Lenacapavir (Oral)

Lenacapavir is used with other medicines to treat human immunodeficiency virus (HIV) infection in patients who have already received other HIV medicines, have HIV that is resistant to multiple HIV medicines, and are currently using HIV medicines that are not working (for example, the medicines are not effective, you cannot handle the side effects, or you cannot take them for safety reasons). HIV is the virus that causes 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 medical conditions that typically occur due to AIDS or HIV disease. It will not prevent you from spreading HIV to others.

This medicine is available only with your doctor's prescription.

It is very important that your doctor checks your progress at regular visits to ensure that 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 become 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, such as pneumonia, herpes, or tuberculosis. Autoimmune disorders (for example, Graves disease, polymyositis, and Guillain-Barré syndrome) may also occur.

Do not take other medicines unless you have discussed them 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 need to think about the risks of taking it compared to the benefits. This is a decision you will make with your doctor. For this medicine, 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, let your healthcare professional know if you have any other types of allergies, like to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on how lenacapavir affects children. Safety and efficacy have not been established.

Geriatric

So far, studies have not shown any specific problems that would limit the usefulness of lenacapavir in older adults.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medicine while breastfeeding. Weigh the possible benefits against the possible risks before taking this medicine while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if an interaction could happen. In these cases, your doctor may need to adjust the dose, or take other precautions. It is especially important that your healthcare professional knows if you are taking any of the medicines listed below when you are using this medicine. The following interactions have been selected 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 decide 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 needed in some situations. If both medicines are prescribed together, your doctor may change the dose or how often you take 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 around the time of eating or with certain types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do, they may need medical attention.

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

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:

• Tablet

Therapeutic Class: Antiretroviral Agent

Take this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

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

Keep using this medicine for the full time of treatment, even if you begin to feel better. It is also important that you continue taking all of the medicines that your doctor has given you for HIV infection.

This medicine can be taken with or without food.

Do not change the dose or stop using this medicine without checking first with your doctor. When your supply of this medicine is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of this medicine.

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 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.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.