Omalizumab

Class
Biologic agents
Subclass
Anti-IgE monoclonal antibodies
Substance name
Omalizumab, omalizumab-igec
Brand names
Xolair®, Omlyclo®
Common formulations
Solution for injection
Dosage and administration
Adults patients
Asthma • Moderate-to-severe, IgE-mediated, pretreatment serum IgE 30-100 IU/mL, not controlled by ICSs
Weight 30-90 kg
•
150 mg SC q4 weeks
Weight 90-150 kg
•
300 mg SC q4 weeks
Asthma • Moderate-to-severe, IgE-mediated, pretreatment serum IgE 100-200 IU/mL, not controlled by ICSs
Weight 30-90 kg
•
300 mg SC q4 weeks
Weight 90-150 kg
•
225 mg SC q2 weeks
Asthma • Moderate-to-severe, IgE-mediated, pretreatment serum IgE 200-300 IU/mL, not controlled by ICSs
Weight 30-60 kg
•
300 mg SC q4 weeks
Weight 60-90 kg
•
225 mg SC q2 weeks
Weight 90-150 kg
•
300 mg SC q2 weeks
Asthma • Moderate-to-severe, IgE-mediated, pretreatment serum IgE 300-400 IU/mL, not controlled by ICSs
Weight 30-70 kg
•
225 mg SC q2 weeks
Weight 70-90 kg
•
300 mg SC q2 weeks
Asthma • Moderate-to-severe, IgE-mediated, pretreatment serum IgE 400-500 IU/mL, not controlled by ICSs
Weight 30-70 kg
•
300 mg SC q2 weeks
Weight 70-90 kg
•
375 mg SC q2 weeks
Asthma • Moderate-to-severe, IgE-mediated, pretreatment serum IgE 500-600 IU/mL, not controlled by ICSs
Weight 30-60 kg
•
300 mg SC q2 weeks
Weight 60-70 kg
•
375 mg SC q2 weeks
Asthma • Moderate-to-severe, IgE-mediated, pretreatment serum IgE 600-700 IU/mL, not controlled by ICSs
Weight 30-60 kg
•
375 mg SC q2 weeks
Chronic rhinosinusitis with nasal polyps • Pretreatment serum IgE 30-100 IU/mL
Weight 30-40 kg
•
75 mg SC q4 weeks
Weight 40-90 kg
•
150 mg SC q4 weeks
Weight 90-150 kg
•
300 mg SC q4 weeks
Chronic rhinosinusitis with nasal polyps • Pretreatment serum IgE 100-200 IU/mL
Weight 30-40 kg
•
150 mg SC q4 weeks
Weight 40-90 kg
•
300 mg SC q4 weeks
Weight 90-125 kg
•
450 mg SC q4 weeks
Weight 125-150 kg
•
600 mg SC q4 weeks
Chronic rhinosinusitis with nasal polyps • Pretreatment serum IgE 200-300 IU/mL
Weight 30-40 kg
•
225 mg SC q4 weeks
Weight 40-60 kg
•
300 mg SC q4 weeks
Weight 60-90 kg
•
450 mg SC q4 weeks
Weight 90-125 kg
•
600 mg SC q4 weeks
Weight 125-150 kg
•
375 mg SC q2 weeks
Chronic rhinosinusitis with nasal polyps • Pretreatment serum IgE 300-400 IU/mL
Weight 30-40 kg
•
300 mg SC q4 weeks
Weight 40-70 kg
•
450 mg SC q4 weeks
Weight 70-90 kg
•
600 mg SC q4 weeks
Weight 90-125 kg
•
450 mg SC q2 weeks
Weight 125-150 kg
•
525 mg SC q2 weeks
Chronic rhinosinusitis with nasal polyps • Pretreatment serum IgE 400-500 IU/mL
Weight 30-50 kg
•
450 mg SC q4 weeks
Weight 50-70 kg
•
600 mg SC q4 weeks
Weight 70-90 kg
•
375 mg SC q2 weeks
Weight 90-125 kg
•
525 mg SC q2 weeks
Weight 125-150 kg
•
600 mg SC q2 weeks
Chronic rhinosinusitis with nasal polyps • Pretreatment serum IgE 500-600 IU/mL
Weight 30-40 kg
•
450 mg SC q4 weeks
Weight 40-60 kg
•
600 mg SC q4 weeks
Weight 60-70 kg
•
375 mg SC q2 weeks
Weight 70-90 kg
•
450 mg SC q2 weeks
Weight 90-125 kg
•
600 mg SC q2 weeks
Chronic rhinosinusitis with nasal polyps • Pretreatment serum IgE 600-700 IU/mL
