Omalizumab

Omalizumab
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];

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Black Box Warning

WARNING: ANAPHYLAXIS See full prescribing information for complete Boxed Warning. Anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of Xolair. Anaphylaxis has occurred as early as after the first dose of Xolair, but also has occurred beyond 1 year after beginning regularly administered treatment. Because of the risk of anaphylaxis, observe patients closely for an appropriate period of time after Xolair administration. Health care providers administering Xolair should be prepared to manage anaphylaxis that can be life-threatening. Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should symptoms occur.

Overview

Omalizumab is an anti-allergic and anti-asthmatic agent that is FDA approved for the treatment of allergic asthma and chronic idiopathic urticauria. There is a Black Box Warning for this drug as shown here. Common adverse reactions include arthralgia, pain (general), leg pain, fatigue, dizziness, fracture, arm pain, pruritus, dermatitis, earache, nausea, nasopharyngitis, sinusitis, upper respiratory tract infection, viral upper respiratory tract infection, headache, and cough.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Allergic Asthma

• Dosing Information

Administer Xolair 150 to 375 mg by subcutaneous (SC) injection every 2 or 4 weeks. Determine doses (mg) and dosing frequency by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). See the dose determination charts below (Table 1 and Table 2) for appropriate dose assignment. Periodically reassess the need for continued therapy based upon the patient's disease severity and level of asthma control.

Dosing adjustments for Allergic Asthma

Adjust doses for significant changes in body weight (see Table 1 and Table 2). Total IgE levels are elevated during treatment and remain elevated for up to one year after the discontinuation of treatment. Therefore, re-testing of IgE levels during Xolair treatment cannot be used as a guide for dose determination. Interruptions lasting less than one year: Dose based on serum IgE levels obtained at the initial dose determination. Interruptions lasting one year or more: Re-test total serum IgE levels for dose determination.

Chronic Idiopathic Urticaria

• Dosage

Administer Xolair 150 or 300 mg by subcutaneous injection every 4 weeks. Dosing of Xolair in CIU patients is not dependent on serum IgE (free or total) level or body weight. The appropriate duration of therapy for CIU has not been evaluated. Periodically reassess the need for continued therapy.

Preparation and Administration

Prepare Xolair for subcutaneous injection using Sterile Water for Injection (SWFI), USP, ONLY. Each vial of Xolair is for single use only and contains no preservatives. Reconstitution The lyophilized product takes 15–20 minutes to dissolve. The 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. The 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. Use the solution within 8 hours following reconstitution when stored in the vial at 2–8°C (36–46°F), or within 4 hours of reconstitution when stored at room temperature. Reconstituted Xolair vials should be protected from sunlight. Preparation STEP 1: Draw 1.4 mL of SWFI, USP into a 3 mL syringe equipped with a 1 inch, 18-gauge needle. STEP 2: Place the vial upright on a flat surface and using standard aseptic technique, insert the needle and inject the SWFI, USP directly onto the product. STEP 3: Keeping the vial upright, gently swirl the upright vial for approximately 1 minute to evenly wet the powder. Do not shake. STEP 4: After completing STEP 3, gently swirl the vial for 5-10 seconds approximately every 5 minutes in order to dissolve any remaining solids. There should be no visible gel like particles in the solution. Do not use if foreign particles are present.

Note: If it takes longer than 20 minutes to dissolve completely, repeat STEP 4 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. STEP 5: Invert the vial for 15 seconds in order to allow the solution to drain toward the stopper. Using a new 3 mL syringe equipped with a 1-inch, 18-gauge needle, insert the needle into the inverted vial. Position the needle tip at the very bottom of the solution in the vial stopper when drawing the solution into the syringe. Before removing the needle from the vial, pull the plunger all the way back to the end of the syringe barrel in order to remove all of the solution from the inverted vial. STEP 6: Replace the 18-gauge needle with a 25-gauge needle for subcutaneous injection. STEP 7: Expel air, large bubbles, and any excess solution in order to obtain the required 1.2 mL dose. A thin layer of small bubbles may remain at the top of the solution in the syringe.

• Administration

Administer Xolair by subcutaneous injection. The injection may take 5-10 seconds to administer because the solution is slightly viscous. Each vial delivers 1.2 mL (150 mg) of Xolair. Do not administer more than 150 mg per injection site. Divide doses of more than 150 mg among two or more injection sites (Table 3).

Dosage forms and strengths

150 mg of omalizumab as lyophilized, sterile powder in a single-use 5 mL vial.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Omalizumab in adult patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Omalizumab in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding FDA-Labeled Use of Omalizumab in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Omalizumab in pediatric patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Omalizumab in pediatric patients.

Contraindications

The use of Xolair is contraindicated in the following: Severe hypersensitivity reaction to Xolair or any ingredient of Xolair.

Warnings

WARNING: ANAPHYLAXIS See full prescribing information for complete Boxed Warning. Anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of Xolair. Anaphylaxis has occurred as early as after the first dose of Xolair, but also has occurred beyond 1 year after beginning regularly administered treatment. Because of the risk of anaphylaxis, observe patients closely for an appropriate period of time after Xolair administration. Health care providers administering Xolair should be prepared to manage anaphylaxis that can be life-threatening. Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should symptoms occur.

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Omalizumab in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Omalizumab in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Omalizumab in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Omalizumab during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Omalizumab with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Omalizumab with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Omalizumab with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Omalizumab with respect to specific gender populations.

Race

There is no FDA guidance on the use of Omalizumab with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Omalizumab in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Omalizumab in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Omalizumab in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Omalizumab in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Omalizumab in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Omalizumab in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Omalizumab in the drug label.

Pharmacology

There is limited information regarding Omalizumab Pharmacology in the drug label.

Mechanism of Action

Structure

File:Omalizumab01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Omalizumab in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Omalizumab in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Omalizumab in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Omalizumab in the drug label.

How Supplied

Storage

There is limited information regarding Omalizumab Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Omalizumab in the drug label.

Precautions with Alcohol

• Alcohol-Omalizumab interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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