Repatha

Repatha Dosage/Direction for Use

evolocumab

Manufacturer:

Amgen

Distributor:

Zuellig Pharma
Full Prescribing Info
Dosage/Direction for Use
Prior to initiating evolocumab, secondary causes of hyperlipidaemia or mixed dyslipidaemia (e.g., nephrotic syndrome, hypothyroidism) should be excluded.
Posology: Primary Hyperlipidaemia (Including Heterozygous Familial Hypercholesterolaemia) and Prevention of Cardiovascular Events: 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 adolescents aged 12 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 (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 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.
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.
or single use only.
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