Weight 30-40 kg
•
450 mg SC q4 weeks
Weight 40-50 kg
•
600 mg SC q4 weeks
Weight 50-60 kg
•
375 mg SC q2 weeks
Weight 60-80 kg
•
450 mg SC q2 weeks
Weight 80-90 kg
•
525 mg SC q2 weeks
Chronic rhinosinusitis with nasal polyps • Pretreatment serum IgE 700-800 IU/mL
Weight 30-40 kg
•
300 mg SC q2 weeks
Weight 40-50 kg
•
375 mg SC q2 weeks
Weight 50-70 kg
•
450 mg SC q2 weeks
Weight 70-80 kg
•
525 mg SC q2 weeks
Weight 80-90 kg
•
600 mg SC q2 weeks
Chronic rhinosinusitis with nasal polyps • Pretreatment serum IgE 800-900 IU/mL
Weight 30-40 kg
•
300 mg SC q2 weeks
Weight 40-50 kg
•
375 mg SC q2 weeks
Weight 50-60 kg
•
450 mg SC q2 weeks
Weight 60-70 kg
•
525 mg SC q2 weeks
Weight 70-80 kg
•
600 mg SC q2 weeks
Chronic rhinosinusitis with nasal polyps • Pretreatment serum IgE 900-1000 IU/mL
Weight 30-40 kg
•
375 mg SC q2 weeks
Weight 40-50 kg
•
450 mg SC q2 weeks
Weight 50-60 kg
•
525 mg SC q2 weeks
Weight 60-70 kg
•
600 mg SC q2 weeks
Chronic rhinosinusitis with nasal polyps • Pretreatment serum IgE 1000-1100 IU/mL
Weight 30-40 kg
•
375 mg SC q2 weeks
Weight 40-50 kg
•
450 mg SC q2 weeks
Weight 50-60 kg
•
600 mg SC q2 weeks
Chronic rhinosinusitis with nasal polyps • Pretreatment serum IgE 1100-1200 IU/mL
Weight 30-40 kg
•
450 mg SC q2 weeks
Weight 40-50 kg
•
525 mg SC q2 weeks
Weight 50-60 kg
•
600 mg SC q2 weeks
Chronic rhinosinusitis with nasal polyps • Pretreatment serum IgE 1200-1300 IU/mL
Weight 30-40 kg
•
450 mg SC q2 weeks
Weight 40-50 kg
•
525 mg SC q2 weeks
Chronic rhinosinusitis with nasal polyps • Pretreatment serum IgE 1300-1500 IU/mL
Weight 30-40 kg
•
525 mg SC q2 weeks
Weight 40-50 kg
•
600 mg SC q2 weeks
Chronic spontaneous urticaria
•
150-300 mg SC q4 weeks
Food allergy • IgE-mediated, pretreatment serum IgE 30-100 IU/mL
Weight 30-40 kg
•
75 mg SC q4 weeks
Weight 40-90 kg
•
150 mg SC q4 weeks
Weight 90-150 kg
•
300 mg SC q4 weeks
Food allergy • IgE-mediated, pretreatment serum IgE 100-200 IU/mL
Weight 30-40 kg
•
150 mg SC q4 weeks
Weight 40-90 kg
•
300 mg SC q4 weeks
Weight 90-125 kg
•
450 mg SC q4 weeks
Weight 125-150 kg
•
600 mg SC q4 weeks
Food allergy • IgE-mediated, pretreatment serum IgE 200-300 IU/mL
Weight 30-40 kg
•
225 mg SC q4 weeks
Weight 40-60 kg
•
300 mg SC q4 weeks
Weight 60-90 kg
•
450 mg SC q4 weeks
Weight 90-125 kg
•
600 mg SC q4 weeks
Weight 125-150 kg
•
375 mg SC q2 weeks
Food allergy • IgE-mediated, pretreatment serum IgE 300-400 IU/mL
Weight 30-40 kg
•
300 mg SC q4 weeks
Weight 40-70 kg
•
450 mg SC q4 weeks
Weight 70-90 kg
•
600 mg SC q4 weeks
Weight 90-125 kg
•
450 mg SC q2 weeks
Weight 125-150 kg
•
525 mg SC q2 weeks
Food allergy • IgE-mediated, pretreatment serum IgE 400-500 IU/mL
Weight 30-50 kg
•
450 mg SC q4 weeks
Weight 50-70 kg
•
600 mg SC q4 weeks
Weight 70-90 kg
•
375 mg SC q2 weeks
Weight 90-125 kg
•
525 mg SC q2 weeks
Weight 125-150 kg
•
600 mg SC q2 weeks
Food allergy • IgE-mediated, pretreatment serum IgE 500-600 IU/mL
Weight 30-40 kg
•
450 mg SC q4 weeks
Weight 40-60 kg
•
600 mg SC q4 weeks
