Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 27 February 2017
To report SUSPECTED
6.1 Clinical Trials Experience Because clinical trials are conducted under widely
Overall, 2195 subjects received at least 1 dose of CINQAIR.
The above referenced
While a lower dose of CINQAIR 0.3 mg/kg (n=103) was included in a clinical trial,
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
The 3 subjects who experienced
Malignancy also occurred more commonly in patients treated with CINQAIR than placebo (0.6 % and 0.3 %, respectively) [see Warnings and Precautions (5.3)].
CPK elevations and muscle-related
Transient CPK elevations in patients with normal baseline CPK values were observed more frequently with CINQAIR (20 %) versus placebo (18 %) during routine laboratory assessments.
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
These reactions included (but were not
6.2 Immunogenicity As with all therapeutic proteins, there is a
In placebo-controlled studies,
CINQAIR-treated (3 mg/kg) asthma patients over 36 months.
Neutralizing antibodies and product-specific IgE antibodies were not evaluated.
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
2 DOSAGE AND ADMINISTRATION •CINQAIR is for intravenous infusion only.
Do not administer as an intravenous push or bolus (2.1) •CINQAIR should be administered in a healthcare setting by a healthcare
Do not administer as an intravenous push or bolus.
2.2 Preparation and
Preparation of intravenous infusion
1. Remove CINQAIR from the refrigerator. To minimize foaming,
Do not mix or dilute with other drugs.
5. Administer immediately after preparation. If not used immediately, store diluted solutions of CINQAIR in the refrigerator at 2°C to 8°C (36°F to 46°F) or at room temperature up to 25?C (77?F),
3. Use an infusion set with an in-line,
4. Infuse the diluted solution of CINQAIR intravenously, over a 20-50 minute period.
5. Do not infuse CINQAIR concomitantly in the same intravenous line with other agents.
7. Upon completion of the infusion,
8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary
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
Reslizumab has a long half-life [see Clinical Pharmacology (12.3)].
This should be taken into consideration.
In animal reproduction studies, there was
The estimated background risk of major birth
In the U.S. general population, the estimated background risk of major birth
Clinical Considerations Disease-Associated Maternal and/or
Data Animal Data In 2 separate embryo-fetal development studies, pregnant mice and rabbits received a single reslizumab dose during the period of organogenesis at 2, 10, and 50 mg/kg (0.4, 1.5, and 6 times the exposures achieved at the MRHD in mice on an AUC basis and 0.67, 3.3, and 17 times the exposures achieved at the MRHD in rabbits on a mg/ kg basis).
Reslizumab was not teratogenic in mice or rabbits.
Embryo-fetal development of interleukin-5 (IL-5)
In a prenatal and postnatal development study, pregnant CD-1 mice received reslizumab during organogenesis on gestation days 6 and 18 and on postnatal day 14 at 10 or 50 mg/kg (1.5 and 6 times the exposures achieved at the MRHD on an AUC basis).
Reslizumab crossed the placenta of pregnant mice.
Serum concentrations in pups were approximately 6-8 % of those in the dams (parental female mice) on postnatal day 14.
8.2 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 [see Data].
The developmental and health
Data Reslizumab was excreted in milk of lactating CD-1 mice that received reslizumab at 10 or 50 mg/kg (1.5 and 6 times the exposures achieved at the MRHD on an AUC basis) during pregnancy on gestation days 6 and 18 and on postnatal day 14.
Levels of reslizumab in milk were approximately 5-7 % of maternal serum concentrations.
8.4 Pediatric Use CINQAIR is not indicated for use in pediatric patients less than 18 years of age.
CINQAIR was evaluated in 39 patients aged 12 to less than 18 years with asthma in two 52-week
In these studies,
8.5 Geriatric Use CINQAIR was evaluated in 122 patients aged 65 years and older with asthma in two 52-week
|Agency product number||35A26E427H|
|Date Last Revised||09-06-2016|
|Type||HUMAN PRESCRIPTION DRUG|
|Marketing authorisation holder||Teva Respiratory, LLC|
ANAPHYLAXIS Anaphylaxis has been observed with CINQAIR infusion in 0.3 % of patients in placebo-controlled clinical studies.
Anaphylaxis was reported as early as the second dose of CINQAIR [see Warnings and Precautions (5.1),
Patients should be observed for an
ANAPHYLAXIS See full prescribing information for
• Anaphylaxis occurred with CINQAIR infusion in 0.3 % of patients in placebo-controlled studies (5.1) • Patients should be observed for an