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Repatha Generic Name & Formulations
Legal Class
Rx
General Description
Evolocumab 140mg/mL; per prefilled syringe or SureClick autoinjector; soln for SC inj; preservative-free.
Pharmacological Class
Proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor.
See Also
How Supplied
Single-use prefilled syringe—1; Single-use prefilled SureClick autoinjector—1, 2, 3; Single-use Pushtronex system—1
Manufacturer
Generic Availability
NO
Repatha Indications
Indications
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 HeFH to reduce LDL-C. Adjunct to other LDL-lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C.
Repatha Dosage and Administration
Adult
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: initially 420mg once monthly, may increase to 420mg every 2 weeks if response is not achieved in 12 weeks. On lipid apheresis: may initiate with 420mg every 2 weeks; give after session. Assess LDL-C levels as early as 4 weeks after initiation. Patients on once monthly dosing, measure LDL-C just prior to the next scheduled dose. To administer 420mg dose: give over 5mins by using the on-body infusor or as 3 inj consecutively within 30mins using the prefilled syringe or autoinjector.
Children
Primary hyperlipidemia: not established. HeFH or HoFH: <10yrs: not established. Give by SC inj into abdomen, thigh, or upper arm; rotate inj sites. HeFH (≥10yrs): 140mg every 2 weeks or 420mg once monthly. HoFH (≥10yrs): initially 420mg once monthly, may increase to 420mg every 2 weeks if response is not achieved in 12 weeks. On lipid apheresis: may initiate with 420mg every 2 weeks; give after session. Assess LDL-C levels as early as 4 weeks after initiation. Patients on once monthly dosing, measure LDL-C just prior to the next scheduled dose. To administer 420mg dose: give over 5mins by using the on-body infusor or as 3 inj consecutively within 30mins using the prefilled syringe or autoinjector.
Repatha Contraindications
Not Applicable
Repatha Boxed Warnings
Not Applicable
Repatha Warnings/Precautions
Warnings/Precautions
Do not inject into areas that are tender, bruised, red, or indurated. Discontinue if serious allergic reactions (eg, angioedema, rash, urticaria) occur. Latex allergy. Severe hepatic impairment. Pregnancy. Nursing mothers.
Repatha Pharmacokinetics
See Literature
Repatha Interactions
Interactions
Avoid co-administration with other injectable drugs at same inj site.
Repatha Adverse Reactions
Adverse Reactions
Nasopharyngitis, URTI, influenza, back pain, inj site reactions.
Repatha Clinical Trials
See Literature
Repatha Note
Not Applicable
Repatha Patient Counseling
See Literature
