Your heart attack patients are COUNTING ON YOU to prevent them from another CV events: Evolocumab reduced CV risks for heart attack survivors

06 Feb 2022

 

Among patients who had a recent myocardial infarction within 12 months, evolocumab had significantly reduced the future risk of cardiovascular death, myocardial infarction or stroke by 25% (HR=0.75; 95% CI: 0.62-0.91; p=0.003) when compared to placebo, achieving the key secondary endpoint of the subanalysis of the FOURIER study.1* In addition to having a consistent risk reduction benefit regardless of baseline low-density lipoprotein cholesterol (LDL-C) level, evolocumab can further reduce LDL-C by up to 61% when used concomitantly with statin therapy.2 Over a 5-year study period, evolocumab was consistently well-tolerated with a similar safety profile compared to standard of care (SOC) group.3 In fact, as low as 1.4% of patients per year have discontinued evolocumab due to adverse events.3

Until now, more than 1,000,000 patients have benefited from evolocumab worldwide.4 When considering treatment for patients with atherosclerotic cardiovascular disease, evolocumab is a safe and effective option to protect these patients from future cardiovascular events.

 

Abbreviated Prescribing Information Version: HKREPPI03
Please read the full prescribing information prior to administration and full prescribing information is available upon request.

REPATHA® is a registered trademark owned or licensed by Amgen Inc., its subsidiaries, or affiliates.

HK-06191-REP-2021-May

INDICATIONS Hypercholesterolaemia and mixed dyslipidaemia: Repatha is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non‑familial) or mixed dyslipidaemia, as an adjunct to diet: in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL‑C goals with the maximum tolerated dose of 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 adolescents aged 12 years and over with homozygous familial hypercholesterolaemia in combination with other lipid-lowering therapies. Established atherosclerotic cardiovascular disease: 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: in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies or, alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated. DOSAGE AND ADMINISTRATION Primary hypercholesterolaemia and mixed dyslipidaemia in adults: The recommended dose of Repatha is either 140 mg every two 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 two 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. No dose adjustment is necessary in patients with mild to moderate renal impairment. No dose adjustment is necessary in patients with mild 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. The safety and efficacy of Repatha in children aged less than 12 years has not been established in the indication for homozygous familial hypercholesterolaemia. 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 420 mg dose should be delivered using three pre-filled syringes/ autoinjectors administered consecutively within 30 minutes. CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients. SPECIAL WARNINGS AND PRECAUTIONS FOR USE Renal impairment: There is limited experience with Repatha in patients with severe renal impairment (defined as eGFR < 30 mL/min/1.73 m2). Repatha should be used with caution in patients with severe renal impairment. Hepatic impairment: In patients with moderate hepatic impairment, a reduction in total evolocumab exposure was observed that may lead to a reduced effect on LDL‑C reduction. Therefore, close monitoring may be warranted in these patients. Patients with severe hepatic impairment (Child-Pugh C) have not been studied. Repatha should be used with caution in patients with severe hepatic impairment. Dry natural rubber: The needle cover of the glass pre-filled syringe/ autoinjector is made from dry natural rubber (a derivative of latex), which may cause allergic reactions. Sodium content: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. it is essentially ‘sodium-free’. INTERACTIONS An approximately 20% increase in the clearance of evolocumab was observed in patients co-administered statins. This increased clearance is in part mediated by statins increasing the concentration of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) which did not adversely impact the pharmacodynamic effect of evolocumab on lipids. No statin dose adjustments are necessary when used in combination with Repatha. PREGNANCY AND LACTATION Pregnancy: There are no or limited amount of data from the use of Repatha in pregnant women. Repatha should not be used during pregnancy unless the clinical condition of the woman requires treatment with evolocumab. Breast-feeding: It is unknown whether evolocumab is excreted in human milk. A risk to breastfed newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or discontinue/abstain from Repatha therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. Fertility: No data on the effect of evolocumab on human fertility are available. ADVERSE REACTIONS The most commonly reported adverse reactions during pivotal trials, at the recommended doses, were nasopharyngitis (7.4%), upper respiratory tract infection (4.6%), back pain (4.4%), arthralgia (3.9%), influenza (3.2%), and injection site reactions (2.2%). The safety profile in the homozygous familial hypercholesterolaemia population was consistent with that demonstrated in the primary hypercholesterolaemia and mixed dyslipidaemia population. Adverse reactions reported in pivotal, controlled clinical studies, and spontaneous reporting, are displayed by system organ class and frequency below: Infections and infestations: Influenza, Nasopharyngitis, Upper respiratory tract infection (Common); Immune system disorders: Rash (Common), Urticaria (Uncommon); Gastrointestinal disorders: Nausea (Common); Skin and subcutaneous tissue disorders: Angioedema (Rare); Musculoskeletal and connective tissue disorders: Back pain, Arthralgia (Common); General disorders and administration site conditions: Injection site reactions (Common). The most frequent injection site reactions were injection site bruising, erythema, haemorrhage, injection site pain, and swelling. Paediatric population: There is limited experience with Repatha in paediatric patients. No difference in safety was observed between adolescent and adult patients with homozygous familial hypercholesterolaemia. The safety and effectiveness of Repatha in paediatric patients with primary hypercholesterolaemia and mixed dyslipidaemia has not been established. Elderly population: No overall differences in safety or efficacy were observed between these patients and younger patients. Immunogenicity: In clinical studies, 0.3% of patients (48 out of 17,992 patients) treated with at least one dose of Repatha tested positive for binding antibody development. The patients whose sera tested positive for binding antibodies were further evaluated for neutralising antibodies and none of the patients tested positive for neutralising antibodies. The presence of anti-evolocumab binding antibodies did not impact the pharmacokinetic profile, clinical response, or safety of Repatha. OVERDOSE 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.

This is an educational material to HCPs sponsored by Amgen Hong Kong Limited, for the purpose of continuing medical education only.


References
  1. Gencer B, Mach F, Murphy SA, et al. Efficacy of Evolocumab on Cardiovascular Outcomes in Patients With Recent Myocardial Infarction: A Prespecified Secondary Analysis From the FOURIER Trial. JAMA Cardiol. 2020;5(8):1-6.
  2. Sabatine MS, Giugliano RP, Keech AC, et al. Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease. N Engl J Med. 2017;376(18):1713-1722.
  3. Koren MJ, Sabatine MS, Giugliano RP, et al. Long-Term Efficacy and Safety of Evolocumab in Patients With Hypercholesterolemia. J Am Coll Cardiol. 2019;74(17):2132-2146. 
  4. Amgen. Data on file.