SUNLENCA TABLETS Dosage & Rx Info

Sunlenca Tablets Generic Name & Formulations

Legal Class

General Description

Lenacapavir 300mg; tabs.

Pharmacological Class

HIV-1 capsid inhibitor.

How Supplied

Tabs—4, 5; Single-dose vials—2 (w. vial access devices, syringes, needles)

Manufacturer

Gilead Sciences, Inc.

Generic Availability

Sunlenca Tablets Indications

Indications

In combination with other antiretroviral(s) for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations.

Sunlenca Tablets Dosage and Administration

Adult

Tabs: Take with or without food. Injection: Give by SC into abdomen (at least 2 inches from navel); rotate inj site. Can be initiated using 1 of 2 dosage regimens. Option 1 (Day 1): 927mg by SC inj (2×1.5mL injections) and 600mg orally (2×300mg tabs); (Day 2): 600mg orally (2×300mg tabs); (Maintenance): 927mg by SC inj (2×1.5mL injections) every 6 months (26 weeks) from the date of the last inj ± 2 weeks. Option 2 (Days 1 and 2): 600mg orally (2×300mg tabs); (Day 8): 300mg orally (1×300mg tab); (Day 15): 927mg by SC inj (2×1.5mL injections); (Maintenance): 927mg by SC inj (2×1.5mL injections) every 6 months (26 weeks) from the date of the last inj ± 2 weeks. During the maintenance period, if >28 weeks have elapsed since last inj, restart the initiation dosage regimen from Day 1 using Option 1 or Option 2.

Children

Not established.

Sunlenca Tablets Contraindications

Contraindications

Concomitant strong CYP3A inducers (eg, carbamazepine, phenytoin, rifampin, St. John’s wort).

Sunlenca Tablets Boxed Warnings

Not Applicable

Sunlenca Tablets Warnings/Precautions

Warnings/Precautions

Immune reconstitution syndrome. Autoimmune disorders (eg, Graves’ disease, polymyositis, Guillain-Barre syndrome, autoimmune hepatitis) may occur in the setting of immune reconstitution. Missed doses or non-adherence to injections could lead to loss of virologic response and development of resistance. If lenacapavir is discontinued, initiate an alternative antiretroviral regimen no later than 28 weeks after the last lenacapavir inj. Switch to an alternative regimen if virologic failure occurs during therapy. ESRD (estimated CrCL <15mL/min), severe hepatic impairment (Child-Pugh Class C): not studied. Pregnancy. Nursing mothers: not recommended.

Sunlenca Tablets Pharmacokinetics

Distribution

>98.5% human plasma protein bound.

Metabolism

CYP3A (minor), UGT1A1 (minor).

Elimination

Fecal (76%), renal (<1%). Half-life: 10 to 12 days (tablet); 8 to 12 weeks (injection).

Sunlenca Tablets Interactions

Interactions

See Contraindications. Concomitant moderate CYP3A inducers: not recommended. May be potentiated by combined P-gp, UGT1A1, and strong CYP3A inhibitors: concomitant use is not recommended. May potentiate drugs primarily metabolized by CYP3A within 9 months after the last dose of lenacapavir; refer to the prescribing information of sensitive CYP3A substrates. Concomitant antiretrovirals (eg, atazanavir/cobicistat, atazanavir/ritonavir, efavirenz, nevirapine, tipranavir/ritonavir), antimycobacterials (eg, rifabutin, rifapentine), ergot derivatives (eg, dihydroergotamine, ergotamine, methylergonovine): not recommended. Avoid with naloxegol; if unavoidable, decrease naloxegol dose and monitor. Antagonized by oxcarbazepine, phenobarbital: not recommended; consider alternative anticonvulsants. Potentiates digoxin, corticosteroids (eg, dexamethasone, hydrocortisone/cortisone), lovastatin, simvastatin, narcotic analgesics metabolized by CYP3A (eg, fentanyl, oxycodone), tramadol, oral midazolam, triazolam; use caution and monitor. Potentiates direct oral anticoagulants (eg, rivaroxaban, dabigatran, edoxaban), PDE-5 inhibitors (eg, sildenafil, tadalafil, vardenafil). Concomitant with tadalafil (to treat PAH): not recommended. Titrate carefully when initiating buprenorphine or methadone in those taking lenacapavir; use lowest initial or maintenance dose. When initiating lenacapavir in those taking buprenorphine or methadone, dose adjustment may be needed for these drugs.

Sunlenca Tablets Adverse Reactions

Adverse Reactions

Nausea, inj site reactions (evaluate and institute appropriate therapy if clinically significant reactions occur), lab abnormalities.

Sunlenca Tablets Clinical Trials

See Literature

Sunlenca Tablets Note