Repatha

Repatha Dosage/Direction for Use

evolocumab

Manufacturer:

Amgen

Distributor:

Zuellig Pharma

Marketer:

Zuellig Pharma
The information highlighted (if any) are the most recent updates for this brand.
Full Prescribing Info
Dosage/Direction for Use
Prior to initiating Repatha, secondary causes of hyperlipidaemia or mixed dyslipidaemia (e.g., nephrotic syndrome, hypothyroidism) should be excluded.
Posology: Primary hypercholesterolaemia and mixed dyslipidaemia in adults: The recommended dose of Repatha is either 140 mg every 2 weeks or 420 mg once monthly; both doses are clinically equivalent.
Homozygous familial hypercholesterolaemia in adults and adolescents aged 12 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 2 weeks to correspond with their apheresis schedule.
Established atherosclerotic cardiovascular disease in adults: The recommended dose of Repatha is either 140 mg every two weeks or 420 mg once monthly; both doses are clinically equivalent.
Patients with renal impairment: No dose adjustment is necessary in patients with mild to moderate renal impairment, see Precautions for patients with severe renal impairment (eGFR < 30 mL/min/1.73 m2).
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.
Elderly patients (age ≥ 65 years): No dose adjustment is necessary in elderly patients.
Paediatric population: The safety and efficacy of Repatha in children aged less than 18 years has not been established in the indication for primary hypercholesterolaemia and mixed dyslipidaemia. No data are available.
The safety and efficacy of Repatha in children aged less than 12 years has not been established in the indication for homozygous familial hypercholesterolaemia. No data are available.
Method of administration: Subcutaneous use.
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. Repatha must not be administered intravenously or intramuscularly.
The 140 mg dose should be delivered using a single autoinjector. The 420 mg dose should be delivered using three autoinjectors administered consecutively within 30 minutes.
Repatha is intended for patient self-administration after proper training. Administration of Repatha can also be performed by an individual who has been trained to administer the product.
Each pre-filled syringe/autoinjector is 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.
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