Omlyclo
omalizumab-igec · Injection · Subcutaneous
Uses
1 INDICATIONS AND USAGE OMLYCLO is an anti-IgE antibody indicated for: Moderate to severe persistent asthma in adults and pediatric patients 6 years of age and older with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids ( 1.1 ) Chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids, as add-on maintenance treatment ( 1.2 ) IgE-mediated food allergy in adult and pediatric patients aged 1 year and older for the reduction of allergic reactions (Type I), including anaphylaxis, that may occur with accidental exposure to one or more foods. To be used in conjunction with food allergen avoidance ( 1.3 ) Chronic spontaneous urticaria (CSU) in adults and adolescents 12 years of age and older who remain symptomatic despite H1 antihistamine treatment ( 1.4 ) Limitations of Use : Not indicated for acute bronchospasm or status asthmaticus. ( 1.1 , 5.3 ) Not indicated for the emergency treatment of allergic reactions, including anaphylaxis ( 1.3 ) Not indicated for other forms of urticaria. ( 1.4 ) 1.1 Asthma OMLYCLO is indicated for adults and pediatric patients 6 years of age and older with moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids. Limitations of Use: OMLYCLO is not indicated for the relief of acute bronchospasm or status asthmaticus. 1.2 Chronic Rhinosinusitis with Nasal Polyps OMLYCLO is indicated for add-on maintenance treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids. 1.3 IgE-Mediated Food Allergy OMLYCLO is indicated for the reduction of allergic reactions (Type I), including anaphylaxis, that may occur with accidental exposure to one or more foods in adult and pediatric patients aged 1 year and older with IgE-mediated food allergy. OMLYCLO is to be used in conjunction with food allergen avoidance. Limitations of Use: OMLYCLO is not indicated for the emergency treatment of allergic reactions, including anaphylaxis. 1.4 Chronic Spontaneous Urticaria OMLYCLO is indicated for the treatment of adults and adolescents 12 years of age and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment. Limitations of Use: OMLYCLO is not indicated for treatment of other forms of urticaria.
Dosage and administration
For subcutaneous (SC) administration only. ( 2.2 , 2.3 , 2.4 , 2.5 ) See full prescribing information for administration instructions ( 2.6 , 2.7 ). Asthma: OMLYCLO 75 to 375 mg SC every 2 or 4 weeks. Determine dose (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. ( 2.2 ) Chronic Rhinosinusitis with Nasal Polyps : OMLYCLO 75 to 600 mg SC every 2 or 4 weeks. Determine dose (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. ( 2.3 ) IgE-Mediated Food Allergy : OMLYCLO 75 mg to 600 mg SC every 2 or 4 weeks. Determine dose (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 chart. ( 2.4 ) Chronic Spontaneous Urticaria : OMLYCLO 150 or 300 mg SC every 4 weeks. Dosing in CSU is not dependent on serum IgE level or body weight. ( 2.5 ) 2.1 Overview of Dosage Determination Asthma, and Chronic Rhinosinusitis with Nasal Polyps, and IgE-Mediated Food Allergy Determine dosage of OMLYCLO by serum total IgE level (IU/mL) measured before the start of treatment, and by body weight (kg). For patients with asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), and IgE-mediated food allergy, dosage determination should be based on the primary diagnosis for which OMLYCLO is being prescribed. Adjust doses for significant changes in body weight during treatment. Refer to Tables 1 and 2 for the recommended dosage for treatment of asthma, Table 3 for treatment of CRSwNP, and Table 4 for treatment of IgE-mediated food allergy. 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 OMLYCLO 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 (Table 1 or 2 for treatment of asthma, based on the patient's age, Table 3 for treatment of CRSwNP, and Table 4 for treatment of IgE-mediated food allergy). Chronic Spontaneous Urticaria Dosage of OMLYCLO in patients with chronic spontaneous urticaria (CSU) is not dependent on serum IgE (free or total) level or body weight [see Dosage and Administration (2.5) ] . 2.2 Recommended Dosage for Asthma The recommended dosage for asthma is OMLYCLO 75 mg to 375 mg by subcutaneous injection every 2 or 4 weeks based on serum total IgE level (IU/mL) measured before the start of treatment and by body weight (kg) [see Dosage and Administration (2.1) ] . Adult and adolescent patients 12 years of age and older: Initiate dosing according to Table 1. Pediatric patients 6 to <12 years of age: Initiate dosing according to Table 2. Table 1. Subcutaneous OMLYCLO Doses Every 2 or 4 Weeks* for Patients 12 Years of Age and Older with Asthma Table 2. Subcutaneous OMLYCLO Doses Every 2 or 4 Weeks* for Pediatric Patients with Asthma Who Begin OMLYCLO Between the Ages of 6 to <12 Years Table 1 Table 2 Duration of Therapy Periodically reassess the need for continued therapy based upon the patient's disease severity and level of asthma control. 