Xolar
Xolar: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Drug interactions
- 14. Analogs
- 15. Terms and conditions of storage
- 16. Terms of dispensing from pharmacies
- 17. Reviews
- 18. Price in pharmacies
Latin name: Xolair
ATX code: R03DX05
Active ingredient: omalizumab (Omalizumab)
Manufacturer: Novartis Pharma Stein, AG (Novartis Pharma Stein, AG) (Switzerland); Wetter Pharma-Fertigung, GmbH & Co. KG (Vetter Pharma-Fertingung, GmbH & Co. KG) (Germany)
Description and photo update: 2019-09-07
Prices in pharmacies: from 26,700 rubles.
Buy
Xolar is an immunosuppressive drug used for obstructive airways disease and chronic idiopathic urticaria.
Release form and composition
Xolar dosage form:
- lyophilisate for preparing a solution for subcutaneous (s / c) administration: white or almost white lyophilized powder; solvent - a transparent colorless liquid (in a cardboard box 1 bottle of 6 ml of lyophilisate, complete with a 2 ml ampoule of solvent);
- solution for subcutaneous administration: transparent, somewhat opalescent, from light brownish-yellow to colorless (in a cardboard box 1 pallet containing 1 syringe with a fixed needle with a protective cap of 0.5 or 1 ml).
Each pack also contains instructions for the use of Xolar.
Composition of 1 bottle of lyophilisate:
- active substance: omalizumab - 150 mg;
- auxiliary components: polysorbate 20 - 0.4 mg; sucrose - 108 mg; L-histidine - 1.3 mg; L-histidine hydrochloride monohydrate - 2.1 mg.
Solvent: water for injection - 2 ml.
The composition of the solution for 1 syringe with a volume of 0.5 or 1 ml:
- active substance: omalizumab - 75 or 150 mg;
- auxiliary components (75/150 mg): histidine hydrochloride - 1.17 / 2.34 mg; arginine hydrochloride - 21.05 / 42.1 mg; polysorbate 20 - 0.2 / 0.4 mg; histidine - 0.68 / 1.37 mg; water for injection - up to 0.5 / 1 ml.
Xolar is a humanized monoclonal antibodies that are based on recombinant DNA (deoxyribonucleic acid).
Pharmacological properties
Pharmacodynamics
The active component of Xolar is omalizumab - a humanized monoclonal antibody obtained on the basis of recombinant DNA (deoxyribonucleic acid), which selectively binds to immunoglobulin E (IgE). It is an IgG 1 -cappa antibody containing a human structural backbone with complementarity determining regions of a murine antibody that bind IgE.
Atopic bronchial asthma (BA)
When using Xolar for the treatment of atopic AD, omalizumab binds to IgE and prevents its interaction with the high-affinity FcεRI receptor. This helps to reduce the amount of free IgE, which is a triggering factor for the cascade of allergic reactions.
With the use of Xolar in patients with atopic BA, a noticeable decrease in the number of FcεRI receptors is observed on the surface of basophils. When conducting clinical studies, it was found that the serum concentration of free IgE in the blood dose-dependently decreases within 60 minutes after the first dose of the drug and remains at the achieved level in the interval between the administration of subsequent doses.
The average decrease in serum concentration of free IgE in the blood when using Xolar in recommended doses is more than 96%. The total serum concentration of IgE (unbound and bound) in the blood increases after the first dose, which is associated with the formation of the omalizumab-IgE complex, which is characterized by a slower elimination rate compared to free IgE.
The average serum concentration of total IgE in the blood at the 16th week after the administration of the first dose of Xolar is 5 times higher than that before the start of treatment. After discontinuation of the drug, an increase in the concentration of total IgE and a decrease in the concentration of free IgE, due to the therapeutic effect of Xolar, were reversible. Due to the complete elimination of the active substance from the body, an increase in the serum IgE concentration in the blood is not observed. After discontinuation of Xolar, the concentration of total IgE remains elevated for 12 months.
In moderate and severe atopic asthma during therapy, there is a decrease in the frequency of exacerbations. Exacerbation is understood as a condition characterized by a worsening of asthma, in which systemic corticosteroids (glucocorticosteroids) or a doubling of the initial dose of inhaled corticosteroids are required. Also, the use of Xolar, in comparison with placebo, helps to reduce the need for inhaled GCS.
