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| אלרגיה ואימונולוגיהupdateהרפואה
Now you can change the lives of your refractory CSU patients with Xolair®1
LIFE CHANGING 44% of patients were itch and hives-free with Xolair® 300 mg at 12 weeks2
CSU = Chronic Spontaneous Urticaria References: 1. Xolair Israeli prescribing Information approved by the MoH 2. Maurer M et al. Omalizumab for the Treatment of Chronic Idiopathic or Spontaneous Urticaria. N Engl J Med 2013; 368: 924-35 Important note: Before prescribing, consult full prescribing information. Presentation: 150 mg Omalizumab. Powder and solvent for solution for injection. One vial of XOLAIR 150 mg delivers 150 mg of omalizumab in 1.2 ml after reconstitution with 1.4ml water for injection. Xolair is a recombinant DNA-derived humanized IgG 1κ monoclonal antibody. Indications: ♦ Allergic Asthma: Xolair is indicated for adults and adolescents (12 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. Xolair has been shown to decrease the incidence of asthma exacerbations in these patients. Safety and efficacy have not been established in other allergic conditions. ♦ Chronic spontaneous urticaria (CSU): Xolair is indicated as add-on therapy for the treatment of chronic spontaneous urticaria in adult and adolescent (12 years and above) patients with inadequate response to H1 antihistamine treatment. Dosage: ♦ Allergic Asthma: 75-600 mg of Xolair in one to four injections s.c. every two to four weeks according to body weight and baseline serum total IgE level. 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. ♦ Chronic Spontaneous Urticaria: 300 mg s.c. every 4 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. Contraindications: Xolair should not be administered to patients who have experienced a severe hypersensitivity reaction to Xolair. Warnings/Precautions: Xolair has not been shown to alleviate asthma exacerbations acutely and should not be used for the treatment of acute bronchospasm or status asthmaticus; systemic or inhaled corticosteroids should not be abruptly discontinued upon initiation of Xolair therapy; caution in use with renal or hepatic impaired patients, patients with high risk of parasitic infections; Xolair should be used in pregnancy only if clearly needed. Caution should be exercised when administering Xolair to a nursing woman. Occurrence of local or systemic allergic reactions, including anaphylaxis or serum sickness. Because of the risk of anaphylaxis, patients should be closely observed for an appropriate period of time after Xolair administration, and health care providers administering Xolair should be prepared to manage anaphylaxis that can be life-threatening. Interactions: No formal drug interaction studies have been performed with Xolair. Adverse reactions: ♦ Allergic Asthma: Clinical Trials Experience: The most serious adverse reactions occurring in clinical trials with Xolair were anaphylaxis and malignancies. The adverse reactions most commonly observed among patients treated with Xolair in clinical studies included injection site reaction (45%), viral infections (23%), upper respiratory tract infection (20%), sinusitis (16%), headache (15%), and pharyngitis (11%). These events were observed at similar rates in Xolair-treated patients and control patients. Injection site reactions of any severity occurred at a rate of 45% in Xolair-treated compared with 43% in placebo-treated patients. Postmarketing Spontaneous Reports: Anaphylaxis; severe thrombocytopenia; hair loss; serum sickness. ♦ Chronic Spontaneous Urticaria: Adverse reactions from the pooled CSU safety database at 300mg dose of omalizumab (occurring in ≥1% of patients and ≥2% more frequently in omalizumab treatment group than with placebo): Common – sinusitis, headache, arthralgia, injection site reaction, upper respiratory tract infection. Packs: Each pack contains one single use vial of powder and one ampoule of water for injection. Legal classification: Prescription only medicine.
למידע נוסף יש לעיין בעלון לרופא כפי שאושר ע"י משרד הבריאות הישראלי,ה/ה נכבד/רופא
03-9229230 : פקס03-9201111 :'תקווה טל- פתח,36 רח' שחם, רמת סיב- ג‘י.נוברטיס פארמה סרויסס איי
XOL – NSS 10.2014 Based on IL PI – XOL API SEP14 CL V9
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Xol CSU - 09-14 -NOV 2014
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