Pronunciation:

len-a-KAP-a-vir

Brand Names:

• Sunlenca

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Antiretroviral Agent

Uses of This Medicine:

Lenacapavir is used together with other medicines to treat human immunodeficiency virus (HIV) infection in patients who have previously received other HIV medicines, have HIV that is resistant to several HIV medicines, and are currently using HIV medicines that are failing (eg, medicines are not working or no longer work, you cannot tolerate the side effects, or you cannot take because of 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 lowering the amount of HIV in the blood and helps the immune system. This may help delay some of the medical conditions that usually result from AIDS or HIV disease. It will not keep you from spreading HIV to other people.

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

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

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

Children—

Appropriate studies have not been performed on the relationship of age to the effects of lenacapavir in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of lenacapavir in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of 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 required 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
• 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

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure 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 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 (eg, Graves disease, polymyositis, and Guillain-Barré syndrome) may also occur.

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.

Side Effects of This Medicine:

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