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Kineret

"Nov. 1, 2013 (San Diego)- Women who drink one or more sugar-sweetened sodas a day might raise their risk of getting rheumatoid arthritis, according to a new study that links RA risk to the sugary habit. The study does not prove cause and ef"...

Kineret

INDICATIONS

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].

Cryopyrin-Associated Periodic Syndromes (CAPS)

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

DOSAGE AND ADMINISTRATION

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.

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 1.0 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.

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].

Administration

Instructions on appropriate use should be given by the healthcare provider to the patient or caregiver. Patients or caregivers should not be allowed to administer Kineret until the patient or caregiver has demonstrated a thorough understanding of procedures and an ability to inject the product correctly. The prescribed dose of Kineret should be administered according to the instructions for use and any unused portions discarded. After administration of Kineret it is essential to follow the proper procedure for disposal of syringes and any residual drug. See the “PATIENT INFORMATION” insert for detailed instructions on the handling and injection of Kineret.

Do not use Kineret beyond the expiration date shown on the carton. Visually inspect the solution for particulate matter and discoloration before administration. There may be trace amounts of small, translucent-to-white amorphous particles of protein in the solution. 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 a given syringe appears excessive, do not use this syringe.

HOW SUPPLIED

Dosage Forms And Strengths

100 mg/0.67 mL solution for subcutaneous injection. Graduated syringe allows for doses between 20 and 100 mg.

Storage And Handling

Kineret is supplied in single-use preservative free, prefilled glass syringes with 27 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 4 x 7 syringe dispensing pack containing 28 syringes (NDC 66658-234-28). Kineret is also dispensed in a 1 x 7 syringe dispensing pack containing 7 syringes (NDC 66658-234-07).

Storage

Kineret should be stored in the refrigerator at 2° to 8°C (36° to 46°F). DO NOT FREEZE OR SHAKE. Protect from light.

Manufactured by: Swedish Orphan Biovitrum AB (publ) SE-112 76 Stockholm, Sweden License No. 1859. Revised Date: 10/2013

Last reviewed on RxList: 11/7/2013
This monograph has been modified to include the generic and brand name in many instances.

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