Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: Amgen Europe B.V., Minervum 7061, 4817 ZK Breda, The Netherlands
Repatha is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:
Repatha is indicated in adults and adolescents aged 12 years and over with homozygous familial hypercholesterolaemia in combination with other lipid-lowering therapies.
Repatha is indicated in adults with established atherosclerotic cardiovascular disease (myocardial infarction, stroke or peripheral arterial disease) to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors:
For study results with respect to effects on LDL-C, cardiovascular events and populations studied see section 5.1.
Prior to initiating Repatha, secondary causes of hyperlipidaemia or mixed dyslipidaemia (e.g., nephrotic syndrome, hypothyroidism) should be excluded.
The recommended dose of Repatha is either 140 mg every two weeks or 420 mg once monthly; both doses are clinically equivalent.
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.
The recommended dose of Repatha is either 140 mg every two weeks or 420 mg once monthly; both doses are clinically equivalent.
No dose adjustment is necessary in patients with mild to moderate renal impairment, see section 4.4 for patients with severe renal impairment (eGFR < 30 mL/min/1.73 m²).
No dose adjustment is necessary in patients with mild hepatic impairment, see section 4.4 for patients with moderate and severe hepatic impairment.
No dose adjustment is necessary in elderly patients.
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.
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 pre-filled syringe. The 420 mg dose should be delivered using three pre-filled syringes administered consecutively within 30 minutes.
The 140 mg dose should be delivered using a single pre-filled pen. The 420 mg dose should be delivered using three pre-filled pens administered consecutively within 30 minutes.
The 420 mg dose should be delivered using a single cartridge with the automated mini-doser.
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.
For single use only.
For instructions on administration, see section 6.6 and the ‘Instructions for Use’ provided in the carton.
No adverse effects were observed in animal studies at exposures up to 300-fold higher than those in patients treated with Repatha at 420 mg once monthly.
There is no specific treatment for Repatha overdose. In the event of an overdose, the patient should be treated symptomatically, and supportive measures instituted as required.
Repatha 140 mg solution for injection in pre-filled syringe: 3 years.
Repatha 140 mg solution for injection in pre-filled pen: 3 years.
Repatha 420 mg solution for injection in cartridge: 2 years.
Store in a refrigerator (2°C–8°C). Do not freeze.
Repatha 140 mg solution for injection in pre-filled syringe: Keep in the original carton in order to protect from light.
Repatha 140 mg solution for injection in pre-filled pen:Keep in the original carton in order to protect from light.
Repatha 420 mg solution for injection in cartridge: Keep in the original carton in order to protect from light and moisture.
If removed from the refrigerator, Repatha may be stored at room temperature (up to 25°C) in the original carton and must be used within 1 month.
One mL solution in a single use pre-filled syringe made from type I glass with stainless steel 27 gauge needle.
The needle cover of the pre-filled syringe is made from dry natural rubber (a derivative of latex, see section 4.4).
Pack size of one pre-filled syringe.
One mL solution in a single use pre-filled pen made from type I glass with stainless steel 27 gauge needle.
The needle cover of the pre-filled pen is made from dry natural rubber (a derivative of latex, see section 4.4).
Pack sizes of one, two, three or multipack of six (3x2) pre-filled pens.
A 3.5 mL solution in a single use cartridge made from cyclic olefin polymer with elastomer septum and piston as product-contact materials, and a resin cap. The pre-filled cartridge is assembled with a telescopic screw device component. The cartridge assembly is co-packed with an administration device. The fluid path within the administration device is made from stainless steel and non-DEHP polyvinyl chloride, with a stainless steel 29 gauge needle. The administration device contains silver oxide-zinc batteries and includes an adhesive patch made from polyester tape with an acrylate adhesive. The administration device is designed for use only with the provided 3.5 mL pre-filled cartridge assembly.
Pack sizes of one cartridge/automated mini-doser or multipack of three (3x1) cartridges/automated mini-dosers.
Not all pack sizes may be marketed.
Before administration, the solution should be inspected. Do not inject the solution if it contains particles, or is cloudy or discoloured. To avoid discomfort at the site of injection, allow the medicine to reach room temperature (up to 25°C) before injecting. Inject the entire contents.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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