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Omlyclo is a brand name for Omalizumab. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Allergic asthma Omlyclo is indicated in adults, adolescents and children (6 to < 12 years of age). Omlyclo treatment should only be considered for patients with convincing IgE (immunoglobulin E) mediated asthma (see section 4.2). Adults and adolescents (12 years of age and older) Omlyclo is indicated as add-on therapy…
Verbatim from this product's EMA label. Tap a section to expand.
Treatment should be initiated by physicians experienced in the diagnosis and treatment of severe persistent asthma or chronic rhinosinusitis with nasal polyps (CRSwNP). Posology Dosing for allergic asthma and CRSwNP follows the same dosing principles.
The appropriate dose and frequency of omalizumab for these conditions is determined by baseline IgE (IU/ml), measured before the start of treatment, and body weight (kg). Prior to administration of the initial dose, patients should have their IgE level determined by any commercial serum total IgE assay for their dose assignment.
Based on these measurements, 75 to 600 mg of omalizumab in 1 to 4 injections may be needed for each administration. 1). Prescribing physicians should ensure that adult and adolescent patients with IgE below 76 IU/ml and children (6 to < 12 years of age) with IgE below 200 IU/ml have unequivocal in vitro reactivity (RAST) to a perennial allergen before starting therapy.
See Table 1 for a conversion chart and Tables 2 and 3 for the dose determination charts. Patients whose baseline IgE levels or body weight in kilograms are outside the limits of the dose table should not be given omalizumab. The maximum recommended dose is 600 mg omalizumab every two weeks.
0 *Omlyclo 300 mg pre-filled syringe and all dose strengths of pre-filled pen are not intended for use in patients <12 years of age. ** This table represents the least number of injections for the patients, however there are other syringe/pen dosing combinations possible to achieve the desired dose.
Table 2 ADMINISTRATION EVERY 4 WEEKS. Omalizumab doses (milligrams per dose) administered by subcutaneous injection every 4 weeks Body weight (kg) Baseline 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 > 500– 600 300 300 450 600 600 > 600– 700 300 450 600 > 700– 800 > 800– 900 ADMINISTRATION EVERY 2 WEEKS SEE TABLE 3> 900– 1,000 > 1,000– 1,100 *Body weights below 30 kg were not studied in the pivotal trials for CRSwNP.
5 Table 3 ADMINSTRATION EVERY 2 WEEKS. Omalizumab doses (milligrams per dose) administered by subcutaneous injection every 2 weeks Body weight (kg) Baseline 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 ADMINISTRATION EVERY 4 WEEKS SEE TABLE 2> 100– 200 > 200– 300 375 > 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– 1,000 225 300 375 450 525 600 > 1,000– 1,100 225 300 375 450 600 > 1,100– 1,200 300 300 450 525 600 Insufficient data to recommend a dose > 1,200– 1,300 300 375 450 525 > 1,300– 1,500 300 375 525 600 *Body weights below 30 kg were not studied in the pivotal trials for CRSwNP.
Allergic asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) Summary of the safety profile During allergic asthma clinical trials in adult and adolescent patients 12 years of age and older, the most commonly reported adverse reactions were headaches and injection site reactions, including injection site pain, swelling, erythema and pruritus.
In clinical trials in children 6 to < 12 years of age, the most commonly reported adverse reactions were headache, pyrexia and upper abdominal pain. 10 Most of the reactions were mild or moderate in severity. In clinical trials in patients ≥ 18 years of age in CRSwNP, the most commonly reported adverse reactions were headache, dizziness, arthralgia, abdominal pain upper and injection site reactions.
Tabulated list of adverse reactions Table 4 lists the adverse reactions recorded in clinical studies in the total allergic asthma and CRSwNP safety population treated with omalizumab by MedDRA system organ class and frequency. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Frequency categories are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000) and very rare (< 1/10,000). Reactions reported in the post-marketing setting are listed with frequency not known (cannot be estimated from the available data).
e. 4. Anaphylaxis Anaphylactic reactions were rare in clinical trials. However, post-marketing data following a cumulative search in the safety database retrieved a total of 898 anaphylaxis cases. 20 %. Arterial thromboembolic events (ATE) In controlled clinical trials and during interim analyses of an observational study, a numerical imbalance of ATE was observed.
The definition of the composite endpoint ATE included stroke, transient ischaemic attack, myocardial infarction, unstable angina, and cardiovascular death (including death from unknown cause). 12 (51/9,963 patient years) for control patients.
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. 7 General Omalizumab is not indicated for the treatment of acute asthma exacerbations, acute bronchospasm or status asthmaticus.
Omalizumab has not been studied in patients with hyperimmunoglobulin E syndrome or allergic bronchopulmonary aspergillosis or for the prevention of anaphylactic reactions, including those provoked by food allergy, atopic dermatitis, or allergic rhinitis.
Omalizumab is not indicated for the treatment of these conditions. 2). Caution should be exercised when administering omalizumab in these patient populations. Abrupt discontinuation of systemic or inhaled corticosteroids after initiation of omalizumab therapy in allergic asthma or CRSwNP is not recommended.
Decreases in corticosteroids should be performed under the direct supervision of a physician and may need to be performed gradually. Immune system disorders Allergic reactions type I Type I local or systemic allergic reactions, including anaphylaxis and anaphylactic shock, may occur when taking omalizumab, even after a long duration of treatment.
