Omalizumab


Thông tin thuốc gốc
Chỉ định và Liều dùng
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.

Subcutaneous
Chronic idiopathic urticaria
Adult: 300 mg every 4 weeks.
Child: ≥12 years Same as adult dose.
Hướng dẫn pha thuốc
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.
Thận trọng
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.
Phản ứng phụ
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.
MonitoringParameters
Monitor for signs and symptoms of anaphylaxis, infections.
Lab Interference
Total IgE levels may remain elevated for up to 1 yr following treatment.
Tác dụng
Description: 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.
Pharmacokinetics:
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.
Bảo quản
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.
References
Anon. Omalizumab. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 29/04/2014.

Buckingham R (ed). Omalizumab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 29/04/2014.

Information for Healthcare Professionals: Omalizumab (Marketed as Xolair). U.S. FDA. https://www.fda.gov/. Accessed 29/04/2014.

Joint Formulary Committee . Omalizumab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 29/04/2014.

Joint Formulary Committee. Omalizumab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 29/04/2014.

McEvoy GK, Snow EK, Miller J et al (eds). Omalizumab. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 29/04/2014.

Xolair Inj, Soln (Genentech, Inc). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 29/04/2014.

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