cinqair
reslizumab · by teva respiratory llc
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Overview
11 DESCRIPTION CINQAIR (reslizumab) is a humanized interleukin-5 antagonist monoclonal antibody (IgG4κ). Reslizumab is produced by recombinant DNA technology in murine myeloma non-secreting 0 (NS0) cells. Reslizumab has a molecular weight of approximately 147 kDa. CINQAIR is a sterile, preservative-free, clear to slightly hazy/opalescent, colorless to slightly yellow solution (injection) for intravenous infusion. Since CINQAIR is a protein, proteinaceous particles may be present in the solution that appear as translucent to white, amorphous particulates. Each single-use vial contains 100 mg reslizumab in 10 mL. Each mL contains 10 mg of reslizumab, glacial acetic acid (0.12 mg), sodium acetate trihydrate (2.45 mg), and sucrose (70 mg), with a pH of 5.5.
How to use
2 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 ) 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 )]. 2.2 Preparation and Administration Instructions CINQAIR is provided as a solution in a single-use vial for intravenous infusion only and should be prepared by a healthcare professional using aseptic technique as follows: Preparation of intravenous infusion Remove CINQAIR from the refrigerator. To minimize foaming, do not shake CINQAIR. Inspect visually for particulate matter and discoloration prior to administration. CINQAIR solution is clear to slightly hazy/opalescent, colorless to slightly yellow liquid. Since CINQAIR is a protein, proteinaceous particles may be present in the solution that appear as translucent…
Side effects
The following adverse reactions are discussed in other sections of the labeling: Anaphylaxis [see Warnings and Precautions ( 5.1 )] Malignancy [see Warnings and Precautions ( 5.3 )] The most common adverse reaction (incidence greater than or equal to 2%) includes oropharyngeal pain. ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals at 1-888-483-8279 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Overall, 2195 subjects received at least 1 dose of CINQAIR. The data described below reflect exposure to CINQAIR in 1611 patients with asthma, including 1120 exposed for up to 16 weeks, 1006 exposed for 6 months, 759 exposed for 1 year, and 249 exposed for longer than 2 years. The above referenced safety exposure for CINQAIR is derived from placebo-controlled studies ranging from 15 to 52 weeks in duration (CINQAIR 0.3 mg/kg and 3 mg/kg [n=1131] and placebo [n=730]) and 480 new CINQAIR 3 mg/kg exposures (previously on placebo) from a single open-label extension study (n=1051). While a lower dose of CINQAIR 0.3 mg/kg (n=103) was included in a clinical trial,…
Warnings
Important safety information
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 )] . 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 )
Interactions
No formal clinical drug interaction studies have been performed with CINQAIR.
May treat
Dosage forms
INJECTABLE
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Frequently asked questions
- What is Cinqair?
- 11 DESCRIPTION CINQAIR (reslizumab) is a humanized interleukin-5 antagonist monoclonal antibody (IgG4κ). Reslizumab is produced by recombinant DNA technology in murine myeloma non-secreting 0 (NS0) cells. Reslizumab has a molecular weight of approximately 147 kDa. CINQAIR is a sterile, preservative-free, clear to slightly hazy/opalescent, colorless to slightly yellow solution (injection) for intravenous infusion. Since CINQAIR is a protein, proteinaceous particles may be present in the solution that appear as translucent to white, amorphous particulates. Each single-use vial contains 100 mg reslizumab in 10 mL. Each mL contains 10 mg of reslizumab, glacial acetic acid (0.12 mg), sodium acetate trihydrate (2.45 mg), and sucrose (70 mg), with a pH of 5.5.
- What does Cinqair treat?
- Cinqair (Reslizumab) is indicated for asthma, per its drug-label indications. This is general reference, not medical advice.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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