Composition, form of production and packaging
Liofilizate for the preparation of a solution for s / c introduction of white or almost white color.
omalizumab 150 mg
Excipients: sucrose - 108 mg, L-histidine - 1.3 mg, L-histidine hydrochloride monohydrate - 2.1 mg, polysorbate 20 - 400 Ојg.
Solvent: water d / u - 2 ml.
Vials of colorless glass with a volume of 6 ml (1) complete with a solvent (1 pc.) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2016.
Omalizumab is a humanized monoclonal antibody obtained on the basis of recombinant DNA selectively binding to immunoglobulin (IgE). Omalizumab is an IgG 1kappa antibody containing a human structural backbone with complementarity determining regions of murine antibodies binding IgE.
Patients with atopic bronchial asthma
Omalizumab binds to IgE and prevents its interaction with the high-affinity Fc-R receptor. Thus, there is a decrease in the amount of free IgE, which is the starting factor for the cascade of allergic reactions.
When the drug is used in patients with atopic bronchial asthma (BA), there is a marked decrease in the number of FcR receptors on the basophil surface.
In clinical trials in patients with asthma, the concentration of free IgE in the blood serum was dose-dependent decreased within 1 hour after the administration of the first dose of Xolar and remained at the reached level between the introduction of subsequent doses. When used at recommended doses, the average decrease in free IgE concentration in serum was more than 96%. The total concentration of IgE (bound and unbound) in the serum increased after the first dose was applied due to the formation of a complex of omalizumab-IgE, characterized by a slower elimination rate compared to free IgE. At 16 weeks after the first dose, the average concentration of total IgE in the blood serum was 5 times higher than before the treatment. After the withdrawal of treatment with the drug, the increase in the concentration of total IgE caused by its action and a decrease in the concentration of free IgE were reversible. After the complete removal of omalizumab from the body, there was no increase in IgE concentration in the blood serum. The concentration of total IgE remained elevated for 1 year after the Xolar drug was discontinued.
With the use of Xolar in patients with moderate and severe atopic BA, there was a significant decrease in the frequency of exacerbations of asthma (defined as worsening of asthma, requiring the use of systemic glucocorticosteroids (GCS) or doubling the initial dose of inhaled glucocorticosteroids) and a decrease in the need for inhaled glucocorticosteroids compared with placebo.
With the use of the drug Xolar for 16 weeks against a background of a gradual decrease in the dose of inhaled or oral GCS, there was also a significant decrease in the frequency of exacerbations of asthma and a decrease in the need for inhaled glucocorticosteroids compared with placebo.
In patients with asthma and year-round allergic rhinitis who received SCS, omalizumab for 28 weeks showed a decrease in the severity of BA symptoms and allergic rhinitis all year round, as well as an improvement in pulmonary function parameters. Reducing the frequency of exacerbations of asthma and improving the quality of life of patients (according to a certified quality of life questionnaire) against the background of therapy with Xolar drug persisted for a long time compared with placebo. With the use of Xolar in children from 6 to 12 years for 52 weeks, there was a decrease in the frequency of exacerbations of asthma compared with the group of patients who received placebo. In another study, when Xolar was used for 28 weeks in children aged 6-12 years, there was a decrease in the frequency and severity of exacerbations of asthma, as well as a reduction in the dose of inhaled glucocorticosteroids by the end of the 28th week of therapy compared with the placebo group.
Patients with chronic idiopathic urticaria
In some patients with chronic idiopathic urticaria (HIC), autoimmune antibodies to IgE and FcsRI receptor were isolated from serum. These antibodies are capable of activating basophils or mast cells, which leads to the release of histamine.
One of the hypotheses of the mechanism of the action of omalizumab in patients with CRC is to reduce the concentration of free IgE in the blood, and then in the skin. As a result, signaling by FcRI receptors is reduced and, consequently, the activation of cells involved in the inflammatory response is suppressed. Thus, the incidence and severity of the symptoms of CIC is reduced.
In addition, it is believed that a decrease in the concentration of circulating IgE leads to a rapid nonspecific desensitization of mast cells in the skin, and FcRI receptors through negative feedback support this reaction.
In clinical studies in patients with HIC, as well as in patients with atopic asthma, the use of omalizumab led to a dose-dependent decrease in the concentration of free IgE and an increase in the concentration of total IgE. The maximum decrease in the concentration of free IgE was observed 3 days after subcutaneous (SC) administration of the first dose of Xolar.