2.3 Recommended Dosage for Chronic Rhinosinusitis with Nasal Polyps The recommended dosage for chronic rhinosinusitis with nasal polyps (CRSwNP) is OMLYCLO 75 mg to 600 mg by subcutaneous injection every 2 or 4 weeks based on serum total IgE level (IU/mL) measure before the start of treatment and by body weight (kg) [see Dosage and Administration (2.1) ] . Refer to Table 3 for recommended dosage based on serum total IgE level and body weight for patients with CRSwNP. Table 3. Subcutaneous OMLYCLO Doses Every 2 or 4 Weeks* for Adult Patients with CRSwNP Duration of Therapy Periodically reassess the need for continued therapy based upon the patient's disease severity and level of symptom control. Table 3 2.4 Recommended Dosage for IgE-Mediated Food Allergy The recommended dosage for IgE-mediated food allergy is OMLYCLO 75 mg to 600 mg by subcutaneous injection every 2 or 4 weeks based on serum total IgE level (IU/mL), measured before the start of treatment, and by body weight [see Dosage and Administration (2.1) ] . Refer to Table 4 for recommended dosage based on serum IgE level and body weight for patients with IgE-mediated food allergy. Table 4. Subcutaneous OMLYCLO Doses Every 2 or 4 Weeks* for Adult and Pediatric Patients 1 Year of Age and Older with IgE-Mediated Food Allergy Duration of Therapy The appropriate duration of therapy for IgE-mediated food allergy has not been evaluated. Periodically reassess the need for continued therapy. Table 4 2.5 Recommended Dosage for Chronic Spontaneous Urticaria The recommended dosage for chronic spontaneous urticaria (CSU) is OMLYCLO 150 mg or 300 mg by subcutaneous injection every 4 weeks. The 300 mg dose may be administered as one subcutaneous injection of 300 mg/2 mL or as two subcutaneous injections of 150 mg/mL. Dosing of OMLYCLO in CSU patients is not dependent on serum IgE (free or total) level or body weight. Duration of Therapy The appropriate duration of therapy for CSU has not been evaluated. Periodically reassess the need for continued therapy. 2.6 Administration Overview Administer OMLYCLO by subcutaneous injection. OMLYCLO is intended for use under the guidance of a healthcare provider. Initiate therapy in a healthcare setting and once therapy has been safely established, the healthcare provider may determine whether self- administration of OMLYCLO prefilled syringe or autoinjector by the patient or caregiver is appropriate, based on careful assessment of risk for anaphylaxis and mitigation strategies.
Dosage forms and strengths
Injection: 75 mg/0.5 mL is a clear to opalescent and colorless to pale brownish- yellow solution in a single-dose prefilled syringe with yellow plunger rod and safety guard. Injection: 150 mg/mL is a clear to opalescent and colorless to pale brownish- yellow solution in a single-dose prefilled syringe with blue plunger rod and safety guard. Injection: 300 mg/2 mL (150 mg/mL) is a clear to opalescent and colorless to pale brownish-yellow solution in a single-dose prefilled syringe with white plunger rod and safety guard Injection: 75 mg/0.5 mL,150 mg/mL, and 300 mg/ 2 mL (150 mg/mL), solution in a single-dose prefilled syringe ( 3 )
Contraindications
4 CONTRAINDICATIONS OMLYCLO is contraindicated in patients with severe hypersensitivity reaction to omalizumab products or any ingredient of OMLYCLO [see Warnings and Precautions (5.1) ] . Severe hypersensitivity reaction to omalizumab products or any ingredient of OMLYCLO ( 4 , 5.1 )
Warnings and precautions
Anaphylaxis: Initiate OMLYCLO therapy in a healthcare setting prepared to manage anaphylaxis which can be life-threatening and observe patients for an appropriate period of time after administration. ( 5.1 ) Malignancy: Malignancies have been observed in clinical studies. ( 5.2 ) Acute Asthma Symptoms: Do not use for the treatment of acute bronchospasm or status asthmaticus. ( 5.3 ) Corticosteroid Reduction: Do not abruptly discontinue corticosteroids upon initiation of OMLYCLO therapy. ( 5.4 ) Eosinophilic Conditions: Be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy, especially upon reduction of oral corticosteroids. ( 5.5 ) Fever, Arthralgia, and Rash: Stop OMLYCLO if patients develop signs and symptoms similar to serum sickness. ( 5.6 ) Potential Medication Error Related to Emergency Treatment of Anaphylaxis: OMLYCLO should not be used for emergency treatment of allergic reactions, including anaphylaxis. ( 5.9 ) 5.1 Anaphylaxis Anaphylaxis has been reported to occur after administration of omalizumab products in premarketing clinical trials and in postmarketing spontaneous reports [see Boxed Warning and Adverse Reactions (6.2) ] . Signs and symptoms in these reported cases have included bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue. Some of these events have been life-threatening. In premarketing clinical trials in patients with asthma, anaphylaxis was reported in 3 of 3,507 (0.1%) patients. Anaphylaxis occurred with the first dose of omalizumab in two patients and with the fourth dose in one patient. The time to onset of anaphylaxis was 90 minutes after administration in two patients and 2 hours after administration in one patient. A case-control study in asthma patients showed that, among omalizumab users, patients with a history of anaphylaxis to foods, medications, or other causes were at increased risk of anaphylaxis associated with omalizumab products, compared to those with no prior history of anaphylaxis [see Adverse Reactions (6.1) ] . In postmarketing spontaneous reports, the frequency of anaphylaxis attributed to omalizumab use was estimated to be at least 0.2% of patients based on an estimated exposure of 57,300 patients from June 2003 through December 2006. Anaphylaxis has occurred as early as after the first dose of omalizumab, but also has occurred beyond one year after beginning regularly scheduled treatment. Approximately 60% to 70% of anaphylaxis cases have been reported to occur within the first three doses of omalizumab, with additional cases occurring sporadically beyond the third dose. Initiate OMLYCLO only in a healthcare setting equipped to manage anaphylaxis, which can be life-threatening. Observe patients closely for an appropriate period of time after administration of OMLYCLO, taking into account the time to onset of anaphylaxis seen in premarketing clinical trials and postmarketing spontaneous reports [see Adverse Reactions (6.1 , 6.2) ] . Inform patients of the signs and symptoms of anaphylaxis, and instruct them to seek immediate medical care should signs or symptoms occur. Once OMLYCLO therapy has been established, administration of OMLYCLO prefilled syringe outside of a healthcare setting by a patient or a caregiver may be appropriate for selected patients. Patient selection, determined by the healthcare provider in consultation with the 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 (e.g., prior history of anaphylaxis), ability to recognize signs and symptoms of anaphylaxis, and ability to perform subcutaneous injections with OMLYCLO prefilled syringe with proper technique according to the prescribed dosing regimen and Instructions for Use [see Dosage and Administration (2.6) , Adverse Reactions (6.1 , 6.2) ]. Discontinue OMLYCLO in patients who experience a severe hypersensitivity reaction [see Contraindications (4) ] . 5.2 Malignancy Malignant neoplasms were observed in 20 of 4,127 (0.5%) omalizumab-treated patients compared with 5 of 2,236 (0.2%) control patients in clinical studies of adults and adolescents ≥12 years of age with asthma and other allergic disorders. The observed malignancies in omalizumab-treated patients were a variety of types, with breast, non-melanoma skin, prostate, melanoma, and parotid occurring more than once, and five other types occurring once each. The majority of patients were observed for less than 1 year. The impact of longer exposure to omalizumab products or use in patients at higher risk for malignancy (e.g., elderly, current smokers) is not known. In a subsequent observational study of 5,007 omalizumab-treated and 2,829 non-omalizumab- treated adolescent and adult patients with moderate to severe persistent asthma and a positive skin test reaction or in vitro reactivity to a perennial aeroallergen, patients were followed for up to 5 years. In this study, the incidence rates of primary malignancies (per 1,000 patient years) were similar among omalizumab-treated (12.3) and non-omalizumab-treated patients (13.0) [see Adverse Reactions (6.1) ] . However, study limitations preclude definitively ruling out a malignancy risk with omalizumab products. Study limitations include: the observational study design, the bias introduced by allowing enrollment of patients previously exposed to omalizumab (88%), enrollment of patients (56%) while a history of cancer or a premalignant condition were study exclusion criteria, and the high study discontinuation rate (44%). 5.3 Acute Asthma Symptoms and Deteriorating Disease Omalizumab products have not been shown to alleviate asthma exacerbations acutely. Do not use OMLYCLO to treat acute bronchospasm or status asthmaticus.
