Praluent Dosage

Recommended Dosage in Adults

• Established cardiovascular disease or with primary hyperlipidemia, including HeFH:
  • The recommended starting dosage of PRALUENT is either 75 mg once every 2 weeks or 300 mg once every 4 weeks administered subcutaneously [see Dosage and Administration (2.4)].
  • 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 to 150 mg subcutaneously every 2 weeks.
• HeFH undergoing LDL apheresis or with HoFH:
  • The recommended dosage of PRALUENT is 150 mg once every 2 weeks administered subcutaneously [see Dosage and Administration (2.4)].
  • 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.

Recommended Dosage in Pediatric Patients aged 8 years and older with HeFH

• ​The recommended dosage of PRALUENT for patients with a body weight less than 50 kg is 150 mg once every 4 weeks administered subcutaneously [see Dosage and Administration (2.4)].
  • ​If the LDL-C lowering response is inadequate, the dosage may be adjusted to 75 mg subcutaneously once every 2 weeks [see Dosage and Administration (2.4)].
• ​The recommended dosage of PRALUENT for patients with a body weight of 50 kg or more is 300 mg once every 4 weeks administered subcutaneously [see Dosage and Administration (2.4)].
  • ​If the LDL-C lowering response is inadequate, the dosage may be adjusted to 150 mg subcutaneously once every 2 weeks [see Dosage and Administration (2.4)].
• Assess LDL-C when clinically appropriate. The LDL-lowering effect of PRALUENT may be measured as early as 4 weeks after initiation.

Missed Doses

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 dosage, instruct the patient to wait until the next dose on the original schedule.
  • For every 4-week dosage, 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.
• In children aged 12 to 17 years, it is recommended that PRALUENT be given by or under the supervision of an adult. In children aged 8 to 11 years, PRALUENT should be given by a caregiver.
• 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.