After the repeated administration of the drug 1 time every 4 weeks, the concentration of free IgE in the blood serum before the administration of the next dose remained at the reached level between 12 and 24 weeks of treatment. The concentration of total IgE in the serum increased after the first dose, due to the formation of an omalizumab-IgE complex, characterized by a slower release rate compared to free IgE. After repeated administration of the drug 1 time every 4 weeks at a dose of 75 mg to 300 mg, the concentration of total IgE in the blood serum at 12 weeks from the start of treatment was 2-3 times higher than before treatment and remained at the reached level during the period between 12 and 24 weeks of treatment. After the Xolar drug was withdrawn for 16 weeks of follow-up, the concentration of total IgE decreased, and the concentration of free IgE increased, approaching the baseline values.
When Xolar was used at doses of 150 and 300 mg every 4 weeks, patients with CIC exhibited reproducible and statistically significant therapeutic effects in reducing the severity of the itching. The effect peaked at week 12 of treatment and persisted throughout the observation period.
In addition, the Xolar 300 mg preparation had a reproducible and statistically significant effect on the urticaria activity index (UAS), the proportion of days without angioedema, the weekly index of sleep disorders, and the quality of life of patients assessed by the Q-Q2oL questionnaire quality of life in patients with HIC), as well as the index DLQI (Dermatological Quality of Life Index).
After SC administration in patients with BA, the absolute bioavailability of omalizumab is on average 62%. When used in doses greater than 0.5 mg / kg, the pharmacokinetics of omalizumab is linear.
Patients with atopic asthma
After a single SC administration in adults and adolescents with BA, the absorption of omalizumab is slow, the peak concentration in serum is achieved on average after 7-8 days.
After repeated administration of omalizumab, the area under the concentration-time curve (AUC) for a period of 0 to 14 days in the equilibrium state was 6 times higher than after the administration of a single dose.
Patients with HIC
After a single SC administration in adults and adolescents with HIC, the absorption of omalizumab is slow, the peak concentration in serum is achieved on average after 6-8 days. When omalizumab is used in patients with HIC in the dose range from 75 mg to 600 mg as a single injection, pharmacokinetics is linear. The minimum concentration of omalizumab in the serum increases in proportion to the increase in dose with 75 mg, 150 mg or 300 mg every 4 weeks.
In vitro, omalizumab with IgE forms a complex of a certain size. In vitro or in vivo, there was no formation of precipitating complexes and complexes whose molecular weight exceeded 1 million daltons.
In clinical studies, there was no specific accumulation of omalizumab in any organs and tissues.
Patients with atopic asthma
In patients with atopic asthma, after the sc administration, the apparent volume of omalizumab distribution was 78 В± 32 ml / kg.
Patients with HIC
Based on the population pharmacokinetic model, it was shown that the distribution of omalizumab in patients with CIC was similar to that in patients with atopic asthma.
The clearance of omalizumab includes both IgG clearance itself and clearance by specific binding and formation of complexes with a target ligand-free IgE serum.
Hepatic elimination of IgG involves degradation in the reticuloendothelial system of the liver and endothelial cells of the liver. Intact IgG is also excreted with bile.
Patients with atopic asthma
In patients with asthma, the half-life of omalizumab from serum averaged 26 days, the apparent clearance was 2.4 В± 1.1 ml / kg / day on average. In addition, with an increase in body weight, a doubling of the apparent apparent clearance was observed twice.
Patients with HIC
Based on the population pharmacokinetic model in patients with HIC, the half-life omalizumab from the serum at an equilibrium concentration averaged 24 days, the apparent clearance at an equilibrium concentration averaged 240 ml / day (corresponding to 3.0 ml / kg / day for a patient weighing 80 kg).
Pharmacokinetics in special clinical cases
Age, race / ethnicity, gender, body weight, body mass index, baseline IgE concentration, autoimmune antibodies to the FcsRI receptor, concurrent use of drugs.
Patients with atopic asthma
Patients with asthma do not require a dose adjustment for omalizumab, depending on the age (6-76 years), race or ethnicity, gender and body mass index.
Patients with HIC
Patients with CRC do not require a dose adjustment of omalizumab, depending on age (12-75 years), race or ethnicity, the patient's sex, body weight, body mass index, baseline IgE concentration, autoimmune antibodies to the Fc-RI receptor, or simultaneous use blockers of H2-histamine receptors and leukotriene receptor antagonists.
Impaired kidney and liver function
Pharmacokinetic and pharmacodynamic parameters of omalizumab in patients with atopic asthma or CHC and impaired renal or hepatic function have not been studied.
