Source: European Medicines Agency (EU) Revision Year: 2026 Publisher: Arrowhead Pharmaceuticals Ireland Limited, One Spencer Dock, North Wall Quay, Dublin 1, D01 X9R7, Ireland
Redemplo is indicated as an adjunct to diet to reduce triglyceride levels in adult patients with familial chylomicronaemia syndrome (FCS) (see section 4.2 for patient selection criteria).
Treatment should be initiated and supervised by a physician experienced in the treatment of patients with FCS.
When considering the use of Redemplo, it is important that FCS diagnosis of a patient is established by either genetic testing, or by the presence of the following clinical criteria: fasting triglyceride (TG) levels ≥10 mmol/L (≥880 mg/dL) that are refractory to standard lipid-lowering therapy and at least one of the following: prior history of acute pancreatitis not caused by alcohol or cholelithiasis, history of recurrent hospitalisations for severe abdominal pain without other explainable cause, history of childhood pancreatitis, or family history of hypertriglyceridaemia-induced pancreatitis.
The recommended dose of plozasiran is 25 mg administered as a single subcutaneous injection every 3 months.
If a dose is missed, plozasiran should be administered as soon as possible. Thereafter, dosing should be resumed every 3 months from the most recently administered dose.
No dose adjustment is required for elderly patients ≥65 years of age (see section 5.2).
No dose adjustment is required for patients with mild (estimated glomerular filtration rate (eGFR) ≥60 to ˂90 mL/min) or moderate (eGFR ≥30 to ˂60 mL/min) renal impairment. Plozasiran has not been studied in patients with severe renal impairment or end-stage renal disease (eGFR ˂30 mL/min) and should only be used in these patients if the anticipated clinical benefit outweighs the potential risk (see section 5.2).
No dose adjustment is required for patients with elevation of aspartate aminotransferase (AST) > upper limit of normal (ULN) and total bilirubin ≤ ULN, or total bilirubin >1.0 to 1.5 × ULN and any AST. Plozasiran has not been studied in patients with moderate or severe hepatic impairment and should only be used in these patients if the anticipated clinical benefit outweighs the potential risk (see section 5.2).
The safety and efficacy of this medicinal product in children and adolescents ˂18 years of age have not yet been established. No data are available.
This medicinal product is intended for subcutaneous use only. It should not be administered intramuscularly or intravenously.
Each pre-filled syringe is for single use only.
The first injection administered by the patient or caregiver should be performed under the guidance of an appropriately qualified healthcare professional.
Sites for injection include the upper arm (when administered by a caregiver), thigh, and abdomen (except for a 5 cm area around the navel). This medicinal product should not be injected into an area where the skin is tender, bruised, red, hard, or cut, or with scars or stretch marks. This medicinal product should not be injected in the same area where other medicines are injected.
For instructions on handling of the medicinal product before administration, see section 6.6.
Detailed instructions for use are provided at the end of the package leaflet.
Doses as high as 100 mg plozasiran (4 times the recommended dose) were administered in phase 1 studies and did not result in any safety concerns. There is no specific treatment for plozasiran overdose. In the event of an overdose, the patient should be treated symptomatically and supportive measures instituted as required.
2 years.
Store in a refrigerator (2°C–8°C). Do not freeze.
The product may be stored at room temperature (15°C–25°C) for a single period of up to 30 days.
The disposal date should be written on the outer carton (i.e. up to 30 days from the date removed from the refrigerator).
The product must be discarded if not used within the 30 days of room temperature storage or the expiry date printed on the outer carton, whichever is earlier.
Single-dose, type I glass pre-filled syringe with a bromobutyl stopper and needle with shield. Each pre-filled syringe contains 0.5 mL solution for injection.
Pack size of 1 pre-filled syringe.
This medicinal product should be inspected visually prior to administration. The solution should be clear and colourless to yellow. If the solution is cloudy or contains visible particulate matter, the content must not be injected and the medicinal product should be returned to the pharmacy.
The pre-filled syringe should be allowed to reach room temperature (15°C–25°C) prior to injection. It should be removed from the refrigerator (2°C–8°C) at least 30 minutes before use. Other methods of warming (e.g. hot water or microwave) should not be used.
Each pre-filled syringe should be used only once and then placed in a sharps disposal container for disposal according to community guidelines.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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