Descovy

What is Descovy?

Descovy is a prescription medicine that may be used in two different ways. Descovy is used:

• to treat HIV-1 infection
  • in adults and children who weigh at least 77 pounds (35 kg) together with other HIV-1 medicines
  • in children who weigh at least 55 pounds (25 kg) and less than 77 pounds (35 kg) together with certain other HIV-1 medicines. Your healthcare provider will determine which other HIV-1 medicines may be used with Descovy.
• for HIV-1 PrEP to reduce the risk of getting HIV-1 infection in adults and adolescents who weigh at least 77 pounds (35 kg). It is not known if Descovy is effective in reducing the risk of getting HIV-1 from certain types of sex.
  • Descovy for PrEP is not for use in people born female (assigned female at birth) who are at risk of getting HIV-1 infection from vaginal sex, because its effectiveness has not been studied.

HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).

Descovy contains the prescription medicines emtricitabine and tenofovir alafenamide.

It is not known if Descovy for treatment of HIV-1 infection is safe and effective in children who weigh less than 55 pounds (25 kg).

It is not known if Descovy is safe and effective in reducing the risk of HIV-1 infection in people who weigh less than 77 pounds (35 kg).

What is the most important information I should know about Descovy?

Descovy can cause serious side effects, including:

• Worsening of hepatitis B virus infection (HBV). Your healthcare provider will test you for HBV infection before or when you start treatment with Descovy. If you have HBV infection and take Descovy, your HBV may get worse (flare-up) if you stop taking Descovy. A "flare-up" is when your HBV infection suddenly returns in a worse way than before.
  • Do not run out of Descovy. Refill your prescription or talk to your healthcare provider before your Descovy is all gone.
  • Do not stop taking Descovy without first talking to your healthcare provider.
  • If you stop taking Descovy, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your HBV infection, or give you a medicine to treat hepatitis B. Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking Descovy.

For more information about side effects, see the section "What are the possible side effects of Descovy?"

Other important information for people who take Descovy to help reduce their risk of getting human immunodeficiency virus-1 (HIV-1) infection, also called pre-exposure prophylaxis or "PrEP":

Before taking Descovy to reduce your risk of getting HIV-1:

• You must be HIV-1 negative to start Descovy. You must get tested to make sure that you do not already have HIV-1 infection.
• Do not take Descovy for HIV-1 PrEP unless you are confirmed to be HIV-1 negative.
• Some HIV-1 tests can miss HIV-1 infection in a person who has recently become infected. If you have flu-like symptoms, you could have recently become infected with HIV-1. Tell your healthcare provider if you had a flu-like illness within the last month before starting Descovy or at any time while taking Descovy. Symptoms of new HIV-1 infection include:
  • tiredness
  • fever
  • joint or muscle aches
  • headache
  • sore throat
  • vomiting or diarrhea
  • rash
  • night sweats
  • enlarged lymph nodes in the neck or groin

While you are taking Descovy for HIV-1 PrEP:

• Descovy does not prevent other sexually transmitted infections (STIs). Practice safer sex by using a latex or polyurethane condom to reduce the risk of getting STIs.
• You must stay HIV-1 negative to keep taking Descovy for HIV-1 PrEP.
  • Know your HIV-1 status and the HIV-1 status of your partners.
  • Ask your partners with HIV-1 if they are taking HIV-1 medicines and have an undetectable viral load. An undetectable viral load is when the amount of virus in the blood is too low to be measured in a lab test. To maintain an undetectable viral load, your partners must keep taking HIV-1 medicines every day. Your risk of getting HIV-1 is lower if your partners with HIV-1 are taking effective treatment.
  • Get tested for HIV-1 at least every 3 months or when your healthcare provider tells you.
  • Get tested for other STIs such as syphilis, chlamydia, and gonorrhea. These infections make it easier for HIV-1 to infect you.
  • If you think you were exposed to HIV-1, tell your healthcare provider right away. They may want to do more tests to be sure you are still HIV-1 negative.
  • Get information and support to help reduce sexual risk behaviors.
  • Do not miss any doses of Descovy. Missing doses increases your risk of getting HIV-1 infection.
• If you do become HIV-1 positive, you need more medicine than Descovy alone to treat HIV-1. Descovy by itself is not a complete treatment for HIV-1.

If you have HIV-1 and take only Descovy, over time your HIV-1 may become harder to treat.

Who should not take Descovy?

