CINQAIR
Clinical safety rating
cautionComprehensive clinical and safety monograph for CINQAIR (CINQAIR).
Comprehensive clinical and safety monograph for CINQAIR (CINQAIR).
Add-on maintenance treatment of patients with severe eosinophilic asthma aged 18 years and older
CINQAIR (reslizumab) is a humanized monoclonal antibody that binds to interleukin-5 (IL-5), inhibiting its binding to the IL-5 receptor on eosinophils. This reduces the production and survival of eosinophils, thereby decreasing eosinophilic inflammation in the airways.
| Metabolism | Reslizumab is a monoclonal antibody and is degraded into small peptides and amino acids via general protein catabolism. Not metabolized by cytochrome P450 enzymes. |
| Excretion | CINQAIR (reslizumab) is a monoclonal antibody that undergoes catabolism to small peptides and amino acids; no renal or biliary excretion of intact drug. Elimination via reticuloendothelial system and proteolysis, not quantified by traditional routes. |
| Half-life | Terminal elimination half-life is approximately 24 days in patients with asthma; this supports every-4-week dosing interval. |
| Protein binding | Reslizumab is an IgG4 monoclonal antibody; no specific protein binding data available, but IgG antibodies typically do not bind to plasma proteins extensively; assumed negligible (< 1% binding to specific transport proteins). |
| Volume of Distribution | Approximately 4.8 L (not standardized to weight; population estimate ~0.07 L/kg for a 70 kg person), reflecting distribution primarily in the vascular space and minimal extravascular distribution. |
| Bioavailability | Reslizumab is administered intravenously only; bioavailability is 100% by IV route; no oral formulation exists. |
| Onset of Action | Intravenous: Improvement in eosinophil counts and clinical parameters observed within 4 weeks of first dose. |
| Duration of Action | Sustained reduction in blood eosinophil counts for at least 4 weeks after a single IV dose; clinical effect duration supports monthly dosing. |
| Molecular Weight | 147000 |
3 mg/kg intravenously over 20-30 minutes every 4 weeks.
| Dosage form | INJECTABLE |
| Renal impairment | No dose adjustment required for renal impairment (eGFR ≥15 mL/min/1.73 m²). Not studied in ESRD. |
| Liver impairment | No dose adjustment required for mild to moderate hepatic impairment (Child-Pugh A or B). Not studied in severe hepatic impairment (Child-Pugh C). |
| Pediatric use | For children aged ≥6 years: 3 mg/kg intravenously over 20-30 minutes every 4 weeks. Maximum dose not specified. |
| Geriatric use | No specific dose adjustment recommended; limited data in patients ≥65 years. Use with caution due to potential comorbidities. |
| 1st trimester | No adequate human data; animal studies show no evidence of fetal harm at doses up to 100 mg/kg (approximately 20 times human exposure). Use only if clearly needed. |
| 2nd trimester | No adequate human data; animal studies show no evidence of fetal harm. Use only if clearly needed. |
| 3rd trimester | No adequate human data; animal studies show no evidence of fetal harm. Use only if clearly needed. |
Clinical note
Comprehensive clinical and safety monograph for CINQAIR (CINQAIR).
| Placental transfer | IgG antibodies are known to cross placental barrier; reslizumab is a humanized IgG4/k monoclonal antibody, expected to cross via FcRn-mediated transport, increasing in later trimesters. |
| Breastfeeding | No data on presence in human milk, effects on breastfed infant, or milk production. Consider developmental and health benefits of breastfeeding alongside mother's clinical need and potential adverse effects on infant. |
| Lactation Rating | L3 (Moderately Safe) |
| Teratogenic Risk | There are no adequate and well-controlled studies in pregnant women. In animal reproduction studies, reslizumab (the active ingredient) was not teratogenic in cynomolgus monkeys at intravenous doses up to 15 mg/kg (approximately 8 times the maximum recommended human dose based on AUC). However, there are no human data for the first trimester. The risk of fetal harm is unknown; use only if clearly needed. |
| Fetal Monitoring | No specific maternal or fetal monitoring is required beyond routine prenatal care. However, because reslizumab can cause hypersensitivity reactions (e.g., anaphylaxis), monitor for signs and symptoms during and after infusion. In pregnant women, standard obstetric monitoring is recommended. |
| Fertility Effects | There are no data on the effect of reslizumab on human fertility. In animal studies, no adverse effects on fertility or reproductive performance were observed in male and female cynomolgus monkeys treated with reslizumab at doses up to 15 mg/kg (approximately 8 times the maximum recommended human dose based on AUC). |
■ FDA Black Box Warning
Anaphylaxis has been reported in association with CINQAIR administration. Observe patients closely during and after infusion. Discontinue immediately if signs or symptoms of anaphylaxis occur.
| Serious Effects |
Known hypersensitivity to reslizumab or any excipients
| Precautions | Anaphylaxis: Observe patients during and after infusion; have appropriate medical support available., Malignancy: Use with caution in patients with pre-existing malignancy., Helminth infection: Treat pre-existing helminth infections before initiating therapy., Systemic corticosteroid withdrawal: Monitor for signs of corticosteroid withdrawal during taper. |
| Food/Dietary | No known food interactions. No dietary restrictions required. |
| Clinical Pearls | Administer via subcutaneous injection only; do not use for acute exacerbations. Monitor for hypersensitivity reactions including anaphylaxis. Reserve for patients with eosinophilic phenotype confirmed by blood eosinophil count ≥150 cells/μL or ≥300 cells/μL if on oral corticosteroids. Not for treatment of other eosinophilic conditions. Risk of herpes zoster; consider vaccination before starting therapy. Do not discontinue systemic or inhaled corticosteroids abruptly. |
| Patient Advice | Store in refrigerator at 2°C to 8°C, protect from light, and allow to warm to room temperature for 30 minutes before injection. · Inject subcutaneously into the thigh, abdomen, or upper arm; rotate injection sites. · Do not use if the solution is cloudy, discolored, or contains particles. · Seek immediate medical attention for signs of allergic reaction such as rash, itching, swelling, or trouble breathing. · Continue other asthma medications as prescribed; do not stop corticosteroids suddenly. · Report any new or worsening symptoms, especially if they occur within 24 hours of injection. · Avoid live vaccines; discuss vaccination history with healthcare provider. · Inform healthcare provider if you have a parasitic infection or are pregnant/breastfeeding. |
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