Side effects
The following clinically significant adverse reactions are described elsewhere in the labeling: Anaphylaxis [see Boxed Warning and Warnings and Precautions (5.1) ] Malignancies [see Warnings and Precautions (5.2) ] Asthma: The most common adverse reactions (≥ 1% of patients) in clinical studies with adult and adolescent patients ≥12 years of age were arthralgia, pain (general), leg pain, fatigue, dizziness, fracture, arm pain, pruritus, dermatitis, and earache. In clinical studies with pediatric patients 6 to <12 years of age, the most common adverse reactions (≥ 3% of patients) were nasopharyngitis, headache, pyrexia, upper abdominal pain, pharyngitis streptococcal, otitis media, viral gastroenteritis, arthropod bites, and epistaxis. ( 6.1 ) Chronic Rhinosinusitis with Nasal Polyps : The most common adverse reactions (≥ 3% of patients) in clinical studies with adult patients included the following: headache, injection site reaction, arthralgia, upper abdominal pain, and dizziness. ( 6.1 ) IgE-Mediated Food Allergy: The most common adverse reactions (≥3% of patients) were injection site reactions and pyrexia. ( 6.1 ) Chronic Spontaneous Urticaria: The most common adverse reactions (≥2% of patients) included the following: nausea, nasopharyngitis, sinusitis, upper respiratory tract infection, viral upper respiratory tract infection, arthralgia, headache, and cough. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact CELLTRION USA, Inc. at 1-800-560-9414 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Adverse Reactions from Clinical Studies in Adult and Adolescent Patients 12 Years of Age and Older with Asthma The data described below reflect omalizumab exposure for 2,076 adult and adolescent patients ages 12 and older, including 1,687 patients exposed for six months and 555 exposed for one year or more, in either placebo-controlled or other controlled asthma studies. The mean age of patients receiving omalizumab was 42 years, with 134 patients 65 years of age or older; 60% were women, and 85% Caucasian. Patients received omalizumab 150 mg to 375 mg every 2 or 4 weeks or, for patients assigned to control groups, standard therapy with or without a placebo. The adverse reactions most frequently resulting in clinical intervention (e.g., discontinuation of omalizumab, or the need for concomitant medication to treat an adverse reaction) were injection site reaction (45%), viral infections (23%), upper respiratory tract infection (20%), sinusitis (16%), headache (15%), and pharyngitis (11%). These reactions were observed at similar rates in omalizumab-treated patients and control patients. Table 6 shows adverse reactions from four placebo-controlled asthma trials that occurred ≥1% and more frequently in adult and adolescent patients 12 years of age and older receiving omalizumab than in those receiving placebo. Adverse reactions were classified using preferred terms from the International Medical Nomenclature (IMN) dictionary. Injection site reactions were recorded separately from the reporting of other adverse reactions. Table 6. Adverse Reactions ≥1% More Frequent in omalizumab-Treated Adult or Adolescent Patients 12 years of Age and Older in Four Placebo-controlled Asthma Trials Adverse reaction Omalizumab n=738 Placebo n=717 Body as a whole Pain 7% 5% Fatigue 3% 2% Musculoskeletal system Arthralgia 8% 6% Fracture 2% 1% Leg pain 4% 2% Arm pain 2% 1% Nervous system Dizziness 3% 2% Skin and appendages Pruritus 2% 1% Dermatitis 2% 1% Special senses Earache 2% 1% There were no differences in the incidence of adverse reactions based on age (among patients under 65), gender or race. Anaphylaxis Case Control Study A retrospective case-control study investigated risk factors for anaphylaxis to omalizumab among patients treated with omalizumab for asthma. Cases with an adjudicated history of anaphylaxis to omalizumab were compared to controls with no such history. The study found that a self-reported history of anaphylaxis to foods, medications or other causes was more common among patients with omalizumab anaphylaxis (57% of 30 cases) compared to controls (23% of 88 controls) [OR 8.1, 95% CI 2.7 to 24.3]. Because this is a case-control study, the study cannot provide the incidence of anaphylaxis among omalizumab users. From other sources, anaphylaxis to omalizumab was observed in 0.1% of patients in clinical trials and at least 0.2% of patients based upon postmarketing reports. Approximately 60% to 70% of cases were reported to occur within the first three doses of omalizumab, with additional cases occurring sporadically beyond the third dose. The time to onset for anaphylaxis was reported to occur within 2 hours for the majority of cases (approximately 75%) [see Warnings and Precautions (5.1) , Adverse Reactions (6.2) ] . Injection Site Reactions In adults and adolescents, injection site reactions of any severity occurred at a rate of 45% in omalizumab-treated patients compared with 43% in placebo-treated patients. The types of injection site reactions included: bruising, redness, warmth, burning, stinging, itching, hive formation, pain, indurations, mass, and inflammation. Severe injection site reactions occurred more frequently in omalizumab-treated patients compared with patients in the placebo group (12% versus 9%). The majority of injection site reactions occurred within 1 hour post injection, lasted less than 8 days, and generally decreased in frequency at subsequent dosing visits.
