SUNLENCA FILM-COATED TABLET 300MG [SIN17188P]

Product Info

SUNLENCA FILM-COATED TABLET 300MG

[SIN17188P]

4.1 Therapeutic indications

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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.2 Posology and method of administration

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.

Posology

Initiation of treatment with lenacapavir requires Sunlenca film-coated tablets to be taken as oral loading prior to administration of Sunlenca injection.

Initiation
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.

Missed dose
If the Day 2 (600 mg) oral dose is missed by:

• less than 6 days, the patient should take 600 mg as soon as possible, and 300 mg on Day 8.

• 6 days or more, the patient should take 600 mg as soon as possible, and 300 mg on Day 15.

If the Day 8 (300 mg) oral dose is missed by:

• less than 6 days, the patient should take 300 mg as soon as possible.

• 6 days or more, the patient should take 300 mg on Day 15.

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.

Special populations

Elderly
No dose adjustment of Sunlenca is required in elderly patients (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Renal impairment
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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information), therefore Sunlenca should be used with caution in these patients.

Hepatic impairment
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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information), therefore Sunlenca should be used with caution in these patients.

Paediatric population
The safety and efficacy of Sunlenca in children under the age of 18 years old has not been established. No data are available.

Method of administration

For oral use.

Sunlenca tablets should be taken orally with or without food (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). The film-coated tablet should not be chewed, crushed, or split, because the effects on lenacapavir absorption have not been studied.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Co-administration with strong inducers of CYP3A, P-gp, and UGT1A1, such as:

• antimycobacterials: rifampicin

• anticonvulsants: carbamazepine, phenytoin

• herbal products: St. John’s wort (Hypericum perforatum)

(see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).