Drug information of RESLIZUMAB

RESLIZUMAB

Drug group:

Reslizumab is used together with other medicines to help control severe asthma in adults.

Reslizumab affects your immune system, reducing levels of a certain type of white blood cell that may contribute to the symptoms of asthma.

Reslizumab may also be used for purposes not listed in this medication guide.
Indicated for the add-on maintenance treatment of patients with severe asthma aged 18 years and older with an eosinophilic phenotype.

Mechanism of effect

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

Pharmacodynamic

A reduction in blood eosinophil counts was observed in clinical studies following an initial infusion of 3 mg/kg reslizumab and was maintained through 52 weeks of treatment with no signs of tachyphylaxis. Greater reductions of blood eosinophils were observed in subjects with higher reslizumab serum concentrations. This effect was independent of the presence of treatment-emergent anti-reslizumab antibodies

Pharmacokinetics

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

Drug indications

Asthma , Asthma - Maintenance

Dosage

Severe asthma: 3 mg/kg IV q4wk infused over 20-50 minutes

Drug contraindications

Hypersensitivity to this drug

Alerts

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 anaphylaxis

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

Points of recommendation

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

Pregnancy level

HAVE NOT BEEN ESTABLISHED

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

Breast feeding warning

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

Drug forms

Cinqair

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