omalizumab


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omalizumab

Xolair

Pharmacologic class: Recombinant DNA-derived immunoglobulin G subclass 1 (IgG1) monoclonal antibody

Therapeutic class: Monoclonal antibody

Pregnancy risk category B

FDA Box Warning

• Anaphylaxis, presenting as bronchospasm, hypotension, syncope, urticaria, or angioedema of throat or tongue, has occurred after administration of omalizumab. Anaphylaxis has occurred after first dose but also has occurred beyond 1 year after beginning treatment. Closely observe patients for appropriate period after administration and be prepared to manage anaphylaxis that can be life-threatening. Inform patients of signs and symptoms of anaphylaxis and have them seek immediate medical care should signs and symptoms occur.

Action

Inhibits binding of IgE to high-affinity IgE receptors on surface of mast cells and basophils

Availability

Powder for injection: 150 mg/vial

Indications and dosages

Persistent asthma in patients with positive skin tests or in vitro reactivity to perennial allergens whose symptoms aren't adequately controlled by inhaled corticosteroids

Adults and adolescents ages 12 and older: 150 to 375 mg subcutaneously q 2 to 4 weeks, with dosing frequency determined by serum IgE level and weight

Dosage adjustment

• Significant weight change

Contraindications

• Hypersensitivity to drug

Precautions

Use cautiously in:
• elderly patients
• pregnant or breastfeeding patients
• children younger than age 12.

Administration

Be aware that omalizumab isn't a rescue drug and isn't intended for acute asthma attacks or status asthmaticus.

Don't discontinue abruptly.
• Don't administer more than 150 mg per injection site.
• Prepare injection only with sterile water for injection.

Adverse reactions

CNS: headache, fatigue, dizziness

EENT: sinusitis, pharyngitis, earache

Musculoskeletal: arthralgia, fracture, leg or arm pain

Respiratory: upper respiratory infection

Skin: pruritus, dermatitis

Other: injection-site reaction, viral infection, pain, cancer, anaphylaxis

Interactions

Drug-diagnostic tests.Serum IgE: elevated level

Patient monitoring

Monitor patient for severe hypersensitivity reactions, including anaphylaxis.

Watch for signs and symptoms of cancer (rare).

Patient teaching

Tell patient to take exactly as prescribed and not to change dosage or stop drug abruptly (unless hypersensitivity reaction occurs).

Instruct patient to discontinue drug and notify prescriber immediately at first sign of hypersensitivity reaction, such as rash, hives, or itching.
• Inform patient that asthma symptoms may not improve immediately after starting drug.
• Tell patient drug isn't intended for acute asthma attacks.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the tests mentioned above.

omalizumab

(o-ma-liz-u-mab) ,

Xolair

(trade name)

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.

Time/action profile (effects on IgE levels)

ROUTEONSETPEAKDURATION
Subcutwithin 1 hrunknownup to 1 yr

Contraindications/Precautions

Contraindicated in: Hypersensitivity; Acute bronchospasm.
Use Cautiously in: Chronic use of inhaled corticosteroids; Obstetric: Use 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; Pediatric: Children <12 yr (safety not established).

Adverse Reactions/Side Effects

Local

  • injection site reactions (most frequent)

Miscellaneous

  • allergic reactions including anaphylaxis (life-threatening)
  • ↑ risk of malignancy

Interactions

Drug-Drug interaction

None noted.

Route/Dosage

Subcutaneous (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

Nursing 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 (wheezing, shortness of breath, cough, chest tightness, trouble breathing, low BP, dizziness, fainting, rapid or weak heartbeat, anxiety, feeling of “impending doom”, flushing, itching, hives, feeling warm, swelling of the throat or tongue, throat tightness, hoarse voice, trouble swallowing) 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 ↑ 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.

