Cinqair

— THERAPEUTIC CATEGORIES —
  • Asthma/COPD
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Cinqair Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Reslizumab 100mg/10mL; soln for IV infusion; preservative-free.

    Pharmacological Class

    Interleukin-5 antagonist.

    How Supplied

    Single-use vial—1

    Storage

    Refrigerate at 2º C to 8º C (36° F to 46° F). 
    Do not freeze. Do not shake. Protect the vials from light.

    Manufacturer

    Teva Pharmaceuticals

    Generic Availability

    NO

    Cinqair Indications

    Indications

    As add-on maintenance treatment of severe asthma in patients ≥18yrs old, and with an eosinophilic phenotype.

    Limitations of Use

    Not for treating other eosinophilic conditions. Not for relief of acute bronchospasm or status asthmaticus.

    Cinqair Dosage and Administration

    Adult

    Give by IV infusion over 20–50mins. ≥18yrs: 3mg/kg once every 4 weeks.

    Children

    <18yrs: not established.

    Cinqair Contraindications

    Not Applicable

    Cinqair Boxed Warnings

    Boxed Warning

    Anaphylaxis.

    Cinqair Warnings/Precautions

    Warnings/Precautions

    Should be administered by healthcare provider prepared to manage anaphylaxis. Observe patient for a period of time post-infusion; discontinue immediately if severe systemic reactions or anaphylaxis occur. Not for treating acute asthma symptoms or exacerbations. Treat pre-existing helminth infections before initiating therapy; discontinue Cinqair if treatment-resistant infection occurs while on therapy until resolves. Avoid abrupt cessation of systemic or inhaled corticosteroids upon Cinqair initiation; reduce dose gradually if appropriate. Reduction may be associated with systemic withdrawal symptoms and/or unmask previously suppressed conditions. Pregnancy. Nursing mothers.

    Warnings/Precautions

    Anaphylaxis 

    • Anaphylaxis to Cinqair was reported in 0.3% of asthma patients in clinical studies; these were observed during or within 20 minutes after completion of the Cinqair infusion and reported as early as the second dose of Cinqair. 
    • Anaphylaxis can be life-threatening. 
    • Cinqair should be administered by a healthcare professional trained to manage anaphylaxis. 
    • Observe patients for an appropriate period of time after Cinqair administration. If severe systemic reactions, including anaphylaxis, occur, discontinue Cinqair immediately and provide appropriate treatment. 

    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.

    Malignancy 

    • In placebo-controlled clinical studies, 6/1028 (0.6%) patients receiving 3 mg/kg Cinqair had at least 1 malignant neoplasm reported vs 2/730 (0.3%) patients in the placebo group. 
    • The observed malignancies in Cinqair-treated patients were diverse and without clustering of any particular tissue type. 
    • After less than six months of exposure to Cinqair, the majority of malignancies were diagnosed.

    Reduction of Corticosteroid Dosage 

    • Clinical studies have not been conducted to assess reduction of maintenance corticosteroid dosages after administration of Cinqair. 
    • Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with Cinqair; if appropriate, gradually reduce corticosteroid dose 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. 
    • 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 Cinqair until infection resolves.

    Pregnancy Considerations

    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. 

    Nursing Mother Considerations

    It is not known whether reslizumab is present in human milk, and the effects of reslizumab on the breast fed infant and on milk production are not known. However, human IgG is known to be present in human milk. Reslizumab was present in the milk of lactating mice following dosing during pregnancy. 

    The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Cinqair and any potential adverse effects on the breast-fed child from Cinqair or the underlying maternal condition.

    Pediatric Considerations

    Cinqair is not indicated for use in pediatric patients <18 years of age. The safety and effectiveness in pediatric patients (aged 17 years and younger) have not been established.

    Geriatric Considerations

    Cinqair was evaluated in 122 patients aged ≥65 years with asthma in two 52-week exacerbation studies and two 16-week lung function studies. No overall differences in safety or effectiveness were observed between these patients and younger patients. Based on available data, no adjustment of the dosage of Cinqair in geriatric patients is necessary.

    Cinqair Pharmacokinetics

    Distribution

    Reslizumab has a volume of distribution of ~5 liters, suggesting minimal distribution to the extravascular tissues.

    Metabolism

    Reslizumab is degraded by enzymatic proteolysis into small peptides and amino acids. 

    Elimination

    Reslizumab clearance was ~7 mL/hour. Reslizumab has a half-life of ~24 days.

    Cinqair Interactions

    Not Applicable

    Cinqair Adverse Reactions

    Adverse Reactions

    Oropharyngeal pain, elevated CPK, myalgia; anaphylaxis, malignancy.

    Cinqair Clinical Trials

    Clinical Trials

    The asthma development program for Cinqair 3 mg/kg (administered once every 4 weeks) included 4 randomized, double-blind, placebo-controlled studies (Studies I-IV) 16 to 52 weeks in duration involving 981 patients ≥12 years of age. While patients aged 12-17 years were included in these trials, Cinqair is not approved for use in this age group. All patients continued their background asthma therapy throughout the duration of the studies.