Since the metabolism of the drug is carried out mainly reticuloendothelial system, a violation of the liver and kidneys have no effect on it. Despite the fact that correction of the dose of omalizumab is not required, the drug should be used with caution in patients in this category.
- Treatment of persistent atopic bronchial asthma of moderate and severe course, the symptoms of which are not adequately controlled by the use of GCS, in patients 6 years and older. The drug Xolar should be used in patients with baseline IgE concentration and body weight corresponding to those listed in the table for the selection of the dosing regimen;
- Treatment of chronic idiopathic urticaria, resistant to therapy with H1-histamine receptor blockers, in patients 12 years and older.
Only for subcutaneous injection! The drug can not be administered intravenously or intramuscularly.
The dose of Xolar and the periodicity of administration are determined based on the initial concentration of IgE (IU / ml) measured before the start of treatment, as well as body weight (kg).
Depending on the initial concentration of IgE (IU / ml) and body weight (kg), the recommended dose is 75 to 600 mg once every 2 or 4 weeks (see Tables 3 and 4).
Xolar should not be used in patients with a baseline IgE concentration and body weight that do not match the dosage regimen listed in the table.
Determination of the number of vials, injections and total volume of Xolar drug solution as a function of the dose, see table 1.
Table 1. Number of vials, number of injections and total volume of drug solution as a function of dose
Dose (mg) Number of vials Number of injections Total solution volume (ml)
75 1 1 0.6
150 1 1 1.2
225 2 2 1.8
300 2 2 2.4
375 3 3 3.0
450 3 3 3.6
525 3 4 4.2
600 4 4 4.8
Calculation of the volume of the drug for each dose
When one bottle of Xolar is diluted, 1.2 ml of the solution for the SC administration is obtained. The algorithm for calculating the dose per injection is presented in Table 2 below.
Table 2. Algorithm for calculating the volume of solution per injection as a function of dose
Dose (mg) Number of injections Solution volume (ml)
75 one injection 0.6 m
150 one injection 1.2
225 first injection 1.2
second injection 0.6
300 first injection 1.2
second injection 1.2
375 first injection 1.2
second injection 1.2
third injection 0.6
450 first injection 1.2
second injection 1.2
third injection 1.2
525 first injection 1.2
second injection 1.2
third injection 1.2
fourth injection 0.6
600 first injection 1.2
second injection 1.2
third injection 1.2
fourth injection 1.2
Duration of treatment, monitoring and dose adjustment
Doses of Xolar should be adjusted for significant changes in body weight (see Tables 3, 4).
For dose determination schemes, see tables 3 and 4.
Table 3. Calculation of the dose of Xolar (mg) for the sc administration every 4 weeks
Body weight (kg)
The initial concentration of IgE (IU / ml) > 20-25 > 25-30 > 30-40 > 40-50 > 50-60 > 60-70 > 70-80 > 80-90 > 90-125 > 125-150
> 30-100 75 75 75 150 150 150 150 150 300 300
> 100-200 150 150 150 300 300 300 300 300 450 600
> 200-300 150 150 225 300 300 450 450 450 600
> 300-400 225 225 300 450 450 450 600 600
> 400-500 225 300 450 450 600 600 It is applied once in 2 weeks
> 500-600 300 300 450 600 600 See table 4
> 600-700 300 450 600
Table 4. Calculation of the dose of Xolar (mg) for the sc administration every 2 weeks
Body weight (kg)
The initial concentration of IgE (IU / ml)> 20-25> 25-30> 30-40> 40-50> 50-60> 60-70> 70-80> 80-90> 90-125> 125-150> 150 -200
> 30-100 Applies once every 4 weeks 225
> 100-200 See table 3 375
> 200-300 375 525
> 300-400 450 525
> 400-500 375 375 525 600
> 500-600 375 450 450 600
> 600-700 225 375 450 450 525
> 700-800 225 225 300 375 450 450 525 600
> 800-900 225 225 300 375 450 525 600
> 900-1000 225 300 375 450 525 600
> 1000-1100 225 300 375 450 600
> 1100-1200 300 300 450 525 600 Not applicable
> 1200-1300 300 375 450 525
> 1300-1500 300 375 525 600
With the use of Xolar during the first 16 weeks in clinical trials, there was a decrease in the incidence of exacerbations of asthma, a reduction in the number of cases of emergency therapy, and improvement in the symptoms of the disease. Evaluation of the effectiveness of Xolar therapy should be performed after at least 12 weeks of treatment with the drug.
