Secukinumab

Important Administration Instructions COSENTYX is for use under the guidance and supervision of a healthcare provider. UnoReady pen, Sensoready pen, and prefilled syringes are for subcutaneous use only. Solution in vials is for intravenous use in adult patients only. Important Subcutaneous Administration Instructions Adult patients may self-administer COSENTYX or be injected by a caregiver after proper training in subcutaneous injection technique.

Pediatric patients should not self-administer COSENTYX. An adult caregiver should prepare and inject COSENTYX after proper training in subcutaneous injection technique. Administer each subcutaneous injection at a different anatomic location (such as upper arms, thighs, or any quadrant of abdomen) than the previous injection, and not into areas where the skin is tender, bruised, erythematous, indurated, or affected by psoriasis.

Administration of subcutaneous COSENTYX in the upper, outer arm may be performed by a caregiver or healthcare provider. The COSENTYX “Instructions for Use” for each presentation and strength contains more detailed instructions on the preparation and administration of COSENTYX for patients and caregivers [see Instructions for Use] .

Important Intravenous Infusion Instructions Intravenous infusion is only for use by a healthcare professional in a healthcare setting. Prepare COSENTYX intravenous infusion by diluting COSENTYX injection in vial(s) and administering based on patient body weight [see Dosage and Administration] . Intravenous infusion may be administered only in adults with PsA, AS, and nr-axSpA.

Preparation for Use of COSENTYX UnoReady Pen, Sensoready Pen, and Prefilled Syringes COSENTYX UnoReady pen, Sensoready pen, and prefilled syringes are for subcutaneous injection only. Before subcutaneous injection, remove COSENTYX from the refrigerator and allow COSENTYX to reach room temperature (15 to 30 minutes for the Sensoready pen and prefilled syringes (150 mg/mL, 75 mg/0.5 mL); 30 to 45 minutes for the UnoReady pen) without removing the needle cap.

The removable cap of the COSENTYX Sensoready pen and prefilled syringes (150 mg/mL, 75 mg/0.5 mL) contains natural rubber latex and should not be handled by latex-sensitive individuals [see Warnings and Precautions] . Inspect COSENTYX visually for particulate matter and discoloration prior to administration. COSENTYX injection is a clear to slightly opalescent, colorless to slightly yellow solution.

Do not use if the liquid contains visible particles, is discolored or cloudy. Discard any unused product.

Preparation and Administration of COSENTYX for Intravenous Use COSENTYX (for intravenous use) must be diluted prior to infusion. Using aseptic technique, prepare COSENTYX (for intravenous use) as follows: Step 1. Volume Calculation Calculate the total volume of COSENTYX for intravenous use solution (in mL) required based on the patient’s actual body weight as follows: Loading dose (6 mg/kg) is 0.24 mL/kg Maintenance dose (1.75 mg/kg) is 0.07 mL/kg Use the number of vials based on total volume needed (one vial contains 5 mL of COSENTYX solution).

Step 2. Dilution Parenteral drug product should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if particulates or discolorations are noted. Follow Table 1 for recommended infusion bag size based on patient's body weight. [See table below.] From the infusion bag, withdraw and discard a volume of 0.9% Sodium Chloride Injection, USP, equal to the calculated volume of the COSENTYX solution required for the patient’s dose [see Dosage and Administration (2.4, 2.6, 2.8)] .

From the vial(s), withdraw the calculated volume (mL) of COSENTYX solution and add slowly into the 0.9% Sodium Chloride Injection, USP infusion bag. To mix the solution, gently invert the bag to avoid foaming. Do not shake. Discard unused COSENTYX product in vials because it does not contain preservatives. Allow the diluted COSENTYX solution for infusion to warm to room temperature prior to the start of the intravenous infusion.

Administer the diluted COSENTYX solution for infusion as soon as possible. If not administered immediately, store the diluted solution either: At room temperature 20ºC to 25ºC (68ºF to 77ºF) for no more than 4.5 hours from the start of the preparation (piercing the first vial) to the completion of infusion. Under refrigeration at 2°C to 8°C (36°F to 46°F) for no more than 24 hours, from the start of the time of the preparation (piercing the first vial) to the completion of infusion.

This time includes the refrigeration of the diluted solution and the time to allow the diluted solution to warm to room temperature. Protect the diluted solution from light during storage under refrigeration. Step 3. Administration Use only an infusion set with an in-line, sterile, non-pyrogenic, low protein-binding filter (pore size 0.2 micrometer).

Administer the infusion at a flow rate of about 3.3 mL/minute for a 100 mL bag or 1.7 mL/min for a 50 mL bag (total administration time: 30 minutes). When administration is complete, flush the line with 0.9% Sodium Chloride Injection, USP to guarantee that all the COSENTYX solution for infusion in the line has been administered.

Do not infuse COSENTYX concomitantly in the same intravenous line with other drugs. No physical or biochemical compatibility studies have been conducted to evaluate the IV coadministration of COSENTYX with other drugs.