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Please refer to the Summary of Product Characteristics before prescribing
Kineret®.
Kineret® 100 mg, solution for injection in a pre-filled syringe.
Active Ingredient: Anakinra
Kineret® (
anakinra) is a human
interleukin-1 receptor antagonist produced by recombinant DNA technology in an
E. coli expression system.
Kineret® (
anakinra) neutralises the biologic activity of
interleukin-1 by competitively inhibiting its binding to the interleukin-1 receptor. Interleukin-1 is a pivotal pro-inflammatory cytokine mediating many cellular responses including those important in
synovial inflammation.
INDICATION: Kineret® is indicated for the treatment of the signs and symptoms of
rheumatoid arthritis in combination with methotrexate, in patients with an inadequate response to methotrexate alone.
DOSAGE AND ADMINISTRATION: The recommended dose of
Kineret® is 100 mg administered once a day by subcutaneous injection. The dose should be administered at approximately the same time each day.
Kineret® treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis. There are insufficient data to recommend the use of
Kineret® in children and adolescents under 18 years of age. In the absence of adequate data,
Kineret® should be used with caution in patients with moderate renal impairment (CL
cr 30 to 50 mL/minute).
CONTRAINDICATIONS: Kineret® should not be used in patients with hypersensitivity to the active substance, any of the excipients or to
E. coli derived proteins.
Kineret® should not be used in patients with severe renal impairment (CL
cr <30 mL/minute).
SPECIAL WARNINGS AND PRECAUTIONS: Allergic reactions associated with administration of
Kineret® during clinical trials were rare. If a severe allergic reaction occurs, administration of
Kineret® should be discontinued and appropriate treatment initiated. Physicians should exercise caution when administering
Kineret® to patients with a history of recurring infections or with underlying conditions which may predispose them to infections.
Kineret® treatment should not be initiated in patients with neutropenia (ANC <1.5 x 10
9/L). It is recommended that neutrophil counts be assessed prior to initiating
Kineret® treatment, and while receiving
Kineret® monthly during the first 6 months of treatment and quarterly thereafter. In patients who become neutropenic (ANC <1.5 x 10
9/L) the ANC should be monitored closely and
Kineret® treatment should be discontinued. It is unknown if chronic exposure to
Kineret® can increase the incidence of malignancies. The use of
Kineret® in patients with pre-existing malignancy is not recommended. 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 in patients receiving
Kineret®. In clinical trials, no overall differences in safety or effectiveness were observed between patients of
>65 years of age 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. Concurrent administration of
Kineret® and
etanercept has been associated with an increased risk of serious infections and neutropenia compared to
etanercept alone. The concurrent administration of
Kineret® and
etanercept or other TNF antagonists is not recommended.
INTERACTIONS: Interactions between
Kineret® and other medicinal products have not been investigated in formal studies. In clinical trials, no interactions between
Kineret® and other medicinal products (including nonsteroidal anti-inflammatory drugs,
corticosteroids, and DMARDs) have been observed. In a clinical trial with patients receiving background methotrexate, patients treated with
Kineret® and etanercept were observed to have a higher rate of serious infections (7%) and neutropenia than patients treated with etanercept alone and higher than observed in previous trials where
Kineret® was used alone. The concurrent administration of
Kineret® and etanercept or other TNF antagonists is not recommended.
PREGNANCY AND LACTATION: The use of
Kineret® in pregnant women is not recommended. Women of child-bearing potential should use effective contraception during treatment. It is not known whether anakinra is excreted in human milk. The use of
Kineret® in women who are breast-feeding is not recommended.
UNDESIRABLE EFFECTS: The safety of
Kineret® has been evaluated based on an integrated safety database of 2606 patients with rheumatoid arthritis. Of these patients, 1379 patients have been exposed to doses greater than or equal to the recommended dose of
Kineret® (100 mg/day). The most common and consistently reported treatment-related adverse event associated with
Kineret® were injection site reactions (ISRs). The majority (95%) of ISRs were reported as mild to moderate. At a dose of 100 mg/day, 71% of patients developed an ISR compared to 28% of the placebo-treated patients, which was typically reported within the first 4 weeks of therapy. The median duration of ISRs was 14 to 28 days. The development of ISRs in patients who had not previously experienced ISRs was uncommon after the first month of therapy.
Kineret® has been associated with an increased incidence of serious infections (1.8%) vs placebo (0.7%). In clinical studies the risk for serious infection was higher in patients with a history of asthma vs patients without a history of asthma. The safety and efficacy of
Kineret® in patients with chronic infections have not been evaluated. In studies where patients received concurrent
Kineret® and etanercept, a higher rate of serious infections compared to etanercept alone was observed. Administration of
Kineret® was associated with neutropenia (ANC <1.5 x 10
9/L) in 2.4% of patients compared with 0.4% of placebo patients. None of these patients had serious infections associated with the neutropenia. In studies where patients received concurrent
Kineret® and etanercept, 2% of patients (3/139) developed an ANC <1.0 x 10
9/L. During clinical trials, headaches were reported at a slightly higher rate in
Kineret®-treated patients in comparison to placebo-treated patients. The crude incidence rate of malignancy was the same in the
Kineret®-treated patients and the placebo-treated patients and did not differ from that in the general population. It is unknown if chronic exposure to
Kineret® can increase the incidence of malignancies.
PHARMACEUTICAL PARTICULARS: Solution for injection presented in pre-filled syringes containing 100 mg
anakinra in 0.67 mL. Excipients: sodium citrate, sodium chloride, disodium edetate, polysorbate 80, sodium hydroxide and water for injections. Store at 2 °C to 8 °C (in a refrigerator). Do not freeze. Store in the original container in order to protect from light. For the purpose of ambulatory use,
Kineret® may be removed from storage for a maximum single period of 12 hours at temperatures up to 25 °C.
LEGAL CLASSIFICATION: Medicinal product subject to restricted medical prescription.
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