REDEMPLO Injection for solution Ref.[116088] Active ingredients: Plozasiran

Source: FDA, National Drug Code (US)  Revision Year: 2025 

1. Indications and Usage

REDEMPLO is indicated as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS).

2. Dosage and Administration

2.1 Recommended Dosage

  • The recommended dosage of REDEMPLO is 25 mg injected subcutaneously once every 3 months.

2.2 Important Administration Instructions

  • Prior to initiation, train patients and/or caregivers on proper preparation and administration of REDEMPLO [see Instructions for Use].
  • Adhere to a low-fat diet (less than or equal to 20 grams fat per day) in conjunction with REDEMPLO.
  • Visually inspect the REDEMPLO pre-filled syringe prior to administration. The solution should be clear and colorless to yellow. Do not use if cloudiness, particulate matter, or discoloration is observed prior to administration.
  • Inject REDEMPLO subcutaneously into the front of the thigh or abdomen. The outer area of the upper arm can be used as an injection site if a healthcare provider or caregiver administers the injection.
  • Do not inject REDEMPLO in an area where the skin is damaged (tender, bruised, red, hard, or cut). Do not inject into areas with scars or stretch marks.
  • If a dose is missed, administer REDEMPLO as soon as possible. Resume dosing every 3 months from the date of the most recently administered dose.

16.2. Storage and Handling

Store REDEMPLO refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton, until ready for use.

REDEMPLO prefilled syringe can also be kept at room temperature at 20°C to 25°C (68°F to 77°F) in the original carton for up to 30 days. If not used within the 30 days stored at room temperature, discard REDEMPLO.

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