Generic name: alirocumab 75mg in 1mL
Dosage form: injection, solution
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The recommended starting dose of PRALUENT is 75 mg once every 2 weeks administered subcutaneously, since the majority of patients achieve sufficient LDL-C reduction with this dosage. An alternative starting dosage for patients who prefer less frequent dosing is 300 mg once every 4 weeks (monthly).
For patients receiving PRALUENT 75 mg every 2 weeks, measure LDL-C levels within 4 to 8 weeks of initiating PRALUENT. If the LDL-C response is inadequate, the dosage may be adjusted to the maximum dosage of 150 mg administered every 2 weeks. Reassess LDL-C within 4 to 8 weeks.
For patients receiving PRALUENT 300 mg every 4 weeks, measure LDL-C just prior to the next scheduled dose, since in some patients LDL-C can vary considerably between doses with this regimen [see Clinical Studies (14)]. If LDL-C reduction is inadequate, the dosage may be adjusted to 150 mg every 2 weeks, starting the new dose on the next scheduled dosing date. Reassess LDL-C within 4 to 8 weeks.
If an every-2-week dose is missed, instruct the patient to administer the injection within 7 days from the missed dose and then resume the patient's original schedule. If the missed dose is not administered within 7 days, instruct the patient to wait until the next dose on the original schedule.
If an every-4-week dose is missed, instruct the patient to administer the injection within 7 days from the missed dose and then resume the patient's original schedule. If the missed dose is not administered within 7 days, instruct the patient to administer the dose, starting a new schedule based on this date.
Important Administration Instructions
- Provide proper training to patients and/or caregivers on the preparation and administration of PRALUENT prior to use according to the Instructions for Use. Instruct patients and/or caregivers to read and follow the Instructions for Use each time they use PRALUENT.
- Store PRALUENT in the refrigerator. Allow PRALUENT to warm to room temperature for 30 to 40 minutes prior to use. If needed, PRALUENT may be kept at room temperature up to 77°F (25°C) for a maximum of 30 days in original carton to protect from light. Do not store above 77°F (25°C). After removal from the refrigerator, PRALUENT must be used within 30 days or discarded. [see How Supplied/Storage and Handling (16)]
- PRALUENT should be inspected visually for particulate matter and discoloration prior to administration. If the solution is discolored or contains visible particulate matter, the solution should not be used.
- Follow aseptic injection technique every time PRALUENT is administered.
- Administer PRALUENT by subcutaneous injection into the thigh, abdomen, or upper arm using a single-dose pre-filled pen or single-dose pre-filled syringe.
- Rotate the injection site with each injection.
- To administer the 300 mg dose, give two 150 mg PRALUENT injections consecutively at two different injection sites.
- Do NOT inject PRALUENT into areas of active skin disease or injury such as sunburns, skin rashes, inflammation, or skin infections.
- Do NOT co-administer PRALUENT with other injectable drugs at the same injection site.
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