Xolair

— THERAPEUTIC CATEGORIES —
  • Allergies
  • Asthma/COPD
  • Miscellaneous respiratory disorders
PAGE CONTENTS
  • Jump to Section
  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Xolair Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Omalizumab 150mg/vial; pwd for SC inj after reconstitution; 75mg/0.5mL, 150mg/mL, 300mg/2mL prefilled syringe or autoinjector; soln for SC inj; preservative-free.

    Pharmacological Class

    Antiasthmatic (IgE blocker).

    How Supplied

    Single-dose vial—1; Single-dose prefilled syringe—1; Single-dose prefilled autoinjector—1

    Storage

    Xolair prefilled syringe and autoinjector

    • Store under refrigerated conditions 36°F to 46°F (2°C to 8°C) in the original carton; do not freeze and do not use if the syringe or autoinjector has been frozen or exposed to temps >77°F (25°C).

    • Protect from direct sunlight.

    • Prefilled syringes and autoinjectors can be removed from and placed back into the refrigerator as needed; total combined time out of the refrigerator may not exceed 2 days.

    Xolair vial

    • Store under refrigerated conditions 36°F to 46°F (2°C to 8°C) in the original carton.

    • Do not use beyond the expiration date on carton.

    Manufacturer

    Genentech and Novartis

    Generic Availability

    NO

    Mechanism of Action

    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 CSU symptoms is unknown.

    Xolair Indications

    Indications

    Reduction of allergic reactions (Type I), including anaphylaxis, that may occur with accidental exposure to ≥1 foods in adult and pediatric patients with IgE-mediated food allergy; to be used in conjunction with food allergen avoidance. Chronic spontaneous urticaria (CSU) in symptomatic patients despite H1-antihistamine treatment.

    Limitations of Use

    Not for emergency treatment of allergic reactions, including anaphylaxis. Not for treating other forms of urticaria.

    Xolair Dosage and Administration

    Prior to Treatment Evaluations

    Asthma, and Chronic Rhinosinusitis with Nasal Polyps, and IgE-Mediated Food Allergy

    • Determine dose (mg) and dosing frequency by serum total IgE level (IU/mL) measured before the start of treatment, and by body weight (kg).
    • Dosing determination should be based on the primary diagnosis for which Xolair is being prescribed.
    • Total IgE levels are elevated during therapy and remain elevated for up to one year after the discontinuation of treatment. Therefore, re-testing of IgE levels during Xolair treatment cannot be used as a guide for dose determination.
      • Interruption of Xolair lasting <1 year: Dose based on serum IgE levels obtained at the initial dose determination.
      • Interruption of Xolair lasting ≥1 year: Re-test total serum IgE levels for dose determination.

    Chronic Spontaneous Urticaria 

    • Dosage of Xolair in patients with chronic spontaneous urticaria (CSU) is not dependent on serum IgE (free or total) level or body weight.

    Adults and Children

    IgE-mediated food allergy (<1yr) or CSU (<12yrs): not established. IgE-mediated food allergy: base dose and frequency on baseline serum total IgE level and body weight; see full labeling. CSU: dosing is not dependent on serum total IgE level or body weight. Give by SC inj over 5–15secs into upper arm (by caregiver or healthcare provider), thigh, or abdomen; rotate inj sites; max 150mg per inj site. IgE-mediated food allergy (≥1yr): 75–600mg every 2 or 4 weeks. CSU (≥12yrs): 150mg or 300mg every 4 weeks. Reevaluate periodically. Prefilled syringe or autoinjector: determine if self-administration is appropriate for patient; see full labeling.

    Administration

    Administer Xolair by subcutaneous injection under the guidance of a health care provider.

    Therapy should be initiated in a health care setting; once safely established, the health care provider can determine whether self-administration of Xolair prefilled syringe is appropriate.

    Consider risk factors for anaphylaxis to Xolair and mitigation strategies when selecting patients for self-administration.

    Criteria for Selecting Patients for Self-administration:

    • No prior history of anaphylaxis to Xolair or other agents (eg, food, drugs, biologics).
    • Three doses of Xolair received under guidance with no hypersensitivity reactions.
    • Patient/caregiver can recognize anaphylaxis symptoms and can treat appropriately.
    • Patient/caregiver can perform subcutaneous injections with Xolair prefilled syringe with proper technique.

    Xolair Prefilled Syringe 

    • ≥12yrs: may be self-administered under adult supervision.
    • 1 to 11yrs: should be administered by a caregiver.

