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TRUVADA SIDE EFFECT

  • TRUVADA for a PrEP indication

  • TRUVADA (emtricitabine/tenofovir disoproxil fumarate) is a medicine

  • used in combination with safer sex practices to decrease the chance of

  • getting HIV-1 in adults who are at high risk of getting infected with HIV-1

  • through sex.

  • TRUVADA is also used with other antiviral medicines to treat HIV-1 in

  • adults and children 12 years and older.

  • Only take TRUVADA as part of a complete prevention strategy because

  • TRUVADA is not always effective in preventing a person from getting

  • infected with HIV-1.

  • What is the most important

  • information you should know

  • about taking TRUVADA?

  • TRUVADA can cause serious side effects. Some of these side effects are:

  • Build-up of lactic acid in your blood (lactic acidosis). This is a

  • serious medical emergency that can lead to death. Lactic acidosis

  • can be hard to identify early because the symptoms could seem like

  • symptoms of other health problems. Call your healthcare provider

  • right away if you get these symptoms. They could be signs of

  • lactic acidosis:

    • Feeling very weak or tired

    • Unusual muscle pain

    • Trouble breathing

    • Stomach pain with nausea and/or vomiting

    • Feeling cold, especially in your arms and legs

    • Feeling dizzy or lightheaded

    • Having a fast or irregular heartbeat

  • 4

  • 5

  • Severe liver problems. Severe liver problems can happen in people

  • who take TRUVADA. In some cases, these liver problems can lead

  • to death. Your liver may become large (hepatomegaly), and you may

  • develop fat in your liver (steatosis) when you take TRUVADA. Call your

  • healthcare provider right away if you get these symptoms:

    • Your skin or the white part of your eyes turns yellow (jaundice)

    • Dark “tea-colored” urine

    • Light-colored bowel movements (stools)

    • Loss of appetite for several days or longer

    • Nausea

    • Stomach pain

  • You may be more likely to get lactic acidosis or severe liver problems

  • if you are a woman, are very overweight (obese), or have been taking

  • TRUVADA or a medicine like it for a long time.

  • Worsening of hepatitis B (HBV) infection. If you have HBV infection, it

  • may flare up and get worse if you take TRUVADA and then stop it. A flareup

  • is when your HBV infection suddenly comes back worse than before.

    • Do not run out of TRUVADA. Refill your prescription before your

  • TRUVADA is all gone

    • Do not stop taking TRUVADA without first talking to your healthcare

  • provider

    • If you stop taking TRUVADA, your healthcare provider will need to

  • check your health often. Your healthcare provider will also need to do

  • regular blood tests for several months to check your HBV infection

  • Tell your healthcare provider about any new or unusual symptoms you

  • have after you stop taking TRUVADA.

  • You should not take TRUVADA for a PrEP indication if you are

  • HIV-1 positive or do not know your status

  • Before starting TRUVADA for a PrEP indication

  • You must be HIV-1 negative and stay HIV-1 negative before starting

  • TRUVADA for a PrEP indication. That is why you must:

    • Get tested to be sure you are HIV-1 negative. It is important that you

  • also get tested at least every 3 months as recommended by your

  • healthcare provider while taking TRUVADA

    • Not take TRUVADA to reduce the risk of getting HIV unless you are

  • confirmed to be HIV-1 negative

    • Have no symptoms like feeling weak or tired, fever, sweating a lot

  • (especially at night), rash, vomiting, diarrhea, joint or muscle aches,

  • headache, sore throat, or enlarged lymph nodes in your neck or groin

    • Be prepared to commit to adopting safer sex practices, such as regular

  • and correct use of condoms, limiting your number of sexual partners,

  • knowing the HIV status of your sexual partners, and regular testing

  • for HIV-1 (at least every 3 months) and other sexually transmitted

  • infections, such as syphilis and gonorrhea

    • Make sure you understand the risks and benefits of taking TRUVADA

  • for a PrEP indication as outlined in the TRUVADA Medication Guide and

  • in the Agreement Form, and you have spoken with your healthcare

  • provider about questions and concerns

  • After starting TRUVADA for a PrEP indication

  • Just taking TRUVADA may not keep you from getting HIV-1.

  • TRUVADA does not always prevent HIV-1.

  • 6 7

  • Here are some things you must do after starting TRUVADA for a PrEP

  • indication:

    • You will need to get tested regularly for HIV-1 to make sure that you

  • are still HIV-1 negative. Your healthcare provider will tell you when

    • Tell your healthcare provider if you have any of these symptoms: feeling

  • weak or tired, fever, sweating a lot (especially at night), rash, vomiting,

  • diarrhea, joint or muscle aches, headache, sore throat, or enlarged lymph

  • nodes in your neck or groin. These may be signs of HIV-1 infection

    • You must still practice safer sex at all times

      • Do not have any kind of sex without protection. Always practice

  • safer sex by using a latex or polyurethane condom to lower the

  • chance of sexual contact with semen, vaginal secretions, or blood

    • You must also use other methods to keep from getting HIV-1:

      • Know your HIV-1 status and the HIV-1 status of your partner(s)

      • Get tested regularly for HIV-1. Ask your partner(s) to get tested

      • Get tested for other sexually transmitted infections, such as syphilis

  • and gonorrhea. These infections make it easier for HIV-1 to infect you

      • Do not have risky sex

      • Have fewer sex partners

      • Do not share needles or other drug injection equipment

      • Do not share personal things, like toothbrushes and razors. They

  • can have blood or body fluids on them

    • Do not miss any doses of TRUVADA. Missing doses raises the risk

  • of getting HIV-1. TRUVADA for a PrEP indication may not help you

  • decrease the chance of getting