When therapy is carried out for 16 weeks against the background of a gradual decrease in the dose of oral or inhaled GCS, there is also a significant decrease in the number of BA exacerbations and a decrease in the need for inhaled GCS in comparison with placebo.
In patients with perennial allergic rhinitis and BA, who receive GCS therapy, when using Xolar for 28 weeks, there is a decrease in the severity of symptoms of these diseases, simultaneously with an improvement in the parameters of pulmonary function. In comparison with placebo, a decrease in the number of BA exacerbations and an improvement in the quality of life of patients (based on a certified quality of life questionnaire) with the use of Xolar persists for a long time.
The use of Xolar in children 6–12 years of age for a course of 52 weeks reduces the frequency of exacerbations of asthma, in comparison with patients who received placebo. According to the results of another study, with therapy for a course of 28 weeks, there is a decrease in the severity and frequency of exacerbations of asthma, as well as a decrease in the dose of inhaled corticosteroids used by the end of the 28th week, in comparison with patients receiving placebo.
Chronic idiopathic urticaria (CUI)
Autoimmune antibodies to IgE and FcεRI receptor were isolated from the blood serum of some patients with CIK. They are capable of activating mast cells or basophils, which aids in the release of histamine.
One of the hypotheses of the mechanism of the effect of omalizumab in patients with CCI is a decrease in the concentration of free IgE in the blood, and then in the skin. As a consequence, there is a decrease in signal transmission through the FcεRI receptors, which helps to suppress the activation of cells involved in the inflammatory response. As a result, the severity and frequency of the onset of CCI symptoms decreases.
There is also reason to believe that a decrease in the concentration of circulating IgE contributes to the rapid nonspecific desensitization of mast cells in the skin, due to negative feedback, FcεRI receptors support this reaction.
During clinical studies, it was found that the use of omalizumab in patients with CIK, as in patients with atopic asthma, leads 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 is noted 3 days after the SC administration of the first dose of Xolar.
After repeated use of Xolar (with a frequency of once every 4 weeks), the serum concentration of free IgE in the blood before the administration of the next dose in the period between 12 and 24 weeks of treatment remains at the achieved level. The serum concentration of total IgE in the blood increases after the first dose as a result of the formation of the omalizumab-IgE complex, which, in comparison with free IgE, is characterized by a slower elimination rate.
After repeated use of 75-300 mg of Xolar once every 4 weeks, the serum concentration of total IgE in the blood after 12 weeks from the start of therapy is 2-3 times higher than that before the start of the drug, the concentration at the achieved level remains in the range of 12-24 weeks of treatment. Within 16 weeks after discontinuation of Xolar, the concentration of total IgE decreases, and the concentration of free IgE increases, approaching the initial values.
When using the drug every 4 weeks at a dose of 150 and 300 mg, statistically significant and reproducible therapeutic effects are observed in relation to a decrease in the severity of itching. After 12 weeks of treatment, the effect reaches its maximum and persists throughout the observation period.
Also, therapy at a dose of 300 mg has a statistically significant and reproducible effect in relation to the urticaria activity index (UAS), the proportion of days without angioedema, the weekly index of quality of life and sleep disorders of patients, which is assessed by the Cu-Q2oL questionnaire (to study the quality of life in patients with CCI), as well as the DLQI (Dermatological Quality of Life Index).
Pharmacokinetics
In patients with BA after SC administration, the absolute bioavailability of omalizumab averages 62%. When applied at a dose of 0.5 mg / kg, the pharmacokinetic parameters are linear.
After a single subcutaneous injection in adolescents and adults with atopic BA, absorption of omalizumab occurs slowly, C max (maximum concentration) in the blood serum, on average, is achieved within 7–8 days. The AUC (area under the concentration-time curve) of omalizumab after repeated administration for a period of up to 14 days in an equilibrium state is 6 times higher than that after a single dose.
After a single subcutaneous injection in adolescents and adults with CCI, the absorption of omalizumab occurs slowly, C max (maximum concentration of the substance) in the blood serum, on average, is achieved within 6–8 days. When using Xolar at a dose of 75–600 mg as a single subcutaneous injection, the pharmacokinetic parameters are linear. The minimum serum concentration of omalizumab in the blood increases in proportion to the dose increase with the introduction of 75, 150 or 300 mg every 4 weeks.
With IgE, omalizumab forms a complex of a certain size. The formation of precipitating complexes and complexes with a molecular weight above 1 million daltons is not observed. No specific accumulation of omalizumab in any tissues and organs was detected during clinical trials.
