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KINERET is a brand name for Anakinra, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Rheumatoid arthritis KINERET (anakinra) is indicated for: • reducing the signs and symptoms of active rheumatoid arthritis (RA) in patients 18 years of age or older. • inhibiting the progression of structural damage by reducing erosions and cartilage degradation in patients with active rheumatoid arthritis despite…
Verbatim from this product's HC label. Tap a section to expand.
2 Recommended Dose and Dosage Adjustment Rheumatoid Arthritis: Adults The recommended dose of KINERET (anakinra) for the treatment of active RA is 100 mg/day administered daily by subcutaneous (SC) injection. The dose should be administered at approximately the same time of day every day.
KINERET is provided in single-use prefilled syringes containing the full daily dose.
NOMID:
Adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above.
Starting dose:
The recommended starting dose of KINERET for the treatment of patients with NOMID is 1-2 mg/kg administered daily by SC injection. The graduated syringe allows for doses between 20 and 100 mg. Dose increases may become necessary within 1-2 months based on therapeutic response.
0 mg/kg increments. The usual maintenance dose is 3-4 mg/kg/day, which can be individually adjusted to a maximum of 8 mg/kg/day to control active inflammation. Very limited data is available for doses higher than 5 mg/kg/day. The dose should be administered at approximately the same time of day every day.
KINERET is provided in single-use graduated prefilled syringes, which allow for dose adjustment. 3 Pharmacokinetics, Special Populations and Conditions). There is no clinical experience from KINERET treatment of NOMID patients with renal impairment.
4 Administration Administer only one dose per day. Rotating the injection sites is recommended. Instructions on appropriate use should be given by the health care professional to the patient or care provider. See “Patient Medication Information” for detailed instructions on the handling and injection of KINERET.
Discard any unused portions. After administration of KINERET, it is essential to follow the proper procedure for disposal of syringes, needles and supplies (see Patient Medication Information for instructions). Do not use KINERET beyond the expiration date shown on the carton and prefilled syringe.
Visually inspect the solution for particulate matter and discolouration before administration. There may be small translucent-to-white particles of protein in the solution. This is not unusual for proteinaceous solutions. The prefilled syringe should not be used if the solution is discoloured or cloudy, or if foreign particulate matter is present.
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Immunizations:
No data are available on the effects of vaccination in patients receiving KINERET. Live vaccines should not be given concurrently with KINERET. No data are available on the secondary transmission of infection by live vaccines. Monitoring and Laboratory Tests Patients receiving KINERET may experience a decrease in neutrophil counts.
4%) experienced neutropenia (ANC<1 x 109/L). None of these patients had serious infections associated with the neutropenia. KINERET treatment should not be initiated in patients with neutropenia (ANC <1 x 109/L). Neutrophil counts should be assessed prior to initiating KINERET treatment, and quarterly while receiving KINERET for a period up to 1 year.
Renal Renally Impaired Patients:
From studies performed in non-RA patients with various degrees of renal insufficiency KINERET is known to be substantially excreted by the kidney. The mean plasma clearance of KINERET decreased 70-75% in subjects with severe or end stage renal disease (defined as creatinine clearance less than 30 mL/minute).
Patients with renal impairment should be carefully evaluated before initiating therapy. A dose schedule change may be considered for subjects with severe renal insufficiency or end stage renal disease (see 4 DOSAGE AND ADMINISTRATION and 10 CLINICAL PHARMACOLOGY).
There is no clinical experience from KINERET treatment of NOMID patients with renal impairment.
Reproductive Health:
Female and Male Potential • Fertility KINERET had no observed effect on the fertility, early development, embryo-fetal development, or peri- and postnatal development in the rat at doses up to 100 times the human dose. No effects on embryo-fetal development in the rabbit were observed at doses 100 times the human dose.
, General, Amyloidosis 01/2025 7 WARNINGS AND PRECAUTIONS, General, Drug reaction with eosinophilia and systemic symptoms (DRESS) 08/2025 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed.
RECENT MAJOR LABEL CHANGES .......................................................................................... 2 TABLE OF CONTENTS ............................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION .................................................................... 4 1 INDICATIONS .............................................................................................................
1 Pediatrics................................................................................................................ 2 Geriatrics ................................................................................................................
4 2 CONTRAINDICATIONS ................................................................................................ 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ........................................................... 5 4 DOSAGE AND ADMINISTRATION................................................................................
2 Recommended Dose and Dosage Adjustment ...................................................... 4 Administration ....................................................................................................... 5 Missed Dose ...........................................................................................................
6 5 OVERDOSAGE............................................................................................................ 6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................ 6 7 WARNINGS AND PRECAUTIONS .................................................................................
KINERET (anakinra) is contraindicated in patients with known hypersensitivity to E. coli-derived proteins, KINERET, or any components of the product. For a complete listing of components, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
KINERET (anakinra) Product Monograph Page 5 of 39
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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None of the syringe or needle shield components are made with natural rubber latex. 5 Missed Dose Patients who miss a dose by more than a few hours should be instructed to take the missed dose as soon as possible and contact their doctor or nurse.
