Praluent

PRALUENT^® is indicated:

• To reduce the risk of major adverse cardiovascular (CV) events (coronary heart disease death, myocardial infarction, stroke, or unstable angina requiring hospitalization) in adults at increased risk for these events

  .
• As an adjunct to diet and exercise to reduce low- density lipoprotein cholesterol (LDL-C) in:
  • adults with hypercholesterolemia.
  • adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).
  • adults with homozygous familial hypercholesterolemia (HoFH).

• In adults with hypercholesterolemia, including HeFH (
  2.1 Recommended Dosage in Adults

  • Hypercholesterolemia, 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.
  ):
  • The recommended starting dosage of PRALUENT is either 75 mg once every 2 weeks or 300 mg once every 4 weeks administered subcutaneously.
  • For patients receiving PRALUENT 300 mg every 4 weeks, measure LDL-C just prior to the next scheduled dosage, because LDL-C can vary between dosages in some patients.
  • 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 (
  2.1 Recommended Dosage in Adults

  • Hypercholesterolemia, 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.
  ):
  • The recommended dosage of PRALUENT is 150 mg once every 2 weeks administered subcutaneously.
  • PRALUENT can be administered without regard to the timing of LDL apheresis.
• In pediatric patients with HeFH (
  2.2 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.
  ):
  • The recommended dosage of PRALUENT for patients with a body weight less than 50 kg is 150 mg once every 4 weeks administered subcutaneously.
  • 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.
  • If the LDL-C response is inadequate, the dosage may be adjusted for patients with a body weight less than 50 kg to 75 mg subcutaneously once every 2 weeks or for patients with a body weight of 50 kg or more to 150 mg subcutaneously once every 2 weeks.
• Assess LDL-C when clinically appropriate. The LDL-lowering effect of PRALUENT may be measured as early as 4 weeks after initiation. (
  2.1 Recommended Dosage in Adults

  • Hypercholesterolemia, 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.
  )
• 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. (
  2.4 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. It may take up to 20 seconds to inject PRALUENT.
  • To administer the 300 mg dose, give two 150 mg PRALUENT injections consecutively at two different injection sites.
  )
• To administer the 300 mg dosage, give two 150 mg PRALUENT injections consecutively at two different injection sites. (
  2.4 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. It may take up to 20 seconds to inject PRALUENT.
  • To administer the 300 mg dose, give two 150 mg PRALUENT injections consecutively at two different injection sites.
  )

PRALUENT injection is a clear, colorless to pale yellow solution available as follows:

• 75 mg/mL single-dose pre-filled pen
• 150 mg/mL single-dose pre-filled pen

Available data from clinical trials and postmarketing reports on PRALUENT use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. In animal reproduction studies, there were no effects on embryo-fetal development when rats were subcutaneously administered alirocumab during organogenesis at dose exposures up to 12-fold the exposure at the maximum recommended human dose of 150 mg every two weeks. In monkeys, suppression of the humoral immune response was observed in infant monkeys when alirocumab was dosed during organogenesis to parturition at dose exposures 13-fold the exposure at the maximum recommended human dose of 150 mg every two weeks. No additional effects on pregnancy or neonatal/infant development were observed at dose exposures up to 81-fold the maximum recommended human dose of 150 mg every two weeks. Measurable alirocumab serum concentrations were observed in the infant monkeys at birth at comparable levels to maternal serum, indicating that alirocumab, like other IgG antibodies, crosses the placental barrier. Monoclonal antibodies are transported across the placenta in increasing amounts especially near term; therefore, alirocumab has the potential to be transmitted from the mother to the developing fetus.

The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively.

There is a pregnancy safety study for PRALUENT. If PRALUENT is administered during pregnancy, healthcare providers should report PRALUENT exposure by contacting Regeneron at 1-844-734-6643.