to 30 kg	375 mg
	>30 to 40 kg	450 mg
	>40 to 50 kg	525 mg
	>50 kg	No dose recommendation provided; data insufficient
>1,300 to 1,500 units/mL	≥10 to 12 kg	150 mg	every 2 weeks
	>12 to 15 kg	225 mg
	>15 to 25 kg	300 mg
	>25 to 30 kg	375 mg
	>30 to 40 kg	525 mg
	>40 to 50 kg	600 mg
	>50 kg	No dose recommendation provided; data insufficient
>1,500 to 1,850 units/mL	≥10 to 12 kg	No dose recommendation provided; data insufficient
	>12 to 15 kg	225 mg	every 2 weeks
	>15 to 20 kg	300 mg
	>20 to 25 kg	375 mg
	>25 to 30 kg	450 mg
	>30 to 40 kg	600 mg
	>40 kg	No dose recommendation provided; data insufficient

Urticaria, chronic spontaneous

Urticaria, chronic spontaneous: Children ≥12 years and Adolescents: SUBQ: 150 or 300 mg every 4 weeks. Dosing is not dependent on serum IgE (free or total) level or body weight.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing adjustment for toxicity:

Children and Adolescents:

Severe hypersensitivity reaction or anaphylaxis: Discontinue treatment.

Fever, arthralgia, and rash: Discontinue treatment if this constellation of symptoms occurs.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Adult

(For additional information see "Omalizumab: Drug information")

Dosage guidance:

Dosing: When treating patients with asthma, chronic rhinosinusitis with nasal polyps, and IgE-mediated food allergy, base dosing on the primary diagnosis for which omalizumab is prescribed.

Asthma, moderate to severe allergic

Asthma, moderate to severe allergic: Note: May consider as add-on therapy in patients with moderate to severe allergic asthma (with a positive skin test or in vitro reactivity to perennial aeroallergen) inadequately controlled with standard therapies (eg, an inhaled glucocorticoid with a long-acting beta agonist) (Ref).

SUBQ: Dose and frequency based on actual body weight and pretreatment total IgE serum levels (30 to 700 units/mL). Dosing should be adjusted during therapy for significant changes in actual body weight. Due to elevated IgE levels during therapy, dosing should not be adjusted based on total IgE levels evaluated during treatment or <1 year following interruption of therapy. If therapy has been interrupted for ≥1 year, total IgE levels may be re-evaluated for dosage determination. A minimum of 3 to 6 months of treatment is suggested to determine efficacy (Ref).

**Omalizumab Adult Dosing**
Pretreatment serum IgE	Actual body weight (kg)	Dose (mg) SUBQ	Frequency (weeks)
≥30 to 100 units/mL	30 to 90 kg	150 mg	Every 4 weeks
≥30 to 100 units/mL	>90 to 150 kg	300 mg	Every 4 weeks
>100 to 200 units/mL	30 to 90 kg	300 mg	Every 4 weeks
>100 to 200 units/mL	>90 to 150 kg	225 mg	Every 2 weeks
>200 to 300 units/mL	30 to 60 kg	300 mg	Every 4 weeks
	>60 to 90 kg	225 mg	Every 2 weeks
	>90 to 150 kg	300 mg	Every 2 weeks
>300 to 400 units/mL	30 to 70 kg	225 mg	Every 2 weeks
	>70 to 90 kg	300 mg	Every 2 weeks
	>90 kg	Use not recommended.
>400 to 500 units/mL	30 to 70 kg	300 mg	Every 2 weeks
	>70 to 90 kg	375 mg	Every 2 weeks
	>90 kg	Use not recommended.
>500 to 600 units/mL	30 to 60 kg	300 mg	Every 2 weeks
	>60 to 70 kg	375 mg	Every 2 weeks
	>70 kg	Use not recommended.
>600 to 700 units/mL	30 to 60 kg	375 mg	Every 2 weeks
>600 to 700 units/mL	>60 kg	Use not recommended.

IgE-mediated food allergy

IgE-mediated food allergy: SUBQ: Note: Dose and frequency based on actual body weight and pretreatment total IgE serum levels. Dosing should be adjusted during therapy for significant changes in actual body weight. Dosing should not be adjusted based on total IgE levels taken during treatment or <1 year following interruption of therapy. If therapy has been interrupted for ≥1 year, total IgE levels may be reevaluated for dosage determination. Periodically reassess the need for continued therapy; appropriate duration of therapy has not been evaluated.

