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omalizumab (Rx)Brand and Other Names:Xolair

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

powder for injection

  • 150mg/1.2mL (125mg/mL) after reconstition
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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

Dosage Forms & Strengths

powder for injection

  • 150mg/1.2mL (125mg/mL) after reconstition
more...

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

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Adverse 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%)

<1%

Alopecia

Edema

Anaphylaxis

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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

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Pregnancy & Lactation

Pregnancy Category: B

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.

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Pharmacology

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

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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
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Images

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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