The drug Xolar is intended for long-term therapy. Abolition of the drug, as a rule, leads to the restoration of an increased concentration of free IgE and the development of the corresponding symptoms.
The concentration of total IgE increases during treatment and remains elevated for one year after discontinuation of therapy. Thus, the concentration of IgE on repeated determination against the background of Xolar therapy can not serve as a guide for the selection of the dose of the drug. To select a dose of the drug after the suspension of treatment for a period of less than 1 year should be guided by the concentration of IgE in serum, established before the introduction of the initial dose of the drug.
If treatment with Xolar was suspended for 1 year or more, in order to select a dose of Xolar, the concentration of IgE in serum should be re-determined.
Chronic idiopathic urticaria
The recommended dose of Xolar is 300 mg every 4 weeks as a sc injection. The treating physician should periodically re-evaluate the need for continued therapy with the drug.
The long-term use of omalizumab in clinical trials in patients with HIC is limited.
Application in children and adolescents
Xolar is not recommended for use in patients with atopic asthma before the age of 6 years and in patients with CRC at the age of 12 years due to lack of data on efficacy and safety.
Use in elderly patients
There is limited experience in the use of Xolar in patients older than 65 years. However, there is no evidence of the need for dose adjustment in patients of this age.
Rules for the preparation and administration of a solution
When preparing a solution for the S / C administration of Xolar, follow the instructions below.
1. Using a syringe with an 18 gauge needle, 1.4 ml of water for injections is drawn from the ampoule to prepare the solution.
2. Having established the bottle with the drug vertically, it is pierced with a needle in accordance with the rules of asepsis and injected water directly into the dry substance of the preparation .
3. While keeping the bottle in an upright position, to smoothly impregnate dry matter with water for injection, the bottle is gently rotated (not shaking) for 1 minute.
4. To facilitate dissolution, the vial is rotated for about 5-10 seconds approximately every 5 minutes until all solids are completely dissolved. In some cases, it may take more than 20 minutes to completely dissolve the dry matter. In this case, the above steps are repeated until dissolution of visible gel-like particles.
After complete dissolution of the solids in the solution should be no visible gel-like particles. Acceptable presence of small bubbles or foam on the walls of the vial. The resulting solution should be clear or slightly opalescent, colorless or light yellowish. Do not use if solution is detected foreign particles therein.
5. After removing the needle flip vial for 15 seconds to allow the solution to flow towards the tube. Using a new syringe 3 cm 3Equipped with a 18 gauge needle with a wide lumen, insert the needle into the inverted vial. Place the end of the needle at the lowest point of the solution accumulated in the stopper of the vial, and a syringe type solution. Before removing the needle and pull the piston back completely to the end of the syringe barrel to remove all the solution from the inverted vial.
6. Replace needle 18-gauge needle on gauge 25 for n / k administration.
7. excess air, large bubbles and excess solution to obtain the desired dose (volume 1.2 ml). A thin layer of small bubbles may remain on top of the solution in the syringe.
Since the solution has a certain viscosity, injection times may be 5-10 seconds.
8. The solution of the drug administered s / c in the deltoid region or the anterolateral thigh area, avoiding rash area at urticaria.
Xolair preparation should not be confused with any other drugs or solutions other than water for injection.
The solution should be used immediately after preparation, since the product does not contain antimicrobial preservatives.
If necessary, the solution is allowed to deposit during 8 hours at a temperature of from 2 to 8 В° C and for 4 hours at 30 В° C.
Unused drug residues and packaging waste disposed of in accordance with local requirements.
most common adverse events (AEs) for applying Xolair drug are headache, injection site reactions, including pain, edema, erythema and itching at the injection site. Most AEs were mild or moderate in severity. To determine the frequency of adverse reactions identified in clinical studies, the following criteria were used very often (> 1/10), often (> 1/100 <1/10) infrequently (> 1/1000, <1 / 100), rare (<1/1000).
Infectious and parasitic diseases: rare - pharyngitis; seldom - a parasitic infestation.
Disorders of immune system: rare - anaphylactic reaction and other allergic conditions including angioneurotic edema, appearance of antibodies to omalizumab.
Disorders of the nervous system: often - headache; rarely - dizziness, somnolence, paresthesia, syncope.
Violations by vessels: infrequently - postural hypotension, "tides".
Violations of the respiratory system, organs, thoracic and mediastinal disorders: uncommon - coughing, allergic bronchospasm; rare - swelling of the larynx.
