Lenacapavir

Lenacapavir – Description

• Lenacapavir is a first-in-class, long-acting HIV capsid inhibitor indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (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.
• The multi-stage mechanism of action of lenacapavir is distinguishable from other currently approved classes of antiviral agents and is designed to provide a new pathway for the development of a long-acting treatment option for individuals with multi-drug resistant HIV whose virus no longer effectively responds to therapy.
• While most antivirals act on just one stage of viral replication, lenacapavir is designed to inhibit HIV at multiple stages of its lifecycle and has no known cross resistance exhibited in vitro to other existing drug classes.^6838368385 
• The efficacy of lenacapavir was established in a multicenter clinical trial (n = 36 patients in cohort 1) in which a decrease of at least 0.5 log₁₀ copies/mL in the viral load by day 15 was observed in 21 of 24 patients (88%) in the lenacapavir group compared with 2 of 12 patients (17%) in the placebo group (absolute difference, 71%; 95% CI, 35% to 90%; p less than 0.001).⁶⁸³⁸⁴ 
• The initial dose of lenacapavir is given as oral tablets and subcutaneous injections. Once therapy initiation is completed, lenacapavir is administered subcutaneously once every six months, allowing convenient dosing for patients.
• Lenacapavir is the only HIV treatment option administered twice-yearly. Injection site reactions are common with lenacapavir, and nodules and indurations may persist for several months.^6838368385

Indications & Dosage

•  human immunodeficiency virus (HIV)
•  human immunodeficiency virus (HIV) infection

for initiation and maintenance dosing option 1

Oral dosage

Adults:

600 mg PO plus subcutaneous lenacapavir on day 1, then 600 mg PO on day 2, followed by subcutaneous lenacapavir every 6 months.⁶⁸³⁸³

Sucutaneous dosage

Adults:

927 mg subcutaneously plus oral lenacapavir on Day 1, then oral lenacapavir on Day 2, followed by 927 mg subcutaneously every 6 months (26 weeks +/- 2 weeks).⁶⁸³⁸³

for initiation and maintenance dosing option 2

Oral dosage

Adults:

600 mg PO on days 1 and 2, 300 mg PO on day 8, then subcutaneous lenacapavir on day 15, followed by subcutaneous lenacapavir every 6 months.⁶⁸³⁸³

Subcutaneous dosage

Adults:

927 mg subcutaneously on Day 15 after oral lenacapavir on Days 1, 2 and 8, followed by 927 mg subcutaneously every 6 months (26 weeks +/- 2 weeks).⁶⁸³⁸³

for planned missed injections

NOTE: If a patient plans to miss a scheduled 6-month maintenance injection visit by more than 2 weeks, the oral tablets may be taken for up to 6 months until injections are resumed.⁶⁸³⁸³

Oral dosage

Adults:

300 mg PO once every 7 days for up to 6 months starting 26 to 28 weeks after the last injection. Resume the subcutaneous maintenance injection dosage within 7 days after the last oral dose.⁶⁸³⁸³

for unplanned missed injections

NOTE: To ensure resumption of therapy remains appropriate, clinically reassess (including consideration of lenacapavir resistance testing) any patient who misses a scheduled injection visit.⁶⁸³⁸³

Oral and Subcutaneous dosage

Adults:

During the maintenance period, if more than 28 weeks have elapsed since the last injection and lenacapavir oral tablets have not been taken, restart the initiation dosage regimen from Day 1, using 1 of the recommended options.⁶⁸³⁸³

Maximum Dosage Limits:

•Adults

600 mg PO; 927 mg subcutaneously.

•Geriatric

600 mg PO; 927 mg subcutaneously.

•Adolescents

Safety and efficacy have not been established.

•Children

Safety and efficacy have not been established.

•Infants

Safety and efficacy have not been established.

•Neonates

Safety and efficacy have not been established.