However, most of these reactions occurred within 2 hours after the first and subsequent injections of omalizumab but some started beyond 2 hours and even beyond 24 hours after the injection. The majority of anaphylactic reactions occurred within the first 3 doses of omalizumab.
Therefore, the first 3 doses must be administered either by or under the supervision of a healthcare professional. A history of anaphylaxis unrelated to omalizumab may be a risk factor for anaphylaxis following omalizumab administration.
Therefore, for patients with a known history of anaphylaxis, omalizumab must be administered by a health care professional, who should always have medicinal products for the treatment of anaphylactic reactions available for immediate use following administration of omalizumab.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Treatment duration, monitoring and dose adjustments Allergic asthma Omlyclo is intended for long-term treatment. Clinical trials have demonstrated that it takes at least 12 – 16 weeks for the treatment to show effectiveness. At 16 weeks after commencing Omlyclo therapy patients should be assessed by their physician for treatment effectiveness before further injections are administered.
1, Physician’s overall assessment of treatment effectiveness). Chronic rhinosinusitis with nasal polyps (CRSwNP) In clinical trials for CRSwNP, changes in nasal polyps score (NPS) and nasal congestion score (NCS) were observed at 4 weeks.
The need for continued therapy should be periodically reassessed based upon the patient’s disease severity and level of symptom control. Allergic asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) Discontinuation of treatment generally results in a return to elevated free IgE levels and associated symptoms.
Total IgE levels are elevated during treatment and remain elevated for up to one year after 6 the discontinuation of treatment. Therefore, re-testing of IgE levels during treatment cannot be used as a guide for dose determination. Dose determination after treatment interruptions lasting less than one year should be based on serum IgE levels obtained at the initial dose determination.
Total serum IgE levels may be re-tested for dose determination if treatment has been interrupted for one year or more. Doses should be adjusted for significant changes in body weight (see Tables 2 and 3). Special populations Elderly (65 years of age and older) There are limited data available on the use of omalizumab in patients older than 65 years but there is no evidence that elderly patients require a different dose from younger adult patients.
Renal or hepatic impairment There have been no studies on the effect of impaired renal or hepatic function on the pharmacokinetics of omalizumab. Because omalizumab clearance at clinical doses is dominated by the reticular endothelial system (RES) it is unlikely to be altered by renal or hepatic impairment.
4). Paediatric […]
91). 71). Platelets In clinical trials few patients had platelet counts below the lower limit of the normal laboratory range. Isolated cases of idiopathic thrombocytopenia, including severe cases, have been reported in the post- marketing setting.
Parasitic infections In patients at chronic high risk of helminth infection, a placebo-controlled trial showed a slight numerical increase in infection rate with omalizumab that was not statistically significant. 4). Systemic lupus erythematosus Clinical trial and post-marketing cases of systemic lupus erythematosus (SLE) have been reported in patients with moderate to severe asthma and CSU.
The pathogenesis of SLE is not well understood. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
If an anaphylactic or other serious allergic reaction occurs, administration of omalizumab must be discontinued immediately, and appropriate therapy initiated. Patients should be informed that such reactions are possible, and prompt medical attention should be sought if allergic reactions occur.
8). The clinical relevance of anti-omalizumab antibodies is not well understood. Serum sickness Serum sickness and serum sickness-like reactions, which are delayed allergic type III reactions, have been seen in patients treated with humanised monoclonal antibodies including omalizumab.
The suggested pathophysiologic mechanism includes immune-complex formation and deposition due to development of antibodies against omalizumab. The onset has typically been 1 – 5 days after administration of the first or subsequent injections, also after long duration of treatment.
Symptoms suggestive of serum sickness include arthritis/arthralgias, rash (urticaria or other forms), fever and lymphadenopathy. Antihistamines and corticosteroids may be useful for preventing or treating this disorder, and patients should be advised to report any suspected symptoms.
Churg-Strauss syndrome and hypereosinophilic syndrome Patients with severe asthma may rarely present systemic hypereosinophilic syndrome or allergic eosinophilic granulomatous vasculitis (Churg-Strauss syndrome), both of which are usually treated with systemic corticosteroids.
In rare cases, patients on therapy with anti-asthma medicinal products, including omalizumab, may present or develop systemic eosinophilia and vasculitis. These events are commonly associated with the reduction of oral corticosteroid therapy.
8 In these patients, physicians should be alert to the development of marked eosinophilia, vasculitic rash, worsening pulmonary symptoms, paranasal sinus abnormalities, cardiac complications, and/or neuropathy. Discontinuation of omalizumab should be considered in all severe cases with the above-mentioned immune system disorders.
Parasitic (helminth) infections IgE may be involved in the immunological response to some helminth infections. In patients at chronic high risk of helminth infection, a placebo-controlled trial showed a slight increase in infection rate with omalizumab, although the course, severity, and response to treatment of infection were unaltered.
The helminth infection rate in the overall clinical programme, which was not designed to detect such infections, was less than 1 in 1,000 patients. However, caution may be warranted in patients at high risk of helminth infection, in particular when travelling to areas where helminthic infections are endemic.
If patients do not respond to recommended anti-helminth treatment, discontinuation of omalizumab should be considered. 40 mg/ml. Polysorbates may cause allergic reactions. Patients with polysorbate allergy should not take this medicine.