Disorders of the gastrointestinal tract: rarely - nausea, diarrhea, dyspepsia.
Violations of the skin and subcutaneous tissue disorders: rarely - urticaria, rash, pruritus, photosensitivity; rarely - angioedema.
General disorders and the site of injection:often - injection site reactions such as pain, erythema, pruritus, swelling; rarely - weight gain, fatigue, swelling arms, influenza-like state.
Against the background of therapy with Xolair in the post-registration period of the following adverse events were observed in clinical practice, the frequency of which is unknown, due to the fact that the spontaneous reports of adverse events received voluntarily from a population of uncertain size.
Disorders of immune system: anaphylaxis and anaphylactoid reactions (noted as the first, and with repeated applications of drug in most cases within 2 hours after the s / c injection, in some patients after more than 2 hours after administration Xolair drug), serum sickness may include fever, lymphadenopathy.
Violations of the skin and subcutaneous tissue disorders: alopecia.
Blood disorders and lymphatic system: severe idiopathic thrombocytopenia.
Violations of the respiratory system, organs, thoracic and mediastinal disorders: allergic granulomatous vasculitis (Churg-Strauss syndrome).
Violations by musculoskeletal and connective tissue disorders: arthralgia, myalgia, joint swelling.
In clinical studies in children 6-12 years the following adverse events were noted:
Disorders of the nervous system: very often - headache.
Disorders of the gastrointestinal tract: often - pain in the upper abdomen.
General disorders and at the injection site: very often - fever.
The most frequent adverse events when using the drug Xolair in patients 12 years and older were headache and nasopharyngitis.
The following adverse events occurred in> 1% of patients in all treatment groups and at least 2% more frequently in patients receiving the drug at the recommended doses Xolair (150 mg and 300 mg) compared to the placebo application.
AEs are grouped according to the classification MedDRA organs and organ systems, within each group are listed in order of decreasing frequency of occurrence. The following criteria are used to determine the frequency of occurrence: very common (> 1/10), common (> 1/100, <1/10), uncommon (> 1/1000, <1/100), rarely (<1/1000) , very rare (<1/10000).
Infectious and parasitic diseases: often - nasopharyngitis, sinusitis, upper respiratory tract infections, including viral, urinary tract infection.
Disorders of the nervous system: very often - headache; often - headache in the paranasal sinuses.
Violations by musculoskeletal and connective tissue disorders: often - arthralgia, myalgia, pain in the limbs,musculoskeletal pain.
General disorders and the site of injection: often - fever, injection site reactions, such as swelling, erythema, pain, bruising, itching, bleeding, rash.
Anaphylaxis. In the post-registration period, the frequency of occurrence of anaphylactic reactions when applying Xolair preparation was approximately 0.2% (of all cases of anaphylactic reactions to 500,000 person-years).
Anaphylactic reactions in history, not involving the use of omalizumab, may be a risk factor for development of anaphylactic reactions to Xolair drug.
malignancy. The overall incidence of tumors in the application of the drug Xolair in clinical trials was similar to that in the general population. The incidence of malignant neoplasms in patients treated with the drug Xolair and evaluated in the control group <1/100. In an observational study when compared to patients treated with Xolair drug, and patients receiving other treatment for up to five years, there was no increase in the risk of malignancies. In children 6-12 years of cases of malignancies in patients treated with Xolair has been registered.
Thromboembolic complications.In controlled clinical trials in patients receiving treatment with Xolair, noted thromboembolic complications, including stroke, transient ischemic attack, myocardial infarction, unstable angina, death from cardiovascular causes (including death for unknown reasons). In the analysis of the main factors of cardiovascular risk, the risk ratio was 1.32.
Helminth infestation.Perhaps part IgEv immune response in the development of helminth infestations. In the placebo-controlled trials in patients with allergic diseases and risk of helminth infestations in applying Xolair drug observed slight increase in the incidence of helminthiasis (but within, disease severity and response to therapy is not changed). The overall incidence of helminth infestations in all clinical trials was less than 1 in 1000 (research design did not include a special study of the incidence of helminth diseases).
Changing the number of blood platelets.In applying the drug Xolair in clinical studies in several patients there was a decrease in the platelet count is below normal, which is not accompanied by bleeding or a decrease in hemoglobin concentration. In clinical studies there was no evidence of permanent reduction of platelet count.
Data from other laboratory tests. Significant changes in laboratory parameters in clinical trials have been identified.
