REPATHA SOLUTION FOR INJECTION IN PRE-FILLED AUTOINJECTOR 140MG/ML [SIN15224P]

Product Info

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

[SIN15224P]

4.1 Therapeutic indications

Prevention of Cardiovascular Events

In adults with established cardiovascular disease, Repatha in combination with an optimally dosed statin and/or other lipid-lowering therapies is indicated to reduce the risk of myocardial infarction, stroke, and coronary revascularisation (see section 5.1 Pharmacodynamic properties – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Primary Hypercholesterolaemia and Mixed Dyslipidaemia

Repatha is indicated as an adjunct to diet, for the treatment of adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, and paediatric patients aged 10 years and over with heterozygous familial hypercholesterolaemia to reduce low density lipoprotein cholesterol (LDL-C):

• In combination with a statin or statin with other lipid-lowering therapies in patients who are unable to reach LDL-C goals with a statin or;

• Alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.

Homozygous Familial Hypercholesterolaemia

Repatha is indicated in adults and paediatric patients aged 10 years and over with homozygous familial hypercholesterolaemia in combination with other lipid-lowering therapies.

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.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.