Allergies:
Indications for: XOLAIR
Chronic idiopathic urticaria in symptomatic patients despite H1-antihistamine treatment.
Limitations of Use:
Not for treating other forms of urticaria.
Adult Dosage:
Dosing is not dependent on serum total IgE level or body weight. Give by SC inj over 5–10secs into upper arm (by caregiver or healthcare provider), thigh, or abdomen; rotate inj sites; max 150mg per inj site. ≥12yrs: 150mg or 300mg every 4 weeks. Reevaluate periodically. Prefilled syringe: determine if self-administration is appropriate for patient; see full labeling.
Children Dosage:
<12yrs: not established.
Boxed Warning:
Anaphylaxis.
XOLAIR 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 or nasal polyps: 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.
XOLAIR Classification:
Antiasthmatic (IgE blocker).
Adverse Reactions:
Nausea, nasopharyngitis, sinusitis, upper RTI, viral upper RTI, arthralgia, headache, cough; increased serum total IgE.
Note:
Enroll female patients in pregnancy exposure registry by calling (866) 4XOLAIR.
Generic Drug Availability:
NO
How Supplied:
Single-dose vial—1; Single-dose prefilled syringe—1
Pricing for XOLAIR
Asthma/COPD:
Indications for: XOLAIR
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. Not indicated for treatment of other allergic conditions.
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 5–10secs 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: determine if self-administration is appropriate for patient; see full labeling.
Boxed Warning:
Anaphylaxis.
XOLAIR 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 or nasal polyps: 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.
XOLAIR Classification:
Antiasthmatic (IgE blocker).
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 bite, epistaxis.
Note:
Enroll female patients in pregnancy exposure registry by calling (866) 4XOLAIR.
Generic Drug Availability:
NO
How Supplied:
Single-dose vial—1; Single-dose prefilled syringe—1
Pricing for XOLAIR
Miscellaneous respiratory disorders:
Indications for: XOLAIR
Add-on maintenance treatment of nasal polyps in adults with inadequate response to nasal corticosteroids.
Adult Dosage:
Base dose and frequency on baseline serum total IgE level and body weight; see full labeling. Give by SC inj over 5–10secs 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: determine if self-administration is appropriate for patient; see full labeling.
Children Dosage:
<18yrs: not established.
Boxed Warning:
Anaphylaxis.
XOLAIR 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 or nasal polyps: 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.
XOLAIR Classification:
Antiasthmatic (IgE blocker).
Adverse Reactions:
Headache, inj site reaction, arthralgia, upper abdominal pain, dizziness; increased serum total IgE.
Note:
Enroll female patients in pregnancy exposure registry by calling (866) 4XOLAIR.
Generic Drug Availability:
NO
How Supplied:
Single-dose vial—1; Single-dose prefilled syringe—1
