Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland
Sunlenca tablet, in combination with other antiretroviral(s), is indicated for the treatment of adults with multidrug resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen, for oral loading prior to administration of long-acting lenacapavir injection (see sections 4.2 and 5.1).
Therapy should be prescribed by a physician experienced in the management of HIV infection.
Prior to starting lenacapavir, the healthcare professional should carefully select patients who agree to the required injection schedule and counsel patients about the importance of adherence to scheduled dosing visits to help maintain viral suppression and reduce the risk of viral rebound and potential development of resistance associated with missed doses. In addition, the healthcare professional should counsel patients about the importance of adherence to an optimised background regimen (OBR) to further reduce the risk of viral rebound and potential development of resistance.
Initiation of treatment with lenacapavir requires Sunlenca film-coated tablets to be taken as oral loading prior to administration of Sunlenca injection.
On treatment Day 1 and Day 2, the recommended dose of Sunlenca is 600 mg per day taken orally. On treatment Day 8, the recommended dose is 300 mg taken orally. Then, on treatment Day 15, the recommended dose is 927 mg administered by subcutaneous injection.
Table 1. Recommended treatment regimen for Sunlenca: initiation:
| Treatment time | Dose of Sunlenca: initiation |
| Day 1 | 600 mg orally (2 × 300 mg tablets) |
| Day 2 | 600 mg orally (2 × 300 mg tablets) |
| Day 8 | 300 mg orally (1 × 300 mg tablet) |
| Day 15 | 927 mg subcutaneous injection (2 × 1.5 mL injectionsa) |
a Two injections, each at a separate site in the abdomen.
If the Day 2 (600 mg) oral dose is missed by:
If the Day 8 (300 mg) oral dose is missed by:
Regardless of when the Day 2 or Day 8 oral dose is being taken, subcutaneous injection should be administered on Day 15 as described in Table 1.
If the patient vomits within 3 hours of taking an oral dose of Sunlenca, another oral dose should be taken. If the patient vomits more than 3 hours after taking an oral dose of Sunlenca there is no need to take another oral dose of Sunlenca, and the scheduled dosing regimen should continue.
No dose adjustment of Sunlenca is required in elderly patients (see section 5.2).
No dose adjustment of Sunlenca is required in patients with mild, moderate, or severe renal impairment (creatinine clearance [CrCl] ≥15 mL/min). Sunlenca has not been studied in patients with end stage renal disease (CrCl <15 mL/min or on renal replacement therapy) (see section 5.2), therefore Sunlenca should be used with caution in these patients.
No dose adjustment of Sunlenca is required in patients with mild or moderate hepatic impairment (Child-Pugh Class A or B). Sunlenca has not been studied in patients with severe hepatic impairment (Child-Pugh Class C) (see section 5.2), therefore Sunlenca should be used with caution in these patients.
The safety and efficacy of Sunlenca in children under the age of 18 years old has not been established. No data are available.
For oral use.
Sunlenca tablets should be taken orally with or without food (see section 5.2). The film-coated tablet should not be chewed, crushed, or split, because the effects on lenacapavir absorption have not been studied.
If overdose occurs the patient must be monitored for signs or symptoms of adverse reactions (see section 4.8). Treatment of overdose with Sunlenca consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient. As lenacapavir is highly protein bound, it is unlikely to be significantly removed by dialysis.
2 years.
This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from moisture.
Sunlenca tablets are packaged in child-resistant clear PVC/aluminium/paperboard blister. The blister is packaged with silica gel desiccant in a flexible laminated pouch. Pack size of 5 tablets.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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