Dosage regimen: The recommended dose is 284 mg administered as a single subcutaneous injection: initially, again at 3 months, followed by every 6 months.
Missed dose: If a planned dose of Inclisiran (Sybrava) is missed by less than 3 months, inclisiran (Sybrava) should be administered and dosing maintained according to the patient's original schedule.
If a planned dose of Inclisiran (Sybrava) is missed by more than 3 months, a new dosing schedule should be started - Inclisiran (Sybrava) should be administered initially, again at 3 months, followed by every 6 months.
Treatment Transition from PCSK9 Inhibitor Monoclonal Antibody: Inclisiran (Sybrava) can be administered immediately after the last dose of a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor monoclonal antibody. To maintain LDL-C lowering, it is recommended that inclisiran (Sybrava) is administered within 2 weeks after the last dose of a PCSK9 inhibitor monoclonal antibody.
Special populations: Renal impairment: No dose adjustment is necessary for patients with renal impairment (mild, moderate or severe) or end-stage renal disease. If administering inclisiran (Sybrava) to patients on hemodialysis, hemodialysis should not be performed for at least 72 hours after inclisiran (Sybrava) dosing (see Pharmacology under Actions).
Hepatic impairment: No dose adjustment is necessary for patients with mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment. Patients with severe hepatic impairment (Child-Pugh class C) have not been studied.
Pediatric patients (below 18 years): The safety and efficacy of inclisiran (Sybrava) in patients below 18 years of age have not been established.
Geriatric patients (65 years of age or above): No dose adjustment is necessary in patients 65 years of age or above.
Method of administration: Inclisiran (Sybrava) is intended for administration by a healthcare professional.
Inclisiran (Sybrava) is for subcutaneous injection into the abdomen. Injections should not be given into areas of active skin disease or injury such as sunburns, skin rashes, inflammation, or skin infections.
Inclisiran (Sybrava) should be inspected visually for particulate matter prior to administration. If the solution contains visible particulate matter, the solution should not be used.
Each 284 mg dose is administered using a single pre-filled syringe. Each pre-filled syringe is for single use only.
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