Reslizumab

What is Reslizumab?

Reslizumab (CINQAIR) is an interleukin-5 antagonist monoclonal antibody (IgG4 kappa) used therapeutically to reduce allergic symptoms of asthma in patients with an eosinophilic phenotype.

What are the uses of this medicine?

This medicine is used for maintenance treatment of patients with severe asthma aged 18 years and older with an eosinophilic phenotype.

Limitations of Use:

• CINQAIR is not indicated for treatment of other eosinophilic conditions.
• CINQAIR is not indicated for the relief of acute bronchospasm or status asthmaticus.

How does this medicine work?

• Reslizumab is an interleukin-5 antagonist (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 with a dissociation constant of 81 pM, inhibiting the bioactivity of IL-5 by blocking its binding to the alpha chain of the IL-5 receptor complex expressed on the eosinophil surface.
• Reslizumab, by inhibiting IL-5 signaling, reduces the production and survival of eosinophils; however, the mechanism of reslizumab action in asthma has not been definitively established.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• hypersensitivity to reslizumab or any of its excipients

What drug interactions can this medicine cause?

• No formal clinical drug interaction studies have been performed with CINQAIR.

Is this medicine FDA approved?

• It was approved for use in the United States in 2016.

How should this medicine be used?

Recommended Dosage:

• The recommended dosage regimen is 3 mg/kg once every 4 weeks administered by intravenous infusion over 20-50 minutes.

Administration

• CINQAIR is for intravenous infusion only.
• Do not administer as an intravenous push or bolus.
• CINQAIR should be administered by a healthcare professional prepared to manage anaphylaxis.
• If refrigerated prior to administration, allow the diluted CINQAIR solution to reach room temperature.
• Use an infusion set with an in-line, low protein-binding filter (pore size of 0.2 micron). CINQAIR is compatible with polyethersulfone (PES), polyvinylidene fluoride (PVDF), nylon, and cellulose acetate in-line infusion filters.
• Infuse the diluted solution of CINQAIR intravenously, over a 20 to 50 minute period. Infusion time may vary depending on the total volume to be infused as based upon patient weight.
• Do not infuse CINQAIR concomitantly in the same intravenous line with other agents. No physical or biochemical compatibility studies have been conducted to evaluate the co-administration of CINQAIR with other agents.
• Observe the patient over the infusion and for an appropriate period of time following infusion.
• Upon completion of the infusion, flush the intravenous administration set with 0.9% Sodium Chloride Injection, USP to ensure that all CINQAIR has been administered.
• Discontinue the infusion immediately if the patient experiences a severe systemic reaction, including anaphylaxis .

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Injection: 100 mg/10 mL (10 mg/mL) solution in single-use vials

This medicine is available in fallowing brand namesː

• CINQAIR

What side effects can this medication cause?

The most common side effects of this medicine include:

• throat pain

CINQAIR can cause serious side effects, including:

• Serious allergic reactions (anaphylaxis)

What special precautions should I follow?

• Anaphylaxis to CINQAIR was reported. Anaphylaxis can be life-threatening. CINQAIR should be administered by a healthcare professional prepared to manage anaphylaxis. Patients should be observed for an appropriate period of time after CINQAIR administration. If severe systemic reactions, including anaphylaxis, occur, stop administration of CINQAIR immediately and provide appropriate medical treatment.
• CINQAIR should not be used to treat acute asthma symptoms or acute exacerbations. Do not use CINQAIR to treat acute bronchospasm or status asthmaticus.
• Malignancies were observed in clinical studies.
• Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with CINQAIR. Decrease corticosteroids gradually, if appropriate.
• Treat patients with pre-existing helminth infections before therapy with CINQAIR. If patients become infected while receiving CINQAIR and do not respond to anti-helminth treatment, discontinue CINQAIR until the parasitic infection resolves.

What to do in case of emergency/overdose?

Management for dosage:

• There is no specific treatment for an overdose with CINQAIR.
• If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary.

Can this medicine be used in pregnancy?

• The data on pregnancy exposure from the clinical trials are insufficient to inform on drug-associated risk.

Can this medicine be used in children?

• CINQAIR is not indicated for use in pediatric patients less than 18 years of age.
• The safety and effectiveness in pediatric patients (aged 17 years and younger) have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: reslizumab
• Inactive ingredients: sodium acetate, acetic acid, sucrose

Who manufactures and distributes this medicine?

• Manufactured by: Teva Respiratory, LLC; West Chester

What should I know about storage and disposal of this medication?

• Refrigerate at 2 ºC to 8ºC (36°F to 46°F).
• Do not freeze.
• Do not shake.
• Protect the vials from light by storing in the original package until time of use.

• Dailymed label info on Reslizumab
• FDA Reslizumab