Lenacapavir (Subcutaneous)

Lenacapavir injection is used along with other medicines to treat human immunodeficiency virus (HIV) infection in patients who have previously taken other HIV medicines, have HIV that is resistant to several HIV medicines, and are currently using HIV medicines that are not working (for example, medicines that are ineffective, cause intolerable side effects, or cannot be taken for safety reasons). HIV is the virus that leads to acquired immune deficiency syndrome (AIDS).

This medicine will not cure HIV infection or AIDS. It works by reducing the amount of HIV in the blood and supports the immune system. This may help delay some of the health issues that usually arise from AIDS or HIV disease. It will not prevent you from spreading HIV to others.

This medicine is to be given only by or under the direct supervision of your doctor.

It is very important that your doctor checks your progress at regular visits to ensure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Do not use this medicine together with carbamazepine (Tegretol®), phenytoin (Dilantin®), rifampin (Rifadin®), or St. John’s wort.

Your immune system may get stronger when you start using HIV medicines. Tell your doctor right away if you notice any changes in your health. Sometimes the immune system will start to fight infections that were hidden in your body, including pneumonia, herpes, or tuberculosis. Autoimmune disorders (for example, Graves disease, polymyositis, and Guillain-Barré syndrome) may also occur.

This medicine may cause reactions at the injection site. Check with your doctor right away if you have bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to think about the risks of taking the medicine compared to the benefits it may provide. For this medicine, you should consider the following:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform your healthcare professional about any other kinds of allergies you have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been enough studies on how lenacapavir injection affects children. Its safety and effectiveness in this age group have not been established.

Geriatric

Studies conducted so far have not shown any specific problems in older adults that would limit the usefulness of lenacapavir injection.

Breast Feeding

There are no adequate studies in women to determine if there is a risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while in other cases, two different medicines may be used together even if there might be an interaction. In these situations, your doctor may need to adjust the dose or take other precautions. It is very important for your healthcare professional to know if you are taking any of the medicines listed below when you receive this medicine. The following interactions are based on their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to treat you with this medication or change some of the other medicines you take.

• Apalutamide
• Carbamazepine
• Enzalutamide
• Fosphenytoin
• Lumacaftor
• Mitotane
• Phenytoin
• Rifampin
• St John's Wort

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acalabrutinib
• Alfentanil
• Apixaban
• Aprepitant
• Atazanavir
• Avanafil
• Avapritinib
• Benzhydrocodone
• Bosentan
• Bosutinib
• Budesonide
• Buprenorphine
• Buspirone
• Cenobamate
• Clarithromycin
• Cobicistat
• Cobimetinib
• Codeine
• Conivaptan
• Cortisone
• Cyclosporine
• Dabigatran Etexilate
• Darifenacin
• Darunavir
• Dasatinib
• Dexamethasone
• Digoxin
• Dihydroergotamine
• Dofetilide
• Dronedarone
• Edoxaban
• Efavirenz
• Eletriptan
• Entrectinib
• Eplerenone
• Ergotamine
• Etravirine
• Everolimus
• Felodipine
• Fentanyl
• Finerenone
• Flibanserin
• Fluticasone
• Fosaprepitant
• Hydrocodone
• Hydrocortisone
• Ibrexafungerp
• Ibrutinib
• Indinavir
• Itraconazole
• Ivabradine
• Ivacaftor
• Ketoconazole
• Lomitapide
• Lorlatinib
• Lovastatin
• Lurasidone
• Maraviroc
• Methadone
• Methylergonovine
• Midazolam
• Modafinil
• Nafcillin
• Naloxegol
• Nevirapine
• Oxcarbazepine
• Oxycodone
• Phenobarbital
• Pimavanserin
• Pimozide
• Primidone
• Quetiapine
• Quinidine
• Rifabutin
• Rifapentine
• Ritonavir
• Rivaroxaban
• Sildenafil
• Simvastatin
• Sirolimus
• Tacrolimus
• Tadalafil
• Telaprevir
• Temsirolimus
• Ticagrelor
• Tipranavir
• Tolvaptan
• Tramadol
• Triazolam
• Ubrogepant
• Vardenafil
• Venetoclax
• Voclosporin

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken at the same time as food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Talk with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Along with its needed effects, Lenacapavir (Subcutaneous) may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

Incidence not known

• Dark urine
• fever
• inability to move the arms and legs
• joint pain
• light-colored stools
• muscle tenderness, weakness, or pain
• nausea and vomiting
• skin rash
• sudden numbness and weakness in the arms and legs
• unusual tiredness or weakness
• upper right abdominal or stomach pain
• weight loss
• yellow eyes and skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Sunlenca

Available Dosage Forms:

• Solution

Therapeutic Class: Antiretroviral Agent

A nurse or other trained health professional may give you this medicine. It is given as a shot under your skin, usually in the stomach.

This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Treatment with this medicine contains injections and tablets. There are also 2 options in starting this treatment. Your doctor will decide which option is best for you.

Your doctor will ask you to stay under their care during your treatment with this medicine.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form (solution) and oral dosage form (tablets):For treatment of HIV infection: Option 1: Adults—At first, 927 milligrams (mg) (2 vials) injected under the skin and 600 mg (2 tablets) once a day on Day 1. Followed by 600 mg (2 tablets) once a day on Day 2. For maintenance, 927 mg (2 vials) injected under the skin once a day every 6 months (26 weeks). Children—Use and dose must be determined by your doctor. Option 2: Adults—At first, 600 milligrams (mg) (2 tablets) once a day on Days 1 and 2. Followed by 300 mg (1 tablet) once a day on Day 8. Then, 927 mg (2 vials) injected under the skin on Day 15. For maintenance, 927 mg (2 vials) injected under the skin once a day every 6 months (26 weeks). Children—Use and dose must be determined by your doctor.

Missed Dose

Call your doctor or pharmacist for instructions.