Reslizumab- Cinquair -@-(March 2016)- Bronchodilators
Drug Name:Reslizumab- Cinquair -@-(March 2016)- Bronchodilators
List Of Brands:
Indication Type Description:
Drug Interaction
Indication
Adverse Reaction
Contra-Indications
Dosages/ Overdosage Etc
Patient Information
Pharmacology/ Pharmacokinetics
Pregnancy and lactation
Drug Interaction:
DRUG INTERACTIONS
No formal clinical drug interaction studies have been performed with CINQAIR
Indication:
DRUG INNOVATION - NOVEL DRUG APPROVALS FOR 2016
No Drug Name Active Ingredient Approval Date FDA-Approved use
on Approval date
5. Cinqair Reslizumab 3/23/2016 To treat severe asthma Press release
Drug trials Snapshot
Approved by FDA on 3/23/2016 (Ref- FDA approved List- 2016)
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
CINQAIR safely and effectively. See full prescribing information for CINQAIR.
CINQAIR® (reslizumab) injection, for intravenous
Initial U.S. Approval: 2016
INDICATIONS AND USAGE
CINQAIR is an interleukin-5 antagonist monoclonal antibody
(IgG4 kappa) indicated for add-on maintenance treatment of patients with
severe asthma aged 18 years and older, and with an eosinophilic phenotype.
Limitations of Use: CINQAIR is not indicated for:
treatment of other eosinophilic conditions
relief of acute bronchospasm or status asthmaticus
Adverse Reaction:
ADVERSE REACTIONS
The most common adverse reaction (incidence greater than or equal to 2%)
includes oropharyngeal pain.
Contra-Indications:
CONTRAINDICATIONS
Known hypersensitivity to reslizumab or any of its excipients
WARNING: ANAPHYLAXIS
See full prescribing information for complete boxed warning.
Anaphylaxis occurred with CINQAIR infusion in 0.3% of patients in
placebo-controlled studies
Patients should be observed for an appropriate period of time after
CINQAIR infusion; healthcare professionals should be prepared
to manage anaphylaxis that can be life-threatening
Discontinue CINQAIR immediately if the patient experiences anaphylaxis
WARNINGS AND PRECAUTIONS
Malignancy:
Malignancies were observed in clinical studies.
Reduction in Corticosteroid Dosage: Do not discontinue systemic or
inhaled corticosteroids abruptly upon initiation of therapy with CINQAIR.
Decrease corticosteroids gradually, if appropriate.
Parasitic (Helminth) Infection: 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.
Dosages/ Overdosage Etc:
INDICATIONS AND USAGE
CINQAIR is an interleukin-5 antagonist monoclonal antibody
(IgG4 kappa) indicated for add-on maintenance treatment of patients with
severe asthma aged 18 years and older, and with an eosinophilic phenotype.
Limitations of Use: CINQAIR is not indicated for:
treatment of other eosinophilic conditions
relief of acute bronchospasm or status asthmaticus
DOSAGE AND ADMINISTRATION
CINQAIR is for intravenous infusion only.
Do not administer as an intravenous push or bolus
CINQAIR should be administered in a healthcare setting by a
healthcare professional prepared to manage anaphylaxis
Recommended dosage regimen is 3 mg/kg once every 4 weeks by
intravenous infusion over 20-50 minutes
DOSAGE FORMS AND STRENGTHS
Injection:100 mg/10 mL (10 mg/mL) solution in single-use vials
OVERDOSAGE
Single doses of up to 732 mg have been administered intravenously
to subjects in clinical trials without evidence of dose-related toxicities.
There is no specific treatment for an overdose with CINQAIR.
If overdose occurs, the patient should be treated supportively with appropriate
monitoring as necessary.
Patient Information:
PATIENT COUNSELING INFORMATION
See FDA approved patient labeling (Patient Information).
1.Hypersensitivity/Anaphylaxis
Inform patients that hypersensitivity reactions, including anaphylaxis,
have occurred with administration of CINQAIR.
2. Educate patients on the signs and symptoms of hypersensitivity
reactions and anaphylaxis (e.g., skin or mucosal involvement,
airway compromise, reduced blood pressure).
3.Instruct patients to contact their healthcare professional immediately
if they experience symptoms of an allergic reaction after they have
received their infusion of CINQAIR
.
4.Not for Acute Symptoms or Deteriorating Disease
Inform patients that CINQAIR does not treat acute asthma symptoms
or acute exacerbations.
5.Inform patients to seek medical advice if their asthma remains
uncontrolled or worsens after initiation of treatment with CINQAIR
6.Malignancy
Counsel CINQAIR-treated patients about the risk of malignancies.
7.Reduction of Corticosteroid Dosage
Inform patients not to discontinue systemic or inhaled corticosteroids
except under the direct supervision of a physician.
8.Inform patients that reduction in corticosteroid dose may be associated
with systemic withdrawal symptoms and/or unmask conditions previously
suppressed by systemic corticosteroid therapy .
Manufactured by:
Teva Respiratory, LLC
Frazer, PA 19355
Pharmacology/ Pharmacokinetics:
CLINICAL PHARMACOLOGY
1. Mechanism of Action
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.
Inflammation is an important component in the pathogenesis of asthma.
Multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages,
lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes,
cytokines) are involved in inflammation.
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.
2. Pharmacokinetics
The pharmacokinetics (PK) of reslizumab were characterized in
healthy adults (n=130), in patients with asthma (n=438), and in other
patient populations (n=236).
The PK characteristics of reslizumab were similar across these populations.
Inter-individual variability in peak and overall exposure was
approximately 20-30%.
Peak serum concentrations were typically observed at the end of the
infusion. Serum reslizumab concentrations generally declined from
peak in a biphasic manner.
Following multiple doses, serum concentrations of reslizumab
accumulated approximately 1.5 to 1.9-fold.
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1. Pregnancy
Risk Summary
The data on pregnancy exposure from the clinical trials are insufficient to
inform on drug associated risk. Monoclonal antibodies, such as reslizumab,
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 trimester of pregnancy.
Reslizumab has a long half-life . This should be taken into consideration.
2. Lactation
Risk Summary
It is not known whether reslizumab is present in human milk, and the effects
of reslizumab on the breast fed infant and on milk production are not known.
However, human IgG is known to be present in human milk.
Reslizumab was present in the milk of lactating mice following dosing
during pregnancy. The developmental and health benefits of breast feeding
should be considered along with the mother’s clinical need for CINQAIR
and any potential adverse effects on the breast-fed child from CINQAIR
or the underlying maternal condition
3. Pediatric Use
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.
4. Geriatric Use
CINQAIR was evaluated in 122 patients aged 65 years and older with asthma
in two 52-week exacerbation studies and two 16-week lung function studies.
No overall differences in safety or effectiveness were observed between
these patients and younger patients.
Based on available data, no adjustment of the dosage of CINQAIR in geriatric
patients is necessary.
5. OVERDOSAGE
Single doses of up to 732 mg have been administered intravenously
to subjects in clinical trials without evidence of dose-related toxicities.
There is no specific treatment for an overdose with CINQAIR.
If overdose occurs, the patient should be treated supportively with appropriate
monitoring as necessary.