**Omalizumab Adult Dosing**
Pretreatment serum IgE	Actual body weight (kg)	Dose (mg) SUBQ	Frequency (weeks)
≥30 to 100 units/mL	30 to 40 kg	75 mg	Every 4 weeks
	>40 to 90 kg	150 mg
	>90 to 150 kg	300 mg
>100 to 200 units/mL	30 to 40 kg	150 mg	Every 4 weeks
	>40 to 90 kg	300 mg
	>90 to 125 kg	450 mg
	>125 to 150 kg	600 mg
>200 to 300 units/mL	>30 to 40 kg	225 mg	Every 4 weeks
	>40 to 60 kg	300 mg
	>60 to 90 kg	450 mg
	>90 to 125 kg	600 mg
	>125 to 150 kg	375 mg	Every 2 weeks
>300 to 400 units/mL	>30 to 40 kg	300 mg	Every 4 weeks
	>40 to 70 kg	450 mg
	>70 to 90 kg	600 mg
	>90 to 125 kg	450 mg	Every 2 weeks
	>125 to 150 kg	525 mg	Every 2 weeks
>400 to 500 units/mL	>30 to 50 kg	450 mg	Every 4 weeks
	>50 to 70 kg	600 mg	Every 4 weeks
	>70 to 90 kg	375 mg	Every 2 weeks
	>90 to 125 kg	525 mg
	>125 to 150 kg	600 mg
>500 to 600 units/mL	>30 to 40 kg	450 mg	Every 4 weeks
	>40 to 60 kg	600 mg	Every 4 weeks
	>60 to 70 kg	375 mg	Every 2 weeks
	>70 to 90 kg	450 mg
	>90 to 125 kg	600 mg
	>125 kg	Use not recommended.
>600 to 700 units/mL	>30 to 40 kg	450 mg	Every 4 weeks
	>40 to 50 kg	600 mg	Every 4 weeks
	>50 to 60 kg	375 mg	Every 2 weeks
	>60 to 80 kg	450 mg
	>80 to 90 kg	525 mg
	>90 kg	Use not recommended.
>700 to 800 units/mL	>30 to 40 kg	300 mg	Every 2 weeks
	>40 to 50 kg	375 mg
	>50 to 70 kg	450 mg
	>70 to 80 kg	525 mg
	>80 to 90 kg	600 mg
	>90 kg	Use not recommended.
>800 to 900 units/mL	>30 to 40 kg	300 mg	Every 2 weeks
	>40 to 50 kg	375 mg
	>50 to 60 kg	450 mg
	>60 to 70 kg	525 mg
	>70 to 80 kg	600 mg
	>80 kg	Use not recommended.
>900 to 1,000 units/mL	>30 to 40 kg	375 mg	Every 2 weeks
	>40 to 50 kg	450 mg
	>50 to 60 kg	525 mg
	>60 to 70 kg	600 mg
	>70 kg	Use not recommended.
>1,000 to 1,100 units/mL	>30 to 40 kg	375 mg	Every 2 weeks
	>40 to 50 kg	450 mg
	>50 to 60 kg	600 mg
	>60 kg	Use not recommended.
>1,100 to 1,200 units/mL	>30 to 40 kg	450 mg	Every 2 weeks
	>40 to 50 kg	525 mg
	>50 to 60 kg	600 mg
	>60 kg	Use not recommended.
>1,200 to 1,300 units/mL	>30 to 40 kg	450 mg	Every 2 weeks
	>40 to 50 kg	525 mg	Every 2 weeks
	>50 kg	Use not recommended.
>1,300 to 1,500 units/mL	>30 to 40 kg	525 mg	Every 2 weeks
	>40 to 50 kg	600 mg	Every 2 weeks
	>50 kg	Use not recommended.
>1,500 to 1,850 units/mL	>30 to 40 kg	600 mg	Every 2 weeks
>1,500 to 1,850 units/mL	>40 kg	Use not recommended.

Rhinosinusitis with nasal polyps

Rhinosinusitis (chronic) with nasal polyps: SUBQ: Dose and frequency based on actual body weight and pretreatment total IgE serum levels. Dosing should be adjusted during therapy for significant changes in actual body weight. Dosing should not be adjusted based on total IgE levels taken during treatment or <1 year following interruption of therapy. If therapy has been interrupted for ≥1 year, total IgE levels may be reevaluated for dosage determination. Periodically reassess the need for continued therapy based on the patient's disease severity and level of symptom control.

