Switching To or From Praluent (Alirocumab): What Real Patients Report

What the label says about starting and adjusting

In adults with hypercholesterolemia, including HeFH, the labeled starting dose is 75 mg every 2 weeks or 300 mg every 4 weeks, both subcutaneous [1]. If the LDL-C response is inadequate, the label says the dose may be adjusted to 150 mg every 2 weeks [1]. A 300 mg dose is two consecutive 150 mg injections at two different sites, and the label says to let the pen warm to room temperature for 30 to 40 minutes [1]. LDL-C can be measured as early as 4 weeks after starting; on the 300 mg every-4-weeks schedule, the label says to measure it just before the next scheduled dose, because values can vary between doses [1].

Dose changes during ODYSSEY OUTCOMES

In ODYSSEY OUTCOMES, dose changes followed blinded LDL-C rules. Of 9,451 patients treated with Praluent, 2,615 (27.7%) were adjusted up to 150 mg every 2 weeks, and 805 of those were later down-titrated to 75 mg every 2 weeks. Another 730 (7.7%) of the 9,451 patients, who were on 75 mg every 2 weeks, were switched to placebo in a blinded fashion after two consecutive LDL-C values below 15 mg/dL [1].

Side effects people are most likely to notice

Across nine placebo-controlled trials (2,476 patients on Praluent, 1,276 on placebo, median 65 weeks), reactions reported more often than with placebo were injection site reactions 7% vs 5%, influenza 6% vs 5%, diarrhea 5% vs 4%, myalgia 4% vs 3%, muscle spasms 3% vs 2% and contusion 2% vs 1% [1]. Treatment was stopped for adverse reactions in 5.3% of Praluent patients and 5.1% of placebo patients [1]. In a 48-week trial, local injection site reactions were reported by 16.6% of patients on 300 mg every 4 weeks, 9.6% on 75 mg every 2 weeks and 7.9% on placebo [1].

Stopping Praluent, and serious reactions

At steady state the median apparent half-life is 17 to 20 days [1]. Praluent has no boxed warning; its only Warning and Precaution is hypersensitivity, including hypersensitivity vasculitis, angioedema and reactions requiring hospitalization [1]. The label says to discontinue treatment and treat according to standard of care if signs or symptoms of a serious hypersensitivity reaction occur [1].