Sunlenca tablets

/ Gilead

Therapy should be prescribed by a physician experienced in the management of HIV infection.
Initiation of treatment with lenacapavir requires film-coated tablets to be taken as oral loading prior to administration of injection.
Initiation
On treatment Day 1 and Day 2, the recommended dose of lenacapavir 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.
See prescribing information for full details

This medical product, 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

* Hypersensitivity to the active substance or to any of the excipients.
* 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)

Immune Reconstitution Inflammatory Syndrome
In HIV infected patients 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 lenacapavir 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.
Co-administration of other medicinal products
Co-administration with medicinal products that are moderate inducers of CYP3A and P-gp (e.g. efavirenz) is not recommended.
Co-administration with medicinal products that are strong inhibitors of CYP3A, P-gp, and UGT1A1 together (i.e. all 3 pathways), such as atazanavir/cobicistat is not recommended
See prescribing information for full details.

Common: nausea
See prescribing information for full details

Effect of other medicinal products on the pharmacokinetics of lenacapavir
Lenacapavir is a substrate of CYP3A, P-gp and UGT1A1. Strong inducers of CYP3A, P-gp, and UGT1A1, such as rifampicin, may significantly decrease plasma concentrations of lenacapavir resulting in loss of therapeutic effect and development of resistance, therefore co-administration is contraindicated. Moderate inducers of CYP3A and P-gp, such as efavirenz, may also significantly decrease plasma concentrations of lenacapavir, therefore co-administration is not recommended. Strong inhibitors of CYP3A, P-gp and UGT1A1 together (i.e., all 3 pathways), such as atazanavir/cobicistat, may significantly increase plasma concentrations of lenacapavir, therefore co-administration is not recommended. Strong CYP3A4 inhibitors alone (e.g. voriconazole) or strong inhibitors of CYP3A4 and P-gp together (e.g. cobicistat) do not result in a clinically meaningful increase in lenacapavir exposures.
Effect of lenacapavir on the pharmacokinetics of other medicinal products
Lenacapavir is a moderate inhibitor of CYP3A and a P-gp inhibitor. Caution is advised if lenacapavir is co-administered with a sensitive CYP3A and/or P-gp substrate with a narrow therapeutic index.
See prescribing information for full details

Pregnancy: There are no or limited amount of data from the use of lenacapavir in pregnant women. As a precautionary measure, it is preferable to avoid the use of lenacapavir during pregnancy unless the clinical condition of the women requires treatment with lenacapavir.
Lactation: In order to avoid transmission of HIV to the infant it is recommended that women living with HIV do not breast-feed their infants.
It is unknown whether lenacapavir is excreted in human milk.

If overdose occurs the patient must be monitored for signs or symptoms of adverse reactions. Treatment of overdose with thie medical product 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.