omalizumab (Rx)

Brand and Other Names:Xolair
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injection, single-dose prefilled syringe

  • 75mg/0.5mL
  • 150mg/mL

injection, lyophilized powder for reconstitution

  • 150mg/vial
  • 125mg/mL after reconstitution

Asthma

Indicated for moderate-to-severe persistent asthma in adults with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms 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)

Periodically reassess the need for continued therapy based upon disease severity and level of symptom control

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

Nasal Polyps

Indicated for add-on maintenance treatment of nasal polyps in adults aged ≥18 years with inadequate response to nasal corticosteroids

75-600 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)

Periodically reassess the need for continued therapy based upon disease severity and level of symptom control

Dosing Considerations

  • Asthma and nasal polyps

    • Determine dose and administration frequency by serum total IgE level (IU/mL) measured before initiating, and by body weight
    • Adjust dose for significant changes in body weight during treatment
    • Total IgE levels after initiating
      • Elevated during treatment and for up to 1 year after discontinuing treatment; therefore,re-testing IgE levels cannot be used as a guide for dose determination
      • Interruptions lasting <1 year: Dose based on serum IgE levels obtained at initial dose determination
      • Interruptions lasting >1 year: Re-test total serum IgE levels for dose determination
  • Limitations of use

    • Asthma: Not indicated for the relief of acute bronchospasm or status asthmaticus, or for treating other allergic conditions
    • CIU: Not indicated for other forms of urticaria

Dosage Forms & Strengths

injection, single-dose prefilled syringe

  • 75mg/0.5mL
  • 150mg/mL

injection, lyophilized powder for reconstitution

  • 150mg/vial
  • 125mg/mL after reconstitution

Asthma

Indicated for moderate-to-severe persistent asthma in children aged ≥6 years with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms 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)

Periodically reassess the need for continued therapy based upon disease severity and level of symptom control

Chronic Idiopathic Urticaria

Indicated for chronic idiopathic urticaria (CIU) in children aged ≥12 years 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

Asthma

  • Determine dose and administration frequency by serum total IgE level (IU/mL) measured before initiating, and by body weigh
  • Adjust doses for significant changes in body weight during treatment
  • Total IgE levels after initiating
    • Elevated during treatment and for up to 1 year after discontinuing treatment; therefore, re-testing IgE levels cannot be used as a guide for dose determination
    • Interruptions lasting <1 year: Dose based on serum IgE levels obtained at initial dose determination
    • Interruptions lasting >1 year: Re-test total serum IgE levels for dose determination

Limitations of use

  • Asthma: Not indicated for the relief of acute bronchospasm or status asthmaticus, or for treating other allergic conditions
  • CIU: Not indicated for other forms of urticaria
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Adverse Effects

>10%

Asthma (aged ≥12 yr)

  • Injection site reactions (45%)

CIU

  • Headache (12%)

1-10%

Asthma (aged ≥12 yr)

  • Arthralgia (8%)
  • Pain (7%)
  • Leg pain (4%)
  • Dizziness (3%)
  • Fatigue (3%)
  • Earache (2%)
  • Pruritus (2%)
  • Dermatitis (2%)
  • Arm pain (2%)
  • Fracture (2%)

CIU

  • Nasopharyngitis (9.1%)
  • Arthralgia (2.9%)
  • Viral upper respiratory tract infection (2.3%)
  • Nausea (1.1%)
  • Cough (1.1%)
  • Sinusitis (1.1%)
  • Upper respiratory tract infection (1.1%)

Nasal polyps

  • Headache (8.1%)
  • Injection site reactions (5.2%)
  • Upper abdominal pain (3%)
  • Arthralgia (3%)
  • Dizziness (3%)

Postmarketing Reports

Eosinophilic conditions

Fever, arthralgia, rash: Constellation of signs and symptoms, including arthritis/arthralgia, rash (urticaria or other forms), fever and lymphadenopathy similar to serum sickness

Hematologic: Severe thrombocytopenia

Skin: Hair loss

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Warnings

Black Box Warnings

Anaphylaxis

  • Anaphylaxis (eg, bronchospasm, hypotension, syncope, urticaria, angioedema of throat or tongue) reported
  • Anaphylaxis has occurred as early as after first dose, but also has occurred beyond 1 year after beginning regularly administered treatment
  • Initiate therapy in a healthcare setting and closely observe patients for an appropriate period after administration
  • Be prepared to manage anaphylaxis that can be life-threatening
  • Inform patients of the signs and symptoms of anaphylaxis and instruct to seek immediate medical care should symptoms occur
  • Base selection for self-administration on criteria to mitigate risk from anaphylaxis