Drug interactions
No formal drug interaction studies have been performed with omalizumab products. In patients with asthma, CRSwNP, and IgE-mediated food allergy the concomitant use of omalizumab products and allergen immunotherapy has not been evaluated. In patients with CSU, the use of omalizumab products in combination with immunosuppressive therapies has not been studied. No formal drug interaction studies have been performed. ( 7 )
Use in specific populations
8.1 Pregnancy Risk Summary A registry study of omalizumab exposure during pregnancy showed no increase in the rate of major birth defects or miscarriage. There was an increased rate of low birth weight among registry infants compared to infants in the other cohorts, despite average gestational age at birth; however, women taking 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 [ see Data ]. There are risks associated with poorly or moderately controlled asthma in pregnancy [ see Clinical Considerations ]. Human IgG antibodies are known to cross the placental barrier; therefore, omalizumab products may be transmitted from the mother to the developing fetus. In animal reproduction studies, no evidence of fetal harm was observed in Cynomolgus monkeys with subcutaneous doses of omalizumab up to approximately 5 times the maximum recommended human dose (MRHD) [see Data ] . The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk 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. The level of asthma control should be closely monitored in pregnant women and treatment adjusted as necessary to maintain optimal control. Data Human Data A prospective cohort pregnancy exposure registry study conducted in the US from 2006 to 2018, included 250 pregnant women with asthma treated with omalizumab. Of these, 246 patients were exposed to omalizumab in the first trimester of pregnancy, and the median exposure duration was 8.7 months. The registry findings for applicable mother and infant subgroups were compared to age- adjusted frequencies in a disease-matched external cohort of 1,153 pregnant women with asthma (without exposure to omalizumab) identified from healthcare databases of residents in the Canadian province of Quebec, and referred to as the Quebec External Comparator Cohort ("comparator cohort"). Among applicable registry infants, the prevalence of major congenital anomalies (8.1%) was similar to that for infants in the comparator cohort (8.9%). Among applicable registry pregnancies, 99.1% led to live births, similar to 99.3% for the comparator cohort. There was an increased rate of low birth weight among registry infants (13.7%) as compared to the comparator cohort (9.8%); however, women taking 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. The registry study cannot definitively establish the absence of any risk because of methodological limitations, including the observational nature of the registry, small sample size, and potential differences between the registry population and the comparator cohort. Animal Data Reproductive studies have been performed in Cynomolgus monkeys. There was no evidence of maternal toxicity, embryotoxicity, or teratogenicity when omalizumab was administered throughout the period of organogenesis at doses that produced exposures approximately 5 times the MRHD (on a mg/kg basis with maternal subcutaneous doses up to 75 mg/kg/week). Omalizumab did not elicit adverse effects on fetal or neonatal growth when administered throughout late gestation, delivery, and nursing. 8.2 Lactation Risk Summary There is no information regarding the presence of omalizumab products in human milk, or the effects on milk production. However, omalizumab products are human monoclonal antibodies (IgG1 kappa), and immunoglobulin (IgG) is present in human milk in small amounts. The majority of infants (80.9%, 186/230) in the pregnancy exposure registry were breastfed. Events categorized as "infections and infestations" were not significantly increased in infants who were exposed to omalizumab through breastfeeding compared with infants who were not breastfed, or infants who were breastfed without exposure to omalizumab. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for OMLYCLO and any potential adverse effects on the breastfed child from OMLYCLO or from the underlying maternal condition. 8.4 Pediatric Use Asthma Safety and effectiveness of OMLYCLO for moderate to severe persistent asthma who had a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids, have been established in pediatric patients aged 6 years and older. Use of OMLYCLO for this indication is supported by evidence from adequate and well-controlled studies of omalizumab. Omalizumab was evaluated in 2 trials in 926 (omalizumab 624; placebo 302) pediatric patients 6 to <12 years of age with moderate to severe persistent asthma who had a positive skin test or in vitro reactivity to a perennial aeroallergen. One trial was a pivotal trial of similar design and conduct to that of adult and adolescent Asthma Trials 1 and 2. The other trial was primarily a safety study and included evaluation of efficacy as a secondary outcome. In the pivotal trial, omalizumab-treated patients had a statistically significant reduction in the rate of exacerbations (exacerbation was defined as worsening of asthma that required treatment with systemic corticosteroids or a doubling of the baseline ICS dose) [see Clinical Studies (14.1) ] .
