Lenacapavir

IMPORTANT WARNING:

If you are taking lenacapavir to help prevent you from getting HIV, your doctor will test you to see if you have HIV before you begin your treatment. Tell your doctor if you have had any of these symptoms in the last month or if you have any of the following symptoms while taking lenacapavir to help prevent you from getting HIV: fever, tiredness, joint or muscle pain, rash, night sweats, vomiting, diarrhea, headache, sore throat, swollen neck or groin area. Tell your doctor if you think you may have been exposed to HIV. lenacapavir does not always prevent HIV. Your doctor will order HIV tests while you are taking lenacapavir to see if you have become infected with HIV.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain tests before and during your treatment to check your body's response to lenacapavir.

WHY is this medicine prescribed?

Lenacapavir is used to treat human immunodeficiency virus (HIV). Lenacapavir is also used along with practicing safer sex (e.g., condom use) to reduce the risk of HIV infection. Lenacapavir is in a class of medications called HIV capsid inhibitors. It works by decreasing the amount of HIV in the blood.

Although lenacapavir does not cure HIV, it may decrease your chance of developing acquired immunodeficiency syndrome (AIDS) and HIV-related illnesses. Taking these medications and making other life-style changes may decrease the risk of transmitting (spreading) the HIV virus to other people.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Lenacapavir comes as a tablet to take by mouth. Take with or without food once a day. Your doctor will decide how many doses of lenacapavir tablets you should receive when starting lenacapavir injection or for a specific period of time if you are unable to receive scheduled lenacapavir injections. Take lenacapavir at around the same time every day.

Take lenacapavir exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Lenacapavir controls HIV but does not cure it. Continue to take lenacapavir even if you feel well. Do not stop lenacapavir without talking to your doctor. If you stop taking lenacapavir, your HIV may become more difficult to treat.

What SPECIAL PRECAUTIONS should I follow?

Before taking lenacapavir,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any otherdrugs, foods or substances. Tell your doctor or pharmacist about the allergy and whatsymptoms you had.

• some medications should not be taken with lenacapavir. Make sure you have discussed any medications you are currently taking or plan to take before starting lenacapavir with your doctor and pharmacist. Before starting, stopping or changing any medications while taking lenacapavir, please get the advice of your doctor or pharmacist.

• the following nonprescription or herbal products may interact with lenacapavir: St. John's Wort. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking lenacapavir. Do not start any of these medications while taking lenacapavir without discussing with your healthcare provider.

• tell your doctor if you have or have ever had any type of infection that does not go away or that comes and goes such as tuberculosis (TB; a type of lung infection) or cytomegalovirus (CMV; a viral infection that may cause symptoms in patients with weak immune systems).

• tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking lenacapavir, call your doctor.

• tell your doctor if you are breastfeeding or plan to breastfeed. Some of the medication and HIV may be passed to your baby in your breast milk. Talk to your doctor about the risks of breastfeeding your baby if you are taking lenacapavir.

What SPECIAL DIETARY instructions should I follow?

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medication.

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Lenacapavir may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• headache

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• any new symptoms or signs of infection such as fever, rash, swelling, fatigue, body aches, and joint pain

Lenacapavir may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the blister packs until ready to take the doses, and out of reach of children. If provided in a bottle, keep the desiccant (drying agent) packet in the bottle to keep the tablets dry. Do not eat the desiccant packet. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Do not let anyone else take your medication. Your prescription is probably not refillable.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.