Xolair

Xolair

omalizumab

Manufacturer:

Novartis

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Omalizumab
Indications/Uses
Moderate to severe persistent allergic asthma whose symptoms are inadequately controlled w/ inhaled corticosteroids in adults & childn ≥6 yr. Nasal polyps w/ inadequate response to intranasal corticosteroids in adults ≥18 yr. Chronic spontaneous urticaria (CSU) refractory to standard care in adults & adolescents ≥12 yr.
Dosage/Direction for Use
SC Allergic asthma & Nasal polyps 75-600 mg in 1-4 inj every 2-4 wk based on total IgE level & body wt. CSU Recommended dose: 300 mg every 4 wk. Alternatively, 150 mg every 4 wk.
Contraindications
Special Precautions
Not to inj via IV or IM. Anaphylaxis & anaphylactoid reactions; serum sickness & serum sickness-like reactions. Known history of anaphylaxis. Not to be used for acute asthma exacerbations, acute bronchospasm or status asthmaticus. Atopic dermatitis, allergic rhinitis or food allergy. Patients at high risk of helminth infection; w/ hyper-IgE syndrome or allergic bronchopulmonary aspergillosis; autoimmune diseases, immune complex-mediated conditions. Women w/ poorly or moderately controlled asthma. Not recommended to abruptly discontinue systemic or inhaled corticosteroids after initiation of therapy in allergic asthma or nasal polyps. Pre-existing renal or hepatic impairment. Increased risk of pre-eclampsia in mother & prematurity, low birth wt, & small for gestational age in neonate. Closely monitor asthma level in pregnant women. Pregnancy & lactation. Not recommended in childn <6 yr w/ allergic asthma, <12 yr w/ CSU or <18 yr w/ nasal polyps. Elderly ≥65 yr.
Adverse Reactions
Pyrexia; headache. Upper abdominal pain; inj site reactions eg, pain, erythema, pruritus, swelling; dizziness; arthralgia; nasopharyngitis, sinusitis, upper viral resp tract infection.
MIMS Class
Antiasthmatic & COPD Preparations / Antihistamines & Antiallergics
ATC Classification
R03DX05 - omalizumab ; Belongs to the class of other systemic drugs used in the treatment of obstructive airway diseases.
Presentation/Packing
Form
Xolair powd for inj 150 mg
Packing/Price
1's
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