- Hypersensitivity to omalizumab or other component of the product;
- Children under 6 years of age in patients with atopic asthma and up to 12 years in patients with CIU due to the lack of appropriate efficacy and safety data.
Precautions : caution should be used on patients with impaired liver function and / or kidney disease, autoimmune diseases or diseases associated with the accumulation of immune complexes.
In applying the drug Xolair, as when using any other proteinaceous drugs, there can be local or systemic allergic reactions including anaphylactic reactions. Before the introduction of the drug Xolair you need to prepare in advance the appropriate resuscitation equipment and medicines needed for the relief of hypersensitivity reactions. You need to use the drug with caution in patients at increased risk of helminth infestations (especially in endemic areas).
PREGNANCY AND LACTATION
Special for use omalizumab studies in pregnant women have been conducted. In experimental studies, there was no evidence of direct or indirect negative impact of the drug on the course of pregnancy, the developing embryo and fetus during labor and neonatal development. It is known that IgG molecules penetrate gematoplatsentarny barrier. Use of the drug during pregnancy is possible only if the benefit to the mother outweighs the potential risk to the fetus.
Human IgG is excreted in breast milk. It is not known whether omalizumab is excreted in breast milk in humans. It is impossible to eliminate the risk to newborns / infants are breastfed, so omalizumab should not be used during breastfeeding. If necessary, the drug should stop breastfeeding.
Impact on fertility
There are no data on the effect of omalizumab on fertility in humans. Studies have demonstrated the absence of disturbances of male and female fertility in animals by applying multiple doses exceeding 75 mg / kg.
APPLICATION FOR FUNCTIONS OF THE LIVER
It should be used with caution Xolair in patients with impaired renal function
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
It should be used with caution Xolair in patients with impaired hepatic function.
APPLICATION FOR CHILDREN
The drug Xolair is not recommended for use in patients with atopic asthma before the age of six years and in patients with chronic idiopathic urticaria before the age of 12 years due to lack of efficacy and safety data.
APPLICATION IN ELDERLY PATIENTS
There is limited experience with the drug Xolair in patients older than 65 years . However, evidence of the need to correct dose of the drug in patients of this age, no.
When Xolair drug application, as the application of any other proteinaceous drugs, there can be local or systemic allergic reactions including anaphylactic reactions. Before the introduction of the drug Xolair you need to prepare in advance the appropriate resuscitation equipment and medicines needed for the relief of hypersensitivity reactions. Patients should be informed of the possibility of anaphylactic reactions and provide appropriate medical supervision. In clinical studies, anaphylaxis and anaphylactoid reactions observed when using both the first and repeated doses of the drug Xolair. In most cases, the occurrence of such reactions observed during 2 hours after drug administration.
Just as in the application of other humanized monoclonal antibody - a recombinant DNA derivatives, in rare cases the formation of antibodies to omalizumab.
In patients treated with humanized monoclonal antibodies including omalizumab, in rare cases, observed the development of serum sickness and similar conditions, is a manifestation of delayed allergic reactions 3 types. The onset of such conditions normally observed 1-5 days after the first or subsequent injections, as well as long-term therapy. Symptoms allowing suspect development serum sickness include: arthritis / arthralgia, rash (urticaria, or other forms), fever and lymphadenopathy. As prophylaxis and treatment of this disease may use antihistamines and corticosteroids. It is necessary to inform the patient about the possibility of the development of the state and warn of the need to see a doctor when a possible symptoms.
Churg-Strauss syndrome and hypereosinophilic syndrome
patients with severe asthma may in rare cases develop systemic hypereosinophilic syndrome or allergic eosinophilic granulomatous angiitis (Churg-Strauss syndrome) for which treatment therapies commonly used systemic glucocorticosteroids.
In rare cases in patients receiving anti-asthma medicines, including omalizumab, may emerge or develop systemic eosinophilia and vasculitis. These cases are usually associated with a reduction in the dose of oral corticosteroids.
The physician should be alert to the development of marked eosinophilia, vasculitic rash, worsening of pulmonary symptoms, paranasal sinus disease, complications of the heart and / or kidney disease in these patients.
In the case of the aforementioned disorders, severe from the immune system should consider repealing omalizumab.
The drug should not be used to treat acute asthma attacks, acute bronchospasm or status asthmaticus.
Not studied Xolair drug application in patients with elevated IgE concentrations syndrome, allergic bronchopulmonary aspergillosis, for the prophylaxis of anaphylactic reactions, atopic dermatitis, allergic rhinitis and food allergies.
Not studied Xolair drug application in patients with impaired liver function and / or SMO