Descovy

Descovy is a prescription medication used in combination with other medications to treat human immunodeficiency virus (HIV) infection. It comes as a single tablet containing 2 drugs, emtricitabine and tenofovir alafenamide.

Emtricitabine belongs to a group of drugs called nucleoside reverse transcriptase inhibitors (NRTIs) and tenofovir is a nucleotide reverse transcriptase inhibitor (NRTI). These drugs work by preventing the virus from replicating.

This medication comes in tablet form and is taken once daily, with or without food.

The most common side effect of Descovy is nausea. 

Descovy is a prescription medication used in combination with other medications to treat human immunodeficiency virus (HIV) infection in patients 12 years and older. 

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

• Gilead Sciences, Inc.

Serious side effects have been reported with Descovy. See the “Descovy Precautions” section.

The most common side effect of Descovy is nausea.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• atazanavir (Reyataz)
• cobicistat (Tybost)
• darunavir (Prezista)
• dolutegravir (Tivicay)
• lopinavir/ritonavir (Kaletra)
• midazolam (Dormicum, Hypnovel, Versed)
• rilpivirine (Edurant)
• sertraline (Zoloft)

This is not a complete list of Decovy drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Descovy including the following:

• Lactic Acidosis/Severe Hepatomegaly with Steatosis (lactic acid buildup and enlarged fatty liver). Tell your healthcare provider right away if you have some or all of the following symptoms of Lactic Acidosis:
  • feel very weak or tired
  • have unusual (not normal) muscle pain
  • have trouble breathing
  • have stomach pain with nausea or vomiting
  • feel cold, especially in your arms and legs
  • feel dizzy or lightheaded
  • have a fast or irregular heartbeat

• Severe Liver Problems. Tell your healthcare provider right away if you have some or all of the following symptoms of Liver Problems:
  • your skin or the white part of your eyes turns yellow (jaundice)
  • dark “tea-colored” urine
  • light-colored bowel movements (stools)
  • loss of appetite
  • nausea
  • pain, aching, or tenderness on the right side of your stomach
• Worsening of Hepatitis B virus infection. Descovy is not for use to treat chronic hepatitis B virus (HBV) infection. If you have hepatitis B virus (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.
• Fat Redistribution. Tell your healthcare provider right away if you have some or all of the following symptoms of Fat Redistribution:
  • increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the middle of your body (trunk)
  • loss of fat from the legs, arms and face may also happen
• Changes in your immune system (Immune Reconstitution Syndrome). 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 have some or all of the following symptoms of Immune Reconstitution Syndrome:
  • signs/symptoms of any infection such as
    • fever or chills
    • warm or tender skin
    • nausea or vomiting
    • diarrhea
    • low body temperature
    • rapid pulse or breathing
• New or worse kidney problems, including kidney failure. Tell your healthcare provider right away if you have some or all of the following symptoms of kidney problems:
  • Decreased urine output, although occasionally urine output remains normal
  • Fluid retention, causing swelling in your legs, ankles or feet
  • Drowsiness
  • Shortness of breath
  • Fatigue
  • Confusion
  • Nausea
• Bone Problems. Tell your healthcare provider right away if you have some or all of the following symptoms of Bone Problems
  • bone pain
  • softening or thinning bones (may lead to fractures)

Do not take Descovy if you are allergic to Descovy or to any of its ingredients.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Descovy, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Descovy, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Descovy or to any of its ingredients
• have liver problems, including hepatitis B virus infection
• have kidney problems
• have bone problems
• have any other medical conditions
• 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 while taking Descovy. Pregnancy Registry: There is a pregnancy registry for women who take antiviral medicines 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.
  • You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.
  • At least one of the medicines in DESCOVY can pass to your baby in your breast milk. It is not known if the other medicine in DESCOVY can pass into your breast milk. Talk with your healthcare provider about the best way to feed your baby

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

Descovy is a combination of two drugs, emtricitabine and tenofovir alafenamide

• When pregnant women used emtricitabine, their babies did not show any problems related to this medication.

• There are no well-done studies that have been done in humans with tenofovir alafenamide. In animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

It is not known if Descovy can harm your unborn baby. Tell your healthcare provider if you become pregnant while taking Descovy.

Pregnancy Registry: There is a pregnancy registry for women who take antiviral medicines 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.

Tell your doctor if you are breastfeeding or plan to breastfeed.

The Centers for Disease Control and Prevention recommend that HIV-infected mothers not breastfeed their infants, to avoid risking postnatal transmission of HIV.

It is not known if Descovy affects milk production or has effects on the breastfed child. Because of the potential for: 1) HIV transmission (in HIV-negative infants); 2) developing viral resistance (in HIV-positive infants); and 3) adverse reactions in a breastfed infant similar to those seen in adults, you should not breastfeed while receiving Descovy.

Take Descovy exactly as prescribed.

Descovy comes as a tablet to be taken once a day, with or without food.

You should take Descovy at the same time each day, to help you to remember your dose.

If you miss a dose, take it as soon as you remember that day. Do not take 2 doses in one day. Do not skip doses.

If you stop taking Decovy, even for a short time, the amount of virus in your blood may increase and may become harder to treat. 

When this medicine is used to treat HIV infection, Descovy is always used with other anti-HIV-1 medicines.

Take Descovy exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. Your doctor will determine the best dose for you.

The recommended dose of Descovy for the treatment of HIV-1 in adults and children 12 years of age and older is one tablet (containing 200 mg of emtricitabine and 25 mg of tenofovir alafenamide), once daily, taken by mouth, with or without food.

Descovy is not indicated for use as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk.

If you take too much Descovy, call your local Poison Control Center or seek emergency medical attention right away.

• Keep Descovy and all other medicines out of reach of children.
• Store Descovy below 30 °C (86 °F)
• Keep Descovy in its original container and keep the container tightly closed.
• Do not keep medicine that is out of date or that you no longer need. If you throw any medicines away make sure that children will not find them.

WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST TREATMENT ACUTE EXACERBATION OF HEPATITIS B

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs in combination with other antiretrovirals. Descovy is not approved for the treatment of chronic hepatitis B virus (HBV) infection, and the safety and efficacy of Descovy have not been established in patients coinfected with human immunodeficiency virus-1 (HIV-1) and HBV. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued products containing emtricitabine (FTC) and/or tenofovir disoproxil fumarate (TDF), and may occur with discontinuation of Descovy. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue Descovy. If appropriate, initiation of anti-hepatitis B therapy may be warranted.