Contraindications

Severe hypersensitivity reaction to omalizumab or any of its excipients

Cautions

Risk of anaphylaxis may occur up to 24 hr after any dose, even if no reaction to the first dose; advise patients to carry emergency self-treatment; discontinue if severe hypersensitivity reaction occurs

Once therapy has been established, administration by prefilled syringe outside of a healthcare setting by a patient or a caregiver may be appropriate for selected patients; patient selection, determined by healthcare provider in consultation with patient, should take into account the pattern of anaphylaxis events seen in premarketing clinical trials and postmarketing spontaneous reports, as well as individual patient risk factors (eg, prior history of anaphylaxis), ability to recognize signs and symptoms of anaphylaxis, and ability to perform subcutaneous injections with prefilled syringe with proper technique according to prescribed dosing regimen and instructions for use

Do not discontinue systemic or inhaled corticosteroids abruptly upon initiating omalizumab; decrease corticosteroids gradually over weeks/months; use with corticosteroids has not been evaluated in patients with CIU

Arthritis/arthralgia, rash, fever, and lymphadenopathy reported

Malignant neoplasms were observed; malignancy rate was 0.5% compared to 0.2% of controls in clinical trials; a 5-year study found difference in the rates of cancer between omalizumab-treated patients and those who were not treated, but due to limitations of the study, increased cancer risk cannot be ruled out

Monitor patients at high risk for geohelminth infection while taking omalizumab

Monitor for eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy, especially upon reduction of oral corticosteroids

Not shown to alleviate asthma exacerbations acutely; not for use in acute bronchospasm or status asthmaticus; patients should seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment with therapy

Elevated serum total IgE levels may persist for up to 1 yr following discontinuation; do not use serum total IgE levels obtained <1 year following discontinuation to reassess dosing regimen for asthma or nasal polyps

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Pregnancy & Lactation

Pregnancy

Exposure during pregnancy showed no increase in rate of major birth defects or miscarriage;

Increased rate of low birth weight among registry infants compared to infants in the other cohorts reported, despite average gestational age at birth; however, women taking the drug during pregnancy also had more severe asthma, which makes it difficult to determine whether ow birth weight is due to drug or disease severity

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

Human IgG antibodies are known to cross placental barrier; therefore, drug may be transmitted from mother to developing fetus

Lactation

Majority of infants (80.9%, 186/230) in pregnancy exposure registry were breastfed; events categorized as “infections and infestations” were not significantly increased in infants who were exposed through breastfeeding compared with infants who were not breastfed, or infants who were breastfed without exposure

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

Lyophilized powder (vials)

  • Reconstitute vial(s) with 1.4 mL sterile water for injection (SWFI) into a 3-mL syringe equipped with a 1-inch, 18-gauge needle; resulting solution is 150 mg/1.2 mL
  • Place vial upright on a flat surface and using standard aseptic technique, insert needle and inject the SWFI directly onto the product
  • Keeping vial upright, gently swirl for ~1 minute to evenly wet powder; do NOT shake
  • Gently swirl the vial for 5-10 seconds at ~5 minutes intervals until there are no visible gel-like particles in the solution; lyophilized product takes 15-20 minutes to completely dissolve; discard if contents of vial do not dissolve completely by 40 minutes
  • Reconstituted solution will appear clear or slightly opalescent, somewhat viscous, and may have a few small bubbles or foam around the edge of the vial
  • To obtain the full 1.2-mL dose withdraw with a new needle and 3-mL syringe all of product from the vial before expelling any air or excess solution from syringe

Prefilled syringes

  • Each carton contains 1 syringe
  • Check expiration date on carton; discard if expired
  • Remove carton from refrigerator and set aside for at least 15-30 minutes to calibrate to room temperature (leave syringe in the carton to protect it from light)
  • Do not allow syringe to become hot or speed up the warming process in any way, and do not put the syringe in a microwave or in warm water
  • Visually inspect syringe; solution should be clear to slightly opalescent and colorless to pale brownish-yellow; discard if the liquid is cloudy, discolored, or contains foreign particles

SC Administration

Administer by SC injection

Recommended injection sites are the upper arm and the front and middle of the thighs

Do not inject into moles, scars, bruises, or areas where the skin is tender, red, hard, or if there are breaks in the skin

