Generic Name and Formulations:
Evolocumab 140mg/mL; per prefilled syringe or SureClick autoinjector; soln for SC inj; preservative-free.
Indications for REPATHA:
To reduce the risk of MI, stroke, and coronary revascularization in adults with established cardiovascular (CV) disease. 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.
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 (eg, angioedema, rash, urticaria) occur. Severe hepatic impairment. Pregnancy. Nursing mothers.
Proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor.
Avoid co-administration with other injectable drugs at same inj site.
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