Amgen has announced that the Repatha (evolocumab) Pushtronix® System (single-dose on-body infusor with prefilled cartridge) will be discontinued.
Repatha, a proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor, is indicated as adjunctive therapy to reduce low-density lipoprotein cholesterol (LDL-C): in adults with primary hyperlipidemia including heterozygous familial hypercholesterolemia (HeFH); in pediatric patients aged 10 years and older with HeFH; and in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia. It is also approved to reduce the risk of myocardial infarction, stroke, and coronary revascularization in adults with established cardiovascular disease.
According to the Company, the decision to discontinue the Repatha Pushtronex System was not due to the product’s quality, efficacy or safety. The Repatha Pushtronex System will be discontinued as of June 30, 2024.
Patients continuing with Repatha treatment should be transitioned to either the single-dose prefilled syringe (140mg/mL) or the single-dose prefilled SureClick® autoinjector (140mg/mL).
Each single-dose Pushtronex system delivers a 3.5mL solution containing 420mg of evolocumab. With this discontinuation, the 420mg dose of Repatha can be administered by giving 3 injections consecutively within 30 minutes using the single-dose prefilled autoinjector or single-dose prefilled syringe.
References:
- Important notice for patients: discontinuation of Repatha (evolocumab) Pushtronex® System (single-dose on-body infusor with prefilled cartridge). News release. Amgen. April 12, 2024. Accessed April 15, 2024. https://www.repatha.com/pushtronexsystemupdate.
- US Food and Drug Administration. FDA drug shortages. April 12, 2024. Accessed April 15, 2024. https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Evolocumab+Injection&st=d&tab=tabs-4&panels=0.
- Repatha. Package insert. Amgen; 2021. Accessed April 15, 2024. https://www.pi.amgen.com/-/media/Project/Amgen/Repository/pi-amgen-com/Repatha/repatha_pi_hcp_english.pdf.