싱케어주(레슬리주맙)

® is indicated for the add-on maintenance treatment of patients with severe asthma aged 18 years and older with an eosinophilic phenotype [see Clinical Studies ( 14 )] . Limitation of Use: CINQAIR is not indicated for treatment of other eosinophilic conditions. CINQAIR is not indicated for the relief of acute bronchospasm or status asthmaticus [see Warnings and Precautions ( 5.2 )] . CINQAIR is an interleukin-5 antagonist monoclonal antibody (IgG4 kappa) indicated for add-on maintenance treatment of patients with severe asthma aged 18 years and older, and with an eosinophilic phenotype ( 1 ). Limitations of Use : CINQAIR is not indicated for: treatment of other eosinophilic conditions ( 1 ) relief of acute bronchospasm or status asthmaticus ( 1 )

is contraindicated in patients who have known hypersensitivity to reslizumab or any of its excipients [see Warnings and Precautions ( 5.1 )] . Known hypersensitivity to reslizumab or any of its excipients ( 4 )

Malignancy: Malignancies were observed in clinical studies. ( 5.3 ) Reduction in Corticosteroid Dosage: Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with CINQAIR. Decrease corticosteroids gradually, if appropriate. ( 5.4 ) Parasitic (Helminth) Infection: Treat patients with pre-existing helminth infections before therapy with CINQAIR. If patients become infected while receiving CINQAIR and do not respond to anti-helminth treatment, discontinue CINQAIR until the parasitic infection resolves. ( 5.5 ) 5.1 Anaphylaxis Anaphylaxis to CINQAIR was reported in 0.3% of asthma patients in placebo-controlled clinical studies [see Adverse Reactions ( 6.1 )] . These events were observed during or within 20 minutes after completion of the CINQAIR infusion and reported as early as the second dose of CINQAIR. Manifestations included dyspnea, decreased oxygen saturation, wheezing, vomiting, and skin and mucosal involvement, including urticaria. In all 3 cases, CINQAIR was discontinued. Anaphylaxis can be life-threatening. CINQAIR should be administered by a healthcare professional prepared to manage anaphylaxis. Patients should be observed for an appropriate period of time after CINQAIR administration. If severe systemic reactions, including anaphylaxis, occur, stop administration of CINQAIR immediately and provide appropriate medical treatment. Prior to CINQAIR administration, inform patients of the signs and symptoms of anaphylaxis and instruct …

8.1 Pregnancy Risk Summary The data on pregnancy exposure from the clinical trials are insufficient to inform on drug-associated risk. Monoclonal antibodies, such as reslizumab, are transported across the placenta in a linear fashion as pregnancy progresses; therefore, potential effects on a fetus are likely to be greater during the second and third trimester of pregnancy. Reslizumab has a long half-life [see Clinical Pharmacology ( 12.3 )] . This should be taken into consideration. In animal reproduction studies, there was no evidence of embryo-fetal adverse developmental effects with intravenous administration of reslizumab during organogenesis to pregnant mice and rabbits at doses that …