Reslizumab

Reslizumab is an interleukin-5 antagonist (IgG4, kappa). IL-5 is the major cytokine responsible for the growth and differentiation, recruitment, activation, and survival of eosinophils.

• 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.ICD-10: J45.909

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

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 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.

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.

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, 3 mg/kg is the only recommended dose [see Dosage and Administration ( 2.1 )] . Of the 1611 patients, 1596 received the 3 mg/kg dose, 1028 of which were in the placebo-controlled studies.

8.1 Pregnancy 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 animal reproduction studies, there was no evidence of embryo-fetal adverse developmental effects with intravenous administration of reslizumab during organogenesis to pregnant mice and rabbits at doses that produced exposures up to approximately 6 times the exposure at the maximum recommended human dose (MRHD) in mice and approximately 17 times the exposure at the MRHD in rabbits [see Data] . The estimated background risk of major birth defects and miscarriage for the indicated population(s) are unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Metabolism

The pharmacokinetics (PK) of reslizumab were characterized in healthy adults (n=130), in patients with asthma (n=438), and in other patient populations (n=236). The PK characteristics of reslizumab were similar across these populations.

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.

• Mar 23, 2016BLABLA761033Teva Respiratory Llc

1. 1Dyspnoea9614%
2. 2Asthma9214%
3. 3Drug Ineffective8312%
4. 4Incorrect Dose Administered8012%
5. 5Hypertension6710%
6. 6Cough477.0%
7. 7Headache436.4%
8. 8Wheezing406.0%
9. 9Fatigue395.8%
10. 10Oropharyngeal Pain314.6%
11. 11Myalgia304.5%
12. 12Pneumonia304.5%
13. 13Nausea294.3%
14. 14Chest Discomfort274.0%
15. 15Malaise263.9%

The 10 most recently updated of 28 ClinicalTrials.gov registrations naming Reslizumab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Dupilumab as Add-On Therapy for Hypereosinophilic Syndrome With Partial Clinical Response to Eosinophil-Depleting Biologic Agents
  Recruiting · Phase 2 · Interventional · 30 enrolled · National Institute of Allergy and Infectious Diseases (NIAID)
  NCT06477653updated 2026-05-11
• A Retrospective Chart Review to Investigate Clinical Remission in Patients With Severe Asthma Treated With Biologics in the United Kingdom National Health Service
  Completed · Observational · 415 enrolled · AstraZeneca
  NCT06261567updated 2025-08-19
• Pharmacodynamic Biomarkers to Support Biosimilar Development: Interleukin-5 Antagonists
  Completed · Phase 1 · Interventional · 72 enrolled · Food and Drug Administration (FDA)
  NCT04183192updated 2024-04-22
• Efficacy of Reslizumab Dose Escalation in Patients With Severe Asthma
  Completed · Phase 4 · Interventional · 10 enrolled · McMaster University
  NCT04710134updated 2024-01-25
• Comparison of Biologicals in Treatment of Severe Asthma
  Completed · Observational · 64 enrolled · Helsinki University Central Hospital
  NCT04158050updated 2023-12-04
• Fluctuation Analyses of Asthma Patients With Biologics Use
  Unknown · Observational · 48 enrolled · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  NCT06024707updated 2023-11-01
• A Study of Reslizumab in Patients 12 Years of Age and Older With Severe Eosinophilic Asthma
  Terminated · Phase 3 · Interventional · 391 enrolled · Teva Branded Pharmaceutical Products R&D, Inc.
  NCT03052725updated 2022-12-14
• Reslizumab to Prevent Post-treatment Eosinophilia in Loiasis
  Completed · Phase 2 · Interventional · 31 enrolled · National Institute of Allergy and Infectious Diseases (NIAID)
  NCT01111305updated 2022-01-27
• A Study to Evaluate the Efficacy and Safety of Reslizumab (3.0 mg/kg) in the Reduction of Clinical Asthma Exacerbations in Patients (12-75 Years of Age) With Eosinophilic Asthma
  Completed · Phase 3 · Interventional · 489 enrolled · Teva Branded Pharmaceutical Products R&D, Inc.
  NCT01287039updated 2021-11-09
• Study of Reslizumab in Participants With Uncontrolled Asthma and Elevated Blood Eosinophils
  Completed · Phase 3 · Interventional · 468 enrolled · Teva Branded Pharmaceutical Products R&D, Inc.
  NCT02452190updated 2021-11-09

Frequently asked questions

How does Reslizumab work?

Reslizumab is an interleukin-5 antagonist (IgG4, kappa). IL-5 is the major cytokine responsible for the growth and differentiation, recruitment, activation, and survival of eosinophils.

What is Reslizumab used for?

According to FDA labeling, Reslizumab carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Reslizumab?

Reslizumab is classified as Other systemic drugs for obstructive airway diseases, Interleukin-5 Antagonist, Interleukin-5 Antagonists.

What are the brand names for Reslizumab?

Reslizumab is marketed under brand names including Cinqair.

What are the contraindications for Reslizumab?

Reslizumab labeling lists contraindications including: CINQAIR is contraindicated in patients who have known hypersensitivity to reslizumab or any of its excipients [see Warnings and Precautions ( 5.1 )] .. Always consult the full prescribing information and a clinician.