Generic Name and Formulations:
Evolocumab 140mg/mL; per prefilled syringe or SureClick autoinjector; soln for SC inj; preservative-free.
Indications for REPATHA:
Adjunct to diet, alone or in combination with other lipid-lowering therapies, in adults with primary hyperlipidemia (including heterozygous familial hypercholesterolemia [HeFH]) to reduce LDL-C. Adjunct to diet and other LDL-lowering therapies, in patients with homozygous familial hypercholesterolemia (HoFH) requiring additional lowering of LDL-C. To reduce the risk of MI, stroke, and coronary revascularization in adults with established cardiovascular (CV) disease.
Give by SC inj into abdomen, thigh, or upper arm; rotate inj sites. Primary hyperlipidemia, HeFH or CV disease: 140mg every 2 weeks or 420mg once monthly. HoFH: (≥13yrs): 420mg once monthly; measure LDL-C levels 4–8 weeks after initiation. To administer 420mg dose: give over 9 mins by using the on-body infusor or as 3 inj consecutively within 30 mins using the prefilled syringe or autoinjector.
Primary hyperlipidemia or HeFH: not established. HoFH: <13yrs: not established.
Do not inject into areas that are tender, bruised, red, or indurated. Discontinue if serious allergic reactions occur. Severe hepatic impairment. Pregnancy. Nursing mothers.
Avoid co-administration with other injectable drugs at same inj site.
Proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor.
Nasopharyngitis, URTI, influenza, back pain, inj site reactions.
Single-use prefilled syringe—1; Single-use prefilled SureClick autoinjector—1, 2, 3; Single-use Pushtronex system—1