RESLIZUMAB 
Pronounciation
- (res-LIZ-ue-mab)
Trade Name(s)
- Cinqair
Testing for eosinophilic phenotype indicated. See Maternal/Child.
3 mg/kg once every 4 weeks as an infusion over 20 to 50 minutes.
No dose adjustments required based on age, gender, or race. Clinical studies have not been conducted to assess the effect of hepatic or renal impairment on the pharmacokinetics of reslizumab.
Supplied as a clear to slightly hazy/opalescent, colorless to slightly yellow solution in single-use vials containing 100 mg/10 mL (10 mg/mL). May contain a few translucent to white amorphous particulates. Do not shake. Aseptic technique required. Allow solution to reach room temperature. Withdraw the proper volume of reslizumab from the vial(s) based on the recommended weight-based dose and slowly add to a 50-mL infusion bag of NS. Gently invert to mix the solution. Do not shake.
Use of an infusion set with an in-line, low–protein-binding, 0.2-micron filter is required. Compatible with polyethersulfone (PES), polyvinylidene fluoride (PVDF), nylon, and cellulose acetate in-line infusion filters.
Before use, refrigerate at 2° to 8° C (36° to 46° F) in original carton to protect from light. Do not freeze. Do not shake. Administer diluted solution immediately after preparation or may be refrigerated or kept at RT (up to 25° C [77° F]), protected from light, for up to 16 hours. Time between preparation and administration should not exceed 16 hours. If refrigerated before administration, allow the diluted solution to reach RT. Discard unused portion.
Manufacturer states, “Do not mix or dilute with other drugs. Do not infuse concomitantly in the same IV line with other agents.” Compatible with polyvinylchloride (PVC) or polyolefin infusion bags and with polyethersulfone (PES), polyvinylidene fluoride (PVDF), nylon, and cellulose acetate in-line infusion filters.
For IV infusion only. Do not administer as an IV push or bolus. Use of an infusion set with an in-line, low–protein-binding, 0.2-micron filter is required.
Administer a single dose as an infusion over 20 to 50 minutes. Infusion time varies depending on total volume to be infused based on weight-based dosing. After administration, flush the IV line with NS to ensure that all of the reslizumab has been administered.
Inflammation is an important component in the pathogenesis of asthma. Multiple cell types and mediators are involved in inflammation. Reslizumab is a humanized interleukin-5 antagonist monoclonal antibody (IgG4, kappa). IL-5 is the major cytokine responsible for the growth and differentiation, recruitment, activation, and survival of eosinophils. Reslizumab binds to IL-5, inhibiting the bioactivity of IL-5. By inhibiting IL-5 signaling, reslizumab reduces the production and survival of eosinophils, one of the cell types implicated in the inflammation seen with asthma. Specific mechanism of action not definitively established. Following administration of reslizumab, reductions in blood eosinophil counts were observed and maintained through 52 weeks of treatment. There is minimal distribution into the extravascular tissues. Reslizumab is degraded by enzymatic proteolysis into small peptides and amino acids. Half-life is approximately 24 days.
Add-on maintenance treatment of patients with severe asthma who have an eosinophilic phenotype and are 18 years of age or older.
Not indicated for the treatment of other eosinophilic conditions.
■ Not indicated for the relief of acute bronchospasm or status asthmaticus.
For IV use only.
■ Administered by or under the direction of a physician knowledgeable in its use and in a facility equipped to monitor the patient and respond to any medical emergency.
■ Hypersensitivity reactions, including anaphylaxis, have been reported.
■ Should not be used to treat acute asthma symptoms or acute exacerbations. Do not use to treat acute bronchospasm or status asthmaticus.
■ Malignant neoplasms have been reported. The majority were diagnosed within less than 6 months of exposure to reslizumab. The observed malignancies were diverse in nature and without clustering of any particular tissue type.
■ No clinical studies have been conducted to assess the reduction of maintenance corticosteroid doses following administration of reslizumab. Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of reslizumab therapy. Reductions in corticosteroid dose, if appropriate, should be gradual and under physician supervision.
■ Eosinophils may be involved in the immunologic response to some helminth infections. The effects of reslizumab on the immune response against parasitic infections are unknown. Patients with known parasitic infections were excluded from clinical studies.
■ A therapeutic protein, there is a potential for immunogenicity.
■ See Monitor.
Monitor for S/S of a hypersensitivity reaction during and following completion of the infusion. In clinical trials, anaphylaxis was observed during or within 20 minutes after completion of the infusion and was reported as early as the second dose of reslizumab. Manifestations included decreased oxygen saturation, dyspnea, skin and mucosal involvement (including urticaria), vomiting, and wheezing.
■ If a taper in the maintenance steroid dose is initiated, monitor for systemic withdrawal symptoms and/or conditions previously suppressed by systemic corticosteroid therapy.
■ Treat pre-existing helminth infections before initiating reslizumab. Discontinue treatment until infection resolves in patients who become infected during therapy and do not respond to anti-helminth treatment.
Immediately report any S/S of a hypersensitivity reaction (e.g., chest discomfort, cough, dyspnea, postural dizziness, pruritus, rash, throat irritation, urticaria, wheezing) occurring during or after administration.
■ Does not treat acute asthma symptoms or acute exacerbations. Seek medical advice if asthma remains uncontrolled or worsens after initiation of treatment with reslizumab.
■ Malignancies have been reported.
■ Do not discontinue or reduce the dose of maintenance systemic or inhaled corticosteroids except under the direct supervision of a physician.
Use during pregnancy only if clearly needed. In females with poorly or moderately controlled asthma, evidence demonstrates an increased risk of pre-eclampsia in the mother and an increased risk of prematurity, low birth weight, and smaller for gestational age in the neonate. The level of asthma control should be closely monitored in pregnant females and treatment adjusted as necessary to maintain optimal control. Monoclonal antibodies such as reslizumab cross the placental barrier. The potential effects on a fetus are likely to be greater during the second and third trimester of pregnancy. Consider the long half-life of reslizumab.
■ Use caution during breastfeeding; effects unknown.
■ Safety and effectiveness for use in pediatric patients 17 years of age or younger not established.
No overall differences in safety or effectiveness observed between younger patients and patients 65 years of age and older. No dose adjustment is necessary.
No formal drug interaction studies have been performed. Population pharmacokinetics analyses indicate that concomitant use of either leukotriene antagonists (e.g., montelukast) or corticosteroids does not affect the pharmacokinetics of reslizumab.
Oropharyngeal pain is the most common side effect. Less commonly reported adverse reactions include myalgia and transient creatine phosphokinase (CPK) elevations. Hypersensitivity reactions (including anaphylaxis) and malignancy are the most serious side effects.
Keep the physician informed of all side effects. Most will be treated symptomatically. If a hypersensitivity reaction occurs, discontinue the infusion immediately and treat with oxygen, epinephrine, antihistamines (e.g., IV diphenhydramine), corticosteroids, albuterol, vasopressors (e.g., dopamine), and ventilation equipment as indicated. Symptoms of overdose were not noted in clinical trials. If overdose occurs, monitor patients for S/S of adverse effects. Resuscitate as necessary.