Weight 60-70 kg
•
375 mg SC q2 weeks
Weight 70-90 kg
•
450 mg SC q2 weeks
Weight 90-125 kg
•
600 mg SC q2 weeks
Food allergy • IgE-mediated, pretreatment serum IgE 600-700 IU/mL
Weight 30-40 kg
•
450 mg SC q4 weeks
Weight 40-50 kg
•
600 mg SC q4 weeks
Weight 50-60 kg
•
375 mg SC q2 weeks
Weight 60-80 kg
•
450 mg SC q2 weeks
Weight 80-90 kg
•
525 mg SC q2 weeks
Food allergy • IgE-mediated, pretreatment serum IgE 700-800 IU/mL
Weight 30-40 kg
•
300 mg SC q2 weeks
Weight 40-50 kg
•
375 mg SC q2 weeks
Weight 50-70 kg
•
450 mg SC q2 weeks
Weight 70-80 kg
•
525 mg SC q2 weeks
Weight 80-90 kg
•
600 mg SC q2 weeks
Food allergy • IgE-mediated, pretreatment serum IgE 800-900 IU/mL
Weight 30-40 kg
•
300 mg SC q2 weeks
Weight 40-50 kg
•
375 mg SC q2 weeks
Weight 50-60 kg
•
450 mg SC q2 weeks
Weight 60-70 kg
•
525 mg SC q2 weeks
Weight 70-80 kg
•
600 mg SC q2 weeks
Food allergy • IgE-mediated, pretreatment serum IgE 900-1000 IU/mL
Weight 30-40 kg
•
375 mg SC q2 weeks
Weight 40-50 kg
•
450 mg SC q2 weeks
Weight 50-60 kg
•
525 mg SC q2 weeks
Weight 60-70 kg
•
600 mg SC q2 weeks
Food allergy • IgE-mediated, pretreatment serum IgE 1000-1100 IU/mL
Weight 30-40 kg
•
375 mg SC q2 weeks
Weight 40-50 kg
•
450 mg SC q2 weeks
Weight 50-60 kg
•
600 mg SC q2 weeks
Food allergy • IgE-mediated, pretreatment serum IgE 1100-1200 IU/mL
Weight 30-40 kg
•
450 mg SC q2 weeks
Weight 40-50 kg
•
525 mg SC q2 weeks
Weight 50-60 kg
•
600 mg SC q2 weeks
Food allergy • IgE-mediated, pretreatment serum IgE 1200-1300 IU/mL
Weight 30-40 kg
•
450 mg SC q2 weeks
Weight 40-50 kg
•
600 mg SC q2 weeks
Food allergy • IgE-mediated, pretreatment serum IgE 1300-1500 IU/mL
Weight 30-40 kg
•
525 mg SC q2 weeks
Weight 40-50 kg
•
600 mg SC q2 weeks
Food allergy • IgE-mediated, pretreatment serum IgE 1500-1850 IU/mL
Weight 30-40 kg
•
600 mg SC q2 weeks
Other off-label uses
•
Prevention of venom immunotherapy-related adverse reactions in patients with hymenoptera sting allergy
Indications for use
Labeled indications
Adults
•
Treatment of asthma (moderate-to-severe, IgE-mediated, pretreatment serum IgE 100-200 IU/mL, not controlled by ICSs)
•
Treatment of asthma (moderate-to-severe, IgE-mediated, pretreatment serum IgE 200-300 IU/mL, not controlled by ICSs)
•
Treatment of asthma (moderate-to-severe, IgE-mediated, pretreatment serum IgE 30-100 IU/mL, not controlled by ICSs)
•
Treatment of asthma (moderate-to-severe, IgE-mediated, pretreatment serum IgE 300-400 IU/mL, not controlled by ICSs)
•
Treatment of asthma (moderate-to-severe, IgE-mediated, pretreatment serum IgE 400-500 IU/mL, not controlled by ICSs)
•
Treatment of asthma (moderate-to-severe, IgE-mediated, pretreatment serum IgE 500-600 IU/mL, not controlled by ICSs)
•
Treatment of asthma (moderate-to-severe, IgE-mediated, pretreatment serum IgE 600-700 IU/mL, not controlled by ICSs)
•
Treatment of chronic rhinosinusitis with nasal polyps (pretreatment serum IgE 100-200 IU/mL)
•
Treatment of chronic rhinosinusitis with nasal polyps (pretreatment serum IgE 1000-1100 IU/mL)
•