**Omalizumab Adult Dosing**
Pretreatment serum IgE	Actual body weight (kg)	Dose (mg) SUBQ	Frequency (weeks)
≥30 to 100 units/mL	30 to 40 kg	75 mg	Every 4 weeks
	>40 to 90 kg	150 mg
	>90 to 150 kg	300 mg
>100 to 200 units/mL	30 to 40 kg	150 mg	Every 4 weeks
	>40 to 90 kg	300 mg
	>90 to 125 kg	450 mg
	>125 to 150 kg	600 mg
>200 to 300 units/mL	30 to 40 kg	225 mg	Every 4 weeks
	>40 to 60 kg	300 mg
	>60 to 90 kg	450 mg
	>90 to 125 kg	600 mg
	>125 to 150 kg	375 mg	Every 2 weeks
>300 to 400 units/mL	30 to 40 kg	300 mg	Every 4 weeks
	>40 to 70 kg	450 mg
	>70 to 90 kg	600 mg
	>90 to 125 kg	450 mg	Every 2 weeks
	>125 to 150 kg	525 mg	Every 2 weeks
>400 to 500 units/mL	30 to 50 kg	450 mg	Every 4 weeks
	>50 to 70 kg	600 mg	Every 4 weeks
	>70 to 90 kg	375 mg	Every 2 weeks
	>90 to 125 kg	525 mg
	>125 to 150 kg	600 mg
>500 to 600 units/mL	30 to 40 kg	450 mg	Every 4 weeks
	>40 to 60 kg	600 mg	Every 4 weeks
	>60 to 70 kg	375 mg	Every 2 weeks
	>70 to 90 kg	450 mg
	>90 to 125 kg	600 mg
	>125 kg	Use not recommended.
>600 to 700 units/mL	30 to 40 kg	450 mg	Every 4 weeks
	>40 to 50 kg	600 mg	Every 4 weeks
	>50 to 60 kg	375 mg	Every 2 weeks
	>60 to 80 kg	450 mg
	>80 to 90 kg	525 mg
	>90 kg	Use not recommended.
>700 to 800 units/mL	30 to 40 kg	300 mg	Every 2 weeks
	>40 to 50 kg	375 mg
	>50 to 70 kg	450 mg
	>70 to 80 kg	525 mg
	>80 to 90 kg	600 mg
	>90 kg	Use not recommended.
>800 to 900 units/mL	30 to 40 kg	300 mg	Every 2 weeks
	>40 to 50 kg	375 mg
	>50 to 60 kg	450 mg
	>60 to 70 kg	525 mg
	>70 to 80 kg	600 mg
	>80 kg	Use not recommended.
>900 to 1,000 units/mL	30 to 40 kg	375 mg	Every 2 weeks
	>40 to 50 kg	450 mg
	>50 to 60 kg	525 mg
	>60 to 70 kg	600 mg
	>70 kg	Use not recommended.
>1,000 to 1,100 units/mL	30 to 40 kg	375 mg	Every 2 weeks
	>40 to 50 kg	450 mg
	>50 to 60 kg	600 mg
	>60 kg	Use not recommended.
>1,100 to 1,200 units/mL	30 to 40 kg	450 mg	Every 2 weeks
	>40 to 50 kg	525 mg
	>50 to 60 kg	600 mg
	>60 kg	Use not recommended.
>1,200 to 1,300 units/mL	30 to 40 kg	450 mg	Every 2 weeks
	>40 to 50 kg	525 mg	Every 2 weeks
	>50 kg	Use not recommended.
>1,300 to 1,500 units/mL	30 to 40 kg	525 mg	Every 2 weeks
	>40 to 50 kg	600 mg	Every 2 weeks
	>50 kg	Use not recommended.

Urticaria, chronic spontaneous

Urticaria, chronic spontaneous: Note: Dosing is not dependent on serum IgE (free or total) level or body weight. May consider as add-on therapy in patients with persistent symptoms despite adequately titrated antihistamine therapy (Ref).

SUBQ: Initial: 300 mg every 4 weeks; alternatively, may initiate at 150 mg every 4 weeks, although this dose has been associated with reduced efficacy (Ref). If response is inadequate after 4 to 6 months, may consider dose escalation by increasing the dose and/or shortening the dosing interval to every 2 weeks (off-label) up to 600 mg every 2 to 4 weeks (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Incidences reported in adolescents and adults unless otherwise noted.

