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Drug overview for XOLAIR (omalizumab):
Generic name: omalizumab (OH-ma-LIZ-ue-mab)
Drug class: Monoclonal Antibodies To Immunoglobulin E (IgE)
Therapeutic class: Respiratory Therapy Agents
Omalizumab, a chimeric human-murine (humanized) anti-IgE monoclonal antibody, is an antiasthmatic and antiallergic agent.
No enhanced Uses information available for this drug.
Generic name: omalizumab (OH-ma-LIZ-ue-mab)
Drug class: Monoclonal Antibodies To Immunoglobulin E (IgE)
Therapeutic class: Respiratory Therapy Agents
Omalizumab, a chimeric human-murine (humanized) anti-IgE monoclonal antibody, is an antiasthmatic and antiallergic agent.
No enhanced Uses information available for this drug.
DRUG IMAGES
XOLAIR 150 MG/1.2 ML POWDER VL
The following indications for XOLAIR (omalizumab) have been approved by the FDA:
Indications:
Chronic idiopathic urticaria
Chronic rhinosinusitis with nasal polyposis
IgE-mediated food allergy
Moderate persistent asthma
Severe persistent asthma
Professional Synonyms:
Anaphylactic food allergy
Indications:
Chronic idiopathic urticaria
Chronic rhinosinusitis with nasal polyposis
IgE-mediated food allergy
Moderate persistent asthma
Severe persistent asthma
Professional Synonyms:
Anaphylactic food allergy
The following dosing information is available for XOLAIR (omalizumab):
In patients with asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), and IgE-mediated food allergy, dosage should be based on the primary diagnosis for which omalizumab is prescribed. Initial dosing in patients with these conditions is determined based on serum total IgE levels and body weight. Dosage of omalizumab in patients with chronic spontaneous urticaria (CSU) is not dependent on serum IgE level or body weight.
Omalizumab is administered by subcutaneous injection only. The drug is commercially available as a lyophilized powder that must be reconstituted prior to administration and also available as prefilled syringes and autoinjectors. The lyophilized powder should be prepared and administered by a healthcare provider.
The prefilled syringes and autoinjectors may be self-administered by adolescents 12 years of age and older (under adult supervision) and by adults. The prefilled syringes may be administered by a caregiver to pediatric patients 1 to 11 years of age; however, the autoinjectors are not intended for use in pediatric patients younger than 12 years of age.
The prefilled syringes and autoinjectors may be self-administered by adolescents 12 years of age and older (under adult supervision) and by adults. The prefilled syringes may be administered by a caregiver to pediatric patients 1 to 11 years of age; however, the autoinjectors are not intended for use in pediatric patients younger than 12 years of age.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| XOLAIR 150 MG/1.2 ML POWDER VL | Maintenance | Adults inject 1.2 milliliters (150 mg) by subcutaneous route every 4 weeks |
| XOLAIR 75 MG/0.5 ML SYRINGE | Maintenance | Adults inject 75 mg by subcutaneous route every 4 weeks |
| XOLAIR 75 MG/0.5 ML AUTOINJECT | Maintenance | Adults inject 75 mg by subcutaneous route every 4 weeks |
| XOLAIR 150 MG/ML SYRINGE | Maintenance | Adults inject 150 mg by subcutaneous route every 4 weeks |
| XOLAIR 150 MG/ML AUTOINJECTOR | Maintenance | Adults inject 150 mg by subcutaneous route every 4 weeks |
| XOLAIR 300 MG/2 ML SYRINGE | Maintenance | Adults inject 300 mg by subcutaneous route every 4 weeks |
| XOLAIR 300 MG/2 ML AUTOINJECT | Maintenance | Adults inject 300 mg by subcutaneous route every 4 weeks |
No generic dosing information available.
The following drug interaction information is available for XOLAIR (omalizumab):
There are 0 contraindications.
