AdultPediatricDosage Forms & Strengths IV solution 100mg/10mL vial (10mg/mL) Asthma Add-on maintenance treatment of patients with an eosinophilic phenotype Severe asthma: 3 mg/kg IV q4wk infused over 20-50 minutes Dosing Considerations Limitations of use: Not indicated for treatment of other eosinophilic conditions or relief of acute bronchospasm or status asthmaticusSafety and efficacy not established >10% Elevated CPK, transient (20%) 1-10% Treatment-emergent antibody response (5.4%) Oropharyngeal pain (2.6%) Musculoskeletal (2.2%) Myalgias (1%) <1% Elevated CPK >10x ULN (0.8%) Malignancy (0.6%) Anaphylaxis (0.3%) Black Box Warnings Anaphylaxis occurred in 0.3% of patients in placebo-controlled studies Manifestations included dyspnea, decreased oxygen saturation, wheezing, vomiting, and skin and mucosal involvement, including urticaria Observe patients for an appropriate period after infusion; healthcare professionals should be prepared to manage anaphylaxis that can be life-threatening Discontinue immediately if the patient experiences anaphylaxisContraindications Known hypersensitivity to reslizumab or its excipients Cautions Anaphylaxis reported observed during or within 20 minutes after completion of the IV infusion and reported as early as the second dose (see Black Box Warnings) Not for use to treat acute asthma symptoms or acute exacerbations No clinical studies have been conducted to assess reduction of maintenance corticosteroid dosages following administration of reslizumab; do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of reslizumab therapy Diverse malignancies observed with reslizumab vs placebo in clinical trials (0.6% vs 0.3%) Treat patients with pre-existing helminth infections before initiating reslizumab; if patients become infected during reslizumab treatment and do not respond to antihelminth treatment, discontinue reslizumab until infection resolves Pregnancy Data are insufficient regarding drug-associated risk during pregnancy Monoclonal antibodies 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 trimesters of pregnancy Reslizumab has a long half-life; this should be taken into consideration Clinical considerations Increased risk of preeclampsia in women with poorly or moderately controlled asthma Prematurity, low birth weight, and small for gestational age observed in neonates whose mothers have poor or moderate asthma control Asthma control should be closely monitored in pregnant women and treatment adjusted as necessary to maintain optimal control Animal studies Not teratogenic in mice or rabbits; data based on 2 single-dose studies in pregnant mice and rabbits during organogenesis 0.4, 1.5, and 6 times the exposures achieved at the maximum recommended human dose (MRHD) in mice on an AUC basis and 0.67, 3.3, and 17 times the exposures achieved at the MRHD in rabbits on a mg/kg basis Lactation Unknown if distributed in human breast milk; however, human IgG is known to be present in human milk Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal conditionPregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action Interleukin-5 (IL-5) antagonist monoclonal antibody (IgG kappa); binds to IL-5, thereby inhibiting IL-5 bioactivity by blocking its binding to IL-5 alpha receptor complex expressed on the eosinophil surface IL-5 is the major cytokine responsible for eosinophil growth and differentiation, recruitment, activation, and survival Inflammation is an important component of asthma pathogenesis Multiple cell types (eg, mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (eg, histamine, eicosanoids, leukotrienes, cytokines) are involved in inflammation In patients with asthma, the eosinophilic phenotype is associated with compromised lung function, more frequent symptoms, and increased risk of exacerbations Absorption Peak plasma concentration: Observed at end of IV infusion Distribution Vd: 5 L Metabolism Similar to other monoclonal antibodies, reslizumab is degraded by enzymatic proteolysis into small peptides and amino acids Elimination Half-life: 24 days Clearance: 7 mL/hr IV Preparation Remove from refrigerator To minimize foaming, do not shake Inspect visually for particulate matter and discoloration prior to administration; solution should appear clear to slightly hazy/opalescent, colorless to slightly yellow liquid Since reslizumab 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 proper volume from the vial(s) based on recommended weight-based dosage; discard any unused portion Dispense syringe contents slowly to minimize foaming into a 50-mL 0.9% NaCl infusion bag Compatible with polyvinylchloride (PVC) or polyolefin infusion bags Gently invert bag to mix solution; do not shake Do not mix or dilute with other drugs Administer immediately after preparation; if not used immediately, refrigerate diluted solution at 2-8°C (36-46°F) or at room temperature up to 25ºC (77ºF), protected from light, for up to 16 hr The time between preparation and administration should not exceed 16 hr IV Administration For IV infusion only following further dilution; do not administer as IV push or bolus Administer in a healthcare setting by a healthcare professional prepared to manage anaphylaxis If refrigerated before administration, allow diluted solution to reach room temperature Use an infusion set with in-line, low protein-binding filter (pore size of 0.2-micron) Compatible with polyethersulfone (PES), polyvinylidene fluoride (PVDF), nylon, and cellulose acetate in-line infusion filters Infuse diluted solution IV over 20-50 minutes; infusion time may vary depending on the total volume to be infused as based on patient weight Do not infuse concomitantly in the same IV line with other agents; no physical or biochemical compatibility studies conducted Monitor for hypersensitivity during the infusion and for an appropriate period afterwards Upon infusion completion, flush IV line with 0.9% NaCl to ensure that entire reslizumab dose has been administered Storage Unopened vials Refrigerate at 2-8ºC (36-46°F) Do not freeze Do not shake Protect the vials from light by storing in the original package until time of use Diluted solution If not used immediately, refrigerate at 2-8°C (36-46°F) or at room temperature up to 25ºC (77ºF), protected from light, for up to 16 hr Time between preparation and administration should not exceed 16 hr Do not shake BRAND FORM. UNIT PRICE PILL IMAGE Cinqair intravenous- 10 mg/mL vialCopyright © 2010 First DataBank, Inc.A Patient Handout is not currently available for this monograph.Print FormularyPatient DiscountsAdding plans allows you to compare formulary status to other drugs in the same class.To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.Create Your List of PlansAdding plans allows you to:View the formulary and any restrictions for each plan.Manage and view all your plans together – even plans in different states.Compare formulary status to other drugs in the same class.Access your plan list on any device – mobile or desktop. The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information. View explanations for tiers and restrictions Tier Description 1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs. 2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs. 3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs. 4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. 5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. 6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. NC NOT COVERED – Drugs that are not covered by the plan. Code Definition PA Prior Authorization Drugs that require prior authorization. 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