Prior to initiating Evolocumab (Repatha), secondary causes of hyperlipidaemia or mixed dyslipidaemia (e.g., nephrotic syndrome, hypothyroidism) should be excluded.
Posology: Hyperlipidaemia (including HeFH): Adults and Paediatric Patients (aged 10 years and over): The recommended dose of Evolocumab (Repatha) is either 140 mg every two weeks or 420 mg once monthly; both doses are clinically equivalent.
Homozygous familial hypercholesterolaemia in adults and paediatric patients aged 10 years and over: The initial recommended dose is 420 mg once monthly. After 12 weeks of treatment, dose frequency can be up-titrated to 420 mg once every 2 weeks if a clinically meaningful response is not achieved. Patients on apheresis may initiate treatment with 420 mg every two weeks to correspond with their apheresis schedule.
Established atherosclerotic cardiovascular disease in adults: The recommended dose of Evolocumab (Repatha) is either 140 mg every two weeks or 420 mg once monthly; both doses are clinically equivalent.
Special populations: Elderly patients (age ≥ 65 years): No dose adjustment is necessary in elderly patients.
Patients with renal impairment: No dose adjustment is necessary in patients with renal impairment (see Pharmacology: Pharmacokinetics under Actions).
Patients with hepatic impairment: No dose adjustment is necessary in patients with mild hepatic impairment, see Precautions for patients with moderate and severe hepatic impairment.
Paediatric population: The safety and effectiveness of Evolocumab (Repatha) have not been established in paediatric patients with heterozygous familial hypercholesterolaemia (HeFH) or homozygous familial hypercholesterolaemia (HoFH) who are younger than 10 years old or in paediatric patients with other types of hyperlipidaemia.
Method of administration: Subcutaneous use.
Evolocumab (Repatha) is for subcutaneous injection into the abdomen, thigh or upper arm region. Injection sites should be rotated and injections should not be given into areas where the skin is tender, bruised, red, or hard.
Evolocumab (Repatha) must not be administered intravenously or intramuscularly.
Evolocumab (Repatha) solution for injection in pre-filled syringe 140 mg: The 140 mg dose should be delivered using a single pre-filled syringe. The 420 mg dose should be delivered using three pre-filled syringes administered consecutively within 30 minutes.
Evolocumab (Repatha) solution for injection in pre-filled autoinjector 140 mg: The 140 mg dose should be delivered using a single pre-filled autoinjector. The 420 mg dose should be delivered using three pre-filled autoinjectors administered consecutively within 30 minutes.
Evolocumab (Repatha) is intended for patient self-administration after proper training. Administration of Evolocumab (Repatha) can also be performed by an individual who has been trained to administer the product.
For single use only.
For instructions on administration, see Special precautions for disposal and other handling under Cautions for Usage and the 'Instructions for Use' provided in the carton.
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