>10%:

Local: Injection-site reaction (asthma: 45%, severe 12%; chronic spontaneous urticaria and chronic rhinosinusitis with nasal polyps: 3% to 5%; IgE-mediated food allergy: children and adolescents: 16%; may include bleeding at injection site, bruising at injection site, burning sensation at injection site, erythema at injection site, induration at injection site, injection-site pruritus, pain at injection site, residual mass at injection site, swelling at injection site, urticaria at injection site, warm sensation at injection site)

Nervous system: Headache (children: ≥3%; adolescents and adults: 6% to 12%)

1% to 10%:

Cardiovascular: Peripheral edema (≥2%)

Dermatologic: Alopecia (≥2%), dermatitis (2%), pruritus (2%), urticaria (≥2%)

Gastrointestinal: Upper abdominal pain (children: ≥3%; adults: 3%), viral gastroenteritis (children: ≥3%)

Genitourinary: Urinary tract infection (≥2%)

Infection: Fungal infection (≥2%)

Nervous system: Anxiety (≥2%), dizziness (3%), fatigue (3%), migraine (≥2%), pain (7%)

Neuromuscular & skeletal: Arthralgia (3% to 8%), bone fracture (2%), limb pain (2% to 4%), musculoskeletal pain (≥2%), myalgia (≥2%)

Otic: Otalgia (2%), otitis media (children: ≥3%)

Respiratory: Asthma (≥2%), cough (2%), epistaxis (children: ≥3%), nasopharyngitis (children: ≥3%; adolescents and adults: 9%), oropharyngeal pain (≥2%), sinus headache (≥2%), sinusitis (5%), streptococcal pharyngitis (children: ≥3%), upper respiratory tract infection (3%), viral upper respiratory tract infection (≤2%)

Miscellaneous: Fever (children, adolescents, and adults: 2% to 6%)

<1%:

Hematologic & oncologic: Malignant neoplasm

Hypersensitivity: Anaphylaxis, angioedema

Immunologic: Antibody development (children, adolescents, and adults)

Frequency not defined: Hematologic & oncologic: Increased serum immunoglobulins (total IgE)

Postmarketing:

Cardiovascular: Eosinophilic granulomatosis with polyangiitis (Cisneros 2013)

Dermatologic: Skin rash

Hematologic & oncologic: Decreased serum immunoglobulins (free IgE), eosinophilia, lymphadenopathy, thrombocytopenia (severe)

Hypersensitivity: Serum sickness

Neuromuscular & skeletal: Arthritis

Contraindications

Severe hypersensitivity reaction to omalizumab or any component of the formulation

Warnings/Precautions

Concerns related to adverse effects:

• Cardiovascular effects: Cerebrovascular events, including transient ischemic attack and ischemic stroke, have been reported.

• Eosinophilia and vasculitis: In rare cases, patients may present with systemic eosinophilia, sometimes presenting with clinical features of vasculitis consistent with eosinophilic granulomatosis with polyangiitis (formerly known as Churg-Strauss), a condition which is often treated with systemic corticosteroid therapy. Health care providers should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients. A causal association between omalizumab and these underlying conditions has not been established.

• Fever/arthralgia/rash: Reports of a constellation of symptoms including fever, arthritis or arthralgia, rash, and lymphadenopathy have been reported with postmarketing use (symptoms resemble those seen in patients experiencing serum sickness, although circulating immune complexes or a skin biopsy consistent with a Type III hypersensitivity reaction were not seen with these cases). Onset of symptoms generally occurred 1 to 5 days following the first or subsequent doses. Discontinue therapy in any patient reporting this constellation of signs/symptoms.

• Hypersensitivity/anaphylactoid reactions: Approximately 60% to 70% of cases reported occur within the first 3 doses; time to onset was within 2 hours for ~75% of cases; however, reactions have been reported with subsequent doses (after 39 doses) and with a time to onset of up to 4 days after administration. A case-control study showed that asthma patients with a history of anaphylaxis to foods, medications, or other causes were at an increased risk of anaphylaxis. An epinephrine autoinjector should be prescribed for all patients receiving omalizumab (Lieberman 2015). Discontinue therapy following any severe reaction.

• Malignant neoplasms: Have been reported rarely with use in short-term studies; impact of long-term use is not known.

