Data from FDA (Food and Drug Administration, USA) - Curated by EPG Health - Last updated 15 May 2018
Rheumatoid Arthritis (RA)
5 %) are injection site reaction,
6.1 Clinical Studies Experience in RA The most serious
These reactions were the most common reason for withdrawing from studies.
Studies 1 and 4 used the
The patients studied were representative of the general population of patients with rheumatoid arthritis.
Injection-site Reactions The most common and consistently reported
In Studies 1 and 4,
The ISRs typically lasted for 14 to 28 days and were characterized by 1 or more of the following: erythema, ecchymosis, inflammation, and
The incidence of serious
The incidence of serious
Majority of patients (73 %) continued on study drug after the
Patients with asthma appeared to be at higher risk of
In open-label extension studies, the overall rate of
In clinical studies and postmarketing experience, cases of
In patients who received both Kineret and etanercept for up to 24 weeks, the incidence of
The most common
Malignancies Among 5300 RA patients treated with Kineret in clinical trials for a mean of 15 months (approximately 6400 patient years of treatment), 8 lymphomas were observed for a rate of 0.12 cases/100 patient years.
This is 3.6 fold
Thirty-seven malignancies other than lymphoma were observed.
Of these, the most common were breast, respiratory system, and digestive system.
There were 3 melanomas observed in Study 4 and its
The significance of this finding is not known.
While patients with RA, particularly
Hematologic Events In placebo-controlled studies with Kineret, 8 % of patients receiving
Nine Kineret-treated patients (0.4 %) developed neutropenia (ANC < 1 x 109/L).
9 % of patients receiving
Of patients treated concurrently with Kineret and etanercept 2 % developed neutropenia (ANC < 1 x 109/L).
While neutropenic, one patient developed cellulitis which recovered with antibiotic therapy.
2 % of patients receiving
Hypersensitivity Reactions Hypersensitivity reactions including anaphylactic reactions, angioedema, urticaria, rash, and pruritus have been reported with Kineret.
Immunogenicity As with all therapeutic proteins, there is potential for immunogenicity.
In Studies 1 and 4, from which
The detection of antibody formation is highly dependent on the sensitivity and specificity of the assays.
Additionally, the observed incidence of antibody (including neutralizing antibody)
For these reasons, comparison of the incidence of
Lipids Cholesterol elevations were observed in some patients treated with Kineret.
5 % in Kineret-treated patients over a 6-month period.
Table 1: Percent of RA Patients Reporting
Patients were treated with a starting dose of 1 to 2 mg/kg/day and an
Among pediatric NOMID patients, doses up to 7.6 mg/kg/day have been maintained for up to 15 months.
There were 24 serious
The most common type of SAEs
Five SAEs were related to
The most commonly reported AEs during the first
The most commonly reported AEs during the 60-month study period, calculated as the number of events/patient years of exposure, were arthralgia,
The AE profiles for different age groups <2 years, 2-11 years, and 12-17 years corresponded to the AE profile for patients?18 years, with the exception of
In one patient Kineret administration was temporarily stopped during an
The reporting frequency for
Hematologic Events After start of Kineret treatment neutropenia was reported in 2 patients.
One of these patients experienced an upper respiratory tract
Both episodes of neutropenia resolved over time with continued Kineret treatment.
Injection Site Reactions In total, 17 injection site reactions (ISRs) were reported in 10 patients during the 60-month study period.
Out of the 17 ISRs, 11 (65 %) occurred during the first month and 13 (76 %) were reported during the first
Immunogenicity The immunogenicity of Kineret in NOMID patients was not evaluated.
Most common (>10 % of patients) treatment-emergent
6.3 Postmarketing Experience The following
Because these reactions are reported voluntarily from
2 DOSAGE AND ADMINISTRATION Rheumatoid Arthritis (RA) The
The dose should be administered at approximately the same time every day (2.1) Physicians should consider a dose of 100 mg of Kineret administered every other day for RA patients who have
(2.2) Physicians should consider administration of the prescribed Kineret dose every other day for NOMID patients who have
The dose should be administered at approximately the same time every day.
2.2 Cryopyrin-Associated Periodic Syndromes (CAPS)
Each syringe is intended for a single use.
A new syringe must be used for each dose.
2.4 Administration Instructions on
Patients or caregivers should not be allowed to administer Kineret until the patient or caregiver has demonstrated a
The prescribed dose of Kineret should be administered according to
After administration of Kineret it is essential to follow the
See the “Information for Patients” insert for
Visually inspect the solution for particulate matter and
There may be
The prefilled syringe should not be used if the solution is discolored or cloudy, or if foreign particulate matter is present.
If the number of translucent-to-white amorphous particles in
8 USE IN SPECIFIC POPULATIONS Pediatric use: Kineret is indicated for use in pediatric patients with NOMID (8.4) Geriatric use: Because there is a higher incidence of
Reproductive studies have been performed in
Because animal reproduction studies are not always predictive of human response, Kineret should be used during pregnancy only if clearly needed.
8.3 Nursing Mothers It is not known whether Kineret is secreted in human milk.
Because many drugs are secreted in human milk,
8.4 Pediatric Use The NOMID study included 36 pediatric patients: 13 below 2 years, 18 between 2 and 11 years, and 5 between 12 and 17 years of age.
A subcutaneous Kineret starting dose of 1-2 mg/kg/day was administered in all age groups.
Kineret was studied in a single randomized,
The 50 patients who achieved a clinical response after a 12-week open-label run-in were randomized to Kineret (25 patients) or placebo (25 patients), administered daily for an additional 16 weeks.
A subset of these patients continued open-label treatment with Kineret for up to 1 year in a companion extension study.
8.5 Geriatric Use A total of 752 RA patients?
65 years of age, including 163 patients?
75 years of age, were studied in clinical trials.
Because there is a higher incidence of
|Agency product number||9013DUQ28K|
|Date Last Revised||06-07-2015|
|Type||HUMAN PRESCRIPTION DRUG|
|Storage and handling||Storage Kineret should be stored in the refrigerator at 2°C to 8°C (36°F to 46°F). DO NOT FREEZE OR SHAKE. Protect from light. Rx only|
|Marketing authorisation holder||Swedish Orphan Biovitrum AB (publ)|