finishing up [6:<18 years of age. 1 Geriatric Use No overall differences in efficacy or safety observed in patients 65 years of age compared with younger patients. 1 Hepatic Impairment Pharmacokinetics not studied in patients with hepatic impairment. 1 (See Special Populations under Pharmacokinetics.) Renal Impairment Pharmacokinetics not studied in patients with renal impairment. 1 (See Special Populations under Pharmacokinetics,) Common Adverse Effects Headache, 2 3 upper respiratory tract infection, 2 3 allergic rhinitis, 2 back pain, 2 sinusitis, 3 urinary tract infection, 3 dyspnea, 3 dizziness, 2 oropharyngeal pain, 1 2 nausea/vomiting. 2 3 Interactions for Cinqair No formal drug interaction studies to date. 1 Drugs Metabolized by Hepatic Microsomal Enzymes Unlikely to affect CYP1A2, 2B6, or 3A4. 1 Specific Drugs Drug Interaction Corticosteroids No effect on reslizumab pharmacokinetics 1 Leukotriene-receptor antagonists No effect on reslizumab pharmacokinetics 1 Cinqair Pharmacokinetics Absorption Bioavailability Peak plasma concentrations typically occur at end of IV infusion. 1 Serum concentrations generally decline in a biphasic manner. 1 Following repeated IV administration, 1.5- to 1.9-fold accumulation of the drug observed. 1 Onset Decreased blood eosinophil count observed as early as 2 3 days following IV administration. 1 Distribution Extent Distributed into milk in mice. 1 Not known whether distributed into human milk. 1 (See Lactation under Cautions.) Elimination Metabolism Metabolized by proteolytic enzymes. 1 Half-life 24 days. 1 Special Populations Hepatic impairment: No substantial differences in pharmacokinetics in patients with mild hepatic impairment (total bilirubin concentrations> 1 times but not >1.5 times the ULN or total bilirubin concentrations not exceeding the ULN with AST concentrations exceeding the ULN) compared with those having normal hepatic function. 1 Renal impairment: No substantial differences in pharmacokinetics in patients with mild (estimated GFR of 60 89 mL/minute per 1.73 m 2 ) or moderate (estimated GFR of 30 59 mL/minute per 1.73 m 2 ) renal impairment compared with those having normal renal function. 1 Stability Storage Parenteral Injection 2 8 C in original package to protect from light. 1 Do not shake or freeze. 1 Diluted solution: May store at 2 8 C or at room temperature up to 25 C and protect from light for up to 16 hours after dilution. 1 Time between dilution and administration not >16 hours. 1 Compatibility For information on systemic interactions resulting from concomitant use, see Interactions. Parenteral Solution Compatibility Compatible Sodium chloride 0.9% Drug Compatibility Do not mix or dilute with any other drug. 1 Do not infuse in the same IV line with any other drug. 1 Actions Recombinant DNA-derived humanized interleukin-5 (IL-5) receptor antagonist monoclonal antibody and IgG 4 kappa immunoglobulin. 1 Inhibits binding of IL-5 to the alpha chain of the IL-5 receptor complex expressed on the eosinophil cell surface. 1 Blocks IL-5 signaling, thereby interfering with growth, differentiation, recruitment, activation, and survival of eosinophils. 1 Advice to Patients Risk of hypersensitivity reactions (e.g, including anaphylaxis). 1 Advise patients of signs and symptoms of anaphylaxis (e.g., skin or mucosal involvement, airway compromise, reduced BP). 1 Instruct patients to immediately contact a clinician if they experience symptoms of an allergic reaction after receiving reslizumab infusion. 1 (See Hypersensitivity under Cautions.) Importance of informing patients that reslizumab does not relieve acute asthma symptoms or exacerbations. 1 Advise patients to contact their clinician if asthma remains uncontrolled or worsens after treatment initiation. 1 Advise patients of possible increased risk of malignancy. 1 Importance of informing patients with asthma receiving inhaled or systemic corticosteroids not to discontinue or reduce corticosteroid dosage, since withdrawal symptoms or worsening of asthma may occur; change corticosteroid dosage only under direct supervision of a clinician. 1 Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses. 1 Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed. 1 Importance of informing patients of other important precautionary information. 1 (See Cautions.) Preparations Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. Reslizumab Routes Dosage Forms Strengths Brand Names Manufacturer Parenteral Concentrate for injection, for IV infusion only 10 mg/mL (100 mg) Cinqair Teva AHFS DI Essentials. Copyright 2017, Selected Revisions March 22, 2017. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. References 1. Teva. Cinqair (reslizumab) injection, for intravenous use prescribing information. Frazer, PA; 2016 Jun. 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; 3:355-66. [PubMed 25736990] 3. Bjermer L, Lemiere C, Maspero J et al. Reslizumab for inadequately controlled asthma with elevated blood eosinophil levels: a randomized phase 3 study. Chest . 2016; :3:355-66. [PubMed 27056586] 4. Corren J, Weinstein S, Janka L et al. Phase 3 study of reslizumab in patients with poorly controlled asthma: Effects across a broad range of eosinophil counts. Chest . 2016; :150:789-98. [PubMed 27018175] 5. Katz LE, Gleich GJ, Hartley BF et al. Blood eosinophil count is a useful biomarker to identify patients with severe eosinophilic asthma. Ann Am Thorac Soc . 2014; 11:531-6. [PubMed 24606022] 6. Walford HH, Doherty TA. Diagnosis and management of eosinophilic asthma: a US perspective. J Asthma Allergy . 2014; 7:53-65. [PubMed 24748808] 7. Varricchi G, Bagnasco D, Borriello F et al. Interleukin-5 pathway inhibition in the treatment of eosinophilic respiratory disorders: evidence and unmet needs. Curr Opin Allergy Clin Immunol . 2016; 16:186-200. [PubMed 26859368] 8. George L, Brightling CE. Eosinophilic airway inflammation: role in asthma and chronic obstructive pulmonary disease. Ther Adv Chronic Dis . 2016; 7:34-51. [PubMed 26770668] 9. Chung KF, Wenzel SE, Brozek JL et al. International ERS/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J . 2014; 43:343-73. [PubMed 24337046] 10. Mukherjee M, Sehmi R, Nair P. Anti-IL5 therapy for asthma and beyond. World Allergy Organ J . 2014; 7:32. [PubMed 25709744] Next Pregnancy Warnings Print this page Add to My Med List More about Cinqair (reslizumab) Side Effects During Pregnancy Dosage Information Support Group Pricing & Coupons En Español 2 Reviews Add your own review/rating Drug class: interleukin inhibitors Consumer resources Cinqair Cinqair (Advanced Reading) Professional resources Cinqair (FDA) Reslizumab (AHFS Monograph) Related treatment guides Asthma ] FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Manufacturer Teva Pharmaceuticals USA, Inc. Drug Class Interleukin inhibitors Related Drugs Asthma prednisone , triamcinolone , montelukast , Singulair , ipratropium , Breo Ellipta , Medrol , dexamethasone , methylprednisolone , Dulera , Medrol Dosepak , Xopenex , Atrovent , Decadron , levalbuterol , Deltasone , flunisolide , Solu-Medrol , Depo-Medrol , Atrovent HFA , fluticasone / vilanterol , More... Cinqair Rating 2 User Reviews 8.5 /10 2 User Reviews 8.5 Rate it! yule
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