After n / k administration in patients with atopic asthma and urticaria apparent V d (volume of distribution) omalizumab was 78 ± 32 ml / kg.
The clearance of omalizumab includes the clearance of IgG and the clearance that occurs by specific binding and complexation with the target ligand, free serum IgE.
Hepatic elimination of IgG is degradation in the RES (reticuloendothelial system) of the liver and liver endothelial cells. Also, intact IgG is excreted in the bile.
T 1/2 (half-life) of omalizumab from serum in patients with asthma is on average 26 days, the average apparent clearance is 2.4 ± 1.1 ml / kg per day. In the case of a 2-fold increase in the patient's weight, an approximately 2-fold increase in apparent clearance is noted.
The average T 1/2 of omalizumab from serum in patients with CCI at the equilibrium concentration is 24 days, at the equilibrium concentration, the average apparent clearance is 240 ml per day (for patients weighing 80 kg, this corresponds to 3 ml / kg per day).
The pharmacokinetics and pharmacodynamics of omalizumab in patients with atopic asthma or CIC associated with impaired renal and hepatic function have not been studied.
Metabolism of omalizumab is carried out mainly by RES, impaired renal and liver function does not affect it. No dose adjustment is required, but Xolar should be used with caution in this group of patients.
Indications for use
- persistent atopic bronchial asthma of moderate and severe course in patients from 6 years old, when the use of inhaled GCS symptoms are not sufficiently controlled;
- chronic idiopathic urticaria in patients from 12 years old, when there is resistance to therapy with histamine H 1 receptor blockers.
Contraindications
Absolute:
- age up to 6 years in the treatment of atopic asthma;
- age up to 12 years in the treatment of CCI;
- individual intolerance to the components of the drug.
Relative (Xolar is prescribed under medical supervision):
- impaired liver and / or kidney function;
- autoimmune diseases or diseases associated with the accumulation of immune complexes;
- the presence of an increased risk of developing helminthic invasions;
- pregnancy and lactation.
Due to the likelihood of the development of local or systemic allergic reactions, including anaphylactic reactions, the appropriate resuscitation equipment and drugs that are necessary to stop hypersensitivity reactions must be prepared in advance before the introduction of Xolar.
Xolar, instructions for use: method and dosage
Xolar is intended exclusively for administration into the subcutaneous fat, intravenous or intramuscular administration of the solution is prohibited.
Atopic bronchial asthma (BA)
The dosage regimen is determined based on the initial IgE concentration (IU / ml), which is measured before starting treatment, as well as the patient's body weight (kg).
The dose of Xolar varies between 75-600 mg once every 2 or 4 weeks.
The recommended dosing regimen depending on the dose (number of syringes 75 or 150 mg / number of injections / total volume of solution):
- 75 mg: 1 or 0 pcs. / 1 pc. / 0.5 ml;
- 150 mg: 0 or 1 pc. / 1 pc. / 1 ml;
- 225 mg: 1 or 1 pc. / 2 pcs. / 1.5 ml;
- 300 mg: 0 or 2 pcs. / 2 pcs. / 2 ml;
- 375 mg: 1 or 2 pcs. / 3 pcs. / 2.5 ml;
- 450 mg: 0 or 3 pcs. / 3 pcs. / 3 ml;
- 525 mg: 1 or 3 pcs. / 4 pcs. / 3.5 ml;
- 600 mg: 0 or 4 pcs. / 4 pcs. / 4 ml.
With significant changes in the patient's weight, the dose must be adjusted.
Calculation of the Xolar dose every 4 weeks based on the initial IgE concentration with weight> 20-25 /> 25-30 /> 30-40 /> 40-50 /> 50-60 /> 60-70 /> 70-80 /> 80 –90 /> 90–125 /> 125–150 kg:
- ≥30-100 IU / ml: 75/75/75/150/150/150/150/150/300/300 mg;
- > 100-200 IU / ml: 150/150/150/300/300/300/300/300/450/600 mg;
- > 200-300 IU / ml: 150/150/225/300/300/450/450/450/600 / * mg;
- > 300-400 IU / ml: 225/225/300/450/450/450/600/600 / * / * mg;
- > 400-500 IU / ml: 225/300/450/450/600/600 / * / * / * / * mg;
- > 500-600 IU / ml: 300/300/450/600 / 600 / * / * / * / * / * mg;
- > 600-700 IU / ml: 300 / * / 450/600 / * / * / * / * / * / * mg.
