Active Ingredient: Plozasiran
Plozasiran is indicated as an adjunct to diet to reduce triglyceride levels in adult patients with familial chylomicronaemia syndrome (FCS).
For this indication, competent medicine agencies globally authorize below treatments:
For:
Subcutaneous, 25 milligrams plozasiran, once every 3 months.
When considering the use of plozasiran, 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.
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). Plozasiran should not be injected into an area where the skin is tender, bruised, red, hard, or cut, or with scars or stretch marks. Plozasiran should not be injected in the same area where other medicines are injected.
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