The 75 mg PRALUENT dose was used 78% of the time in ODYSSEY OUTCOMES1
PRALUENT offers 2 powerful levels of LDL-C–lowering efficacy2
PRALUENT also offers a 300 mg monthly dosing option
- The 300 mg monthly dose of PRALUENT is administered as 2 consecutive, subcutaneous 150 mg injections at 2 different injection sites every 4 weeks, each delivered in less than half a minute
- Measure LDL-C levels within 4 to 8 weeks of initiating PRALUENT 75 mg Q2W or just prior to the next scheduled dose for patients receiving PRALUENT 300 mg Q4W
- If the LDL-C response is inadequate, the dosage may be adjusted to the maximum dosage of 150 mg administered every 2 weeks. For patients adjusting from 300 mg Q4W, start the new dose on the next scheduled dosing date
- The PRALUENT 300 mg monthly dose was not evaluated in the ODYSSEY OUTCOMES study
The majority of patients achieve sufficient LDL-C reduction with the 75 mg dosage.
Important Safety Information
- In the primary hyperlipidemia (including HeFH) clinical trials, local injection site reactions including erythema/redness, itching, swelling, and pain/tenderness were reported more frequently in patients treated with PRALUENT 75 mg and/or 150 mg every 2 weeks (7.2% versus 5.1% for PRALUENT and placebo, respectively). Few patients discontinued treatment because of these reactions (0.2% versus 0.4% for PRALUENT and placebo, respectively), but patients receiving PRALUENT had a greater number of injection site reactions, had more reports of associated symptoms, and had reactions of longer average duration than patients receiving placebo.
- The once-monthly (Q4W) 300mg dosing regimen had a higher rate of local injection site reactions as compared to PRALUENT 75 mg Q2W or placebo (16.6%, 9.6%, and 7.9%, respectively) in a trial in which all patients received an injection of drug or placebo every 2 weeks to maintain the blind. The discontinuation rate due to injection site reactions was 0.7% in the 300 mg Q4W arm and 0% in the other 2 arms.
- In a cardiovascular outcomes trial, local injection site reactions were reported in 3.8% of patients treated with PRALUENT versus 2.1% patients treated with placebo, and led to permanent discontinuation in 0.3% of patients versus <0.1% of patients, respectively.
Easy-to-use, prefilled PRALUENT pen2-4
Same device, regardless of the dose, available in 2 different strengths2
Administered every 2 weeks or every 4 weeks (monthly) based on prescribed dose and individual patient preference.
PRALUENT 75 mg and 150 mg
are administered with a single subcutaneous 1-mL injection every 2 weeks*
PRALUENT 300 mg
monthly dose is administered as 2 consecutive, subcutaneous 150-mg injections at 2 different injection sites every 4 weeks
If needed, patients may keep PRALUENT at room temperature up to 77°F (25°C) for a maximum of 30 days in the original carton to protect from light. The pen is not made with natural rubber latex.
*The recommended starting dose is 75 mg once every 2 weeks administered subcutaneously, or alternatively 300 mg once every 4 weeks (monthly) for patients who prefer less frequent dosing. Most patients achieve sufficient LDL-C reduction with the 75-mg dosage.2
Patients self-injected at home with confidence and convenience4†
†Evaluated in a cross-sectional, noninterventional study involving 151 patients enrolled in the PRALUENT randomized clinical trial program (ODYSSEY). The I-TAQ is a 22-item, self-administered questionnaire, developed as a measure of injection-treatment acceptance for use in patients who inject their medications via subcutaneous injections.4