中文药名: 索雷尔注射剂, 乐无喘, 柯耐尔
IMPORTANT SAFETY INFORMATION
Injection site reactions of any severity occurred at a rate of 45% in XOLAIR-treated patients compared with 43% in placebo-treated patients.
The types of injection site reactions included: bruising, redness, warmth, burning, stinging, itching, hive formation, pain, indurations, mass, and inflammation.
XOLAIR(omalizumab) for subcutaneous use 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 areinadequatelycontrolledwithinhaledcorticosteroids.
XOLAIR has been shown to decrease the incidence of asthma exacerbations in these patients.
Important Limitations of Use
XOLAIR is not indicated for treatment of other allergic conditions
XOLAIR is not indicated for the relief of acute bronchospasm or status asthmaticus
XOLAIR is not indicated for use in pediatric patients less than 12 years of age
IMPORTANT SAFETY INFORMATION
Anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of XOLAIR. Anaphylaxis has occurred as early as after the first dose of XOLAIR, but also has occurred beyond 1 year after beginning regularly administered treatment. Because of the risk of anaphylaxis, observe patients closely for an appropriate period of time after XOLAIR administration.
Health care providers administering XOLAIR should be prepared to manage anaphylaxis that can be life-threatening.
Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should symptoms occur (see Warnings and
XOLAIR should only be administered in a healthcare setting by healthcare providers prepared to manage anaphylaxis that can be life-threatening.
XOLAIR should not be administered to patients who have experienced a severe hypersensitivity reaction to XOLAIR or any ingredient of XOLAIR(see Warnings and Precautions). XOLAIR should be discontinued in patients who experience a severe hypersensitivity reaction.
Malignant neoplasms were observed in 20 of 4127 (0.5%) XOLAIR-treated patients compared with 5 of 2236 (0.2%) control patients in clinical studies of asthma and other allergic disorders.
XOLAIR has not been shown to alleviate asthma exacerbations acutely. Do not use XOLAIR to treat acute bronchospasm or status asthmaticus.
A constellation of signs and symptoms including arthritis/arthralgia, rash (urticaria or other forms), fever and lymphadenopathy similar to serum sickness have been reported in post-approval use of XOLAIR in some patients. Physicians should stop XOLAIR if a patient develops this constellation of signs and symptoms.
Patients should be given and instructed to read the accompanying Medication Guide before starting treatment and before each subsequent treatment.
Do not abruptly discontinue corticosteroid use upon initiation of XOLAIR therapy. Decrease corticosteroids gradually under the direct supervision of a physician.
In patients >12 years of age, the most commonly observed adverse reactions (>1% more frequent in XOLAIR-treated patients) from 4 placebo-controlled asthma studies were arthralgia (8%), pain (general)(7%), leg pain (4%), fatigue (3%), dizziness (3%), fracture (2%), arm pain (2%), pruritus (2%), dermatitis (2%), and earache (2%).
The adverse events most frequently resulting in clinical intervention(e.g. discontinuation of XOLAIR, or the need for concomitant medication to treat an adverse event), in either placebo-controlled or other controlled asthma studies, were 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.
Generic Name and Formulations:
Omalizumab 150mg/vial; pwd for SC inj after reconstitution; preservative-free.
Genentech and Novartis
Indications for XOLAIR:
Moderate to severe persistent asthma in patients with a (+) skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled by inhaled corticosteroids.
Adult Dose for XOLAIR:
Base dose and frequency on baseline serum total IgE level and body weight; see literature. Give by SC inj over 5–10 seconds; max 150mg per inj site. 150–375mg every 2 or 4 weeks. Reevaluate periodically.
Children's Dose for XOLAIR:
Antiasthmatic (IgE blocker).
Not for treating acute attacks. Have medications for treating anaphylaxis available, monitor for at least 2 hours after inj; may have delayed reaction. Elevated serum IgE levels may persist for up to 1 year after stopping therapy. Patients at risk of malignancy. Pregnancy (Cat.B). Nursing mothers.
Inj site reactions, viral infections, upper respiratory tract infections (eg, sinusitis, pharyngitis), headache; hypersensitivity reactions (discontinue if severe), anaphylaxis (may be fatal), antibody formation, malignancies.