    Xolair Autoinjector 

    • ≥12yrs: may be self-administered under adult supervision. Autoinjectors (all doses) are intended for use only in adults and adolescents aged 12 years and older.
    • 1 to 11yrs: autoinjectors (all doses) are not intended for use in pediatric patients under 12 years of age.

    Xolair Prefilled Syringe and Autoinjector Administration Instructions

    • Persons with latex allergies should not handle Xolair prefilled syringe. The needle cap of Xolair 75mg/0.5mL and 150mg/mL prefilled syringes contain a derivative of natural rubber latex.
    • Determine the number of prefilled syringes or autoinjectors needed for dosage; if more than 1, administer each injection at least 1 inch apart from other injection sites.
    • Administer subcutaneous injection into the thigh or abdomen (avoid 2 inch area around navel); outer area of upper arm may be used if the injection is given by a caregiver or health care provider.
    • Injection may take up to 15 seconds to administer.

    Xolair Lyophilized Powder Administration Instructions

    • Should be prepared and injected by a health care provider.
    • Determine the number of vials needed to be reconstituted to deliver dose.
    • Reconstitute with Sterile Water for injection
    • The lyophilized product takes 15–20 minutes to dissolve.
    • Use the Xolair solution within 8 hours following reconstitution when stored in the vial at 2ºC to 8ºC (36ºF to 46ºF), or within 4 hours of reconstitution when stored at room temperature.
    • Administer Xolair by subcutaneous injection; the injection may take 5–10 seconds to administer because the solution is slightly viscous.
    • Do not administer more than 150mg (contents of 1 vial) per injection site.

    Nursing Considerations

    Administer Xolair by subcutaneous injection; the injection may take 5–10 seconds to administer because the solution is slightly viscous (vials); or up to 15 seconds (prefilled syringes or autoinjectors). 

    Do not administer more than 150mg (contents of 1 vial) per injection site. 

    Divide doses of more than 150mg between 2 or more injection sites. 

    Choose a different injection site for each new injection at least 1 inch from the area used for other injections.

     

    Xolair Contraindications

    Not Applicable

    Xolair Boxed Warnings

    Boxed Warning

    Anaphylaxis.

    Boxed Warning

    Anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of Xolair.

    • Anaphylaxis has occurred as early as the first dose but has also occurred beyond 1 year after initiating regular treatment.
    • Approximately 60–70% of anaphylaxis cases have been reported to occur within the first 3 doses.
    • Xolair should be initiated in a health care setting.
    • Patients should be closely observed after administration.
    • Healthcare settings should be equipped to manage anaphylaxis.

    Xolair Warnings/Precautions

    Warnings/Precautions

    History of anaphylaxis. Initiate only in a healthcare setting equipped to manage anaphylaxis; monitor closely for a period of time after inj; may have delayed reaction. Discontinue if severe hypersensitivity, constellation of signs/symptoms (fever, arthralgia/arthritis, rash, and lymphadenopathy) occurs. Elevated serum total IgE levels may persist for up to 1 year after stopping therapy. For asthma, nasal polyps, or IgE-mediated food allergy: do not use serum total IgE levels obtained <1 year after discontinuation to reassess dosing regimen. Patients at risk of malignancy (eg, elderly, current smokers) or geohelminth infections; monitor. Eosinophilic conditions. Prefilled syringe (needle shield): latex sensitivity. Avoid abrupt cessation of corticosteroids (systemic or inhaled) for asthma or nasal polyps. Pregnancy. Nursing mothers.

    Pregnancy Considerations

    Xolair may be transmitted from the mother to the developing fetus. A registry study of Xolair exposure during pregnancy showed no increase in the rate of major birth defects or miscarriage.

    Nursing Mother Considerations

    Omalizumab is a human monoclonal antibody (IgG1 kappa), and immunoglobulin (IgG) is present in human milk in small amounts. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Xolair and any potential adverse effects on the breastfed child from omalizumab or from the underlying maternal condition.

    Pediatric Considerations

    Safety and effectiveness in pediatric patients with CSU <12 years of age have not been established.

    Safety and effectiveness in pediatric patients with IgE-mediated food allergy <1 year of age have not been established.

     

    Geriatric Considerations

    No apparent age-related differences were observed in clinical trials, though the number of patients aged 65 and over was not sufficient to determine difference in response.

    Xolair Pharmacokinetics

    Absorption

    Following a single SC dose, omalizumab was absorbed slowly, reaching peak serum concentrations after an average of 7–8 days.

    Distribution

    Apparent volume of distribution: 78 ± 32 mL/kg.

