Dosage & Administration
For subcutaneous (SC) administration only.
See full prescribing information for administration instructions .
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Xolair Prescribing Information
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, initiate XOLAIR therapy in a healthcare setting and closely observe patients for an appropriate period of time after XOLAIR administration. Health care providers administering XOLAIR should be prepared to manage anaphylaxis which can be life-threatening. Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should symptoms occur. Selection of patients for self-administration of XOLAIR should be based on criteria to mitigate risk from anaphylaxis [see Dosage and Administration (2.6), Warnings and Precautions (5.1) and Adverse Reactions (6.1, 6.2)].
Asthma
XOLAIR 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:
XOLAIR is not indicated for the relief of acute bronchospasm or status asthmaticus.
Chronic Rhinosinusitis with Nasal Polyps
XOLAIR 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.
IgE-Mediated Food Allergy
XOLAIR 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.
XOLAIR is to be used in conjunction with food allergen avoidance.
Limitations of Use:
XOLAIR is not indicated for the emergency treatment of allergic reactions, including anaphylaxis.
Chronic Spontaneous Urticaria
XOLAIR 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:
XOLAIR is not indicated for treatment of other forms of urticaria.
Overview of Dosage Determination
Asthma, and Chronic Rhinosinusitis with Nasal Polyps, and IgE-Mediated Food Allergy
- Determine dosage of XOLAIR 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 XOLAIR 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 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 . For pediatric patients 1 to 11 years of age, consideration should be given to the number of prefilled syringe injections needed and volume to be injected relative to the patient's bodyweight.
- For patients requiring more than 1 injection to complete a full dose, administer each injection at least 1 inch apart from other injection sites.
- Administer subcutaneous injection into the thigh or abdomen, avoiding the 2-inch (5 cm) area directly around the navel. The outer area of the upper arms may be used only if the injection is being given by a caregiver or healthcare provider [see Instructions for Use]. The injection may take up to 15 seconds to administer.
Table 5. Number of XOLAIR Prefilled Syringes or Autoinjectors *, Injections and Total Injection Volumes † XOLAIR Dose ‡ 75 mg 150 mg 300mg ‡ Total Volume Injected - *
- The autoinjector (all doses) are not intended for use in patients under 12 years of age.
- †
- This table represents the fewest number of injections for the patient, however, there are other syringe/autoinjector dosing combinations to achieve desired dose.
- ‡
- The 75 mg, 150 mg, 225 mg, 300 mg, and 375 mg XOLAIR doses are approved for use in asthma patients. All doses in the table are approved for use in CRSwNP and IgE-mediated food allergy patients. The 150 mg and 300 mg XOLAIR doses are also approved for use in CSU patients.
75 mg 1 0 0 0.5 mL 150 mg 0 1 0 1 mL 225 mg 1 1 0 1.5 mL 300 mg 0 0 1 2 mL 375 mg 1 0 1 2.5 mL 450 mg 0 1 1 3 mL 525 mg 1 1 1 3.5 mL 600 mg 0 0 2 4 mL
Preparation for Use and Injection of XOLAIR Lyophilized Powder
XOLAIR lyophilized powder should only be prepared and injected by a healthcare provider. The supplied XOLAIR lyophilized powder must be reconstituted with Sterile Water for Injection (SWFI) USP, using the following instructions:
- 1)
- Before reconstitution, determine the number of vials that will need to be reconstituted (each vial delivers 150 mg of XOLAIR in 1.2 mL) (see Table 6).
| XOLAIR Dose * | Number of Vials | Number of Injections | Total Volume Injected |
|---|---|---|---|
| |||
| 75 mg | 1 | 1 | 0.6 mL |
| 150 mg | 1 | 1 | 1.2 mL |
| 225 mg | 2 | 2 | 1.8 mL |
| 300 mg | 2 | 2 | 2.4 mL |
| 375 mg | 3 | 3 | 3.0 mL |
| 450 mg | 3 | 3 | 3.6 mL |
| 525 mg | 4 | 4 | 4.2 mL |
| 600 mg | 4 | 4 | 4.8 mL |
- 2)
- Draw 1.4 mL of SWFI, USP, into a 3 mL syringe equipped with a 1-inch, 18-gauge needle.
- 3)
- 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.
