Dosing and uses of Cinqair (reslizumab)
Adult dosage forms and strengths
IV solution
- 100mg/10mL vial (10mg/mL)
Asthma
Indicated for add-on maintenance treatment of patients with severe asthma aged ≥18 years with an eosinophilic phenotype
3 mg/kg IV q4wk infused over 20-50 minutes
Dosing Considerations
Limitations of use: Not indicated for treatment of other eosinophilic conditions or relief of acute bronchospasm or status asthmaticus
Pediatric dosage forms and strengths
<18 years: Safety and efficacy not established
Cinqair (reslizumab) adverse (side) effects
>10%
Elevated CPK (14%)
1-10%
Oropharyngeal pain (2.6%)
Myalgias (1%)
<1%
Anaphylaxis (0.3%)
Warnings
Black box warnings
Anaphylaxis occurred in 0.3% of patients in placebo-controlled studies
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
Contraindications
Known hypersensitivity to reslizumab or its excipients
Cautions
Anaphylaxis reported observed during or within 20 minutes after completion of the IV infusion (see Black box warnings)
Should not be used 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
Pregnancy
Pregnancy
The data on pregnancy exposure from the clinical trials are insufficient to inform on drug-associated risk
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
Lactation
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
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Cinqair (reslizumab)
Mechanism of action
Interleukin-5 (IL-5) antagonist monoclonal antibody (IgG kappa)
IL-5 is the most selective eosinophil cytokine known and plays a major role in the maturation, activation, and survival of eosinophils
In asthma patients, the eosinophilic phenotype is associated with compromised lung function, more frequent symptoms, and increased risk of exacerbations
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
Administration
IV Preparation
Remove from the refrigerator
To minimize foaming, do not shake
Inspect visually for particulate matter and discoloration prior to administration; solution should appear as a 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 the proper volume from the vial(s), based on the recommended weight-based dosage; discard any unused portion
Dispense syringe contents slowly into an infusion bag containing 50 mL of 0.9% NaCl to minimize foaming
Compatible with polyvinylchloride (PVC) or polyolefin infusion bags
Gently invert the bag to mix the solution; do not shake
Do not mix or dilute with other drugs
Administer immediately after preparation; if not used immediately, store diluted solutions in the refrigerator 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 an IV push or bolus
Should be administered in a healthcare setting by a healthcare professional prepared to manage anaphylaxis
If refrigerated prior to administration, allow the diluted solution to reach room temperature
Use an infusion set with an 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 a 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 have been conducted to evaluate the coadministration with other drugs
Monitor for hypersensitivity during the infusion and for an appropriate period afterwards
Upon completion of the infusion, flush the IV administration set with 0.9% NaCl to ensure that all reslizumab 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, store diluted solutions in the refrigerator 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
- Do not shake
