Kineret (Anakinra)

Dosage and Administration, Administration (

KINERET is an interleukin-1 receptor antagonist indicated for:

• 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 (DMARDs) (
  1.1 Active Rheumatoid Arthritis

  KINERET is indicated for the reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis (RA), in patients 18 years of age or older who have failed 1 or more disease modifying antirheumatic drugs (DMARDs). KINERET can be used alone or in combination with DMARDs other than Tumor Necrosis Factor (TNF) blocking agents

  [see Warnings and Precautions ].
  )

• Treatment of Neonatal-Onset Multisystem Inflammatory Disease (NOMID) (
  1.2 Cryopyrin-Associated Periodic Syndromes (CAPS)

  KINERET is indicated for the treatment of Neonatal-Onset Multisystem Inflammatory Disease (NOMID).
  )

• Treatment of Deficiency of Interleukin-1 Receptor Antagonist (DIRA) (
  1.3 Deficiency of Interleukin-1 Receptor Antagonist (DIRA)

  KINERET is indicated for the treatment of Deficiency of Interleukin-1 Receptor Antagonist (DIRA)
  )

• The recommended dose of KINERET for the treatment of patients with rheumatoid arthritis is 100 mg/day administered daily by subcutaneous injection. The dose should be administered at approximately the same time every day (
  2.1 Active Rheumatoid Arthritis

  The recommended dose of KINERET for the treatment of patients with rheumatoid arthritis is 100 mg/day administered daily by subcutaneous injection. Higher doses did not result in a higher response. The dose should be administered at approximately the same time every day.
  )
• Physicians should consider a dose of 100 mg of KINERET administered every other day for RA patients who have severe renal insufficiency or end stage renal disease (defined as creatinine clearance < 30 mL/min, as estimated from serum creatinine levels) (
  2.4 Renal Impairment

  Physicians should consider administration of the prescribed dose of KINERET every other day for patients who have severe renal insufficiency or end stage renal disease (defined as creatinine clearance < 30 mL/min, as estimated from serum creatinine levels)

  [see Use in Specific Populations and Clinical Pharmacology ]

  .
  )

• The recommended starting dose of KINERET is 1-2 mg/kg daily for NOMID patients. The dose can be individually adjusted to a maximum of 8 mg/kg daily to control active inflammation. (
  2.2 Cryopyrin-Associated Periodic Syndromes (CAPS)

  The recommended starting dose of KINERET is 1-2 mg/kg for NOMID patients. The dose can be individually adjusted to a maximum of 8 mg/kg daily to control active inflammation.

  Adjust doses in 0.5 to 1 mg/kg increments. Once daily administration is generally recommended, but the dose may be split into twice daily administrations. Each syringe is intended for a single use. A new syringe must be used for each dose. Any unused portion after each dose should be discarded.
  )
• Physicians should consider administration of the prescribed KINERET dose every other day for NOMID patients who have severe renal insufficiency or end stage renal disease (defined as creatinine clearance < 30 mL/min, as estimated from serum creatinine levels) (
  2.4 Renal Impairment

  Physicians should consider administration of the prescribed dose of KINERET every other day for patients who have severe renal insufficiency or end stage renal disease (defined as creatinine clearance < 30 mL/min, as estimated from serum creatinine levels)

  [see Use in Specific Populations and Clinical Pharmacology ]

  .
  )

• The recommended starting dose of KINERET is 1-2 mg/kg daily for patients with DIRA. The dose can be individually adjusted to a maximum of 8 mg/kg daily to control active inflammation. (
  2.3 Deficiency of Interleukin-1 Receptor Antagonist (DIRA)

  The recommended starting dose of KINERET is 1-2 mg/kg daily for patients with DIRA. The dose can be individually adjusted to a maximum of 8 mg/kg daily to control active inflammation. Adjust doses in 0.5 to 1 mg/kg increments.

  Each syringe is intended for a single use. A new syringe must be used for each dose. Any unused portion after each dose should be discarded.
  )
• Physicians should consider administration of the prescribed KINERET dose every other day for patients with DIRA who have severe renal insufficiency or end stage renal disease (defined as creatinine clearance < 30 mL/min, as estimated from serum creatinine levels) (
  2.4 Renal Impairment

  Physicians should consider administration of the prescribed dose of KINERET every other day for patients who have severe renal insufficiency or end stage renal disease (defined as creatinine clearance < 30 mL/min, as estimated from serum creatinine levels)

  [see Use in Specific Populations and Clinical Pharmacology ]

  .
  )

See full prescribing information for administration instructions (

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.

• Pediatric use: KINERET is indicated for use in pediatric patients with NOMID and DIRA (
  8.4 Pediatric Use

  Neonatal-Onset Multisystem Inflammatory Disease (NOMID)

  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. An average maintenance dose of 3–4 mg/kg/day was adequate to maintain clinical response throughout the study irrespective of age but a higher dose was, on occasion, required in severely affected patients. The prefilled syringe does not allow doses lower than 20 mg to be administered.

  Deficiency of Interleukin-1 Receptor Antagonist (DIRA)

  The study in DIRA patients included 9 pediatric patients (ages 1 month to 9 years at start of KINERET treatment). Most patients received a starting dose of 1 to 2 mg/kg/day. Doses up to 7.5 mg/kg/day were given. The prefilled syringe does not allow doses lower than 20 mg to be administered.

  Juvenile Rheumatoid Arthritis (JRA)

  The safety and effectiveness of KINERET in the treatment of pediatric patients with Juvenile Rheumatoid Arthritis (JRA) have not been established. KINERET was studied in a single randomized, blinded multi-center trial in 86 patients with polyarticular course JRA; ages 2-17 years receiving a dose of 1 mg/kg subcutaneously daily, up to a maximum dose of 100 mg. 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. An adverse event profile similar to that seen in adult RA patients was observed in these studies. These study data are insufficient to demonstrate efficacy and, therefore, KINERET is not recommended for pediatric use in JRA.
  )
• Geriatric use: Because there is a higher incidence of infections in the elderly population in general, caution should be used in treating the elderly (
  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. No differences in safety or effectiveness were observed between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Because there is a higher incidence of infections in the elderly population in general, caution should be used in treating the elderly.

  This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function.
  )
• Renal impairment: This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function (
  8.6 Renal Impairment

  This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function

  [see Clinical Pharmacology ]

  .
  )