Treatment of chronic rhinosinusitis with nasal polyps (pretreatment serum IgE 1100-1200 IU/mL)
•
Treatment of chronic rhinosinusitis with nasal polyps (pretreatment serum IgE 1200-1300 IU/mL)
•
Treatment of chronic rhinosinusitis with nasal polyps (pretreatment serum IgE 1300-1500 IU/mL)
•
Treatment of chronic rhinosinusitis with nasal polyps (pretreatment serum IgE 200-300 IU/mL)
•
Treatment of chronic rhinosinusitis with nasal polyps (pretreatment serum IgE 30-100 IU/mL)
•
Treatment of chronic rhinosinusitis with nasal polyps (pretreatment serum IgE 300-400 IU/mL)
•
Treatment of chronic rhinosinusitis with nasal polyps (pretreatment serum IgE 400-500 IU/mL)
•
Treatment of chronic rhinosinusitis with nasal polyps (pretreatment serum IgE 500-600 IU/mL)
•
Treatment of chronic rhinosinusitis with nasal polyps (pretreatment serum IgE 600-700 IU/mL)
•
Treatment of chronic rhinosinusitis with nasal polyps (pretreatment serum IgE 700-800 IU/mL)
•
Treatment of chronic rhinosinusitis with nasal polyps (pretreatment serum IgE 800-900 IU/mL)
•
Treatment of chronic rhinosinusitis with nasal polyps (pretreatment serum IgE 900-1000 IU/mL)
•
Treatment of chronic spontaneous urticaria
•
Treatment of food allergy (IgE-mediated, pretreatment serum IgE 100-200 IU/mL)
•
Treatment of food allergy (IgE-mediated, pretreatment serum IgE 1000-1100 IU/mL)
•
Treatment of food allergy (IgE-mediated, pretreatment serum IgE 1100-1200 IU/mL)
•
Treatment of food allergy (IgE-mediated, pretreatment serum IgE 1200-1300 IU/mL)
•
Treatment of food allergy (IgE-mediated, pretreatment serum IgE 1300-1500 IU/mL)
•
Treatment of food allergy (IgE-mediated, pretreatment serum IgE 1500-1850 IU/mL)
•
Treatment of food allergy (IgE-mediated, pretreatment serum IgE 200-300 IU/mL)
•
Treatment of food allergy (IgE-mediated, pretreatment serum IgE 30-100 IU/mL)
•
Treatment of food allergy (IgE-mediated, pretreatment serum IgE 300-400 IU/mL)
•
Treatment of food allergy (IgE-mediated, pretreatment serum IgE 400-500 IU/mL)
•
Treatment of food allergy (IgE-mediated, pretreatment serum IgE 500-600 IU/mL)
•
Treatment of food allergy (IgE-mediated, pretreatment serum IgE 600-700 IU/mL)
•
Treatment of food allergy (IgE-mediated, pretreatment serum IgE 700-800 IU/mL)
•
Treatment of food allergy (IgE-mediated, pretreatment serum IgE 800-900 IU/mL)
•
Treatment of food allergy (IgE-mediated, pretreatment serum IgE 900-1000 IU/mL)
Off-label indications
Adults
•
Prevention of venom immunotherapy-related adverse reactions in patients with hymenoptera sting allergy
Safety risks
Boxed warnings
Anaphylaxis
•
Maintain a high level of suspicion, anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema has been reported to occur following omalizumab administration. Anaphylaxis has been reported to occur as early as after the first dose to more than one year after the initiation of regular treatment. Initiate omalizumab therapy in a healthcare setting and closely observe patients for an appropriate period of time after administration.