Pregnancy
8.1 Pregnancy Risk Summary A registry study of omalizumab exposure during pregnancy showed no increase in the rate of major birth defects or miscarriage. There was an increased rate of low birth weight among registry infants compared to infants in the other cohorts, despite average gestational age at birth; however, women taking 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 [ see Data ]. There are risks associated with poorly or moderately controlled asthma in pregnancy [ see Clinical Considerations ]. Human IgG antibodies are known to cross the placental barrier; therefore, omalizumab products may be transmitted from the mother to the developing fetus. In animal reproduction studies, no evidence of fetal harm was observed in Cynomolgus monkeys with subcutaneous doses of omalizumab up to approximately 5 times the maximum recommended human dose (MRHD) [see Data ] . The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk 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. The level of asthma control should be closely monitored in pregnant women and treatment adjusted as necessary to maintain optimal control. Data Human Data A prospective cohort pregnancy exposure registry study conducted in the US from 2006 to 2018, included 250 pregnant women with asthma treated with omalizumab. Of these, 246 patients were exposed to omalizumab in the first trimester of pregnancy, and the median exposure duration was 8.7 months. The registry findings for applicable mother and infant subgroups were compared to age- adjusted frequencies in a disease-matched external cohort of 1,153 pregnant women with asthma (without exposure to omalizumab) identified from healthcare databases of residents in the Canadian province of Quebec, and referred to as the Quebec External Comparator Cohort ("comparator cohort"). Among applicable registry infants, the prevalence of major congenital anomalies (8.1%) was similar to that for infants in the comparator cohort (8.9%). Among applicable registry pregnancies, 99.1% led to live births, similar to 99.3% for the comparator cohort. There was an increased rate of low birth weight among registry infants (13.7%) as compared to the comparator cohort (9.8%); however, women taking 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. The registry study cannot definitively establish the absence of any risk because of methodological limitations, including the observational nature of the registry, small sample size, and potential differences between the registry population and the comparator cohort. Animal Data Reproductive studies have been performed in Cynomolgus monkeys. There was no evidence of maternal toxicity, embryotoxicity, or teratogenicity when omalizumab was administered throughout the period of organogenesis at doses that produced exposures approximately 5 times the MRHD (on a mg/kg basis with maternal subcutaneous doses up to 75 mg/kg/week). Omalizumab did not elicit adverse effects on fetal or neonatal growth when administered throughout late gestation, delivery, and nursing.
Pediatric use
8.4 Pediatric Use Asthma Safety and effectiveness of OMLYCLO for moderate to severe persistent asthma who had a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids, have been established in pediatric patients aged 6 years and older. Use of OMLYCLO for this indication is supported by evidence from adequate and well-controlled studies of omalizumab. Omalizumab was evaluated in 2 trials in 926 (omalizumab 624; placebo 302) pediatric patients 6 to <12 years of age with moderate to severe persistent asthma who had a positive skin test or in vitro reactivity to a perennial aeroallergen. One trial was a pivotal trial of similar design and conduct to that of adult and adolescent Asthma Trials 1 and 2. The other trial was primarily a safety study and included evaluation of efficacy as a secondary outcome. In the pivotal trial, omalizumab-treated patients had a statistically significant reduction in the rate of exacerbations (exacerbation was defined as worsening of asthma that required treatment with systemic corticosteroids or a doubling of the baseline ICS dose) [see Clinical Studies (14.1) ] . Safety and efficacy of OMLYCLO in pediatric patients with asthma below 6 years of age have not been established. Chronic Rhinosinusitis with Nasal Polyps Safety and effectiveness of OMLYCLO in pediatric patients with chronic rhinosinusitis with nasal polyps (CRSwNP) below 18 years of age have not been established. IgE-Mediated Food Allergy The safety and effectiveness of OMLYCLO for the reduction of allergic reactions (Type I), including anaphylaxis, that may occur with accidental exposure to one or more foods have been established in pediatric patients aged 1 year and older with IgE-mediated food allergy. Use of OMLYCLO for this indication is supported by evidence from an adequate and well-controlled study that included a total of 165 pediatric patients; 61 patients aged 1 year to less than 6 years of age and 104 patients aged 6 to less than 18 years of age. A significantly greater percentage of omalizumab-treated patients compared to placebo-treated patients was able to consume a single dose of food (peanut, cashew, milk, egg) without dose-limiting symptoms [see Clinical Studies (14.3) ]. Safety and effectiveness in pediatric patients with IgE-mediated food allergy below 1 year of age have not been established. Chronic Spontaneous Urticaria The safety and effectiveness of OMLYCLO for chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment have been established in pediatric patients aged 12 years and older. Use of OMLYCLO in this population is supported by evidence from adequate and well-controlled studies of omalizumab. Adolescent patients with CSU were evaluated in 39 patients 12 to 17 years of age (omalizumab 29, placebo 10) included in three randomized, placebo-controlled CSU trials. A numerical decrease in weekly itch score was observed, and adverse reactions were similar to those reported in patients 18 years and older. Safety and effectiveness of OMLYCLO in pediatric patients with CSU below 12 years of age have not been established.