- 4)
- Keeping the vial upright, gently swirl the upright vial for approximately 1 minute to evenly wet the powder. Do not shake.
- 5)
- Gently swirl the vial for 5 to 10 seconds approximately every 5 minutes in order to dissolve any remaining solids. The lyophilized product takes 15 to 20 minutes to dissolve. If it takes longer than 20 minutes to dissolve completely, gently swirl the vial for 5 to 10 seconds approximately every 5 minutes 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.
- 6)
- After reconstitution, XOLAIR solution is somewhat viscous and will appear clear or slightly opalescent. It is acceptable if there are a few small bubbles or foam around the edge of the vial; there should be no visible gel-like particles in the reconstituted solution. Do not use if foreign particles are present.
- 7)
- Invert the vial for 15 seconds in order to allow the solution to drain toward the stopper.
- 8)
- Use the XOLAIR solution within 8 hours following reconstitution when stored in the vial at 2ºC to 8ºC (36ºF to 46ºF), or within 4 hours of reconstitution when stored at room temperature. Reconstituted XOLAIR vials should be protected from sunlight.
- 9)
- 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. The reconstituted product is somewhat viscous. Withdraw all of the product from the vial before expelling any air or excess solution from 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.
- 10)
- Replace the 18-gauge needle with a 25-gauge needle for subcutaneous injection.
- 11)
- Expel air, large bubbles, and any excess solution in order to obtain a volume of 1.2 mL corresponding to a dose of 150 mg of XOLAIR. To obtain a volume of 0.6 mL corresponding to a dose of 75 mg of XOLAIR, expel air, large bubbles and discard 0.6 mL from the syringe. A thin layer of small bubbles may remain at the top of the solution in the syringe.
- 12)
- Administer XOLAIR by subcutaneous injection. The injection may take 5-10 seconds to administer because the solution is slightly viscous. Do not administer more than 150 mg (contents of one vial) per injection site. Divide doses of more than 150 mg between two or more injection sites. Choose a different injection site for each new injection at least 1 inch from the area used for other injections.
Injection:
- 75 mg/0.5 mL is a clear to slightly opalescent and colorless to pale brownish-yellow solution in a single-dose prefilled syringe with needle shield or single-dose prefilled autoinjector
- 150 mg/mL is a clear to slightly opalescent and colorless to pale brownish-yellow solution in a single-dose prefilled syringe with needle shield or single-dose prefilled autoinjector
- 300 mg/2 mL is a clear to slightly opalescent and colorless to pale brownish-yellow solution in a single-dose prefilled syringe with needle shield or single-dose prefilled autoinjector
- For injection: 150 mg white lyophilized powder in a single-dose vial for reconstitution
Pregnancy
Risk Summary
A registry study of XOLAIR 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 XOLAIR 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, XOLAIR 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 XOLAIR. Of these, 246 patients were exposed to XOLAIR 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 XOLAIR) 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 XOLAIR 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.
Lactation
Risk Summary
There is no information regarding the presence of omalizumab in human milk, or the effects on milk production. However, omalizumab is a human monoclonal antibody (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 XOLAIR through breastfeeding compared with infants who were not breastfed, or infants who were breastfed without exposure to XOLAIR.
The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for XOLAIR and any potential adverse effects on the breastfed child from omalizumab or from the underlying maternal condition.
Pediatric Use
Asthma
Safety and effectiveness of XOLAIR 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 XOLAIR for this indication is supported by evidence from adequate and well-controlled studies. XOLAIR was evaluated in 2 trials in 926 (XOLAIR 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, XOLAIR-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 in pediatric patients with asthma below 6 years of age have not been established.
Chronic Rhinosinusitis with Nasal Polyps
Safety and effectiveness 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 XOLAIR 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 XOLAIR 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 XOLAIR-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 XOLAIR 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 XOLAIR in this population is supported by evidence from adequate and well-controlled studies. Adolescent patients with CSU were evaluated in 39 patients 12 to 17 years of age (XOLAIR 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 in pediatric patients with CSU below 12 years of age have not been established.
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 XOLAIR. 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.
XOLAIR is contraindicated in patients with severe hypersensitivity reaction to XOLAIR or any ingredient of XOLAIR [see Warnings and Precautions (5.1)].