Praluent Travel & Timezone-Shift Protocols: A Complete Clinical Guide
At a glance
- Drug / alirocumab (Praluent), a PCSK9 inhibitor monoclonal antibody [1]
- Adult starting doses / 75 mg every 2 weeks or 300 mg every 4 weeks [1]
- 300 mg dose / two consecutive 150 mg injections at two different sites [1]
- Child HeFH missed dose, within 7 days / give it and resume the schedule [1]
- Child HeFH missed dose, more than 7 days / every-2-week schedule waits; every-4-week schedule starts a new schedule [1]
- Warm-up / 30 to 40 minutes at room temperature [1]
- Half-life / 17 to 20 days at steady state [1]
What does the label say about a late dose?
Praluent is injected subcutaneously. Adults with hypercholesterolemia, including HeFH, start at 75 mg every 2 weeks or 300 mg every 4 weeks. The label says the dose may be adjusted to 150 mg every 2 weeks if the LDL-C response is inadequate [1].For children 8 years and older with HeFH, the label dose is 150 mg every 4 weeks under 50 kg and 300 mg every 4 weeks at 50 kg or more. It may be adjusted to 75 mg or 150 mg every 2 weeks, respectively [1]. In this pediatric dosing section the label gives the missed-dose instructions [1]:
- Within 7 days of the missed dose: give it and resume the schedule.
- More than 7 days late on the every-2-week schedule: wait for the next scheduled dose.
- More than 7 days late on the every-4-week schedule: give the dose and start a new schedule.
Because the label counts lateness in days, a shift of a few hours across time zones falls well inside the 7-day window.
How does the 300 mg dose work?
The 300 mg every-4-week dose is not one injection. It is two consecutive 150 mg injections at two different sites [1].For patients on 300 mg every 4 weeks, the label says to measure LDL-C just before the next scheduled dose, because LDL-C can vary between doses in some patients. It also says LDL-C can be measured as early as 4 weeks after starting treatment [1].
What does the label say about warming the pen?
The label says to let the pen warm to room temperature for 30 to 40 minutes before injection, and that an injection can take up to 20 seconds [1].How long does a dose stay active?
Alirocumab binds PCSK9, which increases the number of LDL receptors available to clear LDL-C [1]. After subcutaneous dosing, median time to peak concentration is 3 to 7 days and absolute bioavailability is about 85% [1]. Steady state is reached after 2 to 3 doses, and the median apparent half-life at steady state is 17 to 20 days [1].Frequently asked questions
Can I shift my Praluent dose because of a time zone change?
The label counts a late dose in days, not hours. For children 8 years and older with HeFH, a missed dose is given within 7 days of its scheduled date and the schedule then resumes [1].
What if a child's Praluent dose is more than 7 days late?
The label says to wait for the next dose on the every-2-week schedule. On the every-4-week schedule, give the dose and start a new schedule [1].
Is the 300 mg Praluent dose one injection?
No. It is two consecutive 150 mg injections at two different injection sites [1].
How long should I let the pen warm up?
The label says 30 to 40 minutes at room temperature, and that the injection can take up to 20 seconds [1].
When is LDL-C measured on the every-4-week schedule?
The label says to measure LDL-C just before the next scheduled dose, because LDL-C can vary between doses in some patients. LDL-C can be measured as early as 4 weeks after starting treatment [1].
References
- U.S. National Library of Medicine, DailyMed. Praluent alirocumab injection (Regeneron) prescribing information. Praluent alirocumab injection (Regeneron) label
- Schwartz GG, Steg PG, Szarek M, Bhatt DL, Bittner VA, Diaz R, et al. Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome. N Engl J Med. 2018;379(22):2097-2107. Alirocumab and Cardiovascular Outcomes after Acute Coronary Syndrome