There are 2 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| IgG Antibodies and Derivatives/Efgartigimod-alfa SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Efgartigimod-alfa binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3) CLINICAL EFFECTS: The effectiveness of medicines that bind to FcRn may be decreased.(3) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer of efgartigimod-alfa states that efgartigimod-alfa should not be combined with long-term use of FcRn-binding medications. If the medication is essential for the patient, efgartigimod-alfa should be discontinued.(3) DISCUSSION: Clinical drug interaction studies with efgartigimod-alfa have not been performed. Efgartigimod-alfa may decrease concentrations of compounds that bind to the human FcRn.(3) |
VYVGART, VYVGART HYTRULO |
| IgG Antibodies and Derivatives/Nipocalimab-aahu SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Nipocalimab-aahu binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3) CLINICAL EFFECTS: The effectiveness of medicines that bind to FcRn may be decreased.(3) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer of nipocalimab-aahu states that nipocalimab-aahu should not be combined with long-term use of FcRn-binding medications. If the medication is essential for the patient, nipocalimab-aahu should be discontinued.(3) DISCUSSION: Clinical drug interaction studies with nipocalimab-aahu have not been performed. Nipocalimab-aahu may decrease concentrations of compounds that bind to the human FcRn.(3) |
IMAAVY |
There are 1 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| IgG Antibodies and Derivatives/Rozanolixizumab-noli SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: The neonatal Fc receptor (FcRn) prevents catabolism and mediates recycling of IgG and albumin, which leads to their long persistence in the body.(1,2) Rozanolixizumab-noli binds to FcRn and may decrease systemic exposure of other ligands of FcRn, like immunoglobulins and IgG-based antibodies.(3) CLINICAL EFFECTS: The effectiveness of medications that bind to FcRn may be decreased.(3) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The manufacturer of rozanolixizumab-noli states that concurrent use with medications that bind to the human neonatal Fc receptor (FcRn) should be closely monitored for reduced effectiveness of these medications. If long-term use of such medications is essential for the patient, consider discontinuing rozanolixizumab-noli and use alternative therapies.(3) DISCUSSION: Clinical drug interaction studies with rozanolixizumab-noli have not been performed. Rozanolixizumab-noli may decrease concentrations of compounds that bind to the human FcRn.(3) |
RYSTIGGO |
The following contraindication information is available for XOLAIR (omalizumab):
Drug contraindication overview.
*Known history of severe hypersensitivity to omalizumab or any ingredient in the formulation.
*Known history of severe hypersensitivity to omalizumab or any ingredient in the formulation.
There are 0 contraindications.
There are 1 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Malignancy |
There are 3 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Eosinophilia |
| Mixed intestinal helminthiasis |
| Vasculitis |
The following adverse reaction information is available for XOLAIR (omalizumab):
Adverse reaction overview.
Adverse effects reported in >=1% of adults and adolescents >=12 years of age with asthma receiving omalizumab in clinical studies include arthralgia, general pain, leg pain, fatigue, dizziness, fracture, arm pain, pruritus, dermatitis, and earache. Adverse effects reported in >=3% of pediatric patients 6 to <12 years of age with asthma receiving omalizumab in clinical studies include nasopharyngitis, headache, pyrexia, upper abdominal pain, pharyngitis streptococcal, otitis media, viral gastroenteritis, arthropod bites, and epistaxis. The most common adverse reactions (>=3%) reported in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP) receiving omalizumab in clinical studies include headache, injection site reaction, arthralgia, upper abdominal pain, and dizziness.
The most common adverse reactions (>=3%) reported in patients with IgE-mediated food allergy receiving omalizumab in clinical studies were injection site reactions and pyrexia. Adverse effects (>=2%) reported in patients with chronic spontaneous urticaria receiving omalizumab in controlled clinical studies include nausea, nasopharyngitis, sinusitis, upper respiratory tract infection, viral upper respiratory tract infection, arthralgia, headache, and cough.
Adverse effects reported in >=1% of adults and adolescents >=12 years of age with asthma receiving omalizumab in clinical studies include arthralgia, general pain, leg pain, fatigue, dizziness, fracture, arm pain, pruritus, dermatitis, and earache. Adverse effects reported in >=3% of pediatric patients 6 to <12 years of age with asthma receiving omalizumab in clinical studies include nasopharyngitis, headache, pyrexia, upper abdominal pain, pharyngitis streptococcal, otitis media, viral gastroenteritis, arthropod bites, and epistaxis. The most common adverse reactions (>=3%) reported in patients with chronic rhinosinusitis with nasal polyposis (CRSwNP) receiving omalizumab in clinical studies include headache, injection site reaction, arthralgia, upper abdominal pain, and dizziness.
The most common adverse reactions (>=3%) reported in patients with IgE-mediated food allergy receiving omalizumab in clinical studies were injection site reactions and pyrexia. Adverse effects (>=2%) reported in patients with chronic spontaneous urticaria receiving omalizumab in controlled clinical studies include nausea, nasopharyngitis, sinusitis, upper respiratory tract infection, viral upper respiratory tract infection, arthralgia, headache, and cough.
