Medically reviewed by Drugs.com. Last updated on Apr 25, 2023.
- In adults with established cardiovascular disease or with primary hyperlipidemia, including HeFH:
- The recommended starting dose of PRALUENT is either 75 mg once every 2 weeks or 300 mg once every 4 weeks administered subcutaneously [see Dosage and Administration (2.3)].
- For patients receiving PRALUENT 300 mg every 4 weeks, measure LDL-C just prior to the next scheduled dose, because LDL-C can vary between doses in some patients [see Clinical Studies (14)].
- If the LDL-C response is inadequate, the dosage may be adjusted 150 mg subcutaneously every 2 weeks.
- In adults with HeFH undergoing LDL apheresis or in adults with HoFH:
- The recommended dose of PRALUENT is 150 mg once every 2 weeks administered subcutaneously [see Dosage and Administration (2.3)].
- PRALUENT can be administered without regard to the timing of LDL apheresis.
- Assess LDL-C when clinically appropriate. The LDL-lowering effect of PRALUENT may be measured as early as 4 weeks after initiation.
If a dose is missed:
- Within 7 days from the missed dose, instruct the patient to administer PRALUENT and resume the patient's original schedule.
- More than 7 days after the missed dose:
- For every 2 week dose, instruct the patient to wait until the next dose on the original schedule.
- For every 4 week dose, instruct the patient to administer the dose and start a new schedule based on this date.
Important Administration Instructions
- Train patients and/or caregivers on how to prepare and administer PRALUENT, according to the Instructions for Use and instruct them to read and follow the Instructions for Use each time they use PRALUENT.
- Prior to use, allow PRALUENT to warm to room temperature for 30 to 40 minutes if PRALUENT has been refrigerated [see How Supplied/Storage and Handling (16)].
- Visually inspect PRALUENT prior to administration. PRALUENT is a clear, colorless to pale yellow solution. Do not use if the solution is cloudy, discolored, or contains particles.
- Administer PRALUENT subcutaneously into areas of the thigh, abdomen, or upper arm that are not tender, bruised, red, or indurated. Rotate injection sites for each administration.
- To administer the 300 mg dose, give two 150 mg PRALUENT injections consecutively at two different injection sites.
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