Reslizumab
Indications
Reslizumab is used for:
Asthma
Adult Dose
Asthma
Indicated for add-on maintenance treatment of patients with severe asthma aged >18 years with an eosinophilic phenotype
3 mg/kg IV q4wk infused over 20-50 minutes
Child Dose
<18 years: Safety and efficacy not established
Renal Dose
Administration
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
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
Contra Indications
Known hypersensitivity to reslizumab or its excipients
Precautions
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-Lactation
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
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 condition
Interactions
Adverse Effects
Side effects of Reslizumab :
>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%)
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