Disease-related concerns:

• Asthma: Therapy has not been shown to alleviate acute asthma exacerbations; do not use to treat acute bronchospasm, status asthmaticus, or other allergic conditions.

• Parasitic infections: Use with caution and monitor patients at high risk for parasitic (helminth) infections; risk of infection may be increased; appropriate duration of continued monitoring following therapy discontinuation has not been established.

Concurrent drug therapy issues:

• Corticosteroid therapy: Do not discontinue corticosteroids abruptly following initiation of omalizumab therapy. Reductions in corticosteroid dose should be gradual, if appropriate. Clinicians should note that a reduction in corticosteroid dose may be associated with withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy. The combined use of omalizumab and corticosteroids in patients with chronic spontaneous urticaria has not been evaluated.

Dosage form specific issues:

• Latex: Prefilled syringe: The needle cap may contain natural rubber latex.

Other warnings/precautions:

• Medication errors related to emergency treatment of anaphylaxis: Not to be used for the emergency treatment of allergic reactions, including anaphylaxis; there is a potential for medication errors. Instruct patients that omalizumab is to be used for maintenance use to reduce allergic reactions while avoiding food allergens.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Auto-injector, Subcutaneous:

Xolair: 75 mg/0.5 mL (0.5 mL); 150 mg/mL (1 mL); 300 mg/2 mL (2 mL)

Solution Prefilled Syringe, Subcutaneous:

Xolair: 300 mg/2 mL (2 mL)

Solution Prefilled Syringe, Subcutaneous [preservative free]:

Xolair: 75 mg/0.5 mL (0.5 mL); 150 mg/mL (1 mL)

Solution Reconstituted, Subcutaneous [preservative free]:

Xolair: 150 mg (1 ea)

Generic Equivalent Available: US

Pricing: US

Solution (reconstituted) (Xolair Subcutaneous)

150 mg (per each): $1,661.95

Solution Auto-injector (Xolair Subcutaneous)

75 mg/0.5 mL (per 0.5 mL): $830.98

150 mg/mL (per mL): $1,661.95

300 mg/2 mL (per mL): $1,661.95

Solution Prefilled Syringe (Xolair Subcutaneous)

75 mg/0.5 mL (per 0.5 mL): $830.98

150 mg/mL (per mL): $1,661.95

300 mg/2 mL (per mL): $1,661.95

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Prefilled Syringe, Subcutaneous:

Xolair: 75 mg/0.5 mL (0.5 mL); 150 mg/mL (1 mL)

Solution Reconstituted, Subcutaneous:

Xolair: 150 mg (1 ea)

Administration: Pediatric

Note: Omalizumab prefilled syringes/autoinjectors and reconstituted lyophilized powder are different concentrations; use extra precaution during product selection and during dose volume calculations. Prefilled syringes may be used in ages ≥1 year; autoinjector is only for use in ages ≥12 years.

Parenteral: Administer subcutaneously; the number of injections dependent on dose and dosage form; each injection site should be separated by ≥1 inch. Do not inject into moles, scars, bruises, tender areas, or broken skin. Due to viscosity, injection may take up to 15 seconds to administer.

Administer initial doses and any doses prepared from vials by a health care professional. Observe patient for a minimum of 2 hours after the first 3 injections and 30 minutes after subsequent injections (Ref) or in accordance with individual institution policies and procedures.

Lyophilized powder (vial): Recommended injection sites include the upper arm, stomach, or the front and middle of the thighs.

**Number of Omalizumab Injections Per Dose Using Vial (150 mg/1.2 mL)**
Dose	Total dose volume to be divided per number of injections	Number of injection(s)
75 mg	0.6 mL	1
150 mg	1.2 mL	1
225 mg	1.8 mL	2
300 mg	2.4 mL	2
375 mg	3 mL	3
450 mg	3.6 mL	3
525 mg	4.2 mL	4
600 mg	4.8 mL	4

Autoinjector or prefilled syringe: The prefilled syringe may be used in all ages; the autoinjector is only intended for ages ≥12 years. In patients <12 years of age, doses should be administered by a trained caregiver; patients ≥12 years may self-administer under adult supervision, after training. For pediatric patients 1 to 11 years of age, consideration should be given to the number of prefilled syringe injections needed and volume to be injected relative to the patient's bodyweight. Doses >150 mg will require more than 1 injection; autoinjector/prefilled syringe strengths may be combined to achieve desired dose. Candidates for self-administration should be determined following a risk-benefit assessment using the following criteria: Patient has no prior history of anaphylaxis related or unrelated to omalizumab; patient has previously received ≥3 doses of omalizumab; patient/caregiver has the ability to recognize and manage signs/symptoms of a severe hypersensitivity reaction, including anaphylaxis; and patient/caregiver has the ability to perform injections with proper technique and per the prescribed dosing regimen.