Do not take Descovy for HIV-1 PrEP if:

• you already have HIV-1 infection. If you are HIV-1 positive, you need to take other medicines with Descovy to treat HIV-1. Descovy by itself is not a complete treatment for HIV-1.
• you do not know your HIV-1 infection status. You may already be HIV-1 positive. You need to take other HIV-1 medicines with Descovy to treat HIV-1 infection.

Descovy can only help reduce your risk of getting HIV-1 infection before you are infected.

What should I tell my healthcare provider before taking Descovy?

Before taking Descovy, tell your healthcare provider about all of your medical conditions, including if you:

• have liver problems, including HBV infection
• have kidney problems
• are pregnant or plan to become pregnant. It is not known if Descovy can harm your unborn baby. Tell your healthcare provider if you become pregnant during treatment with Descovy.
  • Pregnancy Registry: There is a pregnancy registry for people who take Descovy during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk with your healthcare provider about how you can take part in this registry.
• are breastfeeding or plan to breastfeed.
  • Do not breastfeed if you take Descovy for treatment of HIV-1 because of the risk of passing HIV-1 to your baby.
  • One of the ingredients in Descovy (emtricitabine) passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Some medicines may interact with Descovy. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.

• You can ask your healthcare provider or pharmacist for a list of medicines that interact with Descovy.
• Do not start a new medicine without telling your healthcare provider. Your healthcare provider can tell you if it is safe to take Descovy with other medicines.

How should I take Descovy?

• Take Descovy exactly as your healthcare provider tells you to take it. If you take Descovy to treat HIV-1 infection, you need to take Descovy with other HIV-1 medicines. Your healthcare provider will tell you what medicines to take and how to take them.
• Take Descovy 1 time each day with or without food.
• If you are on dialysis, take your daily dose of Descovy following dialysis.
• Do not change your dose or stop taking Descovy without first talking with your healthcare provider. Stay under a healthcare provider's care when taking Descovy. Do not miss a dose of Descovy.
• If you take too much Descovy, call your healthcare provider or go to the nearest hospital emergency room right away.
• When your Descovy supply starts to run low, get more from your healthcare provider or pharmacy.
  • If you are taking Descovy for treatment of HIV-1, the amount of virus in your blood may increase if the medicine is stopped for even a short time. The virus may develop resistance to Descovy and become harder to treat.
  • If you are taking Descovy for HIV-1 PrEP, missing doses increases your risk of getting HIV-1 infection.

What are the possible side effects of Descovy?

Descovy may cause serious side effects, including:

• See "What is the most important information I should know about Descovy?"
• Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking medicines to treat HIV-1 infection. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you start having any new symptoms after starting your HIV-1 medicine.
• New or worse kidney problems, including kidney failure. Your healthcare provider should do blood and urine tests to check your kidneys before you start and while taking Descovy. Your healthcare provider may tell you to stop taking Descovy if you develop new or worse kidney problems.
• Too much lactic acid in your blood (lactic acidosis). Too much lactic acid is a serious but rare medical emergency that can lead to death. Tell your healthcare provider right away if you get these symptoms: weakness or being more tired than usual, unusual muscle pain, being short of breath or fast breathing, stomach pain with nausea and vomiting, cold or blue hands and feet, feel dizzy or lightheaded, or a fast or abnormal heartbeat.
• Severe liver problems. In rare cases, severe liver problems can happen that can lead to death. Tell your healthcare provider right away if you get these symptoms: skin or the white part of your eyes turns yellow, dark "tea-colored" urine, light-colored stools, loss of appetite for several days or longer, nausea, or stomach-area pain.

The most common side effect of Descovy for treatment of HIV-1 is nausea.

The most common side effect of Descovy for HIV-1 PrEP is diarrhea.

These are not all of the possible side effects of Descovy.

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

General information about the safe and effective use of Descovy

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Descovy for a condition for which it was not prescribed. Do not give Descovy to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information about Descovy that is written for health professionals.

How should I store Descovy?

• Store Descovy between 68°F to 77°F (20°C to 25°C).
• Keep Descovy in its original container.
• Keep the container tightly closed.

Keep Descovy and all medicines out of reach of children.

What are the ingredients in Descovy?

Active ingredients: emtricitabine and tenofovir alafenamide.

Inactive ingredients: croscarmellose sodium, magnesium stearate, and microcrystalline cellulose.

The tablets are film-coated with a coating material containing indigo carmine aluminum lake, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.

For more information, call 1-800-445-3235 or go to www.DESCOVY.com.