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XOLAIR
Allergies
Asthma/COPD
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Drug Name:

XOLAIR Rx

Generic Name and Formulations:
Omalizumab 150mg/vial; pwd for SC inj after reconstitution; preservative-free.

Company:
Genentech and Novartis

Therapeutic Use:

Indications for XOLAIR:

Chronic idiopathic urticaria in symptomatic patients despite H1-antihistamine treatment.

Limitations Of use:

Not for treating other forms of urticaria.

Adult:

Dosing is not dependent on serum total IgE level or body weight. Give by SC inj over 5–10 seconds; max 150mg per inj site. 150mg or 300mg every 4 weeks. Reevaluate periodically.

Children:

Not established.

Warnings/Precautions:

History of anaphylaxis. Have medications for treating anaphylaxis available, monitor for at least 2 hours after inj; may have delayed reaction. Discontinue if severe hypersensitivity, fever or arthralgia/arthritis occurs. Elevated serum IgE levels may persist for up to 1 year after stopping therapy. Patients at risk of malignancy or geohelminth infections; monitor. Eosinophilic conditions. Avoid abrupt cessation of systemic or inhaled corticosteroids in allergic asthma. Pregnancy. Nursing mothers.

Pharmacological Class:

Antiasthmatic (IgE blocker).

Adverse Reactions:

Nausea, nasopharyngitis, sinusitis, upper RTI, viral upper RTI, arthralgia, headache, cough, serum IgE increase.

Note:

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

Generic Availability:

NO

How Supplied:

Single-use vial (5mL)—1

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 by 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 5–10 seconds; max 150mg per inj site. ≥6yrs: 75–375mg every 2 or 4 weeks. Reevaluate periodically.

Warnings/Precautions:

History of anaphylaxis. Have medications for treating anaphylaxis available, monitor for at least 2 hours after inj; may have delayed reaction. Discontinue if severe hypersensitivity, fever or arthralgia/arthritis occurs. Elevated serum IgE levels may persist for up to 1 year after stopping therapy. Patients at risk of malignancy or geohelminth infections; monitor. Eosinophilic conditions. Avoid abrupt cessation of systemic or inhaled corticosteroids in allergic asthma. Pregnancy. Nursing mothers.

Pharmacological Class:

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 Availability:

NO

How Supplied:

Single-use vial (5mL)—1

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