Classifications: biologic response modifier; monoclonal antibody; respiratory antiinflammatory agent; Therapeutic: antiallergic; antiasthmatic; antiinflammatory
Pregnancy Category: B
75 mg, 150 mg vial
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.
Inhibits release of mediators of the allergic response and has an anti-inflammatory action on the respiratory system.
Control of moderate to severe allergic asthma.
Seasonal allergic rhinitis, food allergies.
Hypersensitivity to omalizumab; severe infections, including chicken pox and other viral infections; acute bronchospasm,
status asthmaticus; malignancies; children <12 y.
Pregnancy (category B), lactation.
Route & Dosage
Adult/Adolescent: SC 150375 mg q24wk. Dose is based on baseline IgE serum levels.
- 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 510 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 510 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
Upper respiratory tract infections, sinusitis
, pharyngitis. Skin:
Rash, pruritus, urticaria, dermatitis. Special Senses:
Slowly absorbed from SC site; 5371% reaches systemic circulation. Peak:
78 d. Half-Life:
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
- Do not accept a live virus vaccine without consulting physician.