**Least Number of Injections (Autoinjector/Prefilled Syringe) to Achieve Dose^a**
Omalizumab dose	Total dose volume (dose divided by 150 mg/mL)	Quantity of 75 mg dosing unit (75 mg/0.5 mL)	Quantity of 150 mg dosing unit (150 mg/mL)	Quantity of 300 mg dosing unit(s) (300 mg/2 mL)
^a Not all dosing units (autoinjectors/prefilled) are appropriate for use in all ages.
75 mg	0.5 mL	1	0	0
150 mg	1 mL	0	1	0
225 mg	1.5 mL	1	1	0
300 mg	2 mL	0	0	1
375 mg	2.5 mL	1	0	1
450 mg	3 mL	0	1	1
525 mg	3.5 mL	1	1	1
600 mg	4 mL	0	0	2

Allow to warm to room temperature for 15 to 30 minutes; leave in carton to protect from light. Do not speed warming process in any way (eg, microwave, warm water). Recommended injection sites include the thigh or abdomen; if being administered by a caregiver or health care professional, may administer in the outer area of upper arms.

Administration: Adult

SUBQ: For SUBQ injection only; doses >150 mg should be divided over >1 injection site (eg, 225 or 300 mg administered as 2 injections, 375 or 450 mg administered as 3 injections, 525 or 600 mg administered as 4 injections); each injection site should be separated by ≥1 inch. Administer into clean skin in the abdomen (avoiding areas within 2 inches of navel) and the front and middle of thighs; health care provider/caregiver may also administer in the upper arm. Do not inject into moles, scars, bruises, tender areas, or broken skin. Injections may take 5 to 10 seconds to administer (solution is slightly viscous). Observe patient for 2 hours after the first 3 injections and 30 minutes after subsequent injections (Ref) or in accordance with individual institution policies and procedures.

Self-administration (prefilled syringe only): Allow to warm to room temperature for 15 to 30 minutes; leave in carton to protect from light. Do not speed warming process in any way (eg, microwave, warm water). Intended for use under guidance of health care provider. Initiate therapy in a health care setting; health care provider will determine if self-administration by the patient or caregiver is appropriate based on risk for anaphylaxis and mitigation strategies.Candidates for self-administration should be determined following a risk-benefit assessment using the following criteria: Patient has no prior history of anaphylaxis related or unrelated to omalizumab; patient has previously received at least 3 doses of omalizumab; patient/caregiver has the ability to recognize and manage signs/symptoms of a severe hypersensitivity reaction, including anaphylaxis; and patient/caregiver has the ability to perform injections with proper technique and per the prescribed dosing regimen.

Storage/Stability

Prefilled syringe: Store at 2°C to 8°C (36°F to 46°F) in the original carton. Protect from direct sunlight; do not freeze. May be removed and placed back in the refrigerator if needed; do not exceed a combined total time of 2 days out of the refrigerator. Discard if exposed to temperatures >25°C (>77°F). Note: Prior to July 2021, the manufacturer's labeling stated that syringes removed from refrigeration must be used within 4 hours.

Vial: Prior to reconstitution, store under refrigeration at 2°C to 8°C (36°F to 46°F) in original carton; product may be shipped at ≤30°C (≤86°F). Following reconstitution, protect from direct sunlight. May be stored for up to 8 hours if refrigerated or 4 hours if stored at room temperature ≤30°C (≤86°F).

Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and at https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/103976s5245lbl.pdf#page=45, must be dispensed with this medication.

Use

Reduction of Type 1 (IgE-mediated) allergic reactions (including anaphylaxis) that may occur with accidental exposure to one of more foods in conjunction with food avoidance (FDA approved in ages ≥1 year and adults); treatment of moderate to severe, persistent asthma in patients who have a positive skin test or in vitro reactivity to a perennial aeroallergen whose symptoms are not adequately controlled with inhaled corticosteroids (FDA approved in ages ≥6 years and adults); treatment of chronic spontaneous urticaria in patients who remain symptomatic despite H₁ antihistamine treatment (FDA approved in ages ≥12 years and adults); maintenance treatment of chronic rhinosinusitis with nasal polyps in patients with inadequate response to nasal corticosteroids as add-on therapy (FDA approved in adults).

