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Reslizumab Approved as Maintenance Therapy for Severe Asthma

Kate Traynor

BETHESDA, MD 23 Mar 2016— FDA and Teva Pharmaceutical Industries Ltd. on March 23 announced the approval of reslizumab injection for i.v. infusion as an add-on maintenance treatment for adults with severe asthma characterized by an eosinophilic phenotype.

The interleukin-5 antagonist is not indicated for the treatment of other eosinophilic conditions, acute bronchospasm, or status asthmaticus.

The company plans to make reslizumab available during the second quarter of this year under the brand name Cinqair.

The labeling (PDF) for reslizumab includes a boxed warning about rare cases of anaphylaxis that occurred during clinical studies of the biologic. The warning advises clinicians to observe patients for an appropriate period of time after each dose is administered and be prepared to manage anaphylaxis if it occurs.

The labeling also warns that malignant neoplasms were reported in clinical studies of patients treated with reslizumab and occurred more frequently than in the placebo group.

Patients infected with parasitic helminths should undergo treatment to resolve the infection before starting reslizumab therapy. If helminth infection occurs during treatment with reslizumab, them monoclonal antibody therapy should be discontinued until the infection is treated and resolves.

It is not known whether corticosteroid maintenance dosages may be safely reduced after the administration of reslizumab. The labeling for the monoclonal antibody therapy warns against discontinuing corticosteroid therapy and states that any reduction in corticosteroid use, if appropriate, should be done gradually and under the supervision of a physician.

The recommended dosage of reslizumab is 3 mg/kg administered once every four weeks by i.v. infusion over 20–50 minutes.

Preparation of a dose involves slowly adding the weight-based amount of reslizumab to an infusion bag containing 50 mL of 0.9% Sodium Chloride Injection, USP. No other medications should be coadministered with reslizumab.

The diluted solution may be refrigerated at 2–8 °C or kept at room temperature up to 25 °C for up to 16 hours, the labeling states. During this time, the solution must be protected from light. The labeling also states that the "time between preparation . . .and administration should not exceed 16 hours."

An infusion set with an inline, low-protein-binding 0.2-µ filter should be used to administer the diluted preparation.

Reslizumab will be supplied in 100-mg single-use vials. The biologic should be kept in its original packaging and refrigerated at 2–8 °C until use.

 

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