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Dear Doctor,
Today, we want to share with you the patient profile of Gauri, who was presented to the ER with an inferior STEMI, underwent PCI and was admitted to the hospital. |
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| As per your long experience, you know that patients with recent MI, like Gauri, are at increased risk of another CV event, and they often fail to rapidly achieve guideline recommended targets after treatment only with a statin therapy.1 |
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Prior to STEMI |
Upon Discharge |
| Treatment |
Rosuvastatin 20 mg |
Rosuvastatin† 40 mg +ezetimibe 10 mg |
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1 month Prior to STEMI |
4-weeks post discharge |
| LDL-C level |
112 mg/dL (2.9 mmol/L) |
90 mg/dL (2.3 mmol/L) |
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| For recent MI patients, Repatha® can achieve an LDL-C level below the ESC/EAS recommended goal of 55 mg/dL (1.4 mmol/L).1 |
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ESC/EAS 2019 Guidelines Recommendations for the LDL-C Treatment goals for very high-risk ACS patients1: |
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| Recommendations |
Class |
Level |
| In secondary prevention for patients at very-high risk, an LDL-C reduction of >_50% from baseline and an LDL-C goal of <1.4 mmol/L (<55 mg/dL) are recommended |
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A |
| In all ACS patients without any contraindication or definite history of intolerance, it is recommended that high-dose statin therapy is initiated or continued as early as possible, regardless of initial LDL-C values |
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A |
| If the LDL-C goal is not achieved after 4 - 6 weeks despite maximal tolerated statin therapy and ezetimibe, the addition of a PCSK9 inhibitor is recommended |
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B |
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Repatha® in patients with recent MI
FOURIER study subanalysis2 |
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The majority of patients with a recent MI in the Repatha® arm achieved an LDL-C level below the ESC/EAS recommended goal of 55 mg/dL (1.4 mmol/L).1,2 |
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| Repatha® added to statin/ezetimibe significantly reduced Gauri's LDL-C to 36 mg/dL (0.9 mmol/L) |
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| *Hypothetical patient profile. †Up titrated from 20 mg post MI. ^Composite of CV death, MI, or stroke3 ¶This was a prespecified secondary analysis of the Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk (FOURIER) trial, in which 27 564 patients with atherosclerotic cardiovascular disease treated with a statin were randomized to evolocumab vs placebo. Patients with prior MI with a known date (n = 22 320) were stratified as having a recent MI (within 12 months of randomization) or a remote MI (more than 12 months prior to randomization). Of 22 320 included patients, 17 516 (78.5%) were male, and the mean (SD) age was 62.2 (9.0) years. Compared with 16 609 patients with a remote MI, 5711 patients with a recent MI were younger and more likely to be treated with high intensity statin (77.3% [4415] vs 69.3% [11 506]). Per protocol, patients with MI within 4 weeks prior to randomization were excluded from the FOURIER trial. Data were collected from February 2013 to November 2016, and data were analyzed from May 2019 to February 2020.3 |
| Abbreviations: ER, Emergency Room; MI, Myocardial infarction; CV, Cardiovascular; LDL-C, Low Density Lipoprotein Cholesterol; STEMI, ST Elevation myocardial infarction; PCI, Percutaneous Coronary Intervention; ESC, European Society of Cardiology; EAS, European Atherosclerosis Society; PCSK9, Proprotein Convertase Subtilisin/Kexin 9 |
ABBREVIATED PRODUCT INFORMATION REPATHA®
SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 140 MG REPATHA® SOLUTION FOR INJECTION IN PRE-FILLED AUTOINJECTOR 140 MG |
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| Composition: Each pre-filled Sureclick autoinjector contains 140 mg of evolocumab in 1 mL of solution. Therapeutic Indication: Indicated for Homozygous familial hypercholesterolaemia in adults and adolescents aged 12 years and over in combination with other lipid-lowering therapies. 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. 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: a) In established atherosclerotic cardiovascular disease (myocardial infarction, stroke or peripheral arterial disease) and Primary hypercholesterolemia 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. b) 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. c) Patients with renal impairment: No dose adjustment is necessary in patients with mild to moderate renal impairment. d) Patients with hepatic impairment: No dose adjustment is necessary in patients with mild hepatic impairment. e) Elderly patients (age ≥ 65 years): No dose adjustment is necessary in elderly patients. f) 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. Administration: 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 autoinjector. The 420 mg dose once monthly or every 2 weeks should be delivered using three pre-filled autoinjectors administered consecutively within 30 minutes. Repatha™ is intended for patient self-administration after proper training. Each pre-filled autoinjector is for single use only. Contraindications: Hypersensitivity to the active substance or to any of the excipients such as Proline, Glacial acetic acid, Polysorbate 80, Sodium hydroxide, Water for injections. Warnings and Precautions: Repatha™ should be used with caution in patients with severe renal impairment. Patients with moderate hepatic impairment require close monitoring. Repatha™ should be used with caution in patients with severe hepatic impairment. Use in Special population: 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. Lactation: 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. Drug Interactions: No formal drug-drug interaction studies have been conducted for Repatha™. The pharmacokinetic interaction between statins and Repatha™ was evaluated in the Repatha™ clinical trials. An approximately 20% increase in the clearance of Repatha™ was observed in patients co-administered statins. Undesirable effects: The most common side effects with Repatha™ during pivotal clinical trials at recommended doses are nasopharyngitis, upper respiratory tract infection, influenza, back pain, arthralgia and injection site reactions. Overdosage: 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. |
API version number & Date of Revision: INREPPI06, January 18, 2024
Further information is available on request. For more information, please refer to the full prescribing information.
Repatha distributed by Dr. Reddys in India under authorization by Amgen. The trademark Repatha® is owned by Amgen. |
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| GGI-CO-A1-AQS-NPINDFY190002-LB-C24-0461 |
| For the use of registered medical practitioner or hospital or laboratory only. |
References: 1. Mach F, Baigent C, Catapano AL, et al. 2019 ESC/EAS Guideline for the management of dyslipidaemias: lipid modification to reduce cardiovascular risk. Eur Heart J. 2020;41(1)111-188.
2. 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 Aug 1;5(8):952-957. |
| INDIA OFFICE: Dr. Reddy's Laboratories Ltd., Greenlands, 7-1-27, Ameerpet, Hyderabad, Telangana 500 016, India. |
| Biologics: Dr. Reddy's Laboratories Ltd., Survey No. 47 Bachupally, Outubullapur, RR Dist - 500 090, Telangana, India. Tel: +91-40-44644000 Fax: +91-4023041418. |
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