* Xolar is applied once every 2 weeks
Calculation of the Xolar dose every 2 weeks based on the initial concentration of IgE with weight> 20-25 /> 25-30 /> 30-40 /> 40-50 /> 50-60 /> 60-70 /> 70-80 /> 80 –90 /> 90–125 /> 125–150 /> 150–200 kg:
- > 30–100 IU / ml: * / * / * / * / * / * / * / * / * / * / 225 mg;
- > 100-200 IU / ml: * / * / * / * / * / * / * / * / * / * / 375 mg;
- > 200-300 IU / ml: * / * / * / * / * / * / * / * / * / 375/525 mg;
- > 300–400 IU / ml: * / * / * / * / * / * / * / * / 450/525 / - mg;
- > 400-500 IU / ml: * / * / * / * / * / * / 375/375/525/600 / - mg;
- > 500-600 IU / ml: * / * / * / * / * / 375/450/450/600 / - / - mg;
- > 600-700 IU / ml: * / 225 / * / * / 375/450/450/525 / - / - / - mg;
- > 700-800 IU / ml: 225/225/300/375/450/450/525/600 / - / - / - mg;
- > 800-900 IU / ml: 225/225/300/375/450/525/600 / - / - / - / - mg;
- > 900-1000 IU / ml: 225/300/375/450/525/600 / - / - / - / - / - mg;
- > 1000-1100 IU / ml: 225/300/375/450/600 / - / - / - / - / - / - mg;
- > 1100-1200 IU / ml: 300/300/450/525/600 / - / - / - / - / - / - mg;
- > 1200-1300 IU / ml: 300/375/450/525 / - / - / - / - / - / - / - mg;
- > 1300-1500 IU / ml: 300/375/525/600 / - / - / - / - / - / - / - mg.
* Xolar is applied once every 4 weeks
- The drug is not used
In the course of clinical studies with the use of Xolar during the first 16 weeks, there was a decrease in the incidence of exacerbations of asthma, a decrease in the number of cases of emergency therapy, and an improvement in the symptoms of the disease was observed. It is necessary to evaluate the effectiveness of therapy after at least 12 weeks of using the drug.
Xolar is intended for long-term therapy. Usually, withdrawal of the drug leads to the restoration of an increased concentration of free IgE and the appearance of corresponding signs of the disease.
During treatment, the concentration of total IgE increases, it remains at an elevated level for one year after discontinuation of the drug. Thus, when re-determining against the background of the use of Xolar, the IgE concentration cannot be a guideline for selecting the dose of the drug. After stopping therapy for up to one year, dose selection should be based on the serum IgE concentration in the blood, which was established before the initial dose was administered.
In cases where Xolar was canceled for a period of one year or more, re-determination of the serum IgE concentration in the blood is required to determine the dosage regimen.
Chronic idiopathic urticaria (CUI)
Xolar is recommended to be administered every 4 weeks at 300 mg. The attending physician should periodically re-evaluate the need for continued therapy.
In patients with CCI, the experience of long-term use of omalizumab in clinical trials is limited.
Preparation and administration of the solution
Choosing a site for injection
Xolar is injected subcutaneously into the anterolateral area of the thigh or into the area of the deltoid muscle, avoiding rashes in patients with urticaria.
If more than one injection is needed at a time, a second injection must be given in the other thigh or arm.
Rules for the preparation and administration of the solution
To prepare a solution for subcutaneous administration using a syringe with an 18-gauge needle, take 1.4 ml of water for injection from the ampoule.
Do not mix Xolar drug with any other drugs or solutions except water for injection.
The vial with the drug must be installed vertically. In this position, it is pierced with a needle, observing the rules of asepsis, and water for injection is injected directly into the dry substance of the drug.
Without changing the position of the bottle, it must be carefully rotated (do not shake) for 1 minute, this will allow the dry substance to be evenly saturated.
In order to facilitate dissolution, the bottle should be rotated for 5-10 seconds approximately every 5 minutes (until all solids dissolve, which sometimes takes more than 20 minutes). The solution should not contain visible gel-like particles. The presence of foam or small bubbles on the walls of the bottle is allowed. The resulting solution should be light yellowish or colorless, transparent or somewhat opalescent. If foreign particles are found in the solution, it cannot be used.
