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XOLAIR is a brand name for Omalizumab, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Allergic Asthma XOLAIR (omalizumab) is indicated for adult and pediatric patients (6 years of age and above) 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. • Adults…
Verbatim from this product's HC label. Tap a section to expand.
4 Administration 02/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .............................................................................................
2 TABLE OF CONTENTS ............................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION .......................................................................
4 1 INDICATIONS ................................................................................................................ 1 Pediatrics .................................................................................................................
2 Geriatrics ................................................................................................................. 4 2 CONTRAINDICATIONS ..................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................. 5 4 DOSAGE AND ADMINISTRATION .................................................................................. 1 Dosing Considerations .............................................................................................
2 Recommended Dose and Dosage Adjustment ........................................................ 3 Reconstitution ......................................................................................................... 4 Administration .........................................................................................................
5 Missed Dose .......................................................................................................... 12 5 OVERDOSAGE.............................................................................................................
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). Signs and symptoms in these reported cases have included angioedema of the throat or tongue, bronchospasm, hypotension, syncope, and/or urticaria. Some of these events have been life-threatening. 1%. 2% based on a total number of anaphylactic reactions observed from an estimated exposure of over 500,000 patient years.
Anaphylaxis and anaphylactoid reactions have been reported following the first or subsequent administrations of Xolair. Although most of these reactions occurred within 2 hours, some occurred beyond 2 hours. Anaphylaxis has occurred as early as after the first dose of Xolair, but also has occurred beyond one year after beginning regularly scheduled treatment.
Approximately 60-70% of anaphylactic reactions occurred within the first 3 doses of Xolair. Therefore, the first 3 doses should be administered either by or under the supervision of a healthcare professional. A history of anaphylaxis unrelated to omalizumab is a risk factor for anaphylaxis following Xolair administration.
Therefore, for patients with a known history of anaphylaxis, Xolair should be administered by a health care professional, who should have medications for the treatment of anaphylactic reactions available for immediate use following administration of Xolair.
When administered in the healthcare setting, patients should be closely observed for an appropriate period of time after administration of Xolair, taking into account the time to onset of anaphylaxis seen in premarketing clinical trials and postmarketing spontaneous reports (see 8 ADVERSE REACTIONS).
Patients should be informed of the signs and symptoms of anaphylaxis, and instructed to seek immediate medical care should signs or symptoms occur (see Information for Patients). 4 Administration, Pre-filled syringe). Xolair should be discontinued in patients who experience a severe hypersensitivity reaction (see 2 CONTRAINDICATIONS).
4 Geriatrics). 2 CONTRAINDICATIONS Xolair (omalizumab) should not be administered to patients with known hypersensitivity to omalizumab or any component of the formulation (see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING), or patients who have experienced a severe hypersensitivity reaction to Xolair (see 7 WARNINGS AND PRECAUTIONS, Anaphylaxis).
PrXOLAIR® (omalizumab) Page 5 of 86 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions Anaphylaxis, presenting as angioedema of the throat or tongue, bronchospasm, hypotension, syncope, and/or urticaria 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. Initiate Xolair therapy in a healthcare setting, closely observe patients for an appropriate period of time after Xolair administration, and be prepared to manage anaphylaxis which can be life-threatening.
Patients should also be informed of the signs and symptoms of anaphylaxis and instructed to seek immediate medical care should symptoms occur (see 7 WARNINGS AND PRECAUTIONS, Information for Patients). The selection of patients for self-administration of XOLAIR should be based on criteria to mitigate the risk from anaphylaxis (see 7 WARNINGS AND PRECAUTIONS, Anaphylaxis).
1 Dosing Considerations Dosing Considerations for Asthma Xolair (omalizumab) 75 to 375 mg is administered SC every 2 or 4 weeks. See the dose determination charts below for appropriate dose assignment. Doses (mg) and dosing frequency are determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg).
Doses of more than 150 mg are divided among more than one injection site to limit injections to not more than 150 mg per site. Because the solution is slightly viscous, the injection may take 5-10 seconds to administer. The need for continued therapy should be periodically reassessed based upon the patient’s disease severity and level of asthma control.
Xolair (omalizumab) should not be administered to patients with known hypersensitivity to omalizumab or any component of the formulation (see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING), or patients who have experienced a severe hypersensitivity reaction to Xolair (see 7 WARNINGS AND PRECAUTIONS, Anaphylaxis).
PrXOLAIR® (omalizumab) Page 5 of 86
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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PrXOLAIR® (omalizumab) Page 16 of 86 Corticosteroid Reduction Systemic or inhaled corticosteroids should not be abruptly discontinued upon initiation of Xolair therapy in allergic asthma or chronic rhinosinusitis with nasal polyps (CRSwNP).
Decreases in corticosteroids should be performed under the direct supervision of a physician and may need to be performed gradually. Information for Patients Patients should be advised of the risk of life-threatening anaphylaxis with Xolair and that there have been reports of anaphylaxis up to 4 days after administration of Xolair.
Xolair should only be initiated in a healthcare setting by healthcare providers. Patients should be closely observed following its administration. Patients should be informed of the signs and symptoms of anaphylaxis. Patients should be instructed to seek immediate medical care should such signs or symptoms occur (see 7 WARNINGS AND PRECAUTIONS, Anaphylaxis).