Potential Nursing Diagnoses

Ineffective airway clearance

Implementation

  • Doses of inhaled corticosteroids may be gradually decreased with supervision of health care professional; do not discontinue abruptly.
  • Subcutaneous: To reconstitute draw 1.4 mL of sterile water for injection into a 3-cc syringe with a 1-inch 18-gauge needle. With vial upright on a flat surface, inject sterile water into vial. Keep vial upright and gently swirl for approximately 1 min to evenly wet powder. Do not shake. Lyophilized omalizumab takes 15–20 min to dissolve. Gently swirl vial for 5–10 seconds every 5 min to dissolve any remaining particles. Solution should be clear or slightly opalescent and may have small bubbles or foam around edge of vial. Do not use if particles are visible or if contents do not dissolve completely within 40 min. Invert vial for 15 seconds to allow solution to drain toward stopper. Solution may be somewhat viscous. In order to obtain full 1.2 mL dose, all of solution must be withdrawn from vial using a new 3-cc syringe with an 18-gauge needle, before expelling any air or excess solution from syringe. Administer within 8 hr if refrigerated or within 4 hr if stored at room temperature. Discard unused solution.
    • Replace 18-gauge needle with a 25-gauge needle for subcut injection. Because solution is slightly viscous, injection may take 5–10 seconds to administer. Divide doses >150 mg into 2 injection sites.

Patient/Family Teaching

  • Explain purpose of medication to patient. Inform patient that they may not see immediate results from omalizumab therapy. Instruct patient to read the Medication Guide before starting and with each injection in case of changes.
  • Instruct patient not to discontinue or reduce other asthma medications, especially inhaled corticosteroids, without consulting health care professional.
  • Advise patient to notify health care professional immediately if symptoms of an allergic reaction occur.

Evaluation/Desired Outcomes

  • Decreased incidence of exacerbations of asthma.

omalizumab

(ō′mə-lĭz′yə-măb′)
n.
A humanized monoclonal antibody, used as an intravenous drug to treat severe asthma.

omalizumab

a monoclonal antibody.
indications This drug is used to treat moderate to severe persistent asthma.
contraindication Known hypersensitivity to this drug prohibits its use.
adverse effects Adverse effects of this drug include earache, dizziness, fatigue, pain, viral infections, sinusitis, upper respiratory infections, pharyngitis, pruritus, dermatitis, injection site reactions, arthralgia, fracture, and leg and arm pain. A life-threatening side effect is malignancy.
References in periodicals archive ?
GENEVA -- Omalizumab for treatment of chronic spontaneous urticaria (CSU) brings about a profound improvement in angioedema-related quality of life, a widely underappreciated dimension of the impairment caused by this disease, Karsten Weller, MD, said at the annual congress of the European Academy of Dermatology and Venereology.
Important guidelines for asthma, such as the Global Initiative for Asthma (GINA) and National Asthma Education and Prevention Expert Panel Report 3 (EPR-3), stated omalizumab can be used for severe asthma patients (4, 5).
Symptoms started settling within second week of giving omalizumab treatment.
A pilot study of omalizumab to facilitate rapid oral desensitization in high-risk peanut-allergic patients.
Results from the three pivotal registration studies for omalizumab in CSU were announced in 2013.
Omalizumab was jointly developed by Genentech and Novartis Pharma, and is copromoted in the United States with Novartis.
By contrast, headache was the most severe side effect observed with omalizumab therapy.
Omalizumab was evaluated in a pivotal 52-week study of 627 children aged 6-11 years with moderate to severe persistent, inadequately controlled allergic asthma, despite treatment with fluticasone at a dose of 200 mcg or more per day (or the equivalent), with or without other controller medications, which included short-acting beta-agonists (a mean of 2,8 puffs/day) and leukotriene antagonists (37%).
In three published, pivotal, phase 3 randomized trials, the clinical response rate to omalizumab at 300 mg every 4 weeks, as defined by a weekly 7-day Urticaria Activity Score (UAS7) of 6 or less at 12 weeks, was 52% in ASTERIA I, 66% in ASTERIA II, and 52% in GLACIAL.
Omalizumab is a humanized monoclonal antibody of IgG1 subclass which binds free IgE antibody, the main trigger of mast cell degranulation and release of histamine, leukotrienes, tryptase, chymase, prostaglandin D2 and other cytokines involved in the pathogenesis of CSU/CIU.
The researchers randomized 28 milk-allergic subjects to omalizumab (Xolair) injections during oral immunotherapy (OIT) and 29 others to dummy shots for 16 months.
London, Mar 17 (ANI): A clinical trial has found that the drug omalizumab, sold under the brand name Xolair, nearly eliminated seasonal increases in asthma attacks and decreased asthma symptoms among inner-city children and youth.