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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.
Inhibits binding of IgE to high-affinity IgE receptors on surface of mast cells and basophils
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
• Significant weight change
• Hypersensitivity to drug
Use cautiously in:
• elderly patients
• pregnant or breastfeeding patients
• children younger than age 12.
☞ 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.
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
Drug-diagnostic tests.Serum IgE: elevated level
☞ Monitor patient for severe hypersensitivity reactions, including anaphylaxis.
☞ Watch for signs and symptoms of cancer (rare).
☞ 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.
Pharmacologic: monoclonal antibodies
Time/action profile (effects on IgE levels)
|Subcut||within 1 hr||unknown||up to 1 yr|
Adverse Reactions/Side Effects
- injection site reactions (most frequent)
- allergic reactions including anaphylaxis (life-threatening)
- ↑ risk of malignancy
Drug-Drug interactionNone noted.
- 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 DiagnosesIneffective airway clearance
- 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.
- 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.
- Decreased incidence of exacerbations of asthma.