    Elimination

    In CSU patients, at steady state, based on population pharmacokinetics, omalizumab serum elimination half-life averaged 24 days and apparent clearance averaged 240mL/day (corresponding to 3.0mL/kg/day for an 80kg patient).

    Xolair Interactions

    Interactions

    Concomitant use of Xolair and allergen immunotherapy has not been evaluated.

    Xolair Adverse Reactions

    Adverse Reactions

    Nausea, nasopharyngitis, sinusitis, upper RTI, viral upper RTI, arthralgia, headache, cough, injection site reactions, pyrexia; increased serum total IgE.

    Xolair Clinical Trials

    Clinical Trials

    Two placebo-controlled, multiple-dose clinical trials of 24 weeks’ duration (CSU Trial 1; n= 319) and 12 weeks’ duration (CSU Trial 2; n=322).

    • Patients received Xolair 75mg, 150mg, or 300mg or placebo by SC injection every 4 weeks in addition to their baseline level of H1 antihistamine therapy for 24 or 12 weeks, followed by a 16-week washout observation period.
    • A total of 640 patients (165 males, 475 females) were included for the efficacy analyses; 84% white; median age, 42 years (range, 12-72).
    • In both trials, patients who received Xolair 150mg or 300mg had greater decreases from baseline in weekly itch severity scores and weekly hive count scores than placebo at week 12.
    • The 75mg dose did not demonstrate consistent evidence of efficacy and is not approved for use in CSU.
    • The appropriate duration of therapy for CSU with Xolair has not been determined.
    • A larger proportion of patients treated with Xolair 300mg reported no itch and no hives at week 12 compared with patients treated with Xolair 150mg, Xolair 75mg, and placebo.

    Xolair Note

    Notes

    Enroll female patients in pregnancy exposure registry by calling (866) 4XOLAIR.

    Xolair Patient Counseling

    Patient Counseling

    Inform patients of the signs and symptoms of anaphylaxis.

    Continue other medications; may not see immediate improvement in symptoms after beginning Xolair therapy.

    Prefilled syringe needle cover contains latex.

    Instruct on injection technique.

    For patients who require >1 injection to complete the prescribed dose, instruct patient to administer all injections consecutively and in one sitting.

    Cost Savings Program

    The Xolair Co-Pay Program is available here.

    Xolair Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Omalizumab 150mg/vial; pwd for SC inj after reconstitution; 75mg/0.5mL, 150mg/mL, 300mg/2mL prefilled syringe or autoinjector; soln for SC inj; preservative-free.

    Pharmacological Class

    Antiasthmatic (IgE blocker).

    How Supplied

    Single-dose vial—1; Single-dose prefilled syringe—1; Single-dose prefilled autoinjector—1

    Storage

    Xolair prefilled syringe and autoinjector

    • Store under refrigerated conditions 36°F to 46°F (2°C to 8°C) in the original carton; do not freeze and do not use if the syringe or autoinjector has been frozen or exposed to temps >77°F (25°C).

    • Protect from direct sunlight.

    • Prefilled syringes and autoinjectors can be removed from and placed back into the refrigerator as needed; total combined time out of the refrigerator may not exceed 2 days.

    Xolair vial

    • Store under refrigerated conditions 36°F to 46°F (2°C to 8°C) in the original carton.

    • Do not use beyond the expiration date on carton.

    Manufacturer

    Genentech and Novartis

    Generic Availability

    NO

    Mechanism of Action

    Omalizumab inhibits the binding of IgE to the high-affinity IgE receptor (FcεRI) on the surface of mast cells, basophils, and dendritic cells, resulting in FcεRI down-regulation on these cells. In allergic asthmatics, treatment with omalizumab inhibits IgE-mediated inflammation, as evidenced by reduced blood and tissue eosinophils and reduced inflammatory mediators, including IL-4, IL-5, and IL-13.

    Xolair Indications

    Indications

    Moderate to severe persistent asthma in patients ≥6yrs of age with a (+) skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids.

    Limitations of Use

    Not for relief of acute bronchospasm or status asthmaticus. 

