TEPEZZA POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 500 MG/VIAL [SIN17539P]

Product Info

TEPEZZA POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 500 MG/VIAL

[SIN17539P]

Indication

1 INDICATIONS AND USAGE

TEPEZZA is indicated in adults for the treatment of moderate to severe Thyroid Eye Disease (TED).

Dosing

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosing

The recommended dose of TEPEZZA is an intravenous infusion of 10 mg/kg for the initial dose followed by an intravenous infusion of 20 mg/kg every three weeks for 7 additional infusions.

2.2 Reconstitution and Preparation

Step 1: Calculate the dose (mg) and determine the number of vials needed for the 10 or 20 mg/kg dosage based on patient weight. Each TEPEZZA vial contains 500 mg of the teprotumumab antibody.

Step 2: Using appropriate aseptic technique, reconstitute each TEPEZZA vial with 10 mL of Sterile Water for Injection, USP. Ensure that the stream of diluent is not directed onto the lyophilized powder, which has a cake-like appearance. Do not shake, but gently swirl the solution by rotating the vial until the lyophilized powder is dissolved. The reconstituted solution has a total volume of 10.5 mL. Withdraw 10.5 mL of reconstituted solution to obtain 500 mg. After reconstitution, the final concentration is 47.6 mg/mL.

Step 3: The reconstituted TEPEZZA solution must be further diluted in 0.9% Sodium Chloride Injection, USP prior to infusion. To prepare the diluted solution, use 100 mL infusion bags for a dose less than 1800 mg, and 250 mL for a dose equal to or greater than 1800 mg. To maintain a constant volume in the infusion bag, a sterile syringe and needle should be used to remove the volume equivalent to the amount of the reconstituted TEPEZZA solution to be placed into the infusion bag. Discard the volume of 0.9% Sodium Chloride Injection, USP withdrawn.

Step 4: Withdraw the required volume from the reconstituted TEPEZZA vial(s) based on the patient’s weight (in kg) and transfer into the intravenous bag containing 0.9% Sodium Chloride Injection, USP. Mix diluted solution by gentle inversion. Do not shake. If refrigerated prior to administration, allow the diluted solution to reach room temperature prior to infusion.

The product does not contain any preservative. The combined storage time of reconstituted TEPEZZA solution in the vial and the diluted solution in the infusion bag containing 0.9% Sodium Chloride Injection, USP is a total of 4 hours at room temperature 20°C to 25°C or up to 48 hours under refrigerated conditions 2°C to 8°C protected from light.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Prior to reconstitution, TEPEZZA is white to off-white lyophilized powder (cake). Upon reconstitution, TEPEZZA is a nearly colorless or slightly brown, clear to opalescent solution which is free of foreign particulate matter. Discard the solution if any particulate matter or discoloration are observed.

Do not freeze the reconstituted or diluted solution.

Discard vial(s) and all unused contents.

No incompatibilities between TEPEZZA and polyethylene (PE), polyvinyl chloride (PVC), polyurethane (PUR) or polyolefin (PO) bags and intravenous administration sets have been observed.

2.3 Administration

Administer the diluted solution intravenously over at least 90 minutes for the first two infusions. If well tolerated, the minimum time for subsequent infusions can be reduced to 60 minutes. If not well tolerated, the minimum time for subsequent infusions should remain at 90 minutes, and pre-medication is recommended for subsequent infusions.

Do not administer as an intravenous push or bolus. TEPEZZA should not be infused concomitantly with other agents.

Contraindications

4 CONTRAINDICATIONS

• Hypersensitivity to the active substance or to any of the excipients [see Description (11) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].

• Pregnancy [see Pregnancy (8.1) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].