OMALIZUMAB

OMALIZUMAB
(o-mal-i-zoo'mab)
Xolair
Classifications: biologic response modifier; monoclonal antibody; respiratory antiinflammatory agent;
Therapeutic: antiallergic
; antiasthmatic; antiinflammatory
Pregnancy Category: B

Availability

75 mg, 150 mg vial

Action

DNA recombinant monoclonal antibody that selectively binds to human IgE. It inhibits binding of IgE to high-affinity IgE receptors on the surface of mast cells and basophils, limiting the release of inflammatory mediators.

Therapeutic Effect

Inhibits release of mediators of the allergic response and has an anti-inflammatory action on the respiratory system.

Uses

Control of moderate to severe allergic asthma.

Unlabeled Uses

Seasonal allergic rhinitis, food allergies.

Contraindications

Hypersensitivity to omalizumab; severe infections, including chicken pox and other viral infections; acute bronchospasm, status asthmaticus; malignancies; children <12 y.

Cautious Use

Pregnancy (category B), lactation.

Route & Dosage

Allergic Asthma
Adult/Adolescent: SC 150–375 mg q2–4wk. Dose is based on baseline IgE serum levels.

Administration

Subcutaneous
  • Reconstitute as follows: 1) Draw 1.4 mL of sterile water for injection into a 3-cc syringe with a 1-inch, 18-gauge needle. 2) Place vial upright on flat surface and inject sterile water. Keep vial upright and gently swirl for about 1 min to wet powder. Do not shake. 3) Gently swirl vial for 5–10 sec q5min to dissolve remaining solids. Some vials may take >20 min to dissolve. Do not use if not completely dissolved by 40 min. 4) Once dissolved, invert vial for 15 sec to allow solution to drain toward stopper. 5) Using a new 3-cc syringe with a 1-inch, 18-gauge needle, insert needle into inverted vial with tip at the very bottom of solution, then withdraw solution. Before removing needle from vial, pull the plunger to end of syringe barrel to remove all solution from inverted vial. 6) Replace 18-gauge needle with a 25-gauge needle for SC injection. 7) Expel air, large bubbles, and any excess solution to obtain the required 1.2 mL dose. A thin layer of small bubbles may remain at top of the solution in syringe.
  • Give SC and rotate injection sites. Solution is viscous and takes 5–10 sec to inject.
  • Use within 8 h of reconstitution when stored in the vial at 2°–8° C (36°–46° F), or within 4 h of reconstitution when stored at room temperature.

Adverse Effects (≥1%)

Body as a Whole: Anaphylaxis/anaphylactoid reactions, injection site reactions (bruising, erythema, warmth, burning, stinging, pruritus, hive formation, pain, induration, inflammation), fatigue, generalized pain. CNS: Headache, dizziness. GI: Nausea, vomiting, diarrhea, abdominal pain. Hematologic: Epistaxis, menorrhagia, hematoma, anemia. Musculoskeletal: Arthralgia. Respiratory: Upper respiratory tract infections, sinusitis, pharyngitis. Skin: Rash, pruritus, urticaria, dermatitis. Special Senses: Earache.

Pharmacokinetics

Absorption: Slowly absorbed from SC site; 53–71% reaches systemic circulation. Peak: 7–8 d. Half-Life: 22 d.

Nursing Implications

Assessment & Drug Effects

  • Monitor for injection site reactions including bruising, redness, warmth, burning, stinging, itching, hive formation, pain, indurations, mass, and inflammation.
  • Lab test: Platelet counts if signs of increased tendency to bleed appear.

Patient & Family Education

  • Do not use this drug for relief of acute bronchospasm or status asthmaticus.
  • Promptly report any of the following: bleeding or unusual bruising, difficulty breathing or shortness of breath, skin rash or hives.
  • Do not accept a live virus vaccine without consulting physician.

Common adverse effects in italic, life-threatening effects underlined; generic names in bold; classifications in SMALL CAPS; Canadian drug name; Prototype drug

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