Repatha, evolocumab
Named-patient access overview. Repatha is coordinated by Reserve Meds for international patients via physician-led cross-border sourcing.
This page is informational, not medical advice.
About Repatha
Repatha (evolocumab) is a fully human IgG2 monoclonal antibody manufactured by Amgen. It binds proprotein convertase subtilisin/kexin type 9 (PCSK9), the circulating protease that targets the low-density lipoprotein receptor (LDLR) on hepatocytes for lysosomal degradation. By neutralizing PCSK9, Repatha extends the lifespan of LDLR on the hepatocyte surface, increases the liver's capacity to clear circulating LDL particles, and drives substantial reductions in LDL cholesterol on top of statin therapy.
Repatha carries US FDA approval to reduce the risk of myocardial infarction, stroke, and coronary revascularization in adults with established cardiovascular disease; as an adjunct to diet and other LDL-lowering therapies in adults and pediatric patients (10 years and older) with heterozygous familial hypercholesterolemia; as an adjunct to diet and other LDL-lowering therapies in adults and pediatric patients (10 years and older) with homozygous familial hypercholesterolemia; and as an adjunct to diet, alone or in combination with other lipid-lowering therapies, in adults with primary hyperlipidemia to reduce LDL cholesterol.
The FOURIER outcomes trial established that adding Repatha to statin therapy in patients with established cardiovascular disease reduces the composite of cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, and coronary revascularization. The mean on-treatment LDL cholesterol in FOURIER fell to roughly 30 mg/dL, demonstrating that very-low LDL is both achievable and well tolerated for the patient populations studied.
Repatha is supplied as a 140 mg per mL single-use prefilled SureClick autoinjector, a single-use prefilled syringe, and a 420 mg per 3.5 mL single-use Pushtronex on-body infusor for once-monthly administration. All presentations require refrigerated storage at 2 to 8 degrees Celsius in the original carton, and unopened product may be kept at room temperature up to 25 degrees Celsius for up to thirty days before use.
How Reserve Meds coordinates Repatha
- Patient or treating physician submits a named-patient request through the Patient Portal.
- Clinical team verifies appropriateness of Repatha for the patient's lipid profile, cardiovascular risk, and destination country.
- Treating physician issues a prescription with clinical justification, lipid panel, and statin-history record.
- Country-specific named-patient or personal-import documentation is prepared in the destination language.
- Repatha is sourced from a DSCSA-compliant US specialty wholesaler with full serialized traceability.
- Validated cold-chain shipment is coordinated to the patient's physician or hospital pharmacy.
- A named concierge stays with the case from intake through delivery confirmation.
Access by country
Reserve Meds publishes a detailed country deep-dive for Repatha in every market we coordinate. Each page below covers the destination-country regulatory pathway (named-patient framework), real costs in local currency and USD, indicative timelines, physician-credential requirements, and cold-chain handling for the route into that country. Tap any country to read the full deep-dive.
Indications, in brief
Established cardiovascular disease. In adults with prior myocardial infarction, prior stroke, or symptomatic peripheral artery disease who are on maximally tolerated statin therapy and still have residual LDL cholesterol elevation, Repatha reduces the risk of recurrent atherothrombotic events. The clinical benefit is consistent across baseline LDL levels and extends to very-low achieved LDL values.
Heterozygous familial hypercholesterolemia (HeFH). HeFH is an autosomal-dominant disorder of LDL clearance, most commonly driven by pathogenic variants in LDLR, APOB, or PCSK9, with prevalence estimated at roughly one in 250 worldwide. Lifelong LDL exposure produces early-onset atherosclerotic cardiovascular disease. Repatha added to statins and ezetimibe further reduces LDL cholesterol and lifetime cardiovascular risk in adults and pediatric patients ten years and older.
Homozygous familial hypercholesterolemia (HoFH). HoFH is a rare and severe form, with very high LDL cholesterol from birth and accelerated atherosclerosis in childhood and early adulthood. Repatha reduces LDL cholesterol in HoFH patients who retain residual LDLR function, complementing other therapies such as statins, ezetimibe, lipoprotein apheresis, and lomitapide where appropriate.
Primary hyperlipidemia. In adults with primary hyperlipidemia who are not at LDL goal on maximally tolerated statin therapy, or who are statin-intolerant, Repatha provides an additional LDL reduction of approximately 55 to 60 percent versus placebo, on top of background lipid therapy.
What every destination country asks for
Documentation we prepare always covers the same medical core: physician letter of medical necessity tied to the labeled indication, recent lipid panel including LDL cholesterol, statin and ezetimibe history with dose and duration, documentation of statin intolerance where claimed, cardiovascular risk profile and any prior atherosclerotic events, family history and genetic confirmation for familial hypercholesterolemia where available, the prescription itself with strength and quantity, and the country-specific named-patient or personal-import application translated into the destination language.
Cold-chain and handling
Every Repatha presentation in our supply chain travels under a validated 2 to 8 degree Celsius cold-chain with continuous temperature logging from the US wholesaler to the destination physician or pharmacy. Hand-off is documented with the temperature record, lot and serial number, and chain-of-custody signature. The label-allowed room-temperature window of up to thirty days at or below 25 degrees Celsius is preserved as buffer at the destination, not consumed in transit.
Start a request for Repatha
Submit a 60-second intake. Our clinical team will reach out as our first cohort opens with case-specific feasibility, an indicative timeline, and a formal quote in your local currency and USD.
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