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
interleukin-5 antagonist is not indicated for the treatment of other
eosinophilic conditions, acute bronchospasm, or status asthmaticus.
plans to make reslizumab available during the second quarter of this year under
the brand name Cinqair.
(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.
also warns that malignant neoplasms were reported in clinical studies of
patients treated with reslizumab and occurred more frequently than in the
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.
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.
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.
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.