Geriatric use
8.5 Geriatric Use In clinical studies, 134 asthma patients, 20 CRSwNP patients, 37 CSU patients and no IgE-mediated food allergy patients 65 years of age or older were treated with omalizumab. Although there were no apparent age-related differences observed in these studies, the number of patients aged 65 and over is not sufficient to determine whether they respond differently from younger patients.
Description
Omalizumab-igec is a recombinant DNA-derived humanized IgG1κ monoclonal antibody that selectively binds to human immunoglobulin E (IgE). The antibody has a molecular weight of approximately 149 kiloDaltons. OMLYCLO is produced by a Chinese hamster ovary cell suspension culture. OMLYCLO (omalizumab-igec) is administered as a subcutaneous (SC) injection and is available in prefilled syringes. OMLYCLO Injection (Prefilled Syringe) OMLYCLO (omalizumab-igec) injection is supplied as a sterile, preservative-free, clear to opalescent and colorless to pale brownish-yellow solution for subcutaneous injection. OMLYCLO (omalizumab-igec) injection is available as a single-dose prefilled syringe. Each 75 mg prefilled syringe delivers 75 mg omalizumab-igec in 0.5 mL and contains arginine hydrochloride (21.065 mg), histidine (0.685 mg), L-histidine hydrochloride monohydrate (1.17 mg), and polysorbate 20 (0.2 mg) in Water for Injection (WFI), USP. The pH of the product is 6.0. Each 150 mg prefilled syringe delivers 150 mg omalizumab-igec in 1 mL and contains arginine hydrochloride (42.13 mg), histidine (1.37 mg), L-histidine hydrochloride monohydrate (2.34 mg), and polysorbate 20 (0.4 mg) in WFI, USP. The pH of the product is 6.0. Each 300 mg prefilled syringe delivers 300 mg omalizumab-igec in 2 mL and contains arginine hydrochloride (84.26 mg), histidine (2.74 mg), L-histidine hydrochloride monohydrate (4.68 mg), and polysorbate 20 (0.8 mg) in WFI, USP. The pH of the product is 6.0.
Mechanism of action
12.1 Mechanism of Action Asthma, Chronic Rhinosinusitis with Nasal Polyps, and IgE-Mediated Food Allergy Omalizumab products inhibit the binding of IgE to the high-affinity IgE receptor (FcεRI) on the surface of mast cells, basophils, and dendritic cells, resulting in FcεRI down-regulation on these cells. In allergic asthmatics, treatment with omalizumab products inhibit IgE-mediated inflammation, as evidenced by reduced blood and tissue eosinophils and reduced inflammatory mediators, including IL-4, IL-5, and IL-13. Chronic Spontaneous Urticaria Omalizumab products bind to IgE and lowers free IgE levels. Subsequently, IgE receptors (FcεRI) on cells down-regulate. The mechanism by which these effects of omalizumab products result in an improvement of chronic spontaneous urticaria (CSU) symptoms is unknown.