Note: Omalizumab is not indicated and should not be used for the following: emergency treatment of allergic reactions to food, including anaphylaxis; treatment of acute bronchospasm or status asthmaticus and treatment of other forms of urticaria.

Medication Safety Issues

Sound-alike/look-alike issues:

Omalizumab may be confused with obinutuzumab, ofatumumab

Administration issues:

150 mg vial: After reconstitution, the concentration is 150 mg/1.2 mL; however, the entire vial contains 202.5 mg (which includes overfill). Ensure that the recommended dose is prepared with the overfill remaining in the vial. Dosing errors have been reported in cases where the entire contents of the vial have been withdrawn after reconstitution (ISMP 2019).

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program

Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy

Loxapine: Agents to Treat Airway Disease may enhance the adverse/toxic effect of Loxapine. More specifically, the use of Agents to Treat Airway Disease is likely a marker of patients who are likely at a greater risk for experiencing significant bronchospasm from use of inhaled loxapine. Management: This is specific to the Adasuve brand of loxapine, which is an inhaled formulation. This does not apply to non-inhaled formulations of loxapine. Risk X: Avoid combination

Rozanolixizumab: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy

Reproductive Considerations

Data related to the use of monoclonal antibodies for the treatment of asthma in pregnancy are limited. The long half-life of monoclonal antibodies should be considered when prescribing to patients planning to become pregnant (Pfaller 2021).

Pregnancy Considerations

Omalizumab crosses the placenta (Majou 2021; Saito 2020).

Omalizumab is a humanized monoclonal antibody (IgG₁). Human IgG crosses the placenta. Fetal exposure is dependent upon the IgG subclass, maternal serum concentrations, placental integrity, newborn birth weight, and gestational age, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis and the highest during the third trimester (Clements 2020; Palmeira 2012; Pentsuk 2009).

Outcome data related to the use of omalizumab in pregnancy are available from case reports of patients with severe asthma (Gemicioğlu 2021; Kupryś-Lipińska 2014; Shakuntulla 2022) or chronic spontaneous urticaria (some also with asthma) (Cuervo-Pardo 2016; Ensina 2017; Ghazanfar 2015; González-Medina 2017; Kocatürk 2022; Liao 2021; Losappio 2020; Shakuntulla 2022). In addition, information from the Xolair Pregnancy Registry (EXPECT) is available. Based on data collected from 250 patients between 2006 and 2018, the incidence of major congenital malformations was not increased when compared to pregnant patients with asthma not treated with omalizumab. The risk of low birth weight infants was increased; however, more severe asthma in the patients taking omalizumab may also have contributed (Namazy 2020).

Uncontrolled asthma is associated with adverse events on pregnancy (increased risk of perinatal mortality, preeclampsia, preterm birth, low-birth-weight infants, cesarean delivery, and the development of gestational diabetes). Poorly controlled asthma or asthma exacerbations may have a greater fetal/maternal risk than what is associated with appropriately used asthma medications. Maternal treatment improves pregnancy outcomes by reducing the risk of some adverse events (eg, preterm birth, gestational diabetes). Maternal asthma symptoms should be monitored monthly during pregnancy (ERS/TSANZ [Middleton 2020]; GINA 2023).

Data related to the use of monoclonal antibodies for the treatment of severe asthma during pregnancy are limited (GINA 2023). In general, monoclonal antibodies should not be initiated during pregnancy. The option to continue treatment in patients who become pregnant during therapy should be considered as part of a shared decision-making process (Dorscheid 2022; Pfaller 2021; Shakuntulla 2022). Use of omalizumab for the treatment of severe asthma in pregnancy may be considered when conventional therapies are insufficient, considering the risks and benefits of therapy (ERS/TSANZ [Middleton 2020]; GINA 2023).

Algorithms are available for the treatment of urticaria. Consider benefits and risks of treatment prior to use in pregnant patients (EAACI [Zuberbier 2022]).

Data collection to monitor pregnancy and infant outcomes associated with asthma and the medications used to treat asthma in pregnancy is ongoing. Health care providers are encouraged to enroll exposed pregnant patients in the MotherToBaby Pregnancy Studies conducted by the Organization of Teratology Information Specialists (OTIS) (1-877-311-8972 or https://mothertobaby.org). Patients may also enroll themselves.

