Rx Item-Kineret 100Mg 0.67 Syringe 7X0.67Ml By Biovitrum Ab

KINERET- anakinra injection, solution
Swedish Orphan Biovitrum AB (publ)

1 INDICATIONS AND USAGE

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 (5.2) ].

1.2 Cryopyrin-Associated Periodic Syndromes (CAPS)


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

2 DOSAGE AND ADMINISTRATION

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.

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 1.0 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.

2.3 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 (8.6) and Clinical Pharmacology (12.3) ].

2.4 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 "Information for Patients" 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.

3 DOSAGE 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.

RX ITEM-Kineret 100Mg 0.67 Syringe 7X0.6
NDC 66658-0234-07 UPC/GTIN No.3-66658-23407-6 Mfg.Part No.23407

Kineret 100Mg 0.67 Syringe 7X0.67Ml By B
BRAND: KINERET NDC: 66658-0234-07,66658023407 UPC: 3-66658-23407-6,366658234076 Biovitrum Ab

ANAKINRA SUB-Q SYRINGE 10
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