Applies to the following strength(s): 140 mg/mL ; 420 mg/3.5 mL
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Hyperlipidemia
-140 mg subcutaneously every 2 weeks, or
-420 mg subcutaneously once a month
-When switching dosage regimens, administer the first dose of the new regimen on the next scheduled date of prior regimen.
-This drug should not be used in patients without familial hypercholesterolemia or atherosclerotic cardio vascular disease.
Uses: Adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease requiring additional lowering of low density lipoprotein cholesterol (LDL-C)
Usual Adult Dose for Homozygous Familial Hypercholesterolemia
-420 mg subcutaneously once a month
-Measure LDL-C levels every 4 to 8 weeks after starting this drug.
-Response to therapy depends on the degree of LDL-receptor function.
Uses: Adjunct to diet and other LDL-lowering therapies (e.g., statins, ezetimibe, LDL apheresis) for the treatment of patients with homozygous familial hypercholesterolemia (HoFH) requiring additional lowering of LDL-C
Renal Dose Adjustments
Mild to moderate renal dysfunction: No adjustment recommended.
Severe renal dysfunction: Data not available
Liver Dose Adjustments
Mild to moderate liver dysfunction (Child-Pugh A or B): No adjustment recommended.
Severe liver dysfunction: Data not available
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Data not available
-To administer 420 mg dose, administer three injections (140 mg each) consecutively within 30 minutes.
-Provide proper training on how to prepare and administer this drug prior to use, according to the instructions for use, including aseptic technique.
-Allow this drug to warm to room temperature for at least 30 minutes prior to use.
-This drug should not be used if the solution is cloudy, discolored, or contain particles.
-Administer the subcutaneous injection into the thigh, abdomen, or upper arm using a single-dose prefilled pen or single-dose prefilled syringe.
-The injection should not be administered into areas that are not tender, bruised, red, or indurated.
-Rotate the injection site.
-This drug should not be co-administered with other injectable drugs at the same injection site.
-Administer the injection as soon as possible if there are more than 7 days until the next scheduled dose, or
-Omit the missed dose and administer the next dose according to the original schedule.
-Store in the refrigerator.
-Alternatively, this drug can be kept at room temperature [up to 25C (77F)] in the original carton to be used within 30 days.
Limitation of use:
-The effect of this drug on cardiovascular morbidity and mortality has not been determined.
Monitoring: LDL levels
-If any signs or symptoms of serious allergic reactions occur, discontinue this drug and seek medical attention.
-Patients and caregivers should read the Patient Information and Instructions For Use (IFU) before starting this drug, and with each refill.
-The needle cover of the glass prefill syringe and the auto-injector contain dry natural rubber (a derivative of latex) that may cause allergic reactions in patients sensitive to latex.
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