    Xolair Dosage and Administration

    Prior to Treatment Evaluations

    Asthma, and Chronic Rhinosinusitis with Nasal Polyps, and IgE-Mediated Food Allergy

    • Determine dose (mg) and dosing frequency by serum total IgE level (IU/mL) measured before the start of treatment, and by body weight (kg).
    • Dosing determination should be based on the primary diagnosis for which Xolair is being prescribed.
    • Total IgE levels are elevated during therapy and remain elevated for up to one year after the discontinuation of treatment. Therefore, re-testing of IgE levels during Xolair treatment cannot be used as a guide for dose determination.
      • Interruption of Xolair lasting <1 year: Dose based on serum IgE levels obtained at the initial dose determination.
      • Interruption of Xolair lasting ≥1 year: Re-test total serum IgE levels for dose determination.

    Chronic Spontaneous Urticaria 

    • Dosage of Xolair in patients with chronic spontaneous urticaria (CSU) is not dependent on serum IgE (free or total) level or body weight.

    Adults and Children

    <6yrs: not established. Base dose and frequency on baseline serum total IgE level and body weight; see full labeling. Give by SC inj over 5–15secs into upper arm (by caregiver or healthcare provider), thigh, or abdomen; rotate inj sites; max 150mg per inj site. ≥6yrs: 75–375mg every 2 or 4 weeks. Reevaluate periodically. Prefilled syringe or autoinjector: determine if self-administration is appropriate for patient; see full labeling.

    Administration

    Administer Xolair by subcutaneous injection under the guidance of a health care provider.

    Therapy should be initiated in a health care setting; once safely established, the health care provider can determine whether self-administration of Xolair prefilled syringe is appropriate.

    Consider risk factors for anaphylaxis to Xolair and mitigation strategies when selecting patients for self-administration.

    Criteria for Selecting Patients for Self-administration:

    • No prior history of anaphylaxis to Xolair or other agents (eg, food, drugs, biologics).
    • Three doses of Xolair received under guidance with no hypersensitivity reactions.
    • Patient/caregiver can recognize anaphylaxis symptoms and can treat appropriately.
    • Patient/caregiver can perform subcutaneous injections with Xolair prefilled syringe with proper technique.

    Xolair Prefilled Syringe 

    • ≥12yrs: may be self-administered under adult supervision.
    • 1 to 11yrs: should be administered by a caregiver.

    Xolair Autoinjector 

    • ≥12yrs: may be self-administered under adult supervision. Autoinjectors (all doses) are intended for use only in adults and adolescents aged 12 years and older.
    • 1 to 11yrs: autoinjectors (all doses) are not intended for use in pediatric patients under 12 years of age.

    Xolair Prefilled Syringe and Autoinjector Administration Instructions

    • Persons with latex allergies should not handle Xolair prefilled syringe. The needle cap of Xolair 75mg/0.5mL and 150mg/mL prefilled syringes contain a derivative of natural rubber latex.
    • Determine the number of prefilled syringes or autoinjectors needed for dosage; if more than 1, administer each injection at least 1 inch apart from other injection sites.
    • Administer subcutaneous injection into the thigh or abdomen (avoid 2 inch area around navel); outer area of upper arm may be used if the injection is given by a caregiver or health care provider.
    • Injection may take up to 15 seconds to administer.

    Xolair Lyophilized Powder Administration Instructions

    • Should be prepared and injected by a health care provider.
    • Determine the number of vials needed to be reconstituted to deliver dose.
    • Reconstitute with Sterile Water for injection
    • The lyophilized product takes 15–20 minutes to dissolve.
    • Use the Xolair solution within 8 hours following reconstitution when stored in the vial at 2ºC to 8ºC (36ºF to 46ºF), or within 4 hours of reconstitution when stored at room temperature.
    • Administer Xolair by subcutaneous injection; the injection may take 5–10 seconds to administer because the solution is slightly viscous.
    • Do not administer more than 150mg (contents of 1 vial) per injection site.

    Nursing Considerations

    Administer Xolair by subcutaneous injection; the injection may take 5–10 seconds to administer because the solution is slightly viscous (vials); or up to 15 seconds (prefilled syringes or autoinjectors). 

    Do not administer more than 150mg (contents of 1 vial) per injection site. 

    Divide doses of more than 150mg between 2 or more injection sites. 

    Choose a different injection site for each new injection at least 1 inch from the area used for other injections.

     

    Xolair Contraindications

    Not Applicable

    Xolair Boxed Warnings

    Boxed Warning

    Anaphylaxis.

    Boxed Warning

    Anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of Xolair.

    • Anaphylaxis has occurred as early as the first dose but has also occurred beyond 1 year after initiating regular treatment.
    • Approximately 60–70% of anaphylaxis cases have been reported to occur within the first 3 doses.
    • Xolair should be initiated in a health care setting.
    • Patients should be closely observed after administration.
    • Healthcare settings should be equipped to manage anaphylaxis.

