Cinqair (reslizumab) injection is an interleukin-5 antagonistmonoclonal antibody (IgG4 kappa) indicated for add-on maintenance treatment of patients with severe asthma aged 18 years and older, and with an eosinophilic phenotype.
What Are Side Effects of Cinqair?
Common side effects of Cinqair include:
mouth and throat pain.
Dosage for Cinqair
The recommended dosage regimen of Cinqair is 3 mg/kg once every 4 weeks by intravenous infusion over 20-50 minutes.
What Drugs, Substances, or Supplements Interact with Cinqair?
Cinqair may interact with other drugs. Tell your doctor all medications and supplements you use.
Cinqair During Pregnancy or Breastfeeding
Tell your doctor if you are pregnant before receiving Cinqair. It is unknown if Cinqair passes into breast milk or if it could affect a nursing infant. Consult your doctor before breastfeeding.
Additional Information
Our Cinqair (reslizumab) injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Cinqair Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Some side effects may occur during or shortly after the injection. Tell your caregiver if you feel dizzy, nauseated, light-headed, itchy, short of breath, or if you have swelling in your face.
Common side effects may include:
sore throat; or
muscle pain.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Because clinical trials are conducted under widely
varying conditions, adverse reaction rates observed in the clinical trials of a
drug cannot be directly compared to rates in the clinical trials of another
drug and may not reflect the rates observed in clinical practice.
Overall, 2195 subjects received at least 1 dose of
CINQAIR. The data described below reflect exposure to CINQAIR in 1611 patients
with asthma, including 1120 exposed for up to 16 weeks, 1006 exposed for 6
months, 759 exposed for 1 year, and 249 exposed for longer than 2 years. The
above referenced safety exposure for CINQAIR is derived from placebo-controlled
studies ranging from 15 to 52 weeks in duration (CINQAIR 0.3 mg/kg and 3 mg/kg
[n=1131] and placebo [n=730]) and 480 new CINQAIR 3 mg/kg exposures (previously
on placebo) from a single open-label extension study (n=1051). While a lower
dose of CINQAIR 0.3 mg/kg (n=103) was included in a clinical trial, 3 mg/kg is
the only recommended dose [see DOSAGE AND ADMINISTRATION]. Of the
1611 patients, 1596 received the 3 mg/kg dose, 1028 of which were in the
placebo-controlled studies. In the placebo-controlled asthma studies, the
population studied was 12 to 76 years of age, 62% female, and 73% white. While
subjects aged 12 to 17 years were included in these trials, CINQAIR is not
approved for use in this age group [see Use In Specific Populations].
Serious adverse reactions that occurred in
placebo-controlled studies in more than 1 subject and in a greater percentage
of subjects treated with CINQAIR (n=1131) than placebo (n=730) included
anaphylaxis (3 subjects vs. 0 subjects, respectively). The 3 subjects who
experienced anaphylaxis were discontinued from the clinical studies [see WARNINGS
AND PRECAUTIONS]. Malignancy also occurred more commonly in patients
treated with CINQAIR than placebo (0.6% and 0.3%, respectively) [see
WARNINGS AND PRECAUTIONS].
Adverse reactions that occurred at greater than or equal
to 2% incidence and more commonly than in the placebo group included 1 event:
oropharyngeal pain (2.6% vs. 2.2%).
CPK Elevations And Muscle-Related Adverse Reactions
Elevated baseline creatine phosphokinase (CPK) was more
frequent in patients randomized to CINQAIR (14%) versus placebo (9%). Transient
CPK elevations in patients with normal baseline CPK values were observed more
frequently with CINQAIR (20%) versus placebo (18%) during routine laboratory
assessments. CPK elevations >10 x ULN, regardless of baseline CPK value,
were 0.8% in the CINQAIR group compared to 0.4% in the placebo group. CPK elevations
>10 x ULN were asymptomatic and did not lead to treatment discontinuation.
Myalgia was reported in 1% (10/1028) of patients in the
CINQAIR 3 mg/kg group compared to 0.5% (4/730) of patients in the placebo
group. On the day of infusion, musculoskeletal adverse reactions were reported
in 2.2% and 1.5% of patients treated with CINQAIR 3 mg/kg and placebo,
respectively. These reactions included (but were not limited to)
musculoskeletal chest pain, neck pain, muscle spasms, extremity pain, muscle
fatigue, and musculoskeletal pain.
Immunogenicity
As with all therapeutic proteins, there is a potential
for immunogenicity. In placebo-controlled studies, a treatment-emergent
anti-reslizumab antibody response developed in 53/983 (5.4%) of CINQAIR-treated
patients (3 mg/kg). In the long-term, open-label study, treatment-emergent anti-reslizumab
antibodies were detected in 49/1014 (4.8%) of CINQAIR-treated (3 mg/kg) asthma
patients over 36 months. The antibody responses were of low titer and often
transient. Neutralizing antibodies were not evaluated. There was no detectable
impact of the antibodies on the clinical pharmacokinetics, pharmacodynamics,
clinical efficacy, and safety of CINQAIR [see CLINICAL PHARMACOLOGY]. Product-specific
IgE antibodies were not detected in patients who reported anaphylactic
reactions.
The data reflect the percentage of patients whose test
results were positive for antibodies to reslizumab in specific assays. The
observed incidence of antibody response is highly dependent on several factors,
including assay sensitivity and specificity, assay methodology, sample handling,
timing of sample collection, concomitant medication, and underlying disease.
For these reasons, comparison of the incidence of antibodies to reslizumab with
the incidence of antibodies to other products may be misleading.
&Copy; Cinqair Patient Information is supplied by Cerner Multum, Inc. and Cinqair Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
