Arcalyst

Indications
Dosage
How Supplied

INDICATIONS

ARCALYST™ (rilonacept) is an interleukin-1 blocker indicated for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in adults and children 12 and older.

DOSAGE AND ADMINISTRATION

General Dosing Information

INJECTION FOR SUBCUTANEOUS USE ONLY.

Dosing

Adult patients 18 years and older: Treatment should be initiated with a loading dose of 320 mg delivered as two, 2 mL, subcutaneous injections of 160 mgeach given on the same day at two different sites. Dosing should be continued with a once-weekly injection of 160 mg administered as a single, 2-mL, subcutaneous injection. ARCALYST (rilonacept) should not be given more often than once weekly. Dosage modification is not required based on advanced age or gender.

Pediatric patients aged 12 to 17 years: Treatment should be initiated with a loading dose of 4.4mg/kg, up to amaximum of 320 mg, delivered as one or two subcutaneous injections with a maximum single-injection volume of 2mL.Dosing should be continued with a once-weekly injection of 2.2 mg/kg, up to a maximum of 160 mg, administered as a single subcutaneous injection, up to 2 mL. If the initial dose is given as two injections, they should be given on the same day at two different sites. ARCALYST (rilonacept) should not be given more often than once weekly.

Preparation for Administration

Each single-use vial of ARCALYST (rilonacept) contains a sterile, white to off-white, preservative-free, lyophilized powder. Reconstitution with 2.3 mL of preservative-free Sterile Water for Injection (supplied separately) is required prior to subcutaneous administration of the drug.

Administration

Using aseptic technique, withdraw 2.3 mL of preservative-free Sterile Water for Injection through a 27-gauge, ½-inch needle attached to a 3-mL syringe and inject the preservative-free SterileWater for Injection into the drug product vial for reconstitution. The needle and syringe used for reconstitution with preservative-free SterileWater for Injection should then be discarded and should not be used for subcutaneous injections. After the addition of preservative-free SterileWater for Injection, the vial contents should be reconstituted by shaking the vial for approximately one minute and then allowing it to sit for one minute. The resulting 80-mg/mL solution is sufficient to allow a withdrawal volume of up to 2mL for subcutaneous administration.The reconstituted solution is viscous, clear, colorless to pale yellow, and essentially free fromparticulates. Prior to injection, the reconstituted solution should be carefully inspected for any discoloration or particulate matter. If there is discoloration or particulate matter in the solution, the product in that vial should not be used.

Using aseptic technique, withdrawthe recommended dose volume, up to 2mL (160 mg), of the solution with a new 27-gauge, ½-inch needle attached to a new 3-mL syringe for subcutaneous injection. EACH VIAL SHOULD BE USED FOR A SINGLE DOSE ONLY. Discard the vial after withdrawal of drug.

Sites for subcutaneous injection, such as the abdomen, thigh, or upper arm, should be rotated. Injections should never be made at sites that are bruised, red, tender, or hard.

Stability and Storage

The lyophilized ARCALYST (rilonacept) product is to be stored refrigerated at 2° to 8°C (36° to 46°F) inside the original carton to protect it from light. Do not use beyond the date stamped on the label. After reconstitution, ARCALYST (rilonacept) may be kept at room temperature, should be protected from light, and should be used within three hours of reconstitution. ARCALYST (rilonacept) does not contain preservatives; therefore, unused portions of ARCALYST (rilonacept) should be discarded.

HOW SUPPLIED

Dosage Forms And Strengths

ARCALYST (rilonacept) is supplied in sterile, single-use, 20-mL, glass vials. Each vial contains 220 mg of rilonacept as a white to off-white, preservative-free, lyophilized powder. Reconstitution with 2.3 mL of preservative-free Sterile Water for Injection is required prior to subcutaneous administration of the drug. The reconstituted ARCALYST (rilonacept) is a viscous, clear, colorless to pale yellow, essentially free from particulates, 80-mg/mL solution.

Storage And Handling

Each 20-mL glass vial of ARCALYST (rilonacept) contains a sterile, white to off-white, preservative-free, lyophilized powder. ARCALYST (rilonacept) is supplied in a carton containing four vials.

The lyophilized ARCALYST (rilonacept) product is to be stored refrigerated at 2 to 8 °C (36° to 46°F) inside the original carton to protect from light. Do not use beyond the date stamped on the label. After reconstitution, ARCALYST (rilonacept) may be kept at room temperature, should be kept from light, and should be used within three hours of reconstitution. ARCALYST (rilonacept) does not contain preservatives; therefore, unused portions of ARCALYST (rilonacept) should be discarded. Discard the vial after a single withdrawal of drug.

Manufactured and distributed by: Regeneron Pharmaceuticals, Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591-6707. 1-877-REGN-777 (1-877-734-6777). Issue Date: 02/27/2008.

Last reviewed on RxList: 8/6/2009
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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