    Xolair Warnings/Precautions

    Warnings/Precautions

    History of anaphylaxis. Initiate only in a healthcare setting equipped to manage anaphylaxis; monitor closely for a period of time after inj; may have delayed reaction. Discontinue if severe hypersensitivity, constellation of signs/symptoms (fever, arthralgia/arthritis, rash, and lymphadenopathy) occurs. Elevated serum total IgE levels may persist for up to 1 year after stopping therapy. For asthma, nasal polyps, or IgE-mediated food allergy: do not use serum total IgE levels obtained <1 year after discontinuation to reassess dosing regimen. Patients at risk of malignancy (eg, elderly, current smokers) or geohelminth infections; monitor. Eosinophilic conditions. Prefilled syringe (needle shield): latex sensitivity. Avoid abrupt cessation of corticosteroids (systemic or inhaled) for asthma or nasal polyps. Pregnancy. Nursing mothers.

    Pregnancy Considerations

    Xolair may be transmitted from the mother to the developing fetus. A registry study of Xolair exposure during pregnancy showed no increase in the rate of major birth defects or miscarriage.

    Nursing Mother Considerations

    Omalizumab is a human monoclonal antibody (IgG1 kappa), and immunoglobulin (IgG) is present in human milk in small amounts. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Xolair and any potential adverse effects on the breastfed child from omalizumab or from the underlying maternal condition.

    Pediatric Considerations

    Xolair was evaluated in 2 trials in 926 pediatric patients 6 to <12 years of age with moderate to severe persistent asthma who had a positive skin test or in vitro reactivity to a perennial aeroallergen.

    Safety and efficacy in pediatric patients with asthma below 6 years of age have not been established.

    Geriatric Considerations

    No apparent age-related differences were observed in clinical trials, though the number of patients aged 65 and over was not sufficient to determine difference in response.

    Xolair Pharmacokinetics

    Absorption

    Following a single SC dose, omalizumab was absorbed slowly, reaching peak serum concentrations after an average of 7–8 days.

    Distribution

    Apparent volume of distribution: 78 ± 32 mL/kg.

    Elimination

    In asthma patients omalizumab serum elimination half-life averaged 26 days, with apparent clearance averaging 2.4 ± 1.1mL/kg/day. Doubling body weight approximately doubled apparent clearance.

    Xolair Interactions

    Interactions

    Concomitant use of Xolair and allergen immunotherapy has not been evaluated.

    Xolair Adverse Reactions

    Adverse Reactions

    Adults: arthralgia, leg/arm/general pain, fatigue, dizziness, fracture, pruritus, dermatitis, earache, serum IgE increase; Children: nasopharyngitis, headache, pyrexia, upper abdominal pain, pharyngitis streptococcal, otitis media, viral gastroenteritis, arthropod bites, epistaxis.

    Adverse Reactions

    Most common:

    •  ≥12 years: arthralgia, pain (general), leg pain, fatigue, dizziness, fracture, arm pain, pruritus, dermatitis, and earache.
    • 6 to <12 years: nasopharyngitis, headache, pyrexia, upper abdominal pain, pharyngitis streptococcal, otitis media, viral gastroenteritis, arthropod bites, and epistaxis.

    See Warnings/Precautions regarding anaphylaxis, malignancy, eosinophilic conditions, fever, arthralgia, and rash. 

    Observational study data suggest a potential increased risk of serious cardiovascular and cerebrovascular events in patients treated with Xolair.

    As with all therapeutic proteins, there is potential for immunogenicity.

    Xolair Clinical Trials

    Clinical Trials

    Safety and efficacy of Xolair were evaluated in 3 randomized, double-blind, placebo-controlled, multicenter trials.

    Asthma Trials 1 and 2

    Patient demographics

    • Forced expiratory volume in one second (FEV1) between 40% and 80% predicted.
    • FEV1 improvement of at least 12% following beta2-agonist administration.
    • Symptomatic and being treated with inhaled corticosteroids (ICS) and short-acting beta2-agonists.

    Trials included a run-in period to achieve a stable conversion to a common ICS (beclomethasone dipropionate), followed by randomization to Xolair or placebo. 

    Patients received Xolair for 16 weeks with an unchanged corticosteroid dose unless an acute exacerbation necessitated an increase. 

    Patients then entered an ICS reduction phase of 12 weeks during which ICS dose reduction was attempted in a stepwise manner.

