Redemplo

Redemplo (plozasiran) is a targeted treatment for familial chylomicronemia syndrome (FCS) used to reduce triglyceride levels. FCS is a rare genetic condition that prevents the body from properly breaking down fats, which leads to high triglyceride levels and recurrent episodes of pancreatitis.

Redemplo works by reducing the production of a natural protein called apoC-III, which can cause triglycerides to build up in the blood. By reducing this protein, Redemplo helps the body clear fat particles more easily, leading to healthier triglyceride levels.

Redemplo is an apolipoprotein C-III (apoC-III)-directed small interfering ribonucleic acid (siRNA).

Redemplo is administered as an injection under the skin (subcutaneous injection) every three months to be used alongside a strict low-fat diet.

Redemplo FDA approval was granted on November 18, 2025, for the treatment of familial chylomicronemia syndrome in adults when used together with a low-fat diet. The FDA approval is based on positive results from the PALISADE study (NCT05089084), where Redemplo significantly reduced triglycerides and lowered the episodes of acute pancreatitis compared to placebo.

At this time, Redemplo is approved only for adults, and its safety and effectiveness in children have not yet been established.

Benefits of Redemplo 25 mg after 10 months in the PALISADE study:

• 80% median reduction of fasting triglyceride levels in Redemplo patients compared to 17% reduction in the placebo group.
• Fewer cases of acute pancreatitis in the Redemplo group.

Redemplo should be used alongside a low-fat diet containing less than or equal to 20 grams of fat each day.

Before using this medicine, tell your healthcare professional about all of your medical conditions, including if you:

• Are pregnant or plan to become pregnant, as it is not known if Redemplo can harm your unborn baby. Tell your healthcare provider if you become pregnant while using this medicine.
• Are breastfeeding or plan to breastfeed, as it is not known if this medicine passes into your breast milk, and if it can harm your baby. Talk with your healthcare provider about the best way to feed your baby while using Redemplo.

The most common Redemplo side effects are headache, nausea, high blood sugar (hyperglycemia), and injection site reactions such as redness, swelling, or discomfort.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088

• Redemplo is a subcutaneous injection, usually once every three months, using a single-dose pre-filled syringe.
• Self-administered in front of your upper legs (thighs) or in your stomach area (abdomen).
• Administered by your healthcare provider or caregiver(s) as an injection in the outer area of your upper arm.

Redemplo may be self-administered after training from your healthcare professional. Although patients or caregivers may eventually perform injections themselves, most receive initial guidance from a healthcare professional.

Other drugs may interact with Redemplo. Tell your healthcare providers about all medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

• Store prefilled syringe in the refrigerator between 36°F to 46°F (2°C to 8°C) in the original carton, until you are ready to use or expiry.
• Prefilled syringes can also be stored at room temperature between 68°F to 77°F (20°C to 25°C) in the original carton for up to 30 days. Throw away the prefilled syringe if kept at room temperature longer than 30 days.

Active ingredients: plozasiran sodium

Inactive ingredients: sodium chloride, water for injection.

Distributed by: Arrowhead Pharmaceuticals, Inc. Pasadena, CA 91105