cinqair
Cinqair (Reslizumab) is an interleukin-5 antagonist used to treat Asthma.
Reslizumab · by Teva Respiratory LLC
Key facts
- Active ingredient
- Reslizumab
- Drug class
- Interleukin-5 Antagonist
- Form
- Injectable
- Strength
- Reslizumab 100MG/10ML
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- asthma
- Manufacturer
- Teva Respiratory LLC
- FDA application
- BLA761033
- FDA boxed warning
- Yes — see the boxed warning
What is Cinqair?
From the FDA label: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
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 to white, amorphous…
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,…
FDA Boxed Warning (the FDA’s most serious warning)
Boxed (black-box) warning — from the FDA label
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 )
Warnings
Important safety information
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 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. ( 5.5 ) 5.1 Anaphylaxis Anaphylaxis to CINQAIR was reported in 0.3% of asthma patients in placebo-controlled clinical studies [see Adverse Reactions ( 6.1 )] . 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 )]. 5.2 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. 5.3 Malignancy In placebo-controlled clinical studies, 6/1028 (0.6%) patients receiving 3 mg/kg CINQAIR had at least 1 malignant neoplasm reported compared to 2/730 (0.3%) patients in the placebo group. The observed malignancies in CINQAIR-treated patients were diverse in nature and without clustering of any particular tissue type. The majority of malignancies were diagnosed within less than six months of exposure to CINQAIR. 5.4 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. 5.5 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.
Who should not take Cinqair
CINQAIR is contraindicated in patients who have known hypersensitivity to reslizumab or any of its excipients [see Warnings and Precautions ( 5.1 )] . Known hypersensitivity to reslizumab or any of its excipients ( 4 )
Overdose — what happens if you take too much
Single doses of up to 732 mg have been administered intravenously to subjects in clinical trials without evidence of dose-related toxicities. There is no specific treatment for an overdose with CINQAIR. If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
No formal clinical drug interaction studies have been performed with CINQAIR.
Storing Cinqair, and how long it keeps
Quoted from this product’s own FDA label. Storage belongs to the product and its device, not to the drug in general — a pen and a tablet of the same medicine are kept completely differently.
- “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.”
Drug class
May treat (source: NIH RxClass)
See how Cinqair ranks — best-rated interleukin-5 antagonist for:
Dosage forms
Injectable
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
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Request a 90-day supply
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Use copay cards
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Frequently asked questions
- What does Cinqair treat?
- Cinqair (Reslizumab) may be used to treat asthma, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- Is there a coupon or discount for Cinqair?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Cinqair. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Cinqair?
- Cinqair is marketed by Teva Respiratory LLC. You can see Teva Respiratory LLC's full profile, rating, and other products on pharmaranks.
- Is Cinqair a brand-name or generic drug?
- Cinqair is a brand-name product with the active ingredient Reslizumab.
- Is Cinqair available over the counter?
- No. Cinqair is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Cinqair come in?
- Cinqair is currently marketed as injectable, per the FDA's National Drug Code Directory.
- What class of drug is Cinqair?
- Cinqair is classified as interleukin-5 antagonist, per the FDA's Established Pharmacologic Class.
- Is Cinqair FDA-registered?
- Cinqair is on record with the U.S. FDA under application number BLA761033. You can verify this on its official FDA label.
- Is Cinqair safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Cinqair. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Cinqair?
- Cinqair's side effects are taken directly from its FDA label. From the label: 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 ).… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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