Then you should remove the needle and turn the bottle over for 15 seconds, this will allow the solution to flow towards the stopper. Using a new syringe of 3 cm 3 with a needle 18 gauge with a wide lumen, inverted bottle need to insert the needle. The end of the needle is placed at the lowest point of the solution that has accumulated in the bottle cap, and the solution is drawn into a syringe. To withdraw the entire solution from an inverted vial, pull the plunger all the way back before removing the needle. The needle must be replaced with a 25 gauge SC needle.
It is necessary to release large bubbles, excess air and excess solution to obtain the required volume of 1.2 ml. A thin layer of small bubbles may remain in the syringe on top of the solution. The solution has a certain viscosity, so the duration of the injection can be from 5 to 10 seconds.
The solution made must be injected immediately after preparation, since it does not contain antibacterial preservatives. It is permissible to store the ready-made solution for 8 hours at a temperature of 2–8 ° C and or 4 hours at a temperature of 30 ° C.
Instructions for using the pre-filled syringe
The syringe needle cap may contain derivatives of natural latex, so patients who are hypersensitive to latex should avoid direct contact with its surface.
The outer carton should be unsealed just before injection. If its integrity has been damaged, the drug should not be used.
Do not touch the activating latches as this will self-activate the needle guard.
The cap from the needle must be removed immediately before the introduction of Xolar.
Before injecting the drug, the syringe box must be removed from the refrigerator in about 20 minutes. If for any reason the injection is delayed, the box can be placed back in the refrigerator. At room temperature (about 25 ° C), the syringe can stay no longer than 4 hours (in total).
Before injection, you need to remove the plastic tray from the pack and remove the syringe from it. It is necessary to inspect the contents of the syringe. Do not use a solution if it looks cloudy or contains insoluble particles.
While holding the syringe horizontally, you should look through the viewing window and verify the dose (75 or 150 mg) and the expiration date.
Then the syringe must be turned vertically, the piston must be pulled back as far as possible and the side of the syringe must be tapped with a finger so that the air rises. The fluid level must be at or above the minimum fill line.
You need to hold the syringe with the needle up and carefully remove the needle cap from it, without touching the open needle. After large air bubbles rise up, it is necessary to slowly push the plunger to remove air from the syringe, preventing the solution from flowing out.
The skin at the injection site should be gently pulled into a small fold, after which a needle is inserted into it. Resting your middle and forefinger on the special projections, you should slowly push the piston all the way down until all the solution is injected. The needle, while continuing to press on the piston, is removed from the skin. Slowly release the plunger, after which the needle will automatically close with a safety catch (a sharp push on the plunger may be required).
The syringe is disposable and must be disposed of after use.
Side effects
Frequency of possible adverse reactions [> 10% - very common; (> 1% and 0.1% and 0.01% and <0.1%) - rarely; <0.01% - very rare].
Atopic bronchial asthma (BA)
Most often, against the background of the use of Xolar, a headache develops, reactions at the injection site, including edema, pain, itching and erythema at the injection site. Most of these disorders are mild to moderate in severity.
Possible violations:
- infectious and parasitic diseases: infrequently - pharyngitis; rarely - parasitic infestations;
- nervous system: often - headache; infrequently - drowsiness, dizziness, syncope, paresthesia;
- immune system: rarely - anaphylactic reactions and other allergic conditions, including angioedema, the appearance of antibodies to omalizumab;
- respiratory system: infrequently - allergic bronchospasm, cough; rarely - laryngeal edema;
- vessels: infrequently - hot flashes, postural hypotension;
- skin and subcutaneous tissue: infrequently - photosensitivity, rash, urticaria, itching;
- digestive system: infrequently - diarrhea, nausea, dyspepsia;
- violations at the injection site and general disorders: often - reactions at the injection site, such as swelling, erythema, pain, itching; infrequently - weight gain, feeling tired, flu-like condition, swelling of the hands.
In clinical practice, in some cases, the development of the following disorders was noted:
- immune system: anaphylactoid and anaphylaxis reactions (occur during the first or repeated use of Xolar, most often within 2 hours after subcutaneous injection), serum sickness;
- lymphatic system and blood: severe idiopathic thrombocytopenia;
- skin and subcutaneous tissue: alopecia;
- musculoskeletal system: myalgia, arthralgia, joint swelling;
- respiratory system: allergic granulomatous angiitis (Churg-Strauss syndrome).