There are 21 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Fracture Injection site sequelae Upper respiratory infection Viral infection |
Acute myocardial infarction Gastroenteritis Pulmonary thromboembolism Unstable angina pectoris |
| Rare/Very Rare |
|---|
|
Allergic dermatitis Anaphylaxis Angioedema Bronchospastic pulmonary disease Eosinophilia Eosinophilic granulomatosis with polyangiitis Hypotension Malignancy Pulmonary hypertension Serum sickness Syncope Thrombocytopenic disorder Transient cerebral ischemia |
There are 27 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Arthralgia Cough Dizziness Earache Fatigue Headache disorder Nausea Pain Pain in extremities Pharyngitis Pruritus of skin Sinusitis |
Epistaxis Erythema Fever Fungal infection Migraine Myalgia Peripheral edema Sore throat Symptoms of anxiety Toothache Urinary tract infection |
| Rare/Very Rare |
|---|
|
Alopecia Lymphadenopathy Skin rash Urticaria |
The following precautions are available for XOLAIR (omalizumab):
Safety and efficacy of omalizumab for the treatment of moderate to severe persistent allergic asthma in pediatric patients 6 years of age or older have been established. Safety and effectiveness of omalizumab in pediatric patients with chronic rhinosinusitis with nasal polyps (CRSwNP) have not been established. Safety and effectiveness of omalizumab for the treatment of IgE-mediated food allergy have been established in pediatric patients 1 year of age or older. Safety and effectiveness of omalizumab in pediatric patients 12 years of age or older with chronic spontaneous urticaria have been established.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
A registry study showed no increase in the rate of major defects or miscarriage with the use of omalizumab during pregnancy. An increased rate of low birth weight was observed among registry infants compared to infants in the other cohorts, despite average gestational age at birth; however, women receiving omalizumab during pregnancy also had more severe asthma, which makes it difficult to determine whether the low birth weight is due to the drug or the disease severity. Human IgG antibodies are known to cross the placental barrier; therefore, omalizumab may be transmitted from the mother to the developing fetus.
No evidence of fetal harm was observed in animal reproduction studies. In women with poorly or moderately controlled asthma, evidence demonstrates that there is an increased risk of preeclampsia in the mother, and prematurity, low birth weight, and small for gestational age in the neonate. In pregnant women, asthma control should be monitored and treatment adjusted as necessary to maintain optimal control.
No evidence of fetal harm was observed in animal reproduction studies. In women with poorly or moderately controlled asthma, evidence demonstrates that there is an increased risk of preeclampsia in the mother, and prematurity, low birth weight, and small for gestational age in the neonate. In pregnant women, asthma control should be monitored and treatment adjusted as necessary to maintain optimal control.
It is not known whether omalizumab is distributed into human milk, or if the drug has any effects on milk production. Since IgG distributes into milk in humans, it is expected that omalizumab will be present in human milk. Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for omalizumab and any potential adverse effects on the breastfed child from the drug or underlying maternal condition.
Experience with omalizumab therapy in geriatric patients 65 years of age or older is insufficient to determine whether they respond differently than younger adults.
The following prioritized warning is available for XOLAIR (omalizumab):
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.
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.
The following icd codes are available for XOLAIR (omalizumab)'s list of indications:
| Chronic idiopathic urticaria | |
| L50.1 | Idiopathic urticaria |
| Chronic rhinosinusitis with nasal polyposis | |
| J32 | Chronic sinusitis |
| J32.8 | Other chronic sinusitis |
| J32.9 | Chronic sinusitis, unspecified |
| J33 | Nasal polyp |
| J33.0 | Polyp of nasal cavity |
| J33.1 | Polypoid sinus degeneration |
| J33.8 | Other polyp of sinus |
| J33.9 | Nasal polyp, unspecified |
| Ige-mediated food allergy | |
| T78.00xA | Anaphylactic reaction due to unspecified food, initial encounter |
| T78.00xD | Anaphylactic reaction due to unspecified food, subsequent encounter |
| Z91.018 | Allergy to other foods |
| Moderate persistent asthma | |
| J45.40 | Moderate persistent asthma, uncomplicated |
| Severe persistent asthma | |
| J45.50 | Severe persistent asthma, uncomplicated |
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