    In both trials, the number of exacerbations per patient was reduced in patients treated with Xolair compared with placebo

    Asthma Trial 3

    Patient demographics

    • No restriction on screening FEV1.
    • Long-acting beta2 agonists allowed.
    • Patients were receiving at least 1000mcg/day fluticasone propionate and a subset was also receiving oral corticosteroids.

    Trial consisted of a run-in period to achieve a stable conversion to a common ICS (fluticasone propionate), followed by randomization to Xolair or placebo.

    Patients received Xolair for 16 weeks with an unchanged corticosteroid dose unless an acute exacerbation necessitated an increase. 

    Patients then entered an ICS reduction phase of 16 weeks during which ICS or oral steroid dose reduction was attempted in a stepwise manner.

    The number of exacerbations in patients treated with Xolair was similar to that in placebo treated patients.

    In all 3 trials, a reduction of asthma exacerbations was not observed in Xolair-treated patients who had FEV1>80% at the time of randomization. Reductions in exacerbations were not seen in patients who required oral steroids as maintenance therapy.

    Asthma Trial 4

    628 pediatric patients 6 to <12 years of age with moderate to severe asthma inadequately controlled despite use of ICS (fluticasone propionate DPI ≥200mcg/day or equivalent) with or without other controller asthma medications.

    Patient demographics

    • Diagnosis of asthma >1 year.
    • Positive skin prick test to at least 1 perennial aeroallergen.
    • History of clinical features (eg, daytime/nighttime symptoms, exacerbations within the year prior to study entry).

    First 24 weeks, steroid doses remained constant from baseline, followed by a 28-week period during which ICS adjustment was allowed.

    At 24 weeks, the Xolair group had a statistically significantly lower rate of asthma exacerbations (0.45 vs. 0.64) with an estimated rate ratio of 0.69 (95% CI, 0.53-0.90). 

    The Xolair group also had a lower rate of asthma exacerbations vs placebo over the full 52-week double-blind treatment period (0.78 vs. 1.36; rate ratio: 0.57; 95% CI, 0.45-0.72).

    Asthma Trial 5

    334 pediatric patients, 298 of whom were 6 to <12 years of age, with moderate to severe asthma who were well-controlled with inhaled corticosteroids (beclomethasone dipropionate 168-420mcg/day).

    A 16-week steroid treatment period was followed by a 12-week steroid dose reduction period.

    Patients treated with Xolair had fewer asthma exacerbations vs placebo during both the 16-week fixed steroid treatment period (0.18 vs. 0.32; rate ratio: 0.58; 95% CI, 0.35-0.96) and the 28-week treatment period (0.38 vs. 0.76; rate ratio: 0.50; 95% CI, 0.36-0.71).

    Xolair Note

    Notes

    Enroll female patients in pregnancy exposure registry by calling (866) 4XOLAIR.

    Xolair Patient Counseling

    Patient Counseling

    Inform patients of the signs and symptoms of anaphylaxis.

    Continue other medications; may not see immediate improvement in symptoms after beginning Xolair therapy.

    Prefilled syringe needle cover contains latex.

    Instruct on injection technique.

    For patients who require >1 injection to complete the prescribed dose, instruct patient to administer all injections consecutively and in one sitting.

    Cost Savings Program

    The Xolair Co-Pay Program is available here.

    Xolair Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Omalizumab 150mg/vial; pwd for SC inj after reconstitution; 75mg/0.5mL, 150mg/mL, 300mg/2mL prefilled syringe or autoinjector; soln for SC inj; preservative-free.

    Pharmacological Class

    Antiasthmatic (IgE blocker).

    How Supplied

    Single-dose vial—1; Single-dose prefilled syringe—1; Single-dose prefilled autoinjector—1

    Storage

    Xolair prefilled syringe and autoinjector

    • Store under refrigerated conditions 36°F to 46°F (2°C to 8°C) in the original carton; do not freeze and do not use if the syringe or autoinjector has been frozen or exposed to temps >77°F (25°C).

    • Protect from direct sunlight.

    • Prefilled syringes and autoinjectors can be removed from and placed back into the refrigerator as needed; total combined time out of the refrigerator may not exceed 2 days.

    Xolair vial

    • Store under refrigerated conditions 36°F to 46°F (2°C to 8°C) in the original carton.

    • Do not use beyond the expiration date on carton.

