Teva Pharmaceutical Industries Ltd.
Treatment for: Asthma
Cinqair (reslizumab) is an interleukin 5 antagonist monoclonal antibody (IgG4 kappa) indicated for add-on maintenance treatment of patients with eosinophilic asthma.
CINQAIR- reslizumab injection, solution, concentrate
Teva Respiratory, LLC
WARNING: ANAPHYLAXIS
Anaphylaxis has been observed with CINQAIR infusion in 0.3% of patients in placebo-controlled clinical studies. Anaphylaxis was reported as early as the second dose of CINQAIR [see Warnings and Precautions (5.1), Adverse Reactions (6)].
Anaphylaxis can be life-threatening. Patients should be observed for an appropriate period of time after CINQAIR administration by a healthcare professional prepared to manage anaphylaxis. Discontinue CINQAIR immediately if the patient experiences signs or symptoms of anaphylaxis [see Dosage and Administration (2.2), Warnings and Precautions (5.1)].
1 INDICATIONS AND USAGE
CINQAIR� 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:
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CINQAIR is not indicated for treatment of other eosinophilic conditions.
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CINQAIR is not indicated for the relief of acute bronchospasm or status asthmaticus [see Warnings and Precautions (5.2)].
2 DOSAGE AND ADMINISTRATION
2.1 Dosing
CINQAIR is for intravenous infusion only. Do not administer as an intravenous push or bolus.
The recommended dosage regimen is 3 mg/kg once every 4 weeks administered by intravenous infusion over 20-50 minutes [see Dosage and Administration (2.2)].
Discontinue the infusion immediately if the patient experiences a severe systemic reaction, including anaphylaxis [see Contraindications (4), Warnings and Precautions (5.1)].
