What are the precautions for taking Napavir Sodium/Salanka?

In the clinical study of Lenapavir sodium/Sunlenca (Sunlenca) in the treatment of Human immunodeficiency virus type 1 (HIV-1) infection (AIDS) , warnings and precautions such as immune reconstitution syndrome, SUNLENCA's long-acting properties and potential related risks, and injection site reactions emerged. Discontinue and resume at reduced dose upon recovery, or permanently discontinue based on severity.

1. Immune reconstitution syndrome

Immune reconstitution syndrome has been reported in patients receiving combination antiretroviral therapy. During the initial phase of combination antiretroviral therapy, patients with a responsive immune system may develop an inflammatory response to indolent or residual opportunistic infections [such as Mycobacterium avium infection, cytomegalovirus, Pneumocystis carinii pneumonia (PCP), or tuberculosis], which may require further evaluation and treatment.

Autoimmune diseases (eg, Graves' disease, polymyositis, Guillain-Barré syndrome, and autoimmune hepatitis) have also been reported to occur in the setting of immune reconstitution; however, the timing of onset is more variable and may occur several months after initiation of treatment.

2. Long-acting properties and potential related risks of lenapavir sodium

Residual concentrations of lenapavir sodium may persist in patients' systemic circulation for long periods of time (up to 12 months or more after the last subcutaneous injection). It is important that patients receive maintenance doses every 6 months, as missed doses or nonadherence may lead to loss of virological response and development of drug resistance. Lenapavir sodium is a moderate CYP3A inhibitor and may increase the potential risk of adverse reactions by increasing the exposure of drugs primarily metabolized by CYP3A when started within 9 months of the last subcutaneous injection of lenapavir sodium.

If lenapavir is discontinued, to minimize the potential risk of developing viral resistance, an alternative, fully suppressive antiretroviral regimen must be initiated, if possible, within 28 weeks of the last injection of lenapavir. If virological failure occurs during treatment, switch the patient to another treatment regimen if possible.

3. Injection site reaction

Taking lenapavir sodium may cause local injection site reactions (ISR). If a clinically significant ISR occurs, evaluate and institute appropriate treatment and follow-up. Manifestations of ISR may include swelling, pain, erythema, nodules, induration, pruritus, extravasation, or mass. Nodules and induration at the injection site may take longer to resolve than other ISRs.

The mechanisms by which injection site nodules and induration persist in some patients are not fully understood, but based on available data, they may be related to the presence of subcutaneous drug depots. In some patients who undergo skin biopsy for injection site nodules or indurations, dermatopathology demonstrates foreign body inflammation or granulomatous reaction. Improper administration (intradermal injection) is associated with serious injection site reactions, including necrosis and ulceration. Be sure to inject lenapavir sodium only subcutaneously in the abdomen.

Reference materials:https://www.drugs.com/sunlenca.html