    Manufacturer

    Genentech and Novartis

    Generic Availability

    NO

    Mechanism of Action

    Omalizumab inhibits the binding of IgE to the high-affinity IgE receptor (FcεRI) on the surface of mast cells, basophils, and dendritic cells, resulting in FcεRI down-regulation on these cells. In allergic asthmatics, treatment with omalizumab inhibits IgE-mediated inflammation, as evidenced by reduced blood and tissue eosinophils and reduced inflammatory mediators, including IL-4, IL-5, and IL-13.

    Xolair Indications

    Indications

    Add-on maintenance treatment of chronic rhinosinusitis with nasal polyps in adults with inadequate response to nasal corticosteroids.

    Xolair Dosage and Administration

    Prior to Treatment Evaluations

    Determine dose (mg) and dosing frequency by serum total IgE level (IU/mL) measured before the start of treatment, and by body weight (kg).

    Dosing determination should be based on the primary diagnosis for which Xolair is being prescribed.

    Interruption of Xolair lasting <1 year: Dose based on serum IgE levels obtained at the initial dose determination.

    Interruption of Xolair lasting 1 year or more: Re-test total serum IgE levels for dose determination.

    Adult

    Base dose and frequency on baseline serum total IgE level and body weight; see full labeling. Give by SC inj over 5–15secs into upper arm (by caregiver or healthcare provider), thigh, or abdomen; rotate inj sites; max 150mg per inj site. ≥18yrs: 75–600mg every 2 or 4 weeks. Reevaluate periodically. Prefilled syringe or autoinjector: determine if self-administration is appropriate for patient; see full labeling.

    Children

    <18yrs: not established.

    Administration

    Administer Xolair by subcutaneous injection under the guidance of a health care provider.

    Therapy should be initiated in a health care setting; once safely established, the health care provider can determine whether self-administration of Xolair prefilled syringe is appropriate.

    Consider risk factors for anaphylaxis to Xolair and mitigation strategies when selecting patients for self-administration.

    Criteria for Selecting Patients for Self-administration:

    • No prior history of anaphylaxis to Xolair or other agents (eg, food, drugs, biologics).
    • Three doses of Xolair received under guidance with no hypersensitivity reactions.
    • Patient/caregiver can recognize anaphylaxis symptoms and can treat appropriately.
    • Patient/caregiver can perform subcutaneous injections with Xolair prefilled syringe with proper technique.

    Xolair Prefilled Syringe 

    • ≥12yrs: may be self-administered under adult supervision.
    • 1 to 11yrs: should be administered by a caregiver.

    Xolair Autoinjector 

    • ≥12yrs: may be self-administered under adult supervision. Autoinjectors (all doses) are intended for use only in adults and adolescents aged 12 years and older.
    • 1 to 11yrs: autoinjectors (all doses) are not intended for use in pediatric patients under 12 years of age.

    Xolair Prefilled Syringe and Autoinjector Administration Instructions

    • Persons with latex allergies should not handle Xolair prefilled syringe. The needle cap of Xolair 75mg/0.5mL and 150mg/mL prefilled syringes contain a derivative of natural rubber latex.
    • Determine the number of prefilled syringes or autoinjectors needed for dosage; if more than 1, administer each injection at least 1 inch apart from other injection sites.
    • Administer subcutaneous injection into the thigh or abdomen (avoid 2 inch area around navel); outer area of upper arm may be used if the injection is given by a caregiver or health care provider.
    • Injection may take up to 15 seconds to administer.

    Xolair Lyophilized Powder Administration Instructions

    • Should be prepared and injected by a health care provider.
    • Determine the number of vials needed to be reconstituted to deliver dose.
    • Reconstitute with Sterile Water for injection
    • The lyophilized product takes 15–20 minutes to dissolve.
    • Use the Xolair solution within 8 hours following reconstitution when stored in the vial at 2ºC to 8ºC (36ºF to 46ºF), or within 4 hours of reconstitution when stored at room temperature.
    • Administer Xolair by subcutaneous injection; the injection may take 5–10 seconds to administer because the solution is slightly viscous.
    • Do not administer more than 150mg (contents of 1 vial) per injection site.

    Nursing Considerations

    Administer Xolair by subcutaneous injection; the injection may take 5–10 seconds to administer because the solution is slightly viscous (vials); or up to 15 seconds (prefilled syringes or autoinjectors). 

    Do not administer more than 150mg (contents of 1 vial) per injection site. 

    Divide doses of more than 150mg between 2 or more injection sites. 

    Choose a different injection site for each new injection at least 1 inch from the area used for other injections.

     

    Xolair Contraindications

    Not Applicable

    Xolair Boxed Warnings

    Boxed Warning

    Anaphylaxis.

    Boxed Warning

    Anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of Xolair.