    Studies I and II 

    • Studies I and II were 52-week studies in 953 patients with asthma who were required to have a blood eosinophil count of ≥400/mcL (within 3 to 4 weeks of dosing), and ≥1 asthma exacerbation requiring systemic corticosteroid use over the past 12 months.
    • The majority of patients (82%) were on medium-high dose inhaled corticosteroids plus a long-acting beta agonist (ICS/LABA) at baseline. 
    • Maintenance oral corticosteroids (OCS) (up to prednisone 10 mg/day or equivalent) were allowed. 
    • Cinqair 3 mg/kg administered once every 4 weeks for a total of 13 doses was evaluated vs placebo. 

    Study III 

    • Study III was a 16-week study in 315 patients who were required to have a blood eosinophil count of ≥400/mcL at screening (within 3 to 4 weeks of dosing).
    • Maintenance OCS were not allowed.
    • Cinqair 3 mg/kg or 0.3 mg/kg administered once every 4 weeks for a total of 4 doses was evaluated vs placebo.
    • While 2 doses of Cinqair were studied, Cinqair 3 mg/kg is the only recommended dose. 

    Study IV 

    • Study IV was a 16-week study in 496 patients unselected for baseline blood eosinophil levels (~80% of patients had a screening [within 3 to 4 weeks of dosing] blood eosinophil count of <400/mcL).
    • Maintenance OCS were not allowed.
    • Cinqair 3 mg/kg administered once every 4 weeks for a total of 4 doses was evaluated vs placebo.

    Exacerbations 
    The primary endpoint for Studies I and II was the frequency of asthma exacerbations for each patient during the 52-week treatment period. 

    • Patients receiving Cinqair 3 mg/kg once every 4 weeks had significant reductions in the rate of all asthma exacerbations vs placebo (Study I: 0.5 [95% CI, 0.37-0.67]; Study II: 0.41 [95% CI, 0.28-0.59]).  
    • Exacerbations requiring systemic corticosteroid use were also reduced in the Cinqair group vs placebo (Study I: 0.45 [95% CI, 0.33-0.62]; Study II: 0.39 [95% CI, 0.27-0.58]).
    • Exacerbations resulting in a hospitalization and/or ER visit were also reduced in the Cinqair group vs placebo (Study I: 0.66 [95% CI, 0.32-1.36]; Study II: 0.69 [95% CI, 0.29-1.65]).  
    • The time to first asthma exacerbation was significantly longer for the Cinqair groups vs placebo in both studies.

    Lung Function 
    The effect of Cinqair 3 mg/kg administered once every 4 weeks on FEV1 over time relative to placebo was assessed in all 4 studies. 
    FEV1 was the primary endpoint in the 16-week lung function studies for Study III and Study IV. 

    Study III also studied a lower dose, Cinqair 0.3 mg/kg, that produced significant but numerically smaller changes in FEV1 and blood eosinophil reduction vs the 3 mg/kg dose. While 2 doses of Cinqair were studied, Cinqair 3 mg/kg is the only recommended dose. 

    Study IV was the only study to test Cinqair 3 mg/kg in asthma patients unselected for blood eosinophils (measured 3 to 4 weeks prior to dosing).

    Over 16 weeks, the mean change from baseline in FEV1 (difference from Cinqair and placebo) was:

    • 137mL (95% CI, 76-198) in Study I,
    • 93mL (95% CI, 30-155) in Study II,
    • 160mL (95% CI, 60-259) in Study III, and
    • 76mL (95 % CI, −6, 158) in Study IV.

    Improvements in FEV1 were seen at 4 weeks after the first Cinqair dose for Studies I and II, and maintained through Week 52.

    The Asthma Control Questionnaire-7 (ACQ-7) and Asthma Quality of Life Questionnaire (AQLQ) were both assessed in Studies I, II, and III. 
    The responder rate for both measures was defined as an improvement in score of 0.5 or more as threshold over 16 weeks.

    • For ACQ-7, the responder rate for those randomized to Cinqair vs. placebo was 69% vs. 65% for Study I, 70% vs. 58% for Study II, and 64% vs. 58% for Study III. 
    • For AQLQ, the responder rate for those randomized to Cinqair vs. placebo was 66% vs. 58% for Study I, 67% vs. 55% for Study II, and 64% vs. 48% for Study III.

    Cinqair Note

    Not Applicable

    Cinqair Patient Counseling

    Patient Counseling

    Hypersensitivity/Anaphylaxis

    • Inform patients that hypersensitivity reactions, including anaphylaxis, have occurred with Cinqair administration. 
    • Educate patients on the signs/symptoms of hypersensitivity reactions and anaphylaxis (eg, skin or mucosal involvement, airway compromise, reduced blood pressure). 
    • Instruct patients to contact their healthcare provider immediately if they experience symptoms of an allergic reaction after they have received Cinqair infusion. 

    Not for Acute Symptoms or Deteriorating Disease

    • Inform patients that Cinqair does not treat acute asthma symptoms or acute exacerbations. 
    • Inform patients to seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment with Cinqair. 

    Malignancy

    • Counsel Cinqair-treated patients about the risk of malignancies. 

    Reduction of Corticosteroid Dosage

    • Inform patients not to discontinue systemic or inhaled corticosteroids except under the direct supervision of a physician. 
    • Inform patients that reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.

    Cost Savings Program

    The Cinqair Affordability Support Program is available here.

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