CINQAIR- reslizumab injection, solution, concentrate

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

RESLIZUMAB (UNII: 35A26E427H) (RESLIZUMAB - UNII:35A26E427H)

Available from:

Teva Respiratory, LLC

INN (International Name):

RESLIZUMAB

Composition:

RESLIZUMAB 10 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

CINQAIR (reslizumab) injection, 100 mg/10 mL (10 mg/mL), is supplied as a preservative-free, sterile, clear to slightly hazy/opalescent, colorless to slightly yellow solution in single-use vials. The following packaging configuration is available: Storage and Stability: Refrigerate at 2 ºC to 8ºC (36°F to 46°F). Do not freeze. Do not shake. Protect the vials from light by storing in the original package until time of use.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

CINQAIR- RESLIZUMAB INJECTION, SOLUTION, CONCENTRATE
TEVA RESPIRATORY, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CINQAIR SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR CINQAIR.
CINQAIR (RESLIZUMAB) INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2016
WARNING: ANAPHYLAXIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
ANAPHYLAXIS OCCURRED WITH CINQAIR INFUSION IN 0.3% OF PATIENTS IN
PLACEBO-CONTROLLED STUDIES (5.1)
PATIENTS SHOULD BE OBSERVED FOR AN APPROPRIATE PERIOD OF TIME AFTER
CINQAIR INFUSION; HEALTHCARE
PROFESSIONALS SHOULD BE PREPARED TO MANAGE ANAPHYLAXIS THAT CAN BE
LIFE-THREATENING (5.1)
DISCONTINUE CINQAIR IMMEDIATELY IF THE PATIENT EXPERIENCES ANAPHYLAXIS
(5.1)
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 (1).
Limitations of Use: CINQAIR is NOT indicated for:
treatment of other eosinophilic conditions (1)
relief of acute bronchospasm or status asthmaticus (1)
DOSAGE AND ADMINISTRATION
CINQAIR is for intravenous infusion only. Do not administer as an
intravenous push or bolus (2.1)
CINQAIR should be administered by a healthcare professional prepared
to manage anaphylaxis (2.2)
Recommended dosage regimen is 3 mg/kg once every 4 weeks by
intravenous infusion over 20-50 minutes (2.1)
DOSAGE FORMS AND STRENGTHS
Injection: 100 mg/10 mL (10 mg/mL) solution in single-use vials (3)
CONTRAINDICATIONS
Known hypersensitivity to reslizumab or any of its excipients (4)
WARNINGS AND PRECAUTIONS
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
helmint