In clinical practice, when using Xolar in children 6–12 years old, the following disorders were observed:
- digestive system: often - pain in the upper abdomen;
- nervous system: very often - headache;
- general disorders: very often - an increase in body temperature.
Chronic idiopathic urticaria (CUI)
Most often, during therapy, the development of headache and nasopharyngitis was noted.
Possible violations:
- infectious and parasitic diseases: often - urinary tract infections, sinusitis, nasopharyngitis, upper respiratory tract infections (including viral genesis);
- musculoskeletal system: often - myalgia, arthralgia, pain in the limbs, musculoskeletal pain;
- nervous system: very often - headache; often - headaches in the paranasal sinuses;
- general disorders and reactions at the injection site: often - fever, reactions at the injection site of Xolar, including itching, swelling, erythema, urticaria, pain, bleeding, hematoma.
Other possible side reactions
- anaphylaxis: anaphylactic reactions recorded during post-marketing use occur in about 0.2% of cases. A risk factor for their development is a burdened history of anaphylactic reactions not associated with the use of omalizumab;
- malignancy: the overall incidence of neoplasms when using Xolar in clinical trials is similar to that in the general population. No malignant neoplasms have been reported in patients aged 6–12 years;
- thromboembolic complications: during controlled clinical trials, the occurrence of thromboembolic complications, including unstable angina pectoris, transient ischemic attacks, stroke, myocardial infarction, death from cardiovascular causes (including death from unknown reasons), was noted. According to the analysis of the main factors of cardiovascular risk, the risk ratio is 1.32;
- helminth invasions: with the development of helminth invasions, IgE may be involved in the immune response. In patients with allergic diseases and the risk of helminthic invasions in placebo-controlled studies, when using Xolar, there was a slight increase in the incidence of helminthiasis (while the course, severity of the disease and response to treatment did not change). In all clinical trials, the overall incidence of helminth invasions is less than 1 ÷ 1000;
- change in the number of blood platelets: in several patients during clinical studies, a decrease in the number of platelets below normal was noted, which was not accompanied by a drop in hemoglobin concentration or bleeding. In clinical studies, a permanent decrease in the number of platelets was not detected.
Overdose
There are no reports of an overdose of omalizumab to date. The highest tolerated dose of Xolar has not been determined.
With a single intravenous administration of up to 4000 mg of omalizumab, signs of dose-limiting toxicity were not observed. With the introduction of the highest cumulative dose - 44,000 mg for 20 weeks, the development of any adverse reactions in the acute / severe course was not recorded.
special instructions
Against the background of the use of Xolar, as well as other protein-containing drugs, local / systemic allergic reactions, including anaphylactic reactions, may occur. It is necessary to introduce Xolar only with the availability of appropriate resuscitation equipment and drugs necessary to stop hypersensitivity reactions. The patient should be informed about the possibility of anaphylactic reactions, and appropriate medical supervision should be established for his condition.
During clinical studies, cases of the development of anaphylaxis and anaphylactoid reactions were recorded when using the first and repeated doses of Xolar. Most often, they occurred within 2 hours after injection.
In rare cases, during the period of therapy, antibodies to omalizumab are formed (as with the use of other humanized monoclonal antibodies).
Rarely, patients treated with humanized monoclonal antibodies, including omalizumab, have developed serum sickness and similar conditions, which are a manifestation of delayed type III allergic reactions. The onset of these conditions is usually noted on the 1-5th day after the first / subsequent injections, as well as during prolonged treatment.
Typical symptoms on the basis of which the development of serum sickness can be suspected: arthritis / arthralgia, rash (in the form of urticaria or other forms), fever and lymphadenopathy. As a treatment and prevention of this pathology, antihistamines and GCS can be used. If these signs occur, you should consult a doctor.
The drug Xolar should not be used for the treatment of acute attacks of asthma, status asthma or acute bronchospasm.
The use of the drug in patients with allergic bronchopulmonary aspergillosis, syndrome of high IgE concentration, atopic dermatitis, allergic rhinitis, food allergy, as well as for the prevention of anaphylactic reactions has not been studied.
The efficacy and safety of Xolar therapy for impaired renal and / or liver function, autoimmune diseases or diseases associated with the accumulation of immune complexes has not been studied. In this regard, caution should be exercised when using the drug in such patients.
After the start of therapy, the use of inhaled or systemic GCS should not be abruptly stopped. The dose of these drugs, used in combination with Xolar, is gradually reduced under the supervision of a physician.
