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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:
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:
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:
None.
Professional Synonyms:
None.
Indications:
None.
Professional Synonyms:
None.
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.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for XOLAIR (omalizumab):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
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 0 severe contraindications.
There are 0 moderate contraindications.
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 0 severe adverse reactions.
There are 0 less severe adverse reactions.
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.
Precaution Exists
Precaution exists. (No data or inconclusive human data.) Use of this drug by breast feeding mothers should be evaluated carefully.
Precaution Exists
Precaution exists. (No data or inconclusive human data.) Use of this drug by breast feeding mothers should be evaluated carefully.
| Drug Name | Excretion Potential | Effect on Infant | Notes |
|---|---|---|---|
| Omalizumab | Unknown. It is unknown whether the drug is excreted in human breast milk. | It is not known whether this drug has an adverse effect on the nursing infant. (No data or inconclusive human data) | Excretion expected; data suggest no significant incr in infant infection risk |
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:
No ICD codes found for this drug.
No ICD codes found for this drug.
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