Patients with Hepatic Impairment Dosing

Dosage adjustments are not required in patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment. Lenacapavir has not been studied in patients with severe hepatic impairment (Child-Pugh Class C).⁶⁸³⁸³

Patients with Renal Impairment Dosing

Dosage adjustments are not required in patients with mild, moderate, or severe renal impairment (estimated creatinine clearance greater than or equal to 15 mL/minute). Lenacapavir has not been studied in patients with end-stage renal disease (estimated creatinine clearance less than 15 mL/minute).⁶⁸³⁸³

Precautions

•  breast-feeding
•  pregnancy

Interactions of Lenacapavir

•  Abacavir; Dolutegravir; Lamivudine
•  Abemaciclib
•  Acalabrutinib
•  Acetaminophen; Caffeine; Dihydrocodeine
•  Acetaminophen; Codeine
•  Acetaminophen; Hydrocodone
•  Acetaminophen; Oxycodone
•  Afatinib
•  Albuterol; Budesonide
•  Alfentanil
•  Alfuzosin
•  Alpelisib
•  Alprazolam
•  Amiodarone
•  Amlodipine
•  Amlodipine; Atorvastatin
•  Amlodipine; Benazepril
•  Amlodipine; Celecoxib
•  Amlodipine; Olmesartan
•  Amlodipine; Valsartan
•  Amlodipine; Valsartan; Hydrochlorothiazide, HCTZ
•  Amobarbital
•  Apalutamide
•  Aprepitant, Fosaprepitant
•  Aripiprazole
•  Aspirin, ASA; Butalbital; Caffeine
•  Aspirin, ASA; Carisoprodol; Codeine
•  Aspirin, ASA; Oxycodone
•  Atazanavir
•  Atazanavir; Cobicistat
•  Atorvastatin
•  Avanafil
•  Avapritinib
•  Avutometinib; Defactinib
•  Barbiturates
•  Benzhydrocodone; Acetaminophen
•  Bexarotene
•  Bosentan
•  Bosutinib
•  Brexpiprazole
•  Brigatinib
•  Bromocriptine
•  Budesonide
•  Budesonide; Formoterol
•  Budesonide; Glycopyrrolate; Formoterol
•  Buprenorphine
•  Buprenorphine; Naloxone
•  Buspirone
•  Butalbital; Acetaminophen
•  Butalbital; Acetaminophen; Caffeine
•  Butalbital; Acetaminophen; Caffeine; Codeine
•  Butalbital; Aspirin; Caffeine; Codeine
•  Cabotegravir; Rilpivirine
•  Capivasertib
•  Carbamazepine
•  Cariprazine
•  Celecoxib; Tramadol
•  Cenobamate
•  Chlorpheniramine; Codeine
•  Chlorpheniramine; Hydrocodone
•  Cilostazol
•  Cisapride
•  Clonazepam
•  Clozapine
•  Cobimetinib
•  Codeine
•  Codeine; Guaifenesin
•  Codeine; Guaifenesin; Pseudoephedrine
•  Codeine; Phenylephrine; Promethazine
•  Codeine; Promethazine
•  Colchicine
•  Conjugated Estrogens; Medroxyprogesterone
•  Cortisone
•  Crizotinib
•  Cyclosporine
•  Dabigatran
•  Dabrafenib
•  Daridorexant
•  Darifenacin
•  Darunavir
•  Darunavir; Cobicistat
•  Darunavir; Cobicistat; Emtricitabine; Tenofovir alafenamide
•  Deflazacort
•  Dexamethasone
•  Dextromethorphan; Quinidine
•  Diazepam
•  Digoxin
•  Dihydroergotamine
•  Diltiazem
•  Disopyramide
•  Dofetilide
•  Dolutegravir
•  Dolutegravir; Lamivudine
•  Dolutegravir; Rilpivirine
•  Doxorubicin
•  Doxorubicin Liposomal
•  Dronabinol
•  Dronedarone
•  Dutasteride; Tamsulosin
•  Duvelisib
•  Edoxaban
•  Efavirenz
•  Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate
•  Efavirenz; Lamivudine; Tenofovir Disoproxil Fumarate
•  Elacestrant
•  Elagolix
•  Elagolix; Estradiol; Norethindrone acetate
•  Eletriptan
