Brand Name
Kineret
Generic Name
Anakinra
View Brand Information FDA approval date: December 15, 2009
Classification: Interleukin-1 Receptor Antagonist
Form: Injection
What is Kineret (Anakinra)?
KINERET is an interleukin-1 receptor antagonist indicated for: Rheumatoid Arthritis Reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis, in patients 18 years of age or older who have failed 1 or more disease modifying antirheumatic drugs .
Approved To Treat
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Brand Information
Kineret (anakinra)
1DOSAGE FORMS AND STRENGTHS
Injection: 100 mg/0.67 mL solution in a single-use prefilled syringe for subcutaneous injection. Graduated syringe allows for doses between 20 and 100 mg.
2CONTRAINDICATIONS
KINERET is contraindicated in patients with known hypersensitivity to
3ADVERSE REACTIONS
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.
3.1Clinical Studies Experience in RA
The most serious adverse reactions were:
- Serious Infections –
- Neutropenia, particularly when used in combination with TNF blocking agents
The most common adverse reaction with KINERET is injection-site reactions. These reactions were the most common reason for withdrawing from studies.
The data described herein reflect exposure to KINERET in 3025 patients, including 2124 exposed for at least 6 months and 884 exposed for at least one year. Studies 1 and 4 used the recommended dose of 100 mg per day. The patients studied were representative of the general population of patients with rheumatoid arthritis.
3.2Clinical Study Experience in NOMID
The data described herein reflect an open-label study in 43 NOMID patients exposed to KINERET for up to 60 months adding up to a total exposure of 159.8 patient years.
Patients were treated with a starting dose of 1 to 2 mg/kg/day and an average maintenance dose of 3-4 mg/kg/day adjusted depending on the severity of disease. Among pediatric NOMID patients, doses up to 7.6 mg/kg/day have been maintained for up to 15 months.
There were 24 serious adverse events (SAEs) reported in 14 of the 43 treated patients. The most common type of SAEs reported were infections
There were no permanent discontinuations of study drug treatment due to AEs. Doses were adjusted in 5 patients because of AEs; all were dose increases in connection with disease flares.
The reporting frequency of AEs was highest during the first 6 months of treatment. The incidence of AEs did not increase over time, and no new types of AEs emerged.
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 most commonly reported AEs during the 60-month study period, calculated as the number of events/patient years of exposure, were arthralgia, headache, pyrexia, upper respiratory tract infection, nasopharyngitis, and rash.
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 years.
3.3Clinical Study Experience in DIRA
The safety data described in this section reflect exposure to KINERET in 9 patients with DIRA treated for up to 10 years in a natural history study (study 17-I-0016). Most patients received a starting dose of 1 to 2 mg/kg/day and thereafter doses were individually adjusted to reach a stable efficacious dose. The highest dose given was 7.5 mg/kg/day. Overall, the safety profile observed in patients with DIRA treated with KINERET was consistent with the safety profile in NOMID patients.
There were 16 serious adverse events (SAEs) reported in 4 out of 9 treated patients. The most common type of SAEs reported (5 events in 2 patients) were infections
The most common adverse events in patients with DIRA were upper respiratory tract infections, rash, pyrexia, influenza like illness and gastroenteritis.
There were no permanent discontinuations of KINERET treatment due to AEs.
3.4Postmarketing Experience
The following adverse reactions have been identified during postapproval use of KINERET. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Hepato-biliary disorders:
- elevations of transaminases,
- non-infectious hepatitis
Hematologic events:
- thrombocytopenia, including severe thrombocytopenia (i.e platelet counts <10x10
Skin and subcutaneous tissue disorders:
- Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
- injection site amyloid deposits
4DRUG INTERACTIONS
No drug-drug interaction studies in human subjects have been conducted. Toxicologic and toxicokinetic studies in rats did not demonstrate any alterations in the clearance or toxicologic profile of either methotrexate or KINERET when the two agents were administered together.
