DOSAGE AND ADMINISTRATION
Initiate dosing with 10 mg/kg for first infusion, followed by 20 mg/kg
every 3 weeks for 7 additional infusions.
Administer TEPEZZA by intravenous infusion over 60 to 90 minutes.
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 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 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 Discard the 0.9% Sodium Chloride, USP volume withdrawn.
- Step 4: Withdraw the required volume from the reconstituted TEPEZZA vial(s) based on the patient’s weight (in kg) and transfer into an intravenous bag containing 0.9% Sodium Chloride Solution, USP to prepare a diluted solution with a total volume of 100 mL (for less than 1800 mg dose) or 250 mL (for 1800 mg and greater dose). Mix diluted solution by gentle inversion. Do not shake. 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 (68°F to 77°F) or up to 48 hours under refrigerated conditions 2°C to 8°C (36°F to 46°F) protected from light. If refrigerated prior to administration, allow the diluted solution to reach room temperature prior to infusion.
- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Upon reconstitution, TEPEZZA is a 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.
DOSAGE FORMS AND STRENGTHS
For injection (intravenous infusion): 500 mg of teprotumumab as a white to off-white lyophilized
powder in a single-dose vial for reconstitution and dilution.
WARNINGS AND PRECAUTIONS
- Infusion reactions: If an infusion reaction occurs, interrupt or slow the rate of infusion and use appropriate medical management.
- Exacerbation of Preexisting Inflammatory Bowel Disease (IBD) : Monitor patients with preexisting IBD for flare of disease; discontinue TEPEZZA if IBD worsens.
- Hyperglycemia: Monitor glucose levels in all patients; treat hyperglycemia with glycemic control medications.
ADVERSE REACTIONS
Most common adverse reactions (incidence greater than 5%) are
muscle spasm, nausea, alopecia, diarrhea, fatigue, hyperglycemia,
hearing impairment, dry skin, dysgeusia and headache.
Referance-
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