Omalizumab


Full Prescribing Info
Dosage/Direction for Use

Subcutaneous
Poorly controlled, moderate to severe asthma
Adult: Doses (mg) and dosing frequency are based on pre-treatment serum IgE levels (IU/mL) and body wt (kg) as follows: ≥30-100 IU/mL: 150 mg (30-90 kg); 300 mg (>90-150 kg). >100-200 IU/mL: 300 mg (30-90 kg). >200-300 IU/mL: 300 mg (30-60 kg). All doses to be taken every 4 wk. >100-200 IU/mL: 225 mg (>90-150 kg). >200-300 IU/mL: 225 mg (>60-90 kg); 300 mg (>90-150 kg). >300-400 IU/mL: 225 mg (30-70 kg); 300 mg (>70-90 kg). >400-500 IU/mL: 300 mg (30-70 kg); 375 mg (>70-90 kg). >500-600 IU/mL: 300 mg (30-60 kg); 375 mg (>60-70 kg). 375 mg (30-60 kg). All doses to be taken every 2 wk. Doses no more than 150 mg should be admin at 1 inj site.
Child: ≥12 yr
Same as adult dose.
Reconstitution: Add sterile water for inj 1.4 mL to upright vial and gently swirl for 5-10 seconds every 5 min until dissolved to produce approx 150 mg/1.2 mL soln. It may take >20 min to dissolve completely. Do not use if powd dissolves w/in 40 min.

Subcutaneous
Chronic idiopathic urticaria

Adult: 300 mg every 4 weeks.
Child: ≥12 years
Same as adult dose.
Reconstitution: Add sterile water for inj 1.4 mL to upright vial and gently swirl for 5-10 seconds every 5 min until dissolved to produce approx 150 mg/1.2 mL soln. It may take >20 min to dissolve completely. Do not use if powd dissolves w/in 40 min.
Special Precautions
Not intended for treatment of acute asthma exacerbations, acute bronchospasm or status asthmaticus. Patient at risk of parasitic infections. May increase risk of malignancy. Delayed onset of anaphylaxis, it usually occurs 2 hr after admin but may also occur up to 4 days to >1 yr after initiation of regular treatment. Avoid abrupt withdrawal of corticosteroid therapy. Renal and hepatic impairment. Childn. Pregnancy and lactation. Monitoring Parameters Monitor for signs and symptoms of anaphylaxis, infections.
Adverse Reactions
Generalised pain, arthralgia, myalgia, fatigue, dizziness, earache, headache, GI disturbances, fractures, pruritus, alopecia, dermatitis, upper resp tract infections, viral infections, sinusitis, pharyngitis, flu-like illness, systemic eosinophilia (e.g. Churg-Strauss syndrome).
Potentially Fatal: Anaphylactic reactions including bronchospasm, hypotension, urticaria, syncope, angioedema of the throat or tongue, cough or chest tightness.
Lab Interference
Total IgE levels may remain elevated for up to 1 yr following treatment.
Action
Omalizumab is an IgG monoclonal antibody (recombinant DNA-derived). It inhibits IgE binding to the high-affinity IgE receptor on mast cells and basophils, thus reducing the release of mediators of the allergic response.
Absorption: Slowly absorbed. Bioavailability: Approx 62%. Time to peak plasma concentration: 7-8 days.
Distribution: Volume of distribution: 78±32 mL/kg.
Metabolism: Undergoes hepatic metabolism.
Excretion: Primarily via hepatic degradation; intact IgG may be secreted in bile. Elimination half-life: Approx 26 days.
Storage
Subcutaneous: Store between 2-8°C. May be transferred at room temp. Do not freeze. Following reconstitution, protect from direct sunlight. Stable for up to 8 hr if refrigerated or 4 hr if at room temp.
ATC Classification
R03DX05 - omalizumab ; Belongs to the class of other systemic drugs used in the treatment of obstructive airway diseases.
Disclaimer: This information is independently developed by CIMS based on omalizumab from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 CIMS. All rights reserved. Powered by CIMSAsia.com
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