In rare cases, patients with severe BA may develop systemic hypereosinophilic syndrome or allergic eosinophilic granulomatous vasculitis (Churg-Strauss syndrome). Usually, systemic corticosteroids are used to treat these pathologies. In rare cases, patients receiving anti-asthma drug therapy, including omalizumab, may develop / present with vasculitis or systemic eosinophilia. As a rule, these cases are associated with a decrease in the dose of oral corticosteroids.
If such patients develop a vasculitic rash, severe eosinophilia, worsening of the course of pulmonary symptoms, pathologies of the paranasal sinuses, nephropathy and / or complications from the heart, the doctor should be alert. If these symptoms are severe, the possibility of canceling omalizumab should be considered.
The needle cap of the syringe containing the solution may contain a natural latex derivative. In patients who are hypersensitive to latex, the safety of using a pre-filled syringe has not been investigated. There is no natural latex in the needle cap, but in spite of this, such patients should avoid direct contact with its surface.
Influence on the ability to drive vehicles and complex mechanisms
In cases where the use of Xolar is accompanied by the development of dizziness, increased fatigue, syncope or drowsiness, you should refrain from driving.
Application during pregnancy and lactation
Xolar is prescribed with caution during pregnancy, provided that the benefits to the mother exceed the potential risks to the fetus / child.
Special studies on the use of Xolar in pregnant women have not been conducted. In experimental studies, no direct or indirect negative effect of therapy on the course of pregnancy, the development of the embryo / fetus, the course of labor and the further development of newborns was identified. It has been found that IgG molecules penetrate the blood-placental barrier.
There is no confirmed data on whether omalizumab is excreted in breast milk (human IgG is excreted). But it is necessary to take into account the likelihood of excretion of the drug during lactation and the possibility of its negative effect on the child, and therefore, breastfeeding must be stopped during the use of Xolar.
There is no information on the effect of omalizumab on fertility. Studies have shown that when multiple doses exceeding 75 mg / kg are used, there are no impairments to male and female fertility in animals.
Pediatric use
In pediatric practice, it is contraindicated to use Xolar for the treatment of atopic BA in children under 6 years of age.
Xolar is not used for the treatment of CCI in children under 12 years of age.
With impaired renal function
Xolar should be used with caution in patients with impaired renal function.
For violations of liver function
Xolar should be used with caution in patients with impaired liver function.
Drug interactions
Enzymes of cytochrome P 450, the mechanisms of the energy release system and binding to proteins do not play a role in the clearance of omalizumab, therefore the probability of drug interaction with other drugs is small. Special studies of the interaction of Xolara with drugs, including vaccines, have not been conducted.
The development of interaction of omalizumab with drugs that are used in the treatment of asthma or CCI is unlikely.
Do not mix Xolar with any other solutions / drugs.
Currently, data on the use of Xolar in combination with specific immunotherapy (hyposensitizing therapy) in the treatment of atopic AD are limited.
The use of Xolar simultaneously with immunosuppressive agents in the treatment of CIK has not been studied.
Analogs
Xolar's analogues are Velispal, Codetim, Glenspirid, Siresp, Fespalen, Fenspirid, Eladon, Pharmaspal.
Terms and conditions of storage
Store at 2-8 ° C. Keep out of the reach of children.
Shelf life:
- lyophilisate for preparing a solution for subcutaneous administration - 4 years;
- solvent - 5 years;
- solution for subcutaneous administration of 75 mg / 0.5 ml and 150 mg / 1 ml - 1.5 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Xolara
Parents of children who are often prescribed a drug for the treatment of bronchial asthma, when its symptoms are not relieved by standard therapy, leave mainly positive reviews about Xolar. Adult patients recommend using the drug, despite its high cost, for the treatment of chronic recurrent urticaria. They note the rapid development of the therapeutic effect of the drug, which is manifested in the disappearance of the symptoms of the disease, improvement in well-being and quality of life.
Price for Xolar in pharmacies
The approximate price for Xolar is:
- lyophilisate for preparation of a solution for subcutaneous administration (1 bottle of 150 mg) - 20,200 rubles;
- solution for subcutaneous administration (1 syringe of 1 ml) - 16 806 rubles.
Xolar: prices in online pharmacies
|
Drug name Price Pharmacy |
|
Xolar 150 mg lyophilisate for the preparation of a solution for subcutaneous administration complete with a solvent 1 pc. RUB 26,700 Buy |
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
