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CINQAIR is a brand name for Reslizumab. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 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: CINQAIR is not indicated for treatment of other eosinophilic conditions. CINQAIR is not indicated…
Verbatim from this product's FDA label. Tap a section to expand.
2 DOSAGE AND ADMINISTRATION CINQAIR is for intravenous infusion only. 1 Dosing CINQAIR is for intravenous infusion only. Do not administer as an intravenous push or bolus. 2 )] . 1 )]. 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 to white, amorphous particulates.
Do not administer if discolored or if other foreign particulate matter is present. Withdraw the proper volume of CINQAIR from the vial(s), based on the recommended weight-based dosage. Discard any unused portion. 9% Sodium Chloride Injection, USP to minimize foaming of CINQAIR (CINQAIR is compatible with polyvinylchloride (PVC) or polyolefin infusion bags).
Gently invert the bag to mix the solution. Do not shake. Do not mix or dilute with other drugs. Administer immediately after preparation. If not used immediately, store diluted solutions of CINQAIR in the refrigerator at 2°C to 8°C (36°F to 46°F) or at room temperature up to 25ºC (77ºF), protected from light, for up to 16 hours.
The time between preparation of CINQAIR and administration should not exceed 16 hours. 1 )] . If refrigerated prior to administration, allow the diluted CINQAIR solution to reach room temperature. 2 micron). CINQAIR is compatible with polyethersulfone (PES), polyvinylidene fluoride (PVDF), nylon, and cellulose acetate in-line infusion filters.
Infuse the diluted solution of CINQAIR intravenously, over a 20 to 50 minute period. Infusion time may vary depending on the total volume to be infused as based upon patient weight. Do not infuse CINQAIR concomitantly in the same intravenous line with other agents.
No physical or biochemical compatibility studies have been conducted to evaluate the co-administration of CINQAIR with other agents. Observe the patient over the infusion and for an appropriate period of time following infusion. 9% Sodium Chloride Injection, USP to ensure that all CINQAIR has been administered.
3 )] The most common adverse reaction (incidence greater than or equal to 2%) includes oropharyngeal pain. 1 ). gov/medwatch. 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.
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). 1 )] . Of the 1611 patients, 1596 received the 3 mg/kg dose, 1028 of which were in the placebo-controlled studies.
In the placebo-controlled asthma studies, the population studied was 12 to 76 years of age, 62% female, and 73% white. 4 )] . Serious adverse reactions that occurred in placebo-controlled studies in more than 1 subject and in a greater percentage of subjects treated with CINQAIR (n=1131) than placebo (n=730) included anaphylaxis (3 subjects vs.
0 subjects, respectively). 1 )] . 3 )] . 6% vs. 2%). CPK elevations and muscle-related adverse reactions Elevated baseline creatine phosphokinase (CPK) was more frequent in patients randomized to CINQAIR (14%) versus placebo (9%). Transient CPK elevations in patients with normal baseline CPK values were observed more frequently with CINQAIR (20%) versus placebo (18%) during routine laboratory assessments.
4% in the placebo group. CPK elevations >10 x ULN were asymptomatic and did not lead to treatment discontinuation. 5% (4/730) of patients in the placebo group. 5% of patients treated with CINQAIR 3 mg/kg and placebo, respectively. These reactions included (but were not limited to) musculoskeletal chest pain, neck pain, muscle spasms, extremity pain, muscle fatigue, and musculoskeletal pain.
5 WARNINGS AND PRECAUTIONS Malignancy: Malignancies were observed in clinical studies. 3 ) Reduction in Corticosteroid Dosage: Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with CINQAIR. Decrease corticosteroids gradually, if appropriate.
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.
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 them to seek immediate medical care if symptoms occur.
Discontinue CINQAIR use permanently if the patient experiences signs or symptoms of anaphylaxis [see Contraindications ( 4 )]. 2 Acute Asthma Symptoms or Deteriorating Disease CINQAIR should not be used to treat acute asthma symptoms or acute exacerbations.
Do not use CINQAIR to treat acute bronchospasm or status asthmaticus. Patients should seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment with CINQAIR. 3%) patients in the placebo group. The observed malignancies in CINQAIR-treated patients were diverse in nature and without clustering of any particular tissue type.
1 )] . Known hypersensitivity to reslizumab or any of its excipients ( 4 )
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2 Immunogenicity As with all therapeutic proteins, there is a potential for immunogenicity. 4%) of CINQAIR-treated patients (3 mg/kg). 8%) of CINQAIR-treated (3 mg/kg) asthma patients over 36 months. The antibody responses were of low titer and often transient.
Neutralizing antibodies were not evaluated. 2 )] . Product-specific IgE antibodies were not detected in patients who reported anaphylactic reactions. The data reflect the percentage of patients whose test results were positive for antibodies to reslizumab in specific assays.
The observed incidence of antibody response is highly dependent on several factors, including assay sensitivity and specificity, assay methodology, sample handling, timing of sample collection, concomitant medication, and underlying disease.
For these reasons, comparison of the incidence of antibodies to reslizumab with the incidence of antibodies to other products may be misleading.
The majority of malignancies were diagnosed within less than six months of exposure to CINQAIR. 4 Reduction of Corticosteroid Dosage No clinical studies have been conducted to assess reduction of maintenance corticosteroid dosages following administration of CINQAIR.
Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with CINQAIR. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.
5 Parasitic (Helminth) Infection Eosinophils may be involved in the immunological response to some helminth infections. Patients with known parasitic infections were excluded from participation in clinical studies. It is unknown if CINQAIR will influence the immune response against parasitic infections.
Treat patients with pre-existing helminth infections before initiating CINQAIR. If patients become infected while receiving treatment with CINQAIR and do not respond to anti-helminth treatment, discontinue treatment with CINQAIR until infection resolves.