How supplied
Injection (Prefilled Syringe) OMLYCLO (omalizumab-igec) injection is a clear to opalescent and colorless to pale brownish-yellow solution for subcutaneous use. OMLYCLO injection is provided in a single-dose prefilled glass syringe with a 27-gauge special thin wall needle. The syringe plunger stopper and needle cap are not made with natural rubber latex. OMLYCLO is available as prefilled syringe as described in Table 17. Table 17. OMLYCLO Prefilled Syringe Strengths and Package Configurations Package Configuration Strength NDC Syringe Counts 1 prefilled syringe with a 27-gauge staked needle syringe with a yellow plunger rod 75 mg/ 0.5 mL 72606-035-01 1 1 prefilled syringe with a 27-gauge staked needle syringe with a blue plunger rod 150 mg/mL 72606-036-01 1 1 prefilled syringe with a 27-gauge staked needle syringe with a white plunger rod 300 mg/2 mL (150 mg/mL) 72606-054-01 1 2 prefilled syringes with a 27-gauge staked needle syringe with a white plunger rod 300 mg/2 mL (150 mg/mL) 72606-054-02 2 (2 × 1) (multipack) The OMLYCLO prefilled syringe is not made with natural rubber. Storage OMLYCLO prefilled syringe should be shipped and stored under refrigerated conditions 36°F to 46°F (2°C to 8°C) in the original carton. Protect from direct sunlight. OMLYCLO prefilled syringe can be removed from and placed back in the refrigerator if needed. The total combined time out of the refrigerator may not be more than 7 days. Do not use if prefilled syringe is left at temperatures above 77°F (25°C ). Do not freeze. Do not use if the prefilled syringe has been frozen. Do not shake.
Storage
Storage OMLYCLO prefilled syringe should be shipped and stored under refrigerated conditions 36°F to 46°F (2°C to 8°C) in the original carton. Protect from direct sunlight. OMLYCLO prefilled syringe can be removed from and placed back in the refrigerator if needed. The total combined time out of the refrigerator may not be more than 7 days. Do not use if prefilled syringe is left at temperatures above 77°F (25°C ). Do not freeze. Do not use if the prefilled syringe has been frozen. Do not shake.
Patient information
Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Anaphylaxis Inform patients of the risk of life-threatening anaphylaxis with OMLYCLO including the following points [see Boxed Warning and Warnings and Precautions (5.1) ] : There have been reports of anaphylaxis occurring up to 4 days after administration of omalizumab products Initiate OMLYCLO only in a healthcare setting by healthcare providers Observe patients closely following administration Inform patients of the signs and symptoms of anaphylaxis Instruct patients to seek immediate medical care should such signs or symptoms occur Potential Medication Error Related to Emergency Treatment of Anaphylaxis Advise patients, parents, or caregivers that OMLYCLO should not be used for the emergency treatment of allergic reactions, including anaphylaxis [see Warnings and Precautions (5.9) ] . Continuation of Other Medications Instruct patients receiving OMLYCLO not to decrease the dose of, or stop taking any other asthma, CRSwNP, CSU or IgE-mediated food allergy medications or allergen immunotherapy unless otherwise instructed by their physician. Inform patients that they may not see immediate improvement in their asthma, CRSwNP, CSU or IgE-mediated food allergy symptoms after beginning OMLYCLO therapy. Instruction on Injection Technique If a patient or caregiver is to administer subcutaneous OMLYCLO prefilled syringe, instruct on injection technique and assess ability to inject subcutaneously to ensure proper administration of OMLYCLO. For patients who require more than 1 injection to complete their prescribed dose, instruct patients to administer all injections consecutively and in one sitting [ See Dosage and Administration (2.7) , Warnings and Precautions (5.1) , and Instructions for Use ].
Label text from the FDA structured product label by CELLTRION USA, Inc. (revised Aug 6, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Omalizumab in 3 products
Omlyclo NDC products (3)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 72606-035 | Omalizumab 75 mg/.5mL Injection | CELLTRION USA, Inc. | BLA |
| 72606-036 | Omalizumab 150 mg/mL Injection | CELLTRION USA, Inc. | BLA |
| 72606-054 | Omalizumab 300 mg/2mL Injection | CELLTRION USA, Inc. | BLA |
Frequently asked questions
What is Omlyclo used for?
1 INDICATIONS AND USAGE OMLYCLO is an anti-IgE antibody indicated for: Moderate to severe persistent asthma in adults and pediatric patients 6 years of age and older with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids ( 1.1 ) Chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18…
What are the side effects of Omlyclo?
The following clinically significant adverse reactions are described elsewhere in the labeling: Anaphylaxis [see Boxed Warning and Warnings and Precautions (5.1) ] Malignancies [see Warnings and Precautions (5.2) ] Asthma: The most common adverse reactions (≥ 1% of patients) in clinical studies with adult and adolescent patients ≥12 years of age were arthralgia, pain (general), leg pain, fatigue,… See the full label for the complete list.
Who makes Omlyclo?
Omlyclo is listed by 1 labeler in the FDA NDC directory, including CELLTRION USA, Inc..