Version May 2024
Anaphylaxis has been observed with reslizumab infusion in 0.3% of patients in placebo-controlled clinical studies. Anaphylaxis was reported as early as the second dose of reslizumab. Anaphylaxis can be life-threatening. Patients should be observed for an appropriate period of time after reslizumab administration by a health care professional prepared to manage anaphylaxis. Discontinue reslizumab immediately if the patient experiences signs or symptoms of anaphylaxis.
Asthma, severe eosinophilic: Note: May consider as add-on therapy in patients with severe eosinophilic asthma inadequately controlled on standard therapies (eg, an inhaled glucocorticoid with a long-acting beta agonist) (Ref). May consider use in patients with peripheral blood eosinophils ≥150 cells/mcL; however, some experts reserve use for patients with peripheral blood eosinophils ≥400 cells/mcL. The eosinophil threshold required for patients on systemic glucocorticoids is less clear (Ref).
IV: 3 mg/kg once every 4 weeks (maximum dose not established). A minimum of 4 months of treatment is suggested to determine efficacy (Ref).
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Refer to adult dosing.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%: Neuromuscular & skeletal: Increased creatine phosphokinase in blood specimen (20%)
1% to 10%:
Immunologic: Antibody development (5%)
Neuromuscular & skeletal: Increased creatine phosphokinase (20%; transient), myalgia (1%)
Respiratory: Oropharyngeal pain (3%)
<1%: Hypersensitivity: Anaphylaxis
Hypersensitivity to reslizumab or any component of the formulation
Concerns related to adverse effects:
• Anaphylaxis [US Boxed Warning]: Anaphylaxis was reported in 0.3% of asthma patients in placebo-controlled studies; these events were observed during or within 20 minutes after completion of infusion, and may occur as early as the second dose. Observe patients for an appropriate period of time after administration. Manifestations included dyspnea, decreased oxygen saturation, wheezing, vomiting, skin and mucosal involvement, including urticaria. If severe systemic reactions, including anaphylaxis occur, discontinue administration immediately and provide appropriate medical treatment.
• Malignancies: Malignancies were observed during clinical trials with the majority being diagnosed within less than 6 months of drug exposure; neoplasms observed were diverse with no predominant histologic type.
Disease-related concerns:
• Asthma: Not indicated for the treatment of acute asthma symptoms (eg, acute bronchospasm) or acute exacerbations, including status asthmaticus.
• Helminth infections: It is unknown if administration of reslizumab will influence a patient's immune response against parasitic infections. Therefore, patients with preexisting helminth infections should undergo treatment of the infection prior to initiation of reslizumab therapy. Patients who become infected during reslizumab treatment and do not respond to anti-helminth therapy should discontinue reslizumab until the infection resolves.
Concurrent drug therapy issues:
• Corticosteroids: Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of reslizumab. Reductions in corticosteroid dose should be gradual, if appropriate. Clinicians should note that a reduction in corticosteroid dose may be associated with withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous [preservative free]:
Cinqair: 100 mg/10 mL (10 mL)
No
Solution (Cinqair Intravenous)
100 mg/10 mL (per mL): $126.00
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, Intravenous:
Cinqair: 100 mg/10 mL (10 mL) [contains mouse (murine) and/or hamster protein]
IV: For IV infusion only; do not administer as an IV push or bolus. Allow diluted solution to reach room temperature. Use an infusion set with an in-line, low protein-binding filter (pore size: 0.2 micron); compatible filters are polyethersulfone (PES), polyvinylidene fluoride (PVDF), nylon, and cellulose acetate. Infuse over 20 to 50 minute period (may vary depending on total volume being infused) and then flush the IV administration set with NS after the infusion is finished. Do not infuse concomitantly in the same IV line with other agents. Observe patient during and for an appropriate time following infusion.
Asthma, severe eosinophilic: Add-on maintenance treatment of severe asthma in adults with an eosinophilic phenotype.
Limitations of use: Not indicated for treatment of other eosinophilic conditions or for the relief of acute bronchospasm or status asthmaticus.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Rozanolixizumab: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy
Data related to the use of monoclonal antibodies for the treatment of asthma in pregnancy are limited. The long half-life of monoclonal antibodies should be considered when treating patients planning to become pregnant (Pfaller 2021). An agent other than reslizumab may be preferred (ERS/TSANZ [Middleton 2020]).
Reslizumab is a humanized monoclonal antibody (IgG4). Human IgG crosses the placenta. Fetal exposure is dependent upon the IgG subclass, maternal serum concentrations, placental integrity, newborn birth weight, and gestational age, generally increasing as pregnancy progresses. The lowest exposure would be expected during the period of organogenesis and the highest during the third trimester (Clements 2020; Palmeira 2012; Pentsuk 2009).
Uncontrolled asthma is associated with adverse events in pregnancy (increased risk of perinatal mortality, preeclampsia, preterm birth, low-birth-weight infants, cesarean delivery, and the development of gestational diabetes). Poorly controlled asthma or asthma exacerbations may have a greater fetal/maternal risk than what is associated with appropriately used asthma medications. Maternal treatment improves pregnancy outcomes by reducing the risk of some adverse events (eg, preterm birth, gestational diabetes) (ERS/TSANZ [Middleton 2020]; GINA 2023).
Data related to the use of monoclonal antibodies for the treatment of severe asthma during pregnancy are limited (GINA 2023). Use of monoclonal antibodies may be considered when conventional therapies are insufficient (ERS/TSANZ [Middleton 2020]). In general, monoclonal antibodies should not be initiated during pregnancy. The option to continue treatment in patients who become pregnant during therapy should be considered as part of a shared decision-making process (Dorscheid 2022; Pfaller 2021; Shakuntulla 2022). The long half-life of reslizumab should be considered if required during pregnancy.
Data collection to monitor pregnancy and infant outcomes associated with asthma and the medications used to treat asthma in pregnancy is ongoing. Health care providers are encouraged to enroll exposed pregnant patients in the MotherToBaby Pregnancy Studies conducted by the Organization of Teratology Information Specialists (877-311-8972 or https://mothertobaby.org). Patients may also enroll themselves.
It is not known if reslizumab is present in breast milk.
Reslizumab is a humanized monoclonal antibody (IgG4). Human IgG is present in breast milk; concentrations in breast milk are dependent upon IgG subclass and postpartum age (Anderson 2021).
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of exposure to the infant and the benefits of treatment to the mother. Use of monoclonal antibodies for the treatment of asthma in lactating patients may be considered when conventional therapies are insufficient; use of an agent other than reslizumab may be preferred (ERS/TSANZ [Middleton 2020]).
Formulation may contain sucrose.
Anaphylaxis/hypersensitivity reactions (during and after infusion); peak flow, and/or other pulmonary function tests; monitor for signs of infection; CBC with differential prior to initiation of treatment and periodically thereafter (Castro 2015).
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 (a cell type associated with inflammation and an important component in the pathogenesis of asthma). Reslizumab, by inhibiting IL-5 signaling, reduces the production and survival of eosinophils; however, the mechanism of reslizumab action in asthma has not been definitively established.
Distribution: Vd: ~5 L
Metabolism: Undergoes proteolytic degradation via enzymes into small peptides and amino acids.
Half-life elimination: ~24 days
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