Truvada

Truvada 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.

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.

Common side effects include diarrhea, dizziness, nausea, and headache.

Truvada is a prescription medicine used to treat adults, and children over 12, with HIV infection. As treatment, Truvada must be combined with at least one other drug.

Truvada is also used to prevent HIV in certain high-risk people. This is known as pre-exposure prophylaxis (PrEP). As PrEP, this medication should be used with correct and consistent condom use, regular HIV testing and screening for and treatment of other sexually transmitted infections. 

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

• Gilead Sciences, Inc.

Truvada may cause serious side effects. See "Drug Precautions" section.

The most common side effects of Truvada in people with HIV-1 infection are:

• diarrhea
• dizziness
• nausea
• headache
• fatigue
• abnormal dreams
• sleeping problems
• rash
• depression
• vomiting

The most common side effects of Truvada in people who take it to prevent HIV-1 infection are:

• stomach-area (abdomen) pain
• headache
• decreased weight

These are not all the side effects of Truvada. If you have questions about side effects, ask your healthcare provider. Report any new or continuing symptoms to your healthcare provider right away. 

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

Do not take Truvada if you also take:

• other medicines that contain tenofovir or emtricitabine (Atripla, Complera, Emtriva, Viread)
• medicines that contain lamivudine (Combivir, Epivir, Epivir-HBV, Epzicom, Trizivir)
• adefovir (Hepsera)

Especially tell your healthcare provider if you take:

• didanosine (Videx EC)
• atazanavir (Reyataz)
• lopinavir with ritonavir (Kaletra)

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

Truvada may cause the following serious side effects:

• buildup of an acid in the blood (lactic acidosis)
• serious liver problems 
• hepatitis B virus infection flare-ups
• kidney problems
• thinning bones (bone mineral density changes)
• increased amount of fat in the upper back and neck which is sometimes referred to as "buffalo hump"
• in some patients with advanced HIV infection (AIDS), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. 

Tell your doctor right away if you get the following signs or symptoms of lactic acidosis:

• extreme weakness or tiredness
• unusual (not normal) muscle pain
• trouble breathing
• stomach pain with nausea (upset stomach) and vomiting
• you feel cold, especially in your arms and legs
• dizziness or lightheadedness
• fast or irregular heartbeat

Tell your doctor right away if you get the following signs or symptoms of liver problems:

• skin or the white part of your eyes turns yellow (jaundice)
• urine (pee) turns dark
• bowel movements (stools) turn light in color
• you don't feel like eating food for several days or longer
• you feel sick to your stomach (nausea)
• you have lower stomach area (abdominal) pain

If you are also infected with the hepatitis B virus (HBV), you need medical exams and blood tests to check for HBV getting worse for several months after stopping treatment with Truvada. People with hepatitis B virus infection, who take Truvada and then stop it, may get "flare-ups" of their hepatitis. A "flare-up" is when the disease suddenly returns in a worse way than before.

• Do not take Truvada if you are allergic to any ingredient found in it. 
• Do not take Truvada if you are already taking Atripla, Combivir (lamivudine/zidovudine), Emtriva, Epivir or Epivir-HBV (lamivudine), Epzicom (abacavir sulfate/lamivudine), Trizivir (abacavir sulfate/lamivudine/zidovudine), or Viread because these medicines contain the same or similar active ingredients.
• Do not take emtricitabine/tenofovir to treat your HIV infection if you are also taking Hepsera to treat your HBV infection.

Avoid doing things that can spread HIV infection since Truvada does not stop you from passing the HIV infection to others.

• Do not share needles or other injection equipment.
• Do not share personal items that can have blood or body fluids on them, like toothbrushes or razor blades.
• Do not have any kind of sex without protection. Always practice safer sex by using a latex or polyurethane condom or other barrier to reduce the chance of sexual contact with semen, vaginal secretions, or blood.

Medicines 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 Truvada there are no specific foods that you must exclude from your diet when receiving this medication.

Tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• have kidney, bone or liver problems (including hepatitis B infection). Be sure and tell your doctor if you are undergoing kidney dialysis treatment.
• are pregnant or breastfeeding

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.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Truvada falls into category B. This medication has been evaluated in a limited number of women during pregnancy and postpartum. Human and animal data suggest that Truvada does not increase the risk of major birth defects overall. However, there are no well controlled studies in pregnant women. Truvada should be during pregnancy only if clearly needed.

If you use Truvada while you are pregnant, talk to your doctor about how you can be on the Antiviral Pregnancy Registry.

Tell your doctor if you are breastfeeding. You should not breastfeed if you are HIV-positive because of the chance of passing the HIV virus to your baby.

Also, it is not known if Truvada can pass into your breast milk and if it can harm your baby. If you are a woman who has or will have a baby, talk with your doctor about the best way to feed your baby.

• Truvada comes as a tablet to be taken once a day, with or without food.
• You should take Truvada 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 Truvada, even for a short time, the amount of virus in your blood may increase. The virus may become harder to treat. 
• When this medicine is used to treat HIV infection, Truvada is always used with other anti-HIV-1 medicines.

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

For HIV-1 treatment, the dose of Truvada for adults and children 12 years of age and older with body weight greater than or equal to 35 kg (greater than or equal to 77 lb) is one tablet (containing 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate), once daily, taken by mouth, with or without food.

The recommended dose, when used to prevent HIV-1 infection in adults, is one tablet (containing 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) once daily taken by mouth, with or without food.

If you have kidney disease, your doctor may have you take emtricitabine/tenofovir less often.

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

• Keep Truvada and all other medicines out of reach of children.
• Store Truvada at room temperature 77 °F (25 °C).
• Keep Truvada 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.

WARNINGS: 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, including Viread, a component of Truvada, in combination with other antiretrovirals.

Truvada is not approved for the treatment of chronic hepatitis B virus (HBV) infection and the safety and efficacy of Truvada have not been established in patients coinfected with HBV and HIV-1. Severe acute exacerbations of hepatitis B have been reported in patients who are coinfected with HBV and HIV-1 and have discontinued Truvada. 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 emtricitabine/tenofovir. If appropriate, initiation of anti-hepatitis B therapy may be warranted.