Efficacy and Safety Profiles

CINQAIR:

  • 1. Reduced exacerbations in Studies I–II
  • 2. Improved lung function in Studies I–IV
  • 3. Improved quality of life in Studies I–III

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IMPORTANT SAFETY INFORMATION (continued)

CONTRAINDICATIONS
  • CINQAIR is contraindicated in patients who have known hypersensitivity to reslizumab or any of its excipients.
WARNINGS AND PRECAUTIONS
  • 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.
  • 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.
  • 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.
  • Parasitic (Helminth) Infection: Eosinophils may be involved in the immunological response to some helminth 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.
ADVERSE REACTIONS
  • Adverse reactions that occurred at ≥2% incidence and more commonly than in the placebo group included 1 event: oropharyngeal pain (2.6% vs. 2.2%).
  • 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.
  • Myalgia was reported in 1% (10/1028) of patients in the CINQAIR 3 mg/kg group compared to 0.5% (4/730) of patients in the placebo group.
  • Immunogenicity: In placebo-controlled studies, a treatment-emergent anti-reslizumab antibody response developed in 53/983 (5.4%) of CINQAIR-treated patients (3 mg/kg). The antibody responses were of low titer and often transient. There was no detectable impact of the antibodies on the clinical pharmacokinetics, pharmacodynamics, clinical efficacy, and safety of CINQAIR.


Please see Full Prescribing Information, including Boxed WARNING.

References

  1. CINQAIR Prescribing Information. Horsham, PA: Teva Respiratory, LLC.
  2. Castro M, Zangrilli J, Wechsler ME, et al. Reslizumab for inadequately controlled asthma with elevated blood eosinophil counts: results from two multicentre, parallel, double-blind, randomised, placebo-controlled, phase 3 trials. Lancet Respir Med. 2015;3:355-366.
  3. Data on file (Clinical Study Report: A 12-Month, Double-Blind, Placebo-Controlled, Parallel-Group 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. Study C38072/3082). Horsham, PA: Teva Respiratory, LLC; January 2015.
  4. Data on file (Clinical Study Report: A 12-Month, Double-Blind, Placebo-Controlled, Parallel-Group 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. Study C38072/3083). Horsham, PA: Teva Respiratory, LLC; February 2015.
  5. Data on file (Clinical Study Report: A 16-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Reslizumab [0.3 or 3.0 mg/kg] as Treatment for Patients [12-75 Years of Age] with Eosinophilic Asthma. Study C38072/3081). Horsham, PA: Teva Respiratory, LLC; January 2015.
  6. Data on file (Clinical Study Report: A 16-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Reslizumab [3.0 mg/kg] Treatment in Patients With Moderate to Severe Asthma. Study C3807/3084). Horsham, PA: Teva Respiratory, LLC; February 2015.
  7. Corren J, Weinstein S, Janka L, Zangrilli J, Garin M. Phase 3 study of reslizumab in patients with poorly controlled asthma: effects across a broad range of eosinophil counts. Chest. 2016;150(4):799-810.
  8. Bjermer L, Lemiere C, Maspero J, Weiss S, Zangrilli J, Germinaro M. Reslizumab for inadequately controlled asthma with elevated blood eosinophil levels: a randomized phase 3 study. Chest. 2016;150(4):789-798.
  9. Juniper EF, Norman GR, Cox FM, Roberts JN. Comparison of the standard gamble, rating scale, AQLQ and SF-36 for measuring quality of life in asthma. Eur Respir J. 2001;18(1):38-44.
  10. Juniper EF, O’Byrne PM, Guyatt GH, Ferrie PJ, King DR. Development and validation of a questionnaire to measure asthma control. Eur Respir J. 1999;14(4):902-907.
  11. Data on file (Clinical Study Report: Summary of Clinical Safety). Frazer, PA: Teva Respiratory, LLC.