Omalizumab
Mechanism :
Omalizumab is an IgG monoclonal antibody (recombinant DNA derived) which inhibits IgE binding to the high-affinity IgE receptor on mast cells and basophils
Indication :
- Asthma: Treatment of moderate to severe persistent asthma in adults and patients 6 years and older who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids.
- Chronic idiopathic urticaria: Treatment of chronic idiopathic urticaria in adults and adolescents 12 years and older who remain symptomatic despite H1 antihistamine treatment.
Contraindications :
Severe hypersensitivity reaction to omalizumab or any component of the formulation.
Dosing :
Give SC.
Asthma:
Dose and frequency based on body weight and pre-treatment total IgE serum levels.
Give SC.
Asthma:
Children 6 to <12 years:
Pre-treatment serum IgE ≥30 to 100 units/mL:
20 to 40 kg: 75 mg every 4 weeks.
>40 to 90 kg: 150 mg every 4 weeks.
>90 to 150 kg: 300 mg every 4 weeks.
Pre-treatment serum IgE >100 to 200 units/mL:
20 to 40 kg: 150 mg every 4 weeks.
>40 to 90 kg: 300 mg every 4 weeks.
>90 to 125 kg: 225 mg every 2 weeks.
>125 to 150 kg: 300 mg every 2 weeks.
Pre-treatment serum IgE >200 to 300 units/mL:
20 to 30 kg: 150 mg every 4 weeks.
>30 to 40 kg: 225 mg every 4 weeks.
>40 to 60 kg: 300 mg every 4 weeks.
>60 to 90 kg: 225 every 2 weeks.
>90 to 125 kg: 300 mg every 2 weeks.
>125 to 150 kg: 375 mg every 2 weeks.
Pre-treatment serum IgE >300 to 400 units/mL:
20 to 30 kg: 225 mg every 4 weeks.
>30 to 40 kg: 300 mg every 4 weeks.
>40 kg to 70 kg: 225 mg every 2 weeks.
>70 to 90 kg: 300 mg every 2 weeks.
>90 kg: Do not administer.
Pre-treatment serum IgE >400 to 500 units/mL:
20 to 25 kg: 225 mg every 4 weeks.
>25 to 30 kg: 300 mg every 4 weeks.
>30 to 50 kg: 225 mg every 2 weeks.
>50 to 70 kg: 300 mg every 2 weeks.
>70 to 90 kg: 375 mg every 2 weeks.
>90 kg: Do not administer.
Pre-treatment serum IgE >500 to 600 units/mL:
20 to 30 kg: 300 mg every 4 weeks.
>30 to 40 kg: 225 mg every 2 weeks.
>40 to 60 kg: 300 mg every 2 weeks.
>60 to 70 kg: 375 mg every 2 weeks.
>70 kg: Do not administer.
Pre-treatment serum IgE >600 to 700 units/mL:
20 to 25 kg: 300 mg every 4 weeks.
>25 to 40 kg: 225 mg every 2 weeks.
>40 to 50 kg: 300 mg every 2 weeks.
>50 to 60 kg: 375 mg every 2 weeks.
>60 kg: Do not administer.
Pre-treatment serum IgE >700 to 900 units/mL:
20 to 30 kg: 225 mg every 2 weeks.
>30 to 40 kg: 300 mg every 2 weeks.
>40 to 50 kg: 375 mg every 2 weeks.
>50 kg: Do not administer.
Pre-treatment serum IgE >900 to 1,100 units/mL:
20 to 25 kg: 225 mg every 2 weeks.
>25 to 30 kg: 300 mg every 2 weeks.
>30 to 40 kg: 375 mg every 2 weeks.
>40 kg: Do not administer.
Pre-treatment serum IgE >1,100 to 1,200 units/mL:
20 to 30 kg: 300 mg every 2 weeks.
>30 kg: Do not administer.
Pre-treatment serum IgE >1,200 to 1,300 units/mL:
20 to 25 kg: 300 mg every 2 weeks.
>25 to 30 kg: 375 mg every 2 weeks.
>30 kg: Do not administer.
Chronic idiopathic urticaria:
≥12 years
150 or 300 mg every 4 weeks. Dosing is not dependent on serum IgE or body weight.
Adverse Effect :
Headache, injection site reaction, peripheral edema, pain, dizziness, fatigue, alopecia, urticarial, upper abdominal pain, UTI, fungal infection, arthralgia, otitis media, nasopharyngitis, epistaxis, asthma, cough.
Interaction :
Belimumab: Monoclonal Antibodies may enhance the adverse/toxic effect of Belimumab.
Loxapine: Agents to Treat Airway Disease may enhance the adverse/toxic effect of Loxapine.
Renal Dose :
Dose in Renal Impairment GFR (mL/min)
| 20-50 | Dose as in normal renal function |
| 10-20 | Dose as in normal renal function. Use with caution |
| <10 | Dose as in normal renal function. Use with caution |
Dose in Patients undergoing Renal Replacement Therapies
| CAPD | Unlikely dialysability. Dose as in GFR<10 mL/min |
| HD | Unlikely dialysability. Dose as in GFR<10 mL/min |
| HDF/High flux | Unlikely dialysability. Dose as in GFR<10 mL/min |
| CAV/VVHD | Unlikely dialysability. Dose as in GFR=10–20 mL/min |
Hepatic Dose :
No dosage adjustments are recommended.