•  Elexacaftor; tezacaftor; ivacaftor
•  Eliglustat
•  Emtricitabine; Rilpivirine; Tenofovir alafenamide
•  Emtricitabine; Rilpivirine; Tenofovir Disoproxil Fumarate
•  Encorafenib
•  Entrectinib
•  Enzalutamide
•  Eplerenone
•  Ergotamine
•  Ergotamine; Caffeine
•  Eslicarbazepine
•  Etrasimod
•  Etravirine
•  Everolimus
•  Ezetimibe; Simvastatin
•  Felodipine
•  Fentanyl
•  Fexinidazole
•  Finasteride; Tadalafil
•  Finerenone
•  Flibanserin
•  Flurazepam
•  Fosamprenavir
•  Fosphenytoin
•  Glecaprevir; Pibrentasvir
•  Guanfacine
•  Homatropine; Hydrocodone
•  Hydrocodone
•  Hydrocodone; Ibuprofen
•  Hydrocortisone
•  Ibrutinib
•  Ifosfamide
•  Infigratinib
•  Isradipine
•  Ivabradine
•  Ivacaftor
•  Ivosidenib
•  Ixabepilone
•  Lapatinib
•  Larotrectinib
•  Lefamulin
•  Lemborexant
•  Levamlodipine
•  Lidocaine
•  Lidocaine; Epinephrine
•  Lidocaine; Prilocaine
•  Lomitapide
•  Lonafarnib
•  Loperamide
•  Loperamide; Simethicone
•  Lorlatinib
•  Lovastatin
•  Lumacaftor; Ivacaftor
•  Lumacaftor; Ivacaftor
•  Lumateperone
•  Lurasidone
•  Lurbinectedin
•  Macitentan; Tadalafil
•  Maraviroc
•  Mavacamten
•  Mavorixafor
•  Medroxyprogesterone
•  Mefloquine
•  Meperidine
•  Metformin; Repaglinide
•  Methadone
•  Methohexital
•  Methylergonovine
•  Midazolam
•  Mitapivat
•  Mitotane
•  Mobocertinib
•  Morphine
•  Nafcillin
•  Naldemedine
•  Naloxegol
•  Nanoparticle Albumin-Bound Paclitaxel
•  Nanoparticle Albumin-Bound Sirolimus
•  Nelfinavir
•  Neratinib
•  Nevirapine
•  Nifedipine
•  Nimodipine
•  Nintedanib
•  Nirogacestat
•  Nisoldipine
•  Olaparib
•  Oliceridine
•  Olmesartan; Amlodipine; Hydrochlorothiazide, HCTZ
•  Omaveloxolone
•  Omeprazole; Amoxicillin; Rifabutin
•  Oxcarbazepine
•  Oxybutynin
•  Oxycodone
•  Paclitaxel
•  Pacritinib
•  Palovarotene
•  Pazopanib
•  Pemigatinib
•  Pentobarbital
•  Perindopril; Amlodipine
•  Pexidartinib
•  Phenobarbital
•  Phenobarbital; Hyoscyamine; Atropine; Scopolamine
•  Phenytoin
•  Pimozide
•  Posaconazole
•  Pralsetinib
•  Primidone
•  Probenecid; Colchicine
•  Propafenone
•  Quinidine
•  Quinine
•  Ranolazine
•  Relugolix
•  Relugolix; Estradiol; Norethindrone acetate
•  Repaglinide
•  Repotrectinib
•  Rifabutin
•  Rifampin
•  Rifapentine
•  Rifaximin
•  Rilpivirine
•  Rimegepant
•  Rivaroxaban
•  Roflumilast
•  Saquinavir
•  Secobarbital
•  Seladelpar
•  Selpercatinib
•  Selumetinib
•  Sildenafil
•  Silodosin
•  Simvastatin
•  Siponimod
•  Sirolimus
•  Sonidegib
•  Sotorasib
•  Sparsentan
•  St. John’s Wort, Hypericum perforatum
•  Sufentanil
•  Suvorexant
•  Suzetrigine
•  Tacrolimus
•  Tadalafil
•  Talazoparib
•  Tamsulosin
•  Tazemetostat
•  Telmisartan; Amlodipine
•  Temsirolimus
•  Tezacaftor; Ivacaftor
•  Ticagrelor
•  Tinidazole
•  Tipranavir
•  Tolvaptan
•  Topotecan
•  Tramadol
•  Tramadol; Acetaminophen
•  Trandolapril; Verapamil
•  Tretinoin, ATRA
•  Triazolam
•  Ubrogepant
•  Vanzacaftor; Tezacaftor; Deutivacaftor
•  Vanzacaftor; Tezacaftor; Deutivacaftor
•  Vardenafil
•  Venetoclax
•  Verapamil
•  Vinblastine
•  Vincristine
•  Vincristine Liposomal
•  Vinorelbine
•  Voclosporin
•  Warfarin
•  Zanubrutinib

