Omalizumab (o-ma-liz-u-mab)
Xolair
Classification
Therapeutic: antiasthmatics
Pharmacologic: monoclonal antibodies
Pregnancy Category B
Indications
Moderate to severe asthma not controlled by inhaled corticosteroids.
Action
Inhibits binding of IgE to receptors on mast cells and eosinophils; preventing the release of mediators of the allergic response. Also decreases amount of IgE receptors on basophils. Therapeutic
Effects: Decreased incidence of exacerbations of asthma.
Pharmacokinetics
Absorption: 62% absorbed slowly from subcut sites.
Distribution: Enters breast milk. Metabolism and Excretion: Degraded similarly to IgG via binding degradation, reticuloendothelial system and the liver.
Half-life: 26 days.
ROUTE: Subcut
ONSET: within 1 hr
PEAK: unknown
DURATION: up to 1 yr
Contraindications/Precautions
Contraindicated in: Hypersensitivity; Acute bronchospasm.
Use Cautiously in: Chronic use of inhaled corticosteroids;
OB: Use in pregnancy only if clearly needed; enroll pregnant women with at least one exposure to omalizumab in the Xolair Pregnancy
Exposure Registry (1-866-496-5247); Lactation:
Safety not established; Pedi: Children 12 yr
(safety not established).
Adverse Reactions/Side Effects
Local: injection site reactions. Misc: allergic reactions including ANAPHYLAXIS,qrisk of malignancy.
Interactions
Drug-Drug: None noted.
Route/Dosage
Subcut (Adults and Children 12 yr): 150– 375 mg every 2–4 wk (determined by pretreatment serum IgE level and body weight).
Availability
Powder for injection: 150 mg/vial.
NURSING IMPLICATIONS
Assessment
- Assess lung sounds and respiratory function prior to and periodically during therapy.
- Assess allergy symptoms (rhinitis, conjunctivitis, hives) before and periodically throughout therapy.
- Assess for allergic reactions (urticaria, tongue and/or throat edema) within 2 hr of first or subsequent injections. Observe patient following injection. Epinephrine, diphenhydramine, and corticosteroids should be available in case of anaphylaxis.
- Monitor for injection site reactions (bruising, redness, warmth, burning, stinging, itching, hives, pain, induration, mass, inflammation). Usually occur within 1 hr of injection, last 8 days, and decrease in frequency with subsequent dosing.
- Lab Test Considerations: Serum IgE levels will increase following administration and may persist for up to 1 year following discontinuation. Serum total IgE levels obtained <1 year following discontinuation may not reflect steady state free IgE levels and should not be used to reassess the dosing regimen.
Ineffective airway clearance
Implementation
- Doses of inhaled corticosteroids may be gradually decreased with supervision of health care professional; do not discontinue abruptly.
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