Contraindications
Hypersensitivity to omalizumab or its components
Acute bronchospasm or status asthmaticus
•
Do not use omalizumab for the treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required.
Anaphylaxis
•
Do not use omalizumab for the emergency treatment of allergic reactions, including anaphylaxis.
Warnings and precautions
Corticosteroid withdrawal, acute exacerbation of asthma, acute exacerbation of chronic rhinosinusitis
•
Use caution in patients receiving systemic or ICSs. Do not discontinue systemic or ICSs abruptly upon initiation of omalizumab for asthma or chronic rhinosinusitis with nasal polyps. Taper corticosteroids gradually.
Eosinophilia, eosinophilic granulomatosis with polyangiitis
•
Maintain a high level of suspicion, as omalizumab has been associated with rare cases of serious systemic eosinophilia and eosinophilic granulomatosis with polyangiitis.
Helminthiasis
•
Use caution in patients at high risk of geohelminth infection.
Increased serum IgE
•
Maintain a high level of suspicion, serum IgE levels increase after administration of omalizumab due to the formation of omalizumab:IgE complexes. Do not use serum total IgE levels obtained < 1 year after discontinuation for reassessing the dosing regimen.
Malignancies
•
Maintain a high level of suspicion, as rare cases of various malignancies, including breast cancer, non-melanoma skin cancer, prostate cancer, melanoma, and parotid cancer, have been reported with omalizumab treatment.
Serum sickness-like reaction
•
Maintain a high level of suspicion, as omalizumab has been associated with cases of serum sickness-like reactions presenting with arthritis/arthralgia, skin rash, fever, and lymphadenopathy with an onset 1-5 days after the first or subsequent doses.
Specific populations
Renal impairment
eGFR 0-90 mL/min/1.73 m²
•
No guidance available.
Renal replacement therapy
Any modality
•
No guidance available.
Hepatic impairment
Any severity
•
No guidance available.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: B1
•
Use only if clearly needed. Omalizumab can cross the placenta since human IgG crosses the placenta. Closely monitor and optimize asthma control during pregnancy.
Breastfeeding
Use only if benefits outweigh potential risks.
Unknown drug levels in breastfed infants.
No overt adverse effects reported in breastfed infants.
Adverse reactions
Very common > 10%
•
Injection site reactions
Common 1-10%
•
Bone fracture, dermatitis, nasopharyngitis, arm pain, pruritus, ear pain, arthralgia, cough, epigastric pain, fatigue, dizziness, fever, headache, leg pain, nausea, pain, sinusitis, upper respiratory tract infections
Uncommon < 1%
•
Anaphylaxis
Unknown frequency
•
↓ platelet count, hair loss, ↑ blood eosinophil count, eosinophilic granulomatosis with polyangiitis, skin cancer, prostate cancer, parotid cancer, breast cancer
Interactions
Drug(s)
Check Interactions
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