REPATHA SOLUTION FOR INJECTION IN PRE-FILLED AUTOINJECTOR 140MG/ML

AMGEN BIOTECHNOLOGY SINGAPORE PTE LTD

AMGEN BIOTECHNOLOGY SINGAPORE PTE LTD

Therapeutic

Prescription Only

INJECTION, SOLUTION

**4.2 Posology and method of administration** Prior to initiating evolocumab, secondary causes of hyperlipidaemia or mixed dyslipidaemia (e.g., nephrotic syndrome, hypothyroidism) should be excluded. Posology _Prevention of Cardiovascular Events in Adults_ The recommended dose of evolocumab is either 140 mg every 2 weeks or 420 mg once monthly; both doses are clinically equivalent. _Primary Hypercholesterolaemia (Heterozygous Familial and Non-Familial) and Mixed Dyslipidaemia_ _Adults and paediatric patients (aged 10 years and over)_ The recommended dose of evolocumab is either 140 mg every 2 weeks or 420 mg once monthly; both doses are clinically equivalent. When switching dosage regimens, administer the first dose of the new regimen on the next scheduled date of the prior regimen. _Homozygous Familial Hypercholesterolaemia in adults and paediatric patients aged 10 years and over_ The initial recommended dose is 420 mg once monthly. Patients on apheresis may initiate treatment with 420 mg every 2 weeks to correspond with their apheresis schedule. _Missed dose_ If a dose is missed, instruct the patient to administer Repatha within 7 days from the missed dose and resume the patient's original schedule. - If an every-2-week dose is not administered within 7 days, instruct the patient to wait until the next dose on the original schedule. - If a once-monthly dose is not administered within 7 days, instruct the patient to administer the dose and start a new schedule based on this date. 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 section 5.2 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Patients with hepatic impairment_ No dose adjustment is necessary in patients with mild hepatic impairment, see section 4.4 for patients with moderate and severe hepatic impairment – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. _Paediatric population_ The safety and effectiveness of 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 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 must not be administered intravenously or intramuscularly. _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. _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. Repatha is intended for patient self-administration after proper training. Administration of evolocumab can also be performed by an individual who has been trained to administer the product. For single use only.