Omalizumab

Registered South African indications:

• Asthma

Contraindication

• Hypersensitivity to the active ingredient or to any of its excipients

Cautions

• Pregnancy 
• Breastfeeding 
• Renal impairment 
• Hepatic impairment 
• Acute asthma
• Parasitic infections
• Latex sensitivity  
• Corticosteriod use

Forms avail. in SA and covered in this monograph: inj

IgE-mediated asthma

• SC (inj): dose dependant on baseline serum IgE levels and body weight.

  Max: 600mg/2 weeks

  See dosing chart below:

Table 1: Omalizumab doses (mg/dose) administered by subcutaneous injection every 4 weeks

Table 2: Omalizumab doses (mg/dose) administered by subcutaneous injection every 2 weeks

Appropriate dose and frequency determined by baseline IgE and body weight

Patients with IgE levels below 76 IU/ml were less likely to experience benefit

Paed. forms avail. in SA and covered in this monograph: inj

IgE-mediated asthma

Younger than 6 years

• SC (inj): Not established for use 

Older than 6 years

• SC (inj): Refer to dosing charts above

Pregnancy

• Caution
• A moderate amount of data on pregnant women (between 300-1,000 pregnancy outcomes) based on pregnancy registry and post-marketing spontaneous reports, indicates no malformative or foeto/neonatal toxicity
• A prospective pregnancy registry study (EXPECT) in 250 pregnant women with asthma exposed to omalizumab showed the prevalence of major congenital anomalies was similar (8.1% vs. 8.9%) between EXPECT and disease-matched (moderate and severe asthma) patients. The interpretation of data may be impacted due to methodological limitations of the study, including small sample size and non-randomised design
• Omalizumab crosses the placental barrier. However, animal studies do not indicate either direct or indirect harmful effects with respect to reproductive toxicity
• Omalizumab has been associated with age-dependent decreases in blood platelets in non-human primates, with greater relative sensitivity in juvenile animals
• If clinically needed, the use of omalizumab may be considered during pregnancy

Breastfeeding

• Caution; not recommended
• Immunoglobulins G (IgGs) are present in human milk and therefore it is expected that omalizumab will be present in human milk. Available data in non-human primates have shown excretion of omalizumab into milk
• The EXPECT study, with 154 infants who had been exposed to omalizumab during pregnancy and through breastfeeding did not indicate adverse effects on the breastfed infant. The interpretation of data may be impacted due to methodological limitations of the study, including small sample size and non-randomised design
• Given orally, immunoglobulin G proteins undergo intestinal proteolysis and have poor bioavailability. No effects on the breastfed newborns/infants are anticipated
• Consequently, if clinically needed, the use of omalizumab may be considered during breastfeeding

Renal Impairment

• Caution; no information available

Hepatic Impairment

• Caution; no information available

Elderly

• No dosage adjustment recommended

Porphyria Information

• Not yet classified (NC)

Central Nervous System Disorders

• Headache
• Syncope
• Paraesthesia
• Somnolence
• Dizziness
• Asthenia

Cardiovascular Disorders

• Postural hypotension
• Flushing

Respiratory Disorders

• Allergic bronchospasm
• Coughing
• Laryngoedema
• Pharyngitis

Gastrointestinal Disorders

• Upper abdominal pain
• Dyspepsia
• Diarrhoea
• Nausea

Endocrine and Metabolic Disorders

• Increased weight

Musculoskeletal Disorders

• Systemic lupus erythematosus
• Arthralgia
• Myalgia
• Joint swelling

Skin and Subcutaneous Tissue Disorders

• Photosensitivity
• Urticaria
• Rash
• Pruritus
• Angioedema
• Alopecia

Immune, Blood and Lymphatic System Disorders

• Anaphylaxis
• Anti-omalizumab antibody development
• Serum sickness
• Idiopathic thrombocytopenia
• Systemic hypereosinophilic syndrome
• Parasitic infection

• Antihelminthic agents
• Antiparasitic agents

None routine. Specific cases may require

• Baseline serum total IgE
• Pulmonary function

• Omalizumab treatment should be initiated by physicians experienced in the diagnosis and treatment of severe persistent asthma or chronic spontaneous urticaria

Omalizumab binds to IgE, preventing binding to mast cells and basophils and therefore inhibiting release of inflammatory mediators.

Injection (per vial) 150mg

• Xolair (Novartis) originator