Cinqair

Drug overview for CINQAIR (reslizumab):

Generic name: RESLIZUMAB (res-LIZ-ue-mab)
Drug class: Monoclonal Antibody, Human Interleukin 5 Antagonist
Therapeutic class: Respiratory Therapy Agents

Reslizumab, a recombinant DNA-derived humanized monoclonal antibody specific for interleukin-5 (IL-5), is an antiasthmatic agent. The drug is an IgG4 kappa immunoglobulin.

No enhanced Uses information available for this drug.

DRUG IMAGES

CINQAIR 100 MG/10 ML VIAL

The following indications for CINQAIR (reslizumab) have been approved by the FDA:

Indications:
Eosinophilic asthma

Professional Synonyms:
Asthma with eosinophilic phenotype
Asthmatic pulmonary eosinophilia

The following dosing information is available for CINQAIR (reslizumab):

Dosing
Administration
CINQAIR
Generic

For adjunctive maintenance therapy of severe eosinophilic asthma in adults, the recommended dosage of reslizumab is 3 mg/kg IV every 4 weeks.

Systemic or inhaled corticosteroid therapy should not be discontinued abruptly upon initiation of reslizumab therapy. If appropriate, reduction in corticosteroid dosage should be performed gradually and directly supervised by a clinician. Reduction in corticosteroid dosage may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by corticosteroid therapy.

Reslizumab is administered by IV infusion. The drug must not be administered by rapid IV injection (e.g., IV push or bolus). Reslizumab injection concentrate must be diluted prior to administration.

Diluted reslizumab solution should be administered in a healthcare setting by a clinician who is prepared to manage anaphylaxis. If the diluted solution is refrigerated, it should reach room temperature prior to administration. An infusion set with a compatible, low-protein-binding 0.2-microm

inline filter should be used (e.g., polyethersulfone (PES), polyvinylidene fluoride (PVDF), nylon, cellulose acetate inline infusion filter). Diluted reslizumab solution should be administered by IV infusion over 20-50 minutes; infusion time may vary depending on the total volume of the solution based upon the patient's weight. To ensure that the entire dose of reslizumab has been administered, the IV administration set should be flushed with 0.9%

sodium chloride injection after IV infusion of the drug is complete. The patient should be observed during the infusion and for an appropriate period of time following the infusion. Reslizumab infusion should be immediately discontinued if the patient experiences a severe systemic reaction, including anaphylaxis.

(See Sensitivity Reactions under Cautions: Warnings/Precautions.) Diluted reslizumab solution should not be administered in the same IV line with any other drug. To date, no physical or biochemical compatibility studies with other drugs have been conducted. Unopened vials containing reslizumab injection concentrate should be stored at 2-8degreesC in the original package, protected from light, and should not be shaken or frozen.

Dosing information for CINQAIR
DRUG LABEL	DOSING TYPE	DOSING INSTRUCTIONS
CINQAIR 100 MG/10 ML VIAL	Maintenance	Adults infuse 3 mg/kg over 20-50 minute(s) by intravenous route every 4 weeks

No generic dosing information available.

Contraindication List
Acute asthma attack

Severe List
Parasitic infection

The following adverse reaction information is available for CINQAIR (reslizumab):

Overview
Severe
Less Severe

Adverse reaction overview.

Adverse effects reported in at least 2% of patients receiving reslizumab and at an incidence higher than that reported with placebo include headache, upper respiratory tract infection, allergic rhinitis, back pain, sinusitis, urinary tract infection, dyspnea, dizziness, oropharyngeal pain, nausea, and vomiting.

There are 2 severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare
Anaphylaxis Malignancy

There are 8 less severe adverse reactions.

More Frequent	Less Frequent
Increased creatine kinase level Sore throat	Fatigue Muscle spasm Musculoskeletal pain Myalgia Neck pain Non-cardiac chest pain

Rare/Very Rare
None.

The following precautions are available for CINQAIR (reslizumab):

Pediatric
Pregnant
Lactation
Geriatric

Safety and efficacy of reslizumab in pediatric patients younger than 18 years of age have not been established.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

Monoclonal antibodies, such as reslizumab, are transported across the placenta in a linear fashion as pregnancy progresses with potential effects on the fetus being more likely during the second and third trimesters. However, there was no evidence of fetal harm in mice and rabbits following administration of reslizumab during organogenesis at dosages producing exposures up to 17 times the exposure at the maximum recommended human dosage.

It is not known whether reslizumab is distributed into human milk. However, the drug is distributed into the milk of lactating mice. Since human IgG is distributed into milk in humans, reslizumab is expected to distribute into human milk. The potential risks of infant exposure to reslizumab should be weighed against the mother's clinical need for the drug as well as the known benefits of breast-feeding.

In clinical trials, no overall differences in efficacy or safety were observed in patients 65 years of age or older when compared with younger patients.