Omalizumab parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Injections of omalizumab.
Drugs List
Therapeutic Indications
Uses
Chronic rhinosinusitis with nasal polyposis
Chronic spontaneous urticaria
Severe persistent asthma caused by perennial air-borne allergens: adjunct
Allergic asthma
Omalizumab should only be used in patients with convincing IgE (immunoglobulin E) mediated asthma.
Adults and children over 12 years
Add-on therapy for severe persistent allergic asthma in patients who have a positive skin test or in-vitro reactivity to a perennial aeroallergen, and who have reduced lung function (FEV1 less than 80%) and also frequent symptoms or waking at night, with multiple severe exacerbations despite daily high dose inhaled corticosteroids and a long acting inhaled beta2-agonist.
Children aged 6 to 12 years
Add-on therapy for severe persistent allergic asthma in patients who have a positive skin test or in-vitro reactivity to a perennial aeroallergen, and also frequent symptoms or waking at night, with multiple severe exacerbations despite daily high dose inhaled corticosteroids and a long acting inhaled beta2-agonist.
Severe chronic rhinosinusitis with nasal polyps (CRSwNP)
Add-on therapy with intranasal corticosteroids (INC) for adults aged over 18 years, when INC treatment alone has not proved sufficient.
Chronic spontaneous urticaria
Add-on therapy for chronic spontaneous urticaria in adults and children over 12 years, in patients with an inadequate response to H1 antihistamine treatment.
Dosage
Allergic asthma patients with IgE lower than 76international units (units)/ml were less likely to experience benefit. Prescribing physicians should ensure that adult and adolescent patients with IgE below 76units/ml and paediatric patients (6 to12 years old) with IgE below 200units/ml have unequivocal in vitro reactivity (RAST) to a perennial allergen before starting therapy.
Adults
Allergic Asthma and Chronic rhinosinusitis with nasal polyps
The appropriate dose and dosing frequency of omalizumab is determined by baseline IgE (units/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 75mg to 600mg of omalizumab in 1 to 4 injections may be needed for each administration.
Patients with body weight lower than 20kg or higher than 150kg should not be given omalizumab for allergic asthma. Patients with body weight lower than 30kg or higher than 150kg should not be given omalizumab for chronic rhinosinusitis with nasal polyps. For dose determination based by bodyweight and IgE levels see product information.
Patients with baseline IgE lower than 30units/ml or higher than 1500units/ml should not be given omalizumab.
The maximum recommended dose is 600mg omalizumab every two weeks.
Chronic Spontaneous Urticaria (CSU)
The recommended dose is 300mg by subcutaneous injection every four weeks.
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.
Children
Allergic Asthma
Children 6 years and over
See Dosage; Adult.
Children under 6 years
Not recommended.
Chronic Spontaneous Urticaria (CSU)
Children 12 years and over
The recommended dose is 300mg by subcutaneous injection every four weeks.
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.
Additional Dosage Information
At 16 weeks after commencing therapy for allergic asthma, patients should be assessed by their physician for treatment effectiveness before further injections are administered. The decision to continue should be based on whether a marked improvement in overall asthma control is seen.
Changes in nasal polyps score and nasal congestion score for the treatment for chronic rhinosinusitis with nasal polyps have been seen at 4 weeks. The decision to continue treatment should be reassessed based on the disease severity and level of symptom control.
Total IgE levels are elevated during treatment and remain elevated for up to one year after the discontinuation of treatment. Therefore, re-testing of IgE levels during 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.
Contraindications
Children under 6 years
Precautions and Warnings
Autoimmune disease
History of anaphylaxis
Susceptibility to helminth infections
Breastfeeding
Hepatic impairment
Pregnancy
Renal impairment
Not suitable for acute treatment of bronchospasm
Avoid abrupt withdrawal of concurrent corticosteroids
Exclude hyperimmunoglobulin E syndrome before commencing treatment
Not all available strengths are licensed for all indications
Treatment to be initiated and supervised by a specialist
Contains polysorbate
Needle cover contains a derivative of latex
For subcutaneous use only
Record name and batch number of administered product
Resuscitation facilities must be immediately available
Monitor patients for signs of adverse cardiovascular effects
Monitor patients with immune complex-mediated conditions
Reassess treatment if Churg-Strauss syndrome-type illness develops
Advise patient to report symptoms of serum sickness
Antibodies to ingredient may develop
May cause anaphylactic / anaphylactoid reactions
Discontinue if serious allergic or anaphylactic reaction occurs
Symptoms suggestive of serum sickness include arthritis/arthralgias, rash (urticaria or other forms), fever and lymphadenopathy.
Physicians should be alert to the development of marked eosinophilia, vasculitic rash, worsening pulmonary symptoms, paranasal sinus abnormalities, cardiac complications, and/or neuropathy.
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 in allergic patients showed a slight increase in infection rate with omalizumab, although the course, severity, and response to treatment of infection were unaltered. 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 this medication should be considered.
Pregnancy and Lactation
Pregnancy
Use omalizumab with caution during pregnancy.
The manufacturer notes that omalizumab may be considered in pregnancy. Omalizumab crosses the placental barrier but the moderate amount of data in human pregnancy indicates no malformative or foeto/neonatal toxicity. Omalizumab has been associated with a decrease in platelets in animals.
Lactation
Use omalizumab with caution during breastfeeding.
The manufacturer notes that omalizumab may be considered during breastfeeding. It is expected that omalizumab will be present in human milk. Data in non-human primates have shown excretion of omalizumab into milk. The EXPECT study did not indicate adverse effects on the breast-fed infant exposed to omalizumab.
Side Effects
Abdominal pain
Allergic reaction
Alopecia
Anaphylactic reaction
Anaphylactic shock
Angioedema
Arm oedema
Arrhythmias
Arthralgia
Bronchospasm
Cardiac failure
Cardiomyopathy
Cerebrovascular disorders
Churg-Strauss syndrome
Cough
Diarrhoea
Dizziness
Dyspepsia
Erythema at injection site
Fatigue
Fever
Flushing
Headache
Increased susceptibility to parasitic infections
Influenza-like symptoms
Injection site reactions
Joint swelling
Laryngeal oedema
Local pain (injection site)
Lymphadenopathy
Myalgia
Myocardial ischaemia
Nausea
Paraesthesia
Pharyngitis
Photosensitivity
Postural hypotension
Pruritus
Pulmonary hypertension
Pyrexia
Rash
Serum sickness
Serum sickness-like reactions
Somnolence
Swelling (injection site)
Syncope
Systemic lupus erythematosus
Thrombocytopenia
Thrombophlebitis
Thrombosis
Urticaria
Weight gain
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: April 2021
Reference Sources
Summary of Product Characteristics: Xolair 75mg solution for injection. Novartis Europharm Limited. Revised July 2020.
Summary of Product Characteristics: Xolair 150mg solution for injection. Novartis Europharm Limited. Revised July 2020.
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