The dose the next day should not be doubled.
0%). Caution should be exercised in patients with underlying airway inflammation; if present or suspected in asthmatic patients, it should be brought under control with appropriate asthma therapy prior to initiating treatment with KINERET.
1 Pregnant Women There are no adequate and well-controlled studies in pregnant women. KINERET should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Reproductive studies have been conducted with KINERET in rats and rabbits at doses up to 100 times the human dose and have revealed no evidence of harm to the fetus.
Because animal reproduction studies are not always predictive of human response, KINERET should be used during pregnancy only if medically necessary. 2 Breast-feeding It is not known whether KINERET is excreted in human milk. Because many drugs are excreted in human milk, precaution should be exercised if KINERET is administered to a breast-feeding woman.
3 Pediatrics Pediatrics (<18 years of age): RA: The efficacy of KINERET in children with RA (JIA) aged 0 to 18 years has not been established.
NOMID:
KINERET is not recommended for use in children below 8 months of age due to lack of clinical data. 4 Geriatrics Geriatrics (>65 years of age): In the pivotal controlled trials in RA, 752 patients 65 years of age or older were enrolled.
No differences in safety or efficacy were observed between these patients and younger patients. Because there is a higher incidence of infections in the elderly population in general, caution should be used in treating the elderly. In the pivotal NOMID trial, no patients 65 years of age or older were enrolled.
1 Adverse Reaction Overview KINERET (anakinra) has been used in studies enrolling over 3000 patients with RA and in studies enrolling over 1400 patients with other diseases. The data described herein reflect exposure to KINERET in 2805 patients including 1958 exposed for at least 6 months and 884 exposed for at least 1 year.
The most common and consistently reported treatment related adverse events were injection site reactions (ISRs). With the exception of ISRs, there appears to be no difference in the proportion of patients who discontinued treatment because of adverse events in the KINERET groups and the placebo group.
8 patient years. 6%) reported 24 serious adverse events (SAEs). The most common type of SAEs were infections (see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX). 3%) patients were considered related to KINERET. One patient experienced KINERET (anakinra) Product Monograph Page 10 of 39 histiocytosis haematophagica (macrophage activation syndrome) in the pivotal NOMID study.
This patient also experienced histiocytosis haematophagica before start of KINERET treatment. A causal relationship between KINERET and histiocytosis haematophagica has not been established. There were no permanent discontinuations of KINERET treatment due to adverse reactions.
The reporting frequency of adverse events (AEs) was highest during the first 6 months of treatment. The most commonly reported AEs during the first 6 months of treatment (incidence >10%) were injection site reaction (ISR), headache, vomiting, arthralgia, pyrexia, and nasopharyngitis.
The incidence of AEs did not increase over time, and no new types of AEs emerged. 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 infections and related symptoms being more frequent in patients <2 […]
1 Pregnant Women ............................................................................................... 2 Breast-feeding .................................................................................................... 3 Pediatrics............................................................................................................
4 Geriatrics ............................................................................................................ 9 8 ADVERSE REACTIONS.................................................................................................
1 Adverse Reaction Overview ................................................................................... 2 Clinical Trial Adverse Reactions ........................................................................... 1 Clinical Trial Adverse Reactions – Pediatrics....................................................
3 Less Common Clinical Trial Adverse Reactions .................................................... 1 Less Common Clinical Trial Adverse Reactions – Pediatrics ............................ 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data.............................................................................................................
5 Post-Market Findings ........................................................................................... 16 9 DRUG INTERACTIONS ..............................................................................................
2 Drug Interactions Overview ................................................................................. 4 Drug-Drug Interactions ........................................................................................ 5 Drug-Food Interactions ........................................................................................
6 Drug-Herb Interactions ........................................................................................ 7 Drug-Laboratory Test Interactions....................................................................... 17 10 CLINICAL PHARMACOLOGY ......................................................................................
1 Mechanism of Action ........................................................................................... 2 Pharmacodynamics .............................................................................................. 3 Pharmacokinetics .................................................................................................
18 11 STORAGE, STABILITY AND DISPOSAL ........................................................................ 20 12 SPECIAL HANDLING INSTRUCTIONS.......................................................................... 20 PART II: SCIENTIFIC INFORMATION .....................................................................................
21 13 PHARMACEUTICAL INFORMATION .......................................................................... 21 14 CLINICAL TRIALS ......................................................................................................
1 Clinical Trials by Indication .................................................................................. 22 Rheumatoid Arthritis .......................................................................................................
22 Neonatal Onset Multisystem Inflammatory Disease (NOMID) ....................................... 26 15 MICROBIOLOGY ...................................................................................................... 28 16 NON-CLINICAL TOXICOLOGY ....................................................................................
28 PATIENT MEDICATION INFORMATION ................................................................................ 30 KINERET […]