Recommended Dosage

SUNLENCA can be initiated using one of two recommended dosage regimens, see Table 1 and Table 2 below. Healthcare providers should determine the appropriate initiation regimen for the patient [see Clinical Pharmacology (12.3)]. SUNLENCA oral tablets may be taken with or without food.

Missed Dose

During the maintenance period, if more than 28 weeks have elapsed since the last injection and if clinically appropriate to continue SUNLENCA treatment, restart the initiation dosage regimen from Day 1, using either Option 1 or Option 2 [see Dosage and Administration (2.1)].

Preparation and Administration of Subcutaneous Injection

SUNLENCA injection is for administration into the abdomen by a healthcare provider.

Use aseptic technique. Visually inspect the solution in the vials and prepared syringe for particulate matter and discoloration prior to administration. SUNLENCA injection is a yellow solution. Do not use SUNLENCA injection if the solution is discolored or if it contains particulate matter. Once the solution is withdrawn from the vials, the subcutaneous injections should be administered as soon as possible [see How Supplied/Storage and Handling (16)].

Refer to Figure 1 to identify the components for use in the administration steps. The administration steps are provided in Figure 2.

The injection kit components are for single use only. Use of a vial access device is required. Two 1.5 mL injections are required for a complete dose.

Figure 1 SUNLENCA Injection Kit Components

Figure 2 SUNLENCA Injection Steps