LEROCHOL Solution for injection Ref.[116114] Active ingredients: Lerodalcibep

2.1 Recommended Dosage

• The recommended dosage of LEROCHOL is 300 mg once monthly administered subcutaneously.
• Assess LDL-C when clinically indicated. The LDL-lowering effect of LEROCHOL may be measured as early as 4 weeks after initiation and, provided monthly dosing is continued, anytime thereafter without regard to timing of the dose.

2.2 Recommendations Regarding Missed Dose(s)

• If a dose is missed by:
  • Less than 7 days, instruct the patient to administer LEROCHOL as soon as possible and resume the patient's original monthly dosage schedule.
  • Seven (7) or more days, instruct the patient to administer LEROCHOL as soon as possible and start a new monthly dosage schedule based on this date.

2.3 Important Administration Instructions

• Train patients and/or their caregivers on how to prepare and administer LEROCHOL, according to the Instructions for Use, and instruct them to read and follow the Instructions for Use each time they use LEROCHOL.
• Prior to use, allow LEROCHOL to warm to room temperature up to 25°C (77°F) for at least 30 minutes if LEROCHOL has been refrigerated <em[see How Supplied/Storage and Handling (16)].
• Visually inspect LEROCHOL prior to administration. LEROCHOL is a clear to slightly opalescent, brownish-yellow to amber solution. Do not use if the solution is cloudy or contains particles.
• Inject LEROCHOL subcutaneously into the abdomen or the upper front thighs. If injected by a healthcare professional or caregiver, the back of the upper arms can also be a site of injection <em[see Instructions for Use]. Do not inject in an area of the skin that is tender, bruised, red, or indurated. Rotate injection sites for each administration.
• To administer the full 300 mg dose, push plunger down until the syringe is empty before removing from the injection site.

Store refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. Do not shake.

If needed, LEROCHOL may be kept at room temperature up to 25°C (77°F) in the original carton and must be used within 3 months of being removed from the refrigerator. If not used within 3 months, discard LEROCHOL. Do not use beyond the expiration date on the container or package.