Rotate injection site for each new injection at least 1 inch from the area used for the last injection

Reconstituted vials

  • Injection may take 5-10 seconds to administer owing to solution viscosity
  • Do not administer >150 mg (contents of 1 vial) per injection site
  • Divide doses >150 mg among 2 or more injection sites
  • Periodically reassess need for continued therapy based on disease severity and level of symptom control

Prefilled syringes

  • Children aged 6-11 years (asthma and CIU): Administer by a caregiver
  • Adults and adolescents aged >12 years: May be self-administered under supervision

Storage

Lyophilized powder

  • Ship at controlled ambient temperature (≤30ºC [≤86ºF])
  • Refrigerate at 2-8ºC (36-46ºF)
  • Do not use beyond the expiration date stamped on carton

Prefilled syringes

  • Ship at controlled ambient temperature (≤30ºC [≤86ºF])
  • Refrigerate at 2-8ºC (36-46ºF)
  • Do not use beyond the expiration date stamped on carton

Reconstituted vials

  • Refrigerate at 2-8ºC (36-46ºF) for up to 8 hr following reconstitution or within 4 hr of reconstitution when stored at room temperature
  • Protect from light
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Images

BRAND FORM. UNIT PRICE PILL IMAGE
Xolair subcutaneous
-
150 mg vial

Copyright © 2010 First DataBank, Inc.

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Patient Handout

Patient Education
omalizumab subcutaneous

OMALIZUMAB - INJECTION

(OH-ma-LIZ-ue-mab)

COMMON BRAND NAME(S): Xolair

WARNING: 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. 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.

USES: Omalizumab is used to control and prevent symptoms (such as wheezing and shortness of breath) caused by asthma that is due to year-round allergens. Controlling symptoms of asthma helps you maintain your normal activities and cuts down on time lost from work or school. Omalizumab may also be used to treat nasal polyps or to treat hives from an unknown cause (chronic idiopathic urticaria-CIU).This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden asthma attacks. If an asthma attack occurs, use your quick-relief inhaler (such as albuterol, salbutamol) as prescribed.

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using omalizumab and each time you get a refill. If you are using this medication at home, read and follow the Instructions for Use leaflet. If you have any questions, ask your doctor or pharmacist.This medication is injected under the skin as directed by your doctor, usually every 2 or 4 weeks for the treatment of asthma or nasal polyps, and every 4 weeks for the treatment of CIU. The first dose is given by a health care professional and you will be monitored in case you have a severe allergic reaction. Later doses may be given by a health care professional or at home.If you are using this medication at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.To increase comfort and make it easier to inject, take the pre-filled syringe out of the refrigerator and let it warm to room temperature for at least 15 to 30 minutes before injecting. Do not warm up this medication in any other way such as heating in the microwave or placing in hot water.The dosage for the treatment of asthma/nasal polyps is based on your weight and lab test results before you start treatment. Tell your doctor if you have any big changes in weight during treatment. Your dose may need to be adjusted. The dosage for the treatment of CIU is based on your medical condition and response to treatment.Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar to keep track of when to get the next dose.Get medical help right away if your asthma symptoms worsen or if you are using your quick-relief inhaler more than usual or more often than prescribed.

SIDE EFFECTS: See also Warning section.Itching, bruising, redness, pain, or swelling at the injection site may occur. Headache may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: unusual lumps/moles/skin changes, numbness/tingling of arms/legs, worsening shortness of breath, coughing up blood, muscle/joint pain, signs of infection (such as sore throat that doesn't go away, fever, cough).Get medical help right away if you have any very serious side effects, including: chest/jaw/left arm pain, unusual sweating, weakness on one side of the body, sudden vision changes, confusion, trouble speaking, pain/redness/swelling of the legs.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: See also Warning section.Before using omalizumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as latex), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Lab and/or medical tests (such as lung function, antibody levels) should be done before you start using this medication and while you are using it. Keep all medical and lab appointments. Consult your doctor for more details.Avoid substances that can worsen breathing problems by causing irritation or allergic reaction, such as smoke, pollen, pet dander, dust, and mold.

MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

STORAGE: Store the pre-filled syringes in the refrigerator. Do not freeze. Keep in the original carton and protect from direct sunlight. After taking it out of the refrigerator, use or discard within 4 hours. Keep all medications away from children and pets.Store the vials in a refrigerator away from light.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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Formulary

FormularyPatient Discounts

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Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
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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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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.