4.1TNF Blocking Agents
A higher rate of serious infections has been observed in patients treated with concurrent KINERET and etanercept therapy than in patients treated with etanercept alone
5OVERDOSAGE
There have been no cases of overdose reported with KINERET in clinical trials of RA or NOMID. In sepsis trials no serious toxicities attributed to KINERET were seen when administered at mean calculated doses of up to 35 times those given patients with RA over a 72-hour treatment period.
6DESCRIPTION
KINERET (anakinra) is a recombinant
KINERET is supplied in single use prefilled glass syringes with 29 gauge needles as a sterile, clear, colorless-to-white, preservative free solution for daily subcutaneous (SC) administration. The solution may contain trace amounts of small, translucent-to-white amorphous proteinaceous particles. Each prefilled glass syringe contains: 0.67 mL (100 mg) of anakinra in a solution (pH 6.5) containing anhydrous citric acid (1.29 mg), disodium EDTA (0.12 mg), polysorbate 80 (0.70 mg), and sodium chloride (5.48 mg) in Water for Injection, USP.
The prefilled syringe contains an outer rigid plastic needle shield attached to an inner needle cover. The syringe or needle shield components are not made with natural rubber latex.
7REFERENCES
- Cockcroft DW and Gault HM. Prediction of creatinine clearance from serum creatinine.
- Sharp JT, Young DY, Bluhm GB, et al. How many joints in the hands and wrists should be included in a score of radiologic abnormalities used to assess rheumatoid arthritis?
- National Cancer Institute. Surveillance, Epidemiology, and End Results Database (SEER) Program. SEER Incidence Crude Rates, 11 Registries, 1992-1999.
8HOW SUPPLIED/STORAGE AND HANDLING
KINERET is supplied in single-use preservative free, prefilled glass syringes with 29 gauge needles. Each prefilled glass syringe contains 100 mg of anakinra per 0.67 mL. The full syringe contains 100 mg anakinra. KINERET is dispensed in a 1 x 7 syringe dispensing pack containing 7 syringes (NDC 66658-234-07).
9PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (
Instruct patients and their caregivers on the proper dosage and administration of KINERET and provide all patients with the “Patient information and Instructions for Use” insert. While this Patient Information and Instructions for Use provides information about the product and its use, it is not intended to take the place of regular discussions between the patient and healthcare provider. The ability to inject subcutaneously should be assessed to ensure proper administration of KINERET. Thoroughly instruct patients and their caregivers on the importance of proper disposal and caution against the reuse of needles, syringes, and drug product. A puncture-resistant container for the disposal of used syringes should be available to the patient. The full container should be disposed of according to the directions provided by the healthcare provider.
Infections: Inform patients that KINERET may lower the ability of their immune system to fight infections. Advise patients of the importance of contacting their doctor if they develop any symptoms of infection.
Injection-site reactions: Physicians should explain to patients that almost a quarter of patients in the clinical trial experienced a reaction at the injection site. Injection-site reactions may include pain, erythema, swelling, pruritus, bruising, mass, inflammation, dermatitis, edema, urticaria, vesicles, warmth, and hemorrhage. Inform patients or their caregivers that the prefilled syringe should be removed from refrigeration and left at room temperature for 30 minutes before injecting. Patients should be advised to rotate the injection site and to avoid injecting into an area that is already swollen or red. Any persistent reaction should be brought to the attention of the prescribing physician.
Hypersensitivity reactions: Inform patients that serious allergic and skin reactions have been reported with KINERET. Advise patients to stop taking KINERET and seek immediate medical attention if they experience any symptoms suggesting allergic reactions (including rash, hives, and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing). Inform patients with DIRA and their caregivers, that DIRA patients may have an increased risk of allergic reactions, particularly in the first several weeks of treatment and they should be monitored closely.
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Manufactured by:
Swedish Orphan Biovitrum AB (publ)
SE-112 76 Stockholm, Sweden
Swedish Orphan Biovitrum AB (publ)
SE-112 76 Stockholm, Sweden
U.S. License No. 1859
© Swedish Orphan Biovitrum AB (publ). All rights reserved.
The product, its production and/or its use may be covered by one or more US Patents, including US Patent Nos. 6,599,873 and 6,858,409 as well as other patents or patents pending.