Asthma patients receiving Xolair should be instructed not to decrease the dose of or stop taking any other asthma medications unless otherwise instructed by their physician. Asthma patients should be told that they may not see immediate improvement in their asthma after beginning Xolair therapy.
Other IgE-Associated disorders Xolair has not been studied in patients with hyperimmunoglobulin E syndrome, allergic bronchopulmonary aspergillosis, or for the prevention of anaphylactic reactions. Xolair has not been adequately studied in food allergy, atopic dermatitis, allergic rhinitis, or parasitic infestations.
Cardiovascular Cardiovascular and Cerebrovascular disorders In controlled clinical trials in adults and adolescents 12 years of age and older, cerebrovascular events including transient ischaemic attack and ischaemic stroke were observed in patients treated with Xolair.
(See 8 ADVERSE REACTIONS). In a 5 year observational study of adults and adolescents, a disproportionate increase of overall cardiovascular and cerebrovascular disorders was observed in the Xolair cohort compared to the non- Xolair cohort (see 8 ADVERSE REACTIONS).
Driving and Operating Machinery Patients receiving Xolair should be informed that if they experience dizziness, fatigue, syncope or somnolence, they should not drive or use machines. Hepatic/Biliary/Pancreatic Xolair therapy has not been studied in patients with pre-existing hepatic impairment.
Caution should be exercised when administering Xolair in these patient populations. Immune Churg-Strauss syndrome and hypereosinophilic syndrome {wording as per SPC} PrXOLAIR® (omalizumab) Page 17 of 86 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 agents, including omalizumab, may present or develop systemic eosinophilia and vasculitis. These events are commonly associated with the reduction of oral corticosteroid therapy. 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.
Immunogenicity As with all DNA derived humanized monoclonal antibodies patients may rarely develop antibodies to omalizumab (See 8 ADVERSE REACTIONS). Discontinuation of omalizumab should be considered in all severe cases of Chrug-Strauss syndrome, hypereosinophilic syndrome and serum sickness.
Serum sickness Serum sickness and serum sickness-like reactions, which are delayed allergic type III […]
Dosing Considerations for Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) The appropriate dose and dosing frequency of Xolair for these conditions is determined by baseline immunoglobulin E (IgE) (IU/mL), measured before the start of treatment, and body weight (kg).
Prior to initial dosing, 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 Xolair in 1 to 4 injections may be needed for each administration.
See Table 5 for a conversion chart and Table 3 for dose determination. Patients whose baseline IgE levels or body weight in kilograms are outside the limits of the dosing table should not be given Xolair. In clinical trials for nasal polyps, changes in nasal polyps score (NPS) and nasal congestion score (NCS) were observed as early as the first assessment at 4 weeks.
Dosing Considerations for Chronic Idiopathic Urticaria Xolair (omalizumab) 150 mg or 300 mg are administered subcutaneously every 4 weeks. 3 Chronic Idiopathic Urticaria). Prescribers are advised to periodically reassess the need for continued therapy.
Clinical trial experience of long-term treatment beyond 6 months in this indication is limited. Dosing of Xolair in CIU patients is not dependent on serum IgE (free or total) level or body weight. 2 Recommended Dose and Dosage Adjustment Recommended Dose for Asthma Patients • Adult and adolescent patients 12 years of age and older: Initiate dose according to Table 1.
• Pediatric patients 6 to <12 years of age: initiate dose according to Table 2. Table 1 - Xolair doses (mg) administered by subcutaneous injection every 4 weeks (light-grey area) or 2 weeks (white area) for adult and adolescents 12 years of age and older for allergic asthma Body weight (kg) Baseline IgE (IU/mL)* Dosing Freq.
4 mcg/L ≥30-100 IU/mL = ≥72-240 ng/mL >100-200 IU/mL = >240-480 ng/mL >200-300 IU/mL = >480-720 ng/mL >300-400 IU/mL = >720-960 ng/mL >400-500 IU/mL = >960-1200 ng/mL >500-600 IU/mL = >1200-1440 ng/mL >600-700 IU/mL = >1440-1680 ng/mL PrXOLAIR® (omalizumab) Page 7 of 86 Table 2 - Xolair doses (mg) administered by subcutaneous injection every 4 weeks (light-grey area) or 2 weeks (white area) for children 6 to <12 years of age for allergic asthma Baseline IgE (IU/mL)* Dosing Freq.
4 mcg/L ≥30-100 IU/mL = ≥72-240 ng/mL >100-200 IU/mL = >240-480 ng/mL >200-300 IU/mL = >480-720 ng/mL >300-400 IU/mL = >720-960 ng/mL >400-500 IU/mL = >960-1200 ng/mL >500-600 IU/mL = >1200-1440 ng/mL >600-700 IU/mL = >1440-1680 ng/mL >700-800 IU/mL = >1680-1920 ng/mL >800-900 IU/mL = >1920-2160 ng/mL >900-1000 IU/mL = >2160-2400 ng/mL >1000-1100 IU/mL = >2400-2640 ng/mL >1100-1200 IU/mL = >2640-2880 ng/mL >1200-1300 IU/mL = […]