XOLAIR
OMALIZUMAB · by NOVARTIS
Composition
Inj: Per ml: Omalizumab 125 mg, powder n vial and solvent in amp.
Indications & Dosage
Prophylaxis of severe persistent allergic asthma: BY SC INJ: Adult: Dose according to immunoglobulin Econcentration and body-weight (consult productliterature). Add-on therapy for chronic spontaneous urticaria in patients with inadequate response to H1 antihistamine treatment: BY SC INJ: Adult: 300 mg every 4 weeks.
Administration
For SC inj only. Doses more than 150 mg should be divided over more than one site, may take 5-10 seconds to administer.Reconstitute using SWFI, and allow 15 to 20 mins (on average) for lyophilized product to dissolve. Draw 1.4 ml sterile water for injection into a 3 ml syringe with a 1 inch 18G needle. Place the vial upright, and inject sterile water into vial gently swirl until solution contains no gel-like particles. Discard if powder takes longer than 40 mins to dissolve
Stability
Store under refrigerated conditions, 2C-8C (36F-46F).
Contraindications
Acute asthma, acute bronchospasm, status asthmatic.
Precautions
Hyper-immunoglobulin E syndrome, renal or hepatic impairment, diabetes allergic broncho-pulmonary aspergillosis, auto- immune disease, immune complex-mediated conditions, susceptibility to hel-minth infection. Withdraw concomitant corticosteroids slowly,
Pregnancy
avoid unless essential
Lactation
Caution advised or avoid unless essential
Side Effects
lnj site reactions, headache, anaphylactic reactions.