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INDICATIONS AND USAGE

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.

Limitations of Use: CINQAIR is not indicated for:

treatment of other eosinophilic conditions
relief of acute bronchospasm or status asthmaticus

IMPORTANT SAFETY INFORMATION

WARNING: ANAPHYLAXIS

Anaphylaxis, occurring in 0.3% of CINQAIR patients in clinical studies, was reported as early as the second dose.
As anaphylaxis can be life-threatening, observe patients after CINQAIR administration and be prepared to manage anaphylaxis. Discontinue CINQAIR immediately if there are signs or symptoms of anaphylaxis.

IMPORTANT SAFETY INFORMATION (continued)

CONTRAINDICATIONS

CINQAIR is contraindicated in patients hypersensitive to reslizumab or its excipients.

WARNINGS AND PRECAUTIONS

Acute Asthma Symptoms or Deteriorating Disease: Do not use CINQAIR to treat acute asthma symptoms or exacerbations, acute bronchospasms, or status asthmaticus. Patients should seek medical advice if their asthma remains uncontrolled or worsens after CINQAIR initiation.
Malignancy: In clinical studies, 6/1028 (0.6%) of CINQAIR patients had at least 1 malignant neoplasm vs 2/730 (0.3%) of placebo patients. The malignancies were diverse without clustering of any tissue type. Most malignancies were diagnosed within 6 months of CINQAIR use.
Reduction of Corticosteroid Dosage: Reduction of maintenance corticosteroids following use of CINQAIR was not assessed. Do not abruptly discontinue systemic or inhaled corticosteroids upon CINQAIR initiation. Reductions in corticosteroid dose, if appropriate, should be gradual and supervised by a physician and may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroids.
Parasitic (Helminth) Infection: Eosinophils may be involved in immunological response to helminth infections. Treat patients with preexisting helminth infections before initiating CINQAIR. If patients become infected while receiving CINQAIR and do not respond to anti-helminth treatment, discontinue CINQAIR until infection resolves.

ADVERSE REACTIONS

The most common adverse reaction (incidence greater than or equal to 2%) includes oropharyngeal pain.

Please see Full Prescribing Information, including Boxed WARNING .

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