SUNLENCA

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.

5 mL injectionsa) a Two injections, each at a separate site in the abdomen. 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.

2). Renal impairment No dose adjustment of Sunlenca is required in patients with mild, moderate, or severe renal impairment (creatinine clearance [CrCl] ≥ 15 mL/min). 2), 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). 2), 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.

Summary of the safety profile The most common adverse reaction in heavily treatment experienced adult participants with HIV was nausea (6%). Tabulated list of adverse reactions A tabulated list of adverse reactions is presented in Table 3.

Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), and not known (cannot be estimated from the available data). 1). Description of selected adverse reactions Immune Reconstitution Inflammatory Syndrome In patients with HIV with severe immune deficiency at the time of initiation of CART, an inflammatory reaction to asymptomatic or residual opportunistic infections may arise.

4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Immune Reconstitution Inflammatory Syndrome In patients with HIV with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymptomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms.

Typically, such reactions have been observed within the first few weeks or months of initiation of CART. Relevant examples include cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis jirovecii pneumonia.

Any inflammatory symptoms should be evaluated and treatment instituted when necessary. Autoimmune disorders (such as Graves’ disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reactivation; however, the reported time to onset is more variable and these events can occur many months after initiation of treatment.

Opportunistic infections Patients should be advised that Sunlenca or any other antiretroviral therapy does not cure HIV infection and that they may still develop opportunistic infections and other complications of HIV infection. Therefore, patients should remain under close clinical observation by physicians experienced in the treatment of patients with HIV associated diseases.

g. 5). e. 5). Excipients This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

1. Co-administration with strong inducers of CYP3A, P-gp, and UGT1A1, such as: • antimycobacterials: rifampicin • anticonvulsants: carbamazepine, phenytoin • herbal products: St. 5).