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XOLAIR (omalizumab)
- Chronic idiopathic urticaria
- Refractory extrinsic asthma
150 mg/mL subcutaneous syringe
- Inject 150 mg by subcutaneous route every 4 weeks
75 mg/0.5 mL subcutaneous syringe
- Inject 75 mg by subcutaneous route every 4 weeks
150 mg subcutaneous solution
- Inject 1.2 milliliters (150 mg) by subcutaneous route every 4 weeks
Chronic idiopathic urticaria
- Inject 150 mg by subcutaneous route every 4 weeks
- Inject 75 mg by subcutaneous route every 4 weeks (to be injected witha 150 mg syringe for a total dose of 225 mg)
- Inject 1.2 milliliters (150 mg) by subcutaneous route every 4 weeks
- Inject 1 milliliter (150 mg) by subcutaneous route every 4 weeks
- Inject 2.4 milliliters (300 mg) by subcutaneous route every 4 weeks divided into 2 doses and given at 2 different injection sites
- Inject 2 milliliters (300 mg) by subcutaneous route every 4 weeks (rotate sites)
- Inject 300 mg by subcutaneous route every 4 weeks (rotate sites)
Refractory extrinsic asthma
- Inject 75 mg by subcutaneous route every 2 weeks
- Inject 75 mg by subcutaneous route every 4 weeks
- Inject 150 mg by subcutaneous route every 2 weeks
- Inject 150 mg by subcutaneous route every 4 weeks
- Inject 0.5 milliliter (75 mg) by subcutaneous route every 2 weeks
- Inject 0.5 milliliter (75 mg) by subcutaneous route every 4 weeks
- Inject 150 mg by subcutaneous route every 2 weeks (to be injected with a 75 mg syringe for a total dose of 225 mg)
- Inject 150 mg by subcutaneous route every 4 weeks (to be injected with a 75 mg syringe for a total dose of 225 mg)
- Inject 300 mg by subcutaneous route every 2 weeks (to be injected with a 75 mg syringe for a total dose of 375 mg)
- Inject 300 mg by subcutaneous route every 4 weeks (to be injected with a 75 mg syringe for a total dose of 375 mg)
- Inject 75 mg by subcutaneous route every 2 weeks (to be injected witha 150 mg syringe for a total dose of 225 mg)
- Inject 75 mg by subcutaneous route every 4 weeks (to be injected witha 150 mg syringe for a total dose of 225 mg)
- Inject 75 mg by subcutaneous route every 2 weeks (to be injected withtwo 150 mg syringes for a total dose of 375 mg)
- Inject 75 mg by subcutaneous route every 4 weeks (to be injected withtwo 150 mg syringes for a total dose of 375 mg)
- Inject 1 milliliter (150 mg) by subcutaneous route every 2 weeks
- Inject 1.2 milliliters (150 mg) by subcutaneous route every 4 weeks
- Inject 1 milliliter (150 mg) by subcutaneous route every 4 weeks
- Inject 1.8 milliliters (225 mg) by subcutaneous route every 2 weeks divided into 2 doses and given at 2 different injection sites
- Inject 2.4 milliliters (300 mg) by subcutaneous route every 2 weeks divided into 2 doses and given at 2 different injection sites
- Inject 2.4 milliliters (300 mg) by subcutaneous route every 4 weeks divided into 2 doses and given at 2 different injection sites
- Inject 3 milliliters (375 mg) by subcutaneous route every 2 weeks using 3 separate injection sites. Do not administer more than 150 mg per injection site.
- None
Contraindicated
- None
Severe
Moderate
- None
- None
Contraindicated
- Malignancy
Severe
Moderate
- Eosinophilia
- Increased cardiovascular event risk
- Mixed intestinal helminthiasis
- Vasculitis
XOLAIR (omalizumab)
- Chronic idiopathic urticaria
- Refractory extrinsic asthma
- Fracture
- Injection site sequelae
- Upper respiratory infection
- Viral infection
- Arthralgias
- Cough
- Dizziness
- Earache
- Fatigue
- Headache disorder
- Limb pain
- Nausea
- Pain
- Pharyngitis
- Pruritus of skin
- Sinusitis
More Frequent
Severe
Less Severe
- Acute myocardial infarction
- Gastroenteritis
- Pulmonary thromboembolism
- Unstable angina pectoris
- Epistaxis
- Erythema
- Fever
- Fungal infection
- Migraine
- Myalgias
- Peripheral edema
- Sore throat
- Symptoms of anxiety
- Toothache
- Urinary tract infection
Less Frequent
Severe
Less Severe
Rare / Very Rare
Severe
- Allergic dermatitis
- Anaphylaxis
- Angioedema
- Bronchospastic pulmonary disease
- Eosinophilia
- Hypotension
- Malignancy
- Pulmonary hypertension
- Syncope
- Thrombocytopenic disorder
- Transient cerebral ischemia
Less Severe
- Alopecia
- Lymphadenopathy
- Skin rash
- Urticaria
Contraindicated
None
Severe Precaution
Omalizumab
Risk of anaphylaxis and potential malignancy. No safety and efficacy established age < 6 years for asthma, age < 12 years for chronic idiopathic urticaria.
- 1 Day – 6 Years
- Risk of anaphylaxis and potential malignancy. No safety and efficacy established age < 6 years for asthma, age < 12 years for chronic idiopathic urticaria.
Management or Monitoring Precaution
None
Omalizumab
- Severity Level:
2
- Additional Notes: Insuff human data avail; consider maternal treatment benefit vs risk
Contraindicated
None
General | Excretion Potential | Effect on Infant | Notes |
None |
Precaution Exists
Omalizumab
Excretion expected; data suggest no significant incr in infant infection risk
General | Excretion Potential | Effect on Infant | Notes |
Evaluate use carefully | Unknown | Not known; no or inclusive data | Excretion expected; data suggest no significant incr in infant infection risk |
No Known Risk
None
General | Excretion Potential | Effect on Infant | Notes |
None |
Contraindicated
None
Precaution Exists
None
No Known Risk
None
- This medication can rarely cause a very serious (sometimes fatal) allergic reaction. This reaction has occurred after the first dose or after later doses, even more than one year after starting treatment. The risk is greater if you have a history of severe allergies to other medications or to foods.<br /><br /> Your health care professional will monitor you closely during treatment for any signs of an allergic reaction. Get medical help right away if you notice any symptoms of a serious allergic reaction, including: itching/swelling (especially of the face/tongue/throat), flushing, trouble breathing, severe dizziness, fainting, or rash/hives. If you have had an allergic reaction to omalizumab, you must never use omalizumab again.
Chronic idiopathic urticaria | |
L50.1 | Idiopathic urticaria |
Refractory extrinsic asthma | |
J45.4 | Moderate persistent asthma |
J45.40 | Moderate persistent asthma, uncomplicated |
J45.5 | Severe persistent asthma |
J45.50 | Severe persistent asthma, uncomplicated |
0-9 | A-Z |
---|---|
J45.4 | Moderate persistent asthma |
J45.40 | Moderate persistent asthma, uncomplicated |
J45.5 | Severe persistent asthma |
J45.50 | Severe persistent asthma, uncomplicated |
L50.1 | Idiopathic urticaria |
Formulary Reference Tool