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Sunlenca is a brand name for Lenacapavir. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 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).
Verbatim from this product's EMA label. Tap a section to expand.
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. 4). 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 SmPC).
3 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). 5 mL injectionsa) a Two injections, each at a separate site in the abdomen.
b From the date of the last injection. 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).
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.
No data are available. Method of administration For subcutaneous use only. 6). 4). For instructions on preparation and administration, see ‘Instructions for Use’ in the package leaflet. ‘Instructions for Use’ are also available as a card in the injection kit.
Summary of the safety profile The most common adverse reactions in heavily treatment-experienced adult participants with HIV were ISRs (76%) and nausea (6%). Tabulated list of adverse reactions 10 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). b Includes injection site swelling, pain, nodule, erythema, induration, pruritus, extravasation, discomfort, mass, haematoma, oedema, and ulcer from CAPELLA; and necrosis identified from post-marketing surveillance.
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). Local injection site reactions Through Week 156 of treatment, most participants had mild (Grade 1, 54%) or moderate (Grade 2, 17%) ISRs. Six percent (4/72) of participants experienced a severe Grade 3 ISR with a median time to resolution of 15 (range: 1 to 71) days.
No participants experienced a Grade 4 ISR. The median time to resolution of all ISRs, excluding nodules and indurations, was 5 days. The median time to resolution of nodules and indurations associated with the first injections of Sunlenca was 191 (Q1, Q3: 71, 366) and 113 (Q1, Q3: 29, 224) days, respectively.
After a median follow-up of 554 days, nodules associated with the first injections of Sunlenca had not resolved in 10% (7/72) of the participants. All indurations associated with the first injections of Sunlenca had resolved. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Risk of resistance following treatment discontinuation If Sunlenca is discontinued, to minimise the risk of developing viral resistance it is essential to adopt an alternative, fully suppressive antiretroviral regimen where possible, no later than 28 weeks after the final injection of Sunlenca.
If virologic failure is suspected, an alternative regimen should be adopted where possible. Use of other medicinal products after discontinuation of lenacapavir If Sunlenca is discontinued, residual concentrations of lenacapavir may remain in the systemic circulation of patients for prolonged periods.
e. 5). These concentrations are not expected to affect the exposures of other antiretroviral agents that are initiated after discontinuation of Sunlenca. 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.
Injection Site Reactions Injection Site Reactions with Improper Administration Improper administration (intradermal injection) has been associated with serious injection site reactions, including necrosis and ulcer. 2). Slow or non-resolving injection site nodules and indurations Administration of Sunlenca may result in local injection site reactions (ISRs), including nodules and indurations.
1. Co-administration with strong inducers of CYP3A, P-gp, and UGT1A1, such as: • antimycobacterials: rifampicin • anticonvulsants: carbamazepine, phenytoin • herbal products: St. 5).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Lenacapavir in European Union.
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It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
The healthcare professional should inform patients that nodules and indurations at the injection site may take longer to resolve than other ISRs or may not resolve. 8). The mechanism driving the persistence of injection site nodules in some participants is not fully understood but may be related to the presence of the subcutaneous drug depot and an associated 5 foreign body response at the injection site.
Non-resolving ISRs should be subject to clinical monitoring. 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 injection, that is to say essentially ‘sodium-free’.