Monitoring Parameters

Anaphylactic/hypersensitivity reactions (observe patients for 2 hours after the first 3 injections and 30 minutes after subsequent injections [Lieberman 2015] or in accordance with individual institution policies and procedures); baseline serum total IgE; FEV₁, peak flow, and/or other pulmonary function tests; monitor for signs of infection.

Mechanism of Action

Asthma and chronic rhinosinusitis with nasal polyps: Omalizumab is an IgG monoclonal antibody (recombinant DNA derived) which inhibits IgE binding to the high-affinity IgE receptor (FcεRI) on mast cells and basophils. By decreasing bound IgE, the activation and release of mediators in the allergic response (early and late phase) is limited. Serum free IgE levels and the number of high-affinity IgE receptors are decreased. Long-term treatment in patients with allergic asthma showed a decrease in asthma exacerbations and corticosteroid usage.

Chronic spontaneous urticaria: Omalizumab binds to IgE and lowers free IgE levels. Subsequently, IgE receptors (FcεRI) on cells down-regulate. The mechanism by which these effects of omalizumab result in an improvement of chronic spontaneous urticaria symptoms is unknown.

Pharmacokinetics (Adult Data Unless Noted)

Onset of action: Response to therapy: ~12 to 16 weeks (87% of patients had measurable response in 12 weeks).

Absorption: Slow following SUBQ injection.

Distribution: V_d: 78 ± 32 mL/kg.

Metabolism: Degradation of IgG and omalizumab:IgE complexes by reticuloendothelial system and endothelial cells in the liver.

Bioavailability: 62%.

Half-life elimination: 26 days (asthma patients); 24 days (chronic spontaneous urticaria patients).

Time to peak: 7 to 8 days.

Excretion: Primarily via hepatic degradation; intact IgG may be secreted in bile.

Brand Names: International

International Brand Names by Country

For country code abbreviations (show table)

(AE) United Arab Emirates: Xolair;
(AR) Argentina: Xolair;
(AT) Austria: Xolair;
(AU) Australia: Xolair;
(BD) Bangladesh: Xolair;
(BE) Belgium: Xolair;
(BG) Bulgaria: Xolair;
(BR) Brazil: Xolair;
(CH) Switzerland: Xolair;
(CL) Chile: Xolair;
(CO) Colombia: Xolair;
(CZ) Czech Republic: Xolair;
(DE) Germany: Xolair;
(DO) Dominican Republic: Xolair;
(EC) Ecuador: Xolair;
(EE) Estonia: Xolair;
(EG) Egypt: Xolair;
(ES) Spain: Xolair;
(FI) Finland: Xolair;
(FR) France: Xolair;
(GB) United Kingdom: Xolair;
(GR) Greece: Xolair;
(HK) Hong Kong: Xolair;
(HR) Croatia: Xolair;
(HU) Hungary: Xolair;
(ID) Indonesia: Xolair;
(IE) Ireland: Xolair;
(IN) India: Bolstran | Emzumab | Xolair;
(IT) Italy: Xolair;
(JO) Jordan: Xolair;
(JP) Japan: Xolair;
(KR) Korea, Republic of: Xolair;
(LB) Lebanon: Xolair;
(LT) Lithuania: Xolair;
(LU) Luxembourg: Xolair;
(LV) Latvia: Xolair;
(MA) Morocco: Xolair;
(MX) Mexico: Xolair;
(NL) Netherlands: Xolair;
(NO) Norway: Xolair;
(NZ) New Zealand: Xolair;
(PE) Peru: Xolair;
(PK) Pakistan: Xolair;
(PL) Poland: Xolair;
(PR) Puerto Rico: Xolair;
(PT) Portugal: Xolair;
(QA) Qatar: Xolair;
(RO) Romania: Xolair;
(RU) Russian Federation: Genolar | Xolair;
(SA) Saudi Arabia: Xolair | Xoliar;
(SE) Sweden: Xolair;
(SI) Slovenia: Xolair;
(SK) Slovakia: Xolair;
(TN) Tunisia: Xolair;
(TR) Turkey: Xolair;
(TW) Taiwan: Xolair;
(ZA) South Africa: Xolair

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Refer to the manufacturer's labeling.
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Topic 12905 Version 213.0

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Omalizumab: Pediatric drug information