SUNLENCA SOLUTION FOR INJECTION 463.5MG/1.5ML [SIN17189P]

Product Info

SUNLENCA SOLUTION FOR INJECTION 463.5MG/1.5ML

[SIN17189P]

4.1 Therapeutic indications

Sunlenca injection, 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 (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.

Each injection should be administered by a healthcare professional.

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.

If Sunlenca is discontinued, it is essential to adopt an alternative, fully suppressive antiretroviral regimen where possible, no later than 28 weeks after the final injection of Sunlenca (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Posology

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.

Oral tablets can be taken with or without food (see Sunlenca tablet Package Insert).

Maintenance
The recommended dose is 927 mg of Sunlenca administered by subcutaneous injection once every 6 months (26 weeks) from the date of the last injection (+/− 2 weeks).

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, the regimen should be restarted from Day 1 (see table 1).

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 subcutaneous use.

Sunlenca injections should be administered into the abdomen (two injections, each at a separate site) by a healthcare professional (see section 6.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). For instructions on preparation and administration, see ‘Instructions for Use’ which is available as a card in the injection kit.

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).