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41353.Nelson MV, Berchou RC, Kareti D, et al. Pharmacokinetic evaluation of erythromycin and caffeine administered with bromocriptine. Clin Pharmacol Ther 1990;47:694-7.

41543.Halcion (triazolam) package insert. New York, NY: Pharmacia and Upjohn Company; 2023 Jan.

41554.Klonopin (clonazepam) tablets package insert. Montgomery, AL: H2-Pharma, LLC; 2023 Jan.

41666.Suboxone (buprenorphine; naloxone) sublingual film package insert. North Chesterfield, VA: Indivior Inc; 2025 May.

41911.Brevital (methohexital) package insert. Chestnut Ridge, NY: Par Pharmaceutical; 2020 Oct.

41934.Lysodren (mitotane) package insert. Sermoneta, Italy: Latin Pharma S.p.A.; 2024 Oct.

42121.Pradaxa (dabigatran) oral capsules package insert. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc.; 2023 Nov.

42227.Latuda (lurasidone) package insert. Marlborough, MA: Sunovion Pharmaceuticals, Inc.; 2025 Jan.

42280.Nuedexta (dextromethorphan hydrobromide; quinidine sulfate capsule) package insert. Aliso Viejo, CA: Avanir Pharmaceuticals, Inc.; 2019 Jun.

42452.Panel on Antiretroviral Therapy and Medical Management of Children Living with HIV. Guidelines for the use of antiretroviral agents in pediatric HIV infection. Available at https://clinicalinfo.hiv.gov/en/guidelines/pediatric-arv/whats-new. Accessed April 11, 2023.

42845.Abilify (aripiprazole) tablets package insert. Rockville, MD: Otsuka America Pharmaceutical, Inc.; 2025 Jan.

43463.Pimozide tablets package insert. Chestnut Ridge, NY: Par Pharmaceuticals; 2017 March.

43551.Daliresp (roflumilast) package insert. Wilmington, DE: AstraZeneca Pharmaceuticals, LP; 2020 Mar.

43566.Intuniv (guanfacine extended-release tablets) package insert. Lexington, MA: Shire US Inc.; 2020 Aug.

44376.Edurant (rilpivirine) package insert. Titusville, NJ: Janssen Therapeutics; 2024 Mar.

44854.Xarelto (rivaroxaban) package insert. Titusville, NJ: Janssen Pharmaceuticals, Inc.; 2023 Feb.

44951.Brilinta (ticagrelor) package insert. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024 Nov.

45458.Xalkori (crizotinib) capsules and pellets package insert. New York, NY: Pfizer Labs; 2023 Sept.

46322.Hycamtin (topotecan hydrochloride) for Injection package insert. Research Triangle Park, NC: GlaxoSmithKline; 2018 Sept.

46638.Panel on Antiretroviral Guidelines for Adults and Adolescents. Guidelines for the use of antiretroviral agents in adults and adolescents with HIV. Department of Health and Human Services. Available at https://clinicalinfo.hiv.gov/en/guidelines/hiv-clinical-guidelines-adult-and-adolescent-arv/whats-new-guidelines. Accessed Sept 12, 2024.

47221.Propulsid (cisapride) package insert. Titusville, NJ; Janssen Pharmaceutica; 2006 Oct. NOTE: As of May 2000; Propulsid has only been available in the United States via an investigational limited access program to ensure proper patient screening and prescribing.

47357.Quinidine gluconate extended-release tablet package insert. Princeton, NJ: Eywa Pharma Inc.; 2021 Dec.

48524.Kalydeco (ivacaftor) package insert. Boston, MA: Vertex Pharmaceuticals Incorporated; 2023 August.

48567.O’Bryan KW and Ratner D. The role of targeted molecular inhibitors in the management of advanced nonmelanoma skin cancer. Semin Cutan Med Surg 2011;30(1):57-61.

48620.Pletal (cilostazol) package insert. Rockville, MD: Otsuka America Pharmaceutical, Inc.; 2017 May.

48893.Methergine (methylergonovine maleate) tablets package insert. East Hanover, NJ: Lupin Pharmaceuticals Inc.; 2016 Jan.

49229.Amytal (amobarbital sodium) package insert. Bridgewater, NJ: Bausch Health US, LLC; 2020 Jul.

49236.Butisol (butabarbital sodium) tablet and solution package insert. Somerset, NJ; Meda Pharmaceuticals, Inc.; 2018 Dec.

49352.Seconal (secobarbital sodium) capsules package insert. Jacksonville, Fl: Ranbaxy Pharmaceuticals, Inc.; 2008 Sept.

49823.Afinitor (everolimus) tablets package insert. East Hanover, NJ:Novartis Pharmaceuticals Corporation; 2022 Feb.

49829.Votrient (pazopanib) tablet package insert. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2024 Jan.

49866.Stendra (avanafil) package insert. Freehold, NJ: Metuchen Pharmaceuticals, LLC.; 2022 Oct.

49903.Zortress (everolimus) package insert. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2024 Feb.

50586.Torisel (temsirolimus) injection package insert. Philadelphia, PA: Wyeth Pharmaceuticals Inc; 2018 March.

50959.Inspra (eplerenone) package insert. New York, NY: G.D. Searle LLC; 2003 Oct.

51027.Ifex (ifosfamide) package insert. Deerfield, IL: Baxter Healthcare Corp; 2018 Jul

51182.Demerol (meperidine tablets and oral solution) package insert. Parsippany, NJ: Validus Pharmaceuticals, LLC; 2023 Dec.

51440.Conzip (tramadol hydrochloride extended-release capsules) package insert. Alpharetta, GA: Vertical Pharmaceuticals LLC; 2023 Dec.

51727.Xtandi (enzalutamide) capsule and tablet package insert. Northbrook, IL:Astellas Pharma US, Inc.; 2025 Jan.

51739.Bosulif (bosutinib) tablet and capsule package insert. Pfizer Labs:New York, NY; 2024 Dec.

52698.Juxtapid (lomitapide) package insert. Cambridge, MA: Aegerion Pharmaceuticals, Inc.; 2019 Dec.

52887.Nexterone (amiodarone) injection package insert. Deerfield, IL: Baxter Healthcare Corporation; 2021 Sept.

53394.Abilify Maintena (aripiprazole) extended-release intramuscular injection package insert. Rockville, MD:Otsuka America Pharmaceutical, Inc.; 2025 Mar.

54802.Tafinlar (dabrafenib) oral package insert. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2025 Apr.

55331.Gilotrif (afatinib) tablets package insert. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc; 2022 April.

55594.Tivicay and Tivicay PD (dolutegravir) package insert. Durham, NC: ViiV Healthcare; 2024 Apr.

55768.Cardizem (diltiazem tablets) package insert. Bridgewater, NJ: Bridgewater, NJ: Bausch Health US, LLC; 2024 Apr.

56303.Hydrocodone bitartrate extended-release capsules package insert. Morristown, NJ: Alvogen, Inc.; 2023 Dec.

56361.Doxorubicin hydrochloride injection package insert. New York, NY: Pfizer Labs; 2019 Dec.

56410.Imbruvica (ibrutinib) capsules, tablets, and oral suspension package insert. South San Francisco, CA: Pharmacyclics, Inc.; 2024 Dec.

56436.Aptiom (eslicarbazepine acetate) package insert. Marlborough, MA: Sunovion Pharmaceuticals Inc.; 2019 Mar.

56579.U.S. Food and Drug Administration (FDA). For Healthcare Professionals: FDA’s Examples of Drugs that Interact with CYP Enzymes and Transporter Systems. Retrieved Aug 2024. Available at: https://www.fda.gov/drugs/drug-interactions-labeling/healthcare-professionals-fdas-examples-drugs-interact-cyp-enzymes-and-transporter-systems

56871.Navelbine (vinorelbine) injection package insert. Parsippany, NJ: Pierre Fabre Pharmaceuticals Inc; 2020 Jan.

57202.Zhou S, Chan E, Pan S, et al. Pharmacokinetic interactions of drugs with St John’s wort. J Psychopharmacol 2004;18:262-76.

57648.Depo-Provera (medroxyprogesterone acetate 400 mg/ml) injection suspension package insert. New York, NY: Pharmacia & Upjohn Company; 2017 Apr.

57780.Belsomra (suvorexant) tablets package insert. Rahway, NJ: Merck Sharp & Dohme LLC; 2025 Mar.

57803.Cerdelga (eliglustat) capsules. Waterford, Ireland: Genzyme Ireland, Ltd.;2018 Sept.

57852.Dostalek M, Pistovcakova J, Jurica J, et al. The effect of St John’s wort (hypericum perforatum) on cytochrome p450 1a2 activity in perfused rat liver. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub 2011;155:253-7.

57937.Movantik (naloxegol) package insert. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2020 April.

58111.Mitigare (colchicine capsules) package insert. Columbus, OH: Hikma Specialty USA Inc.; 2024 May.

58203.Ofev (nintedanib) capsule package insert. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc; 2024 Oct.

58531.Hysingla ER (hydrocodone) extended release tablets package insert. Stamford, CT: Purdue Pharma L.P.; 2023 Dec.

58662.Lynparza (olaparib) tablets package insert. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2023 Nov.

58685.Savaysa (edoxaban) package insert. Basking Ridge, NJ: Daiichi Sankyo, Inc.; 2023 Oct.

59430.Corlanor (ivabradine) package insert. Thousand Oaks, CA: Amgen Inc.; 2021 Aug.

59747.Targretin (bexarotene) capsules package insert. Bridgewater, NJ: Valeant Pharmaceuticals North America LLC; 2013 May.

59891.Orkambi (lumacaftor; ivacaftor) tablet package insert. Boston, MA: Vertex Pharmaceuticals, Inc. 2024 Dec

59949.Rexulti (brexpiprazole) tablets package insert. Rockville, MD: Otsuka America Pharmaceutical Inc; 2025 May.

60000.Odomzo (sonidegib) capsules package insert. Cranbury, NJ: Sun Pharmaceutical Industries, Inc.; 2023 Aug.

60099.Addyi (flibanserin tablets) package insert. Raleigh, NC: Sprout Pharmaceuticals, Inc.; 2021 Sept.

60164.Vraylar (cariprazine capsules) package insert. North Chicago, IL:AbbVie, Inc.; 2024 Nov.

60196.Aristada (aripiprazole lauroxil) extended-release intramuscular suspension package insert. Waltham, MA: Alkermes, Inc.; 2020 Feb.

60281.Cotellic (cobimetinib) tablets package insert. San Francisco, CA: Genentech USA, Inc; 2023 May.

60706.Venclexa (venetoclax) tabs package insert. South San Francisco, CA: Genentech, Inc.; 2022 Jun.

61750.Emflaza (deflazacort) tablets and oral suspension. Warren, NJ: PTC Therapeutics, Inc.; 2024 June.

61831.Symproic (naldemedine) package insert. Florham Park, NJ: Shionogi, Inc.; 2018 Jan.

61909.Alunbrig (brigatinib) tablet package insert. Cambridge, MA: Ariad Pharmaceuticals Inc.; 2022 March.

62065.Isradipine package insert. Parsippany, NJ: Watson Pharma, Inc.; 2014 June.

62127.Nerlynx (neratinib) package insert. Los Angeles, CA: Puma Biotechnology, Inc; 2023 March.

62201.Mavyret (glecaprevir; pibrentasvir) tablets package insert. North Chicago, IL: AbbVie Inc.; 2023 Oct.

62393.Verzenio (abemaciclib) tablets package insert. Indianapolis, IN: Lilly USA, LLC; 2025 Feb.

62578.Calquence (acalabrutinib) capsules package insert. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2025 Jan.

62870.Symdeko (tezacaftor; ivacaftor and ivacaftor tablets) package insert. Boston, MA; Vertex Pharmaceuticals Incorporated: 2023 August.

62874.Erleada (apalutamide) tablets package insert. Horsham, PA: Janssen Products, LP; 2024 Aug.

62889.Apadaz (benzhydrocodone; acetaminophen) tablets package insert. Celebration, FL: Zevra Therapeutics, Inc.; 2023 Dec.

63106.Jynarque (tolvaptan) tablets package insert. Rockville, MD: Otsuka America Pharmaceutical, Inc.; 2025 Mar.

63286.American Association for the Study of Liver Diseases (AASLD), Infectious Diseases Society of America (IDSA). HCV guidance: Recommendations for testing, managing, and treating Hepatitis C. Dec 3, 2023. Available at https://www.hcvguidelines.org.

63317.Braftovi (encorafenib) capsules package insert. Boulder, CO: Array BioPharma Inc.; 2025 Mar.

63328.Aristada Initio (aripiprazole lauroxil extended-release injectable suspension) package insert. Altham, MA:Alkermes, Inc.; 2020 Feb.

63368.Tibsovo (ivosidenib) tablet package insert. Cambridge, MA: Agios Pharmaceuticals; 2023 Oct.

63387.Orilissa (elagolix) tablets package insert. North Chicago, IL: AbbVie Inc.; 2023 Jun.

63459.Wiggins BS, Saseen JJ, Page RL, et al. Recommendations for management of clinically significant drug-drug interactions with statins and select agents used in patients with cardiovascular disease. Circulation 2016;134:e468-e495.

63571.Copiktra (duvelisib) capsules package insert. Las Vegas, NV: Secura Bio, Inc.; 2024 July.

63651.Talzenna (talazoparib) capsules package insert. New York, NY: Pfizer Labs; 2024 March.

63731.Dsuvia (sufentanil) sublingual tablets package insert. Hayward, CA: AcelRx Pharmaceuticals, Inc.; 2023 Dec.

63732.Lorbrena (lorlatinib) tablets package insert. New York, NY: Pfizer Labs; 2021 March.

63780.Vitrakvi (larotrectinib) capsules and oral solution package insert. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc.; 2025 April.

63965.Gloperba (colchicine) oral solution package insert. Palo Alto, CA: Scilex Pharmaceuticals, Inc.; 2024 Aug.

64031.Mayzent (siponimod) tablets package insert. East Hanover, NJ: Novartis Pharmaceutical Corporation; 2024 Jun.

64166.Nayzilam (midazolam) nasal spray package insert. Smyrna, GA: UCG, Inc.; 2023 Jan.

64248.Piqray (alpelisib) package insert. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2024 Jan.

64535.Turalio (pexidartinib) capsules package insert. Basking Ridge, NJ: Daiichi Sankyo, Inc.; 2025 Jan.

64567.Rozlytrek (entrectinib) package insert. South San Francisco, CA: Genentech Inc.; 2024 Jan.

64576.Xenleta (lefamulin) package insert. Dublin, Ireland: Nabriva Therapeutics US, Inc.; 2021 Mar.

64697.Trikafta (elexacaftor; tezacaftor; ivacaftor and ivacaftor tablets) package insert. Boston, MA; Vertex Pharmaceuticals Incorporated. 2024 Dec.

64748.Brukinsa (zanubrutinib) capsules package insert. San Mateo, CA: BeiGene USA, Inc; 2025 Jan.

64768.Xcorpi (cenobamate) tablets package insert. Paramus, NJ: SK Life Science, Inc.; 2024 Apr.

64870.Dayvigo (lemborexant) tablets package insert. Nutley, NJ: Eisai Inc.; 2025 Feb.

64874.Ubrelvy (ubrogepant) tablets package insert. Chicago, IL: Abbvie Inc.; 2025 Mar.

64885.Caplyta (lumateperone) capsules package insert. New York, NY; Intra-Cellular Therapies, Inc.; 2023 Jun.

64922.Ayvakit (avapritinib) tablets package insert. Cambridge, MA: Blueprint Medicines Corporation; 2024 Nov.

64930.Valtoco (diazepam) nasal spray package insert. San Diego, CA: Neurelis, Inc.; 2025 Apr.

64952.Tazverik (tazemetostat) tablet package insert. Cambridge, MA: Epizyme, Inc.; 2024 Aug.

65052.Nurtec ODT (rimegepant) orally disintegrating tablet package insert. New York, NY: Pfizer Labs; 2025 Mar.

65246.Koselugo (selumetinib) capsules package insert. Wilmington, DE: AstraZeneca Pharmaceuticals, LP; 2024 Jan.

65307.Pemazyre (pemigatinib) tablets package insert. Wilmington, DE: Incyte Corporation: 2021 Feb.

65387.Retevmo (selpercatinib) capsules and tablets package insert. Indianapolis, IN: Eli Lilly and Company; 2024 Dec.

65593.Zepzelca (lurbinectedin) injection package insert. Palo Alto, CA: Jazz Pharmaceuticals, Inc.; 2025 Apr.

65809.Olinvyk (oliceridine) injection package insert. Chesterbrook, PA: Trevana, Inc. 2023 Dec.

65884.Gavreto (pralsetinib) capsules package insert. San Francisco, CA: Genentech, Inc.; 2024 March.

66129.Zokinvy (lonafarnib) capsules package insert. Palo Alto, CA: Eiger BioPharmaceuticals, Inc.; 2020 Nov.

66183.Orgovyx (relugolix) tablets package insert. Brisbane, CA: Myovant Sciences, Inc.; 2024 Oct.

66336.Lupkynis (voclosporin) capsules package insert. Rockville, MD: Aurinia Pharma U.S., Inc.; 2024 Apr.

66700.Lumakras (sotorasib) tablet package insert. Thousand Oaks, CA: Amgen, Inc.; 2025 Jan.

66702.Truseltiq (Infigratinib) capsules package insert. Brisbane, CA: QED Therapeutics, Inc.; 2021 May.

66793.Kerendia (finerenone) tablets package insert. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc.; 2022 Sept.

66812.Fexinidazole package insert. Bridgewater, NJ: Sanofi-Aventis U.S. LLC; 2024 Sept.

66964.Trudhesa (dihydroergotamine mesylate) nasal spray package insert. Seattle, WA: Impel NeuroPharma, Inc.; 2021 Sep.

66990.Exkivity (mobocertinib) capsules package insert. Lexington, MA: Takeda Pharmaceuticals America, Inc.; 2023 Sept.

67136.Fyarro (sirolimus protein-bound particles) injectable suspension package insert. Pacific Palisades, CA: Aadi Bioscience, Inc.; 2021 Nov.

67248.Quviviq (daridorexant) tablet package insert. Radnor, PA: Idorsia Pharmaceuticals US Inc; 2024 Sept.

67403.Pyrukynd (mitapivat) tablets package insert.Cambridge, MA: Agios Pharmaceuticals, Inc.; 2025 Jan.

67427.Vonjo (pacritinib) capsules package insert. Seattle, WA: CTI BioPharma Corp; 2024 Nov.

67543.Camzyos (mavacamten) package insert. Princeton, NJ: Bristol-Myers Squibb; 2025 Apr.

68383.Sunlenca (lenacapavir) package insert. Foster City, CA: Gilead Science, Inc.; 2024 Nov.

68384.Segal-Maurer S, DeJesus E, Stellbrink HJ, et al. Capsid inhibition with lenacapavir in multidrug-resistant HIV-1 infection. N Engl J Med 2022;386:1793-1803.

68385.Gilead Press Release, Dec 22, 2022. Sunlenca (lenacapavir) Receives FDA Approval as a First-in-Class, Twice-Yearly Treatment Option for People Living With Multi-Drug Resistant HIV. Available on the world wide web at https://www.gilead.com/news-and-press/press-room/press-releases/2022/12/sunlenca-lenacapavir-receives-fda-approval-as-a-firstinclass-twiceyearly-treatment-option-for-people-living-with-multidrug-resistant-hiv.

68530.Orserdu (elacestrant) tablets package insert. New York, NY; Stemline Therapeutics, Inc: 2023 Jan.

68641.Sparsentan (Filspari) package insert. San Diego, CA: Travere Therapeutics, Inc.; 2024 Sept.

68644.Skyclarys (omaveloxolone) capsules package insert. Cambridge, MA: Biogen U.S. Corporation; 2024 Dec.

68911.Abilify Asimtufii (aripiprazole) extended-release injectable suspension package insert. Rockville, MD: Otsuka America Pharmaceutical, Inc.; 2025 Mar.

69114.Velsipity (etrasimod) package insert. New York, NY: Pfizer, Inc.; 2024 Jun.

69117.Lodoco (colchicine) tablet package insert. Parsippany, NJ: AGEPHA Pharma USA, LLC; 2023 Jun.

69324.Sohonos (palovarotene) capsules package insert. Cambridge, MA: Ipsen Biopharmaceuticals, Inc.; 2023 Aug.

69884.Augtyro (repotrectinib) capsules package insert. Princeton, NJ: Bristol-Meyers Squibb Company; 2024 June.

69896.Truqap (capivasertib) tablets package insert. Wilmington, DE; AstraZeneca Pharmaceuticals LP: 2025 Feb.

69917.Ogsiveo (nirogacestat) tablets package insert. Stamford, CT: SpringWorks Therapeutics, Inc.; 2023 Nov.

70577.Xolremdi (mavorixafor) capsules package insert. Boston, MA: X4 Pharmaceuticals, Inc.; 2024 Apr.

71097.Livdelzi (seladelpar) capsules package insert. Foster City, CA; Gilead Sciences, Inc.; 2024 Aug.

71684.Alyftrek (vanzacaftor, tezacaftor, and deutivacaftor) tablets package insert. Boston, MA: Vertex pharmaceuticals Incorporated; 2024 Dec.

71856.Journavx (suzetrigine) tablets package insert. Boston, MA: Vertex Pharmaceuticals Incorporated; 2025 Jan.

72211.Avmapki Fakzynja Co-Pack (avutometinib; defactinib) oral package insert. Needham, MA: Verastem, Inc.; 2025 May.