Dosing and uses of Xolair (omalizumab)
Adult dosage forms and strengths
powder for injection
- 150mg/1.2mL (125mg/mL) after reconstition
Allergic Asthma
Indicated for moderate-to-severe persistent asthma in patients with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids
150-375 mg SC q2-4Weeks
Determine precise dose and frequency by total IgE level and body weight measured before starting therapy and then periodically (see manufacturer’s prescribing information)
Chronic Idiopathic Urticaria
Indicated for chronic idiopathic urticaria (CIU) in patients who remain symptomatic despite H1 antihistamine treatment
150-300 mg SC q4weeks
Dosing in CIU patients is not dependent on serum IgE level or body weight
Treatment duration for CIU has not been evaluated; periodically reassess the need for continued therapy
Dosing Considerations
Not indicated for treatment of other allergic conditions or other forms of urticaria
Not indicated for the relief of acute bronchospasm or status asthmaticus
Pediatric dosage forms and strengths
powder for injection
- 150mg/1.2mL (125mg/mL) after reconstition
Allergic Asthma
Indicated for moderate-to-severe persistent asthma in patients with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids
<6 years: Safety and efficacy not established
6 to <12 years: 75-375 mg SC q2-4Weeks
≥12 years: 150-375 mg SC q2-4Weeks
Determine precise dose and frequency by total IgE level and body weight measured before starting therapy and then periodically (see manufacturer’s prescribing information)
Chronic Idiopathic Urticaria
Indicated for chronic idiopathic urticaria (CIU) in patients who remain symptomatic despite H1 antihistamine treatment
<12 years: Safety and efficacy not established
≥12 years: 150-300 mg SC q4weeks
Dosing in CIU patients is not dependent on serum IgE level or body weight
Treatment duration for CIU has not been evaluated; periodically reassess the need for continued therapy
Dosing Considerations
Not indicated for treatment of other allergic conditions or other forms of urticaria
Not indicated for the relief of acute bronchospasm or status asthmaticus
Xolair (omalizumab) adverse (side) effects
>10%
Injection site reactions (45%)
Viral infections (23%)
URI (20%)
Sinusitis (16%)
Headache (15%)
Pharyngitis (11%)
1-10%
Pain (7%)
Arthralgia (8%)
Fracture (2%)
Fatigue (3%)
Dermatitis (2%)
Arm pain (4%)
Leg pain (4%)
Dizziness (3%)
Earache (2%)
Pruritus (2%)
Nasopharyngitis (3%)
Pyrexia (3%)
Upper abdominal pain (3%)
Pharyngitis streptococcal (3%)
Otitis media (3%)
Viral gastroenteritis (3%)
Epistaxis (3%)
<1%
Alopecia
Edema
Anaphylaxis
Bronchitis
Urticaria
Warnings
Black box warnings
Anaphylaxis, presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue reported to occur after administration
Anaphylaxis has occurred as early as after the first dose, but also has occurred beyond 1 year after beginning regularly administered treatment
Closely observe patients for an appropriate period of time after administration
Health care providers should be prepared to manage anaphylaxis that can be life-threatening
Inform patients of the signs and symptoms of anaphylaxis and instructed them to seek immediate medical care should symptoms occur
Contraindications
Hypersensitivity
Cautions
Risk of anaphylaxis may occur up to 24 hr after dose and may occur after any dose, even if not reaction to the first dose; advise patients to carry emergency self-treatment
Do not discontinue systemic or inhaled corticosteroids abruptly upon initiating omalizumab; decrease corticosteroids gradually decrease over weeks/months
Eosinophilic conditions reported (rare)
Arthritis/arthralgia, rash, fever, and lymphadenopathy reported
Some studies indicate increased risk of cardiac adverse events
Slightly increased risk of problems involving the heart and blood vessels supplying the brain in patients treated with omalizumaB
In clinical study, malignancy rate 0.5% compared to 0.2% control; a 5-year study found difference in the rates of cancer between omalizumab treated patients and those who were not treated, but dut to limiations of the study, increased cancer risk can not be ruled out
Monitor patients at high risk for goehelminth infection while taking omalizumaB
Monitor for eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy, especially upon reduction of oral corticosteroids
Not for use in acute bronchospasm or status asthmaticus
Pregnancy and lactation
Pregnancy: Data in pregnant women are insufficient to inform on drug associated risk; monoclonal antibodies, such as omalizumab, are transported across placenta in a linear fashion as pregnancy progresses; potential effects on fetus are likely to be greater during second and third trimesters of pregnancy; in women with poorly or moderately controlled asthma, evidence demonstrates that there is increased risk of preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate; level of asthma control should be closely monitored in pregnant women and treatment adjusted as necessary to maintain optimal controL
Lactation: Unknown if distributed into breast milk; use caution
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Xolair (omalizumab)
Mechanism of action
Recombinant humanized monoclonal antibody; selectively binds to IgE and inhibits binding to IgE receptors on surface of mast cells and basophils
Absorption
Bioavailability: 62%
Peak Plasma Time: 7-8 days
Distribution
Vd: 78 +/- 32 mL/kg
Metabolism
Hepatic
Elimination
Half-Life: 26 days
Total Body Clearance: 2.4 +/- 1.1 mL/kg/day
Excretion: Bile
Administration
SC Preparation
Reconstitute vial with 1.4 mL sterile water for injection (SWFI); resulting solution is 150 mg/1.2 mL
Place the vial upright on a flat surface and using standard aseptic technique, insert the needle and inject the SWFI directly onto the product
Keeping the vial upright, gently swirl the upright vial for ~1 minute to evenly wet the powder
Do NOT shake
Gently swirl the vial for 5-10 seconds at ~5 minute intervals to dissolve any remaining solids
The lyophilized product takes 15-20 minutes to dissolve
If it takes >20 minutes to dissolve completely, gently swirl the vial for 5-10 seconds at ~5 minute intervals until there are no visible gel-like particles in the solution
Do not use if the contents of the vial do not dissolve completely by 40 minutes
Fully reconstituted product will appear clear or slightly opalescent and it is acceptable if there are a few small bubbles or foam around the edge of the viaL
Reconstituted product is somewhat viscous
In order to obtain the full 1.2 mL dose, ALL OF THE PRODUCT MUST BE WITHDRAWN from the vial before expelling any air or excess solution from the syringe
SC Administration
Administer by subcutaneous injection
The injection may take 5-10 seconds to administer because the solution is slightly viscous
Do not administer >150 mg (contents of 1 vial) per injection site
Divide doses >150 mg among 2 or more injection sites
Storage
Lyophilized powder
- Ship at controlled ambient temperature (≤30°C [≤86°F])
- Store refrigerated at 2-8°C (36-46°F)
- Do not use beyond the expiration date stamped on carton
Reconstituted vials
- Use solution within 8 hr following reconstitution when stored in the vial at 2-8ºC (36-46ºF), or within 4 hr of reconstitution when stored at room temperature
- Reconstituted vials should be protected from sunlight