    • Anaphylaxis has occurred as early as the first dose but has also occurred beyond 1 year after initiating regular treatment.
    • Approximately 60–70% of anaphylaxis cases have been reported to occur within the first 3 doses.
    • Xolair should be initiated in a health care setting.
    • Patients should be closely observed after administration.
    • Healthcare settings should be equipped to manage anaphylaxis.

    Xolair Warnings/Precautions

    Warnings/Precautions

    History of anaphylaxis. Initiate only in a healthcare setting equipped to manage anaphylaxis; monitor closely for a period of time after inj; may have delayed reaction. Discontinue if severe hypersensitivity, constellation of signs/symptoms (fever, arthralgia/arthritis, rash, and lymphadenopathy) occurs. Elevated serum total IgE levels may persist for up to 1 year after stopping therapy. For asthma, nasal polyps, or IgE-mediated food allergy: do not use serum total IgE levels obtained <1 year after discontinuation to reassess dosing regimen. Patients at risk of malignancy (eg, elderly, current smokers) or geohelminth infections; monitor. Eosinophilic conditions. Prefilled syringe (needle shield): latex sensitivity. Avoid abrupt cessation of corticosteroids (systemic or inhaled) for asthma or nasal polyps. Pregnancy. Nursing mothers.

    Pregnancy Considerations

    Xolair may be transmitted from the mother to the developing fetus. A registry study of Xolair exposure during pregnancy showed no increase in the rate of major birth defects or miscarriage.

    Nursing Mother Considerations

    Omalizumab is a human monoclonal antibody (IgG1 kappa), and immunoglobulin (IgG) is present in human milk in small amounts. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Xolair and any potential adverse effects on the breastfed child from omalizumab or from the underlying maternal condition.

    Pediatric Considerations

    Safety and effectiveness in pediatric patients with chronic rhinosinusitis with nasal polyps <18 years of age have not been established.

    Geriatric Considerations

    No apparent age-related differences were observed in clinical trials, though the number of patients aged 65 and over was not sufficient to determine difference in response.

    Xolair Pharmacokinetics

    Absorption

    Following a single SC dose, omalizumab was absorbed slowly, reaching peak serum concentrations after an average of 7–8 days.

    Distribution

    Apparent volume of distribution: 78 ± 32 mL/kg.

    Elimination

    Clearance of omalizumab involved IgG clearance processes as well as clearance via specific binding and complex formation with its target ligand, IgE.

    Xolair Interactions

    Interactions

    Concomitant use of Xolair and allergen immunotherapy has not been evaluated.

    Xolair Adverse Reactions

    Adverse Reactions

    Headache, inj site reaction, arthralgia, upper abdominal pain, dizziness; increased serum total IgE.

    Xolair Clinical Trials

    Clinical Trials

    Approval was supported by data from the phase 3 POLYP 1 (N=138) and POLYP 2 (N=127) trials evaluating the efficacy and safety of Xolair in adults with nasal polyps who had an inadequate response to nasal corticosteroids.

    Patients  were required to have evidence of bilateral polyps as determined by a nasal polyp score (NPS)≥5 with NPS≥2 in each nostril, despite use of nasal mometasone during the run-in period.

    Patients were randomly assigned to receive either Xolair or placebo by subcutaneous injection every 2 to 4 weeks. 

    The coprimary end points for both trials were change from baseline in NPS at week 24, and change from baseline in average daily Nasal Congestion Score (NCS) to week 24.

    Results from both trials showed that patients treated with Xolair had a statistically significant greater improvement from baseline at week 24 in NPS and NCS compared with placebo, with improvements observed as early as week 4.

    Xolair demonstrated statistically significant improvements on sense of smell score, post-nasal drip, and runny nose in both trials.

    Xolair Note

    Notes

    Enroll female patients in pregnancy exposure registry by calling (866) 4XOLAIR.

    Xolair Patient Counseling

    Patient Counseling

    Inform patients of the signs and symptoms of anaphylaxis.

    Continue other medications; may not see immediate improvement in symptoms after beginning Xolair therapy.

    Prefilled syringe needle cover contains latex.

    Instruct on injection technique.

    For patients who require >1 injection to complete the prescribed dose, instruct patient to administer all injections consecutively and in one sitting.

    Cost Savings Program

    The Xolair Co-Pay Program is available here.

    Images

    • Latest News Your top articles for Wednesday

    • Haymarket Medical NetworkTop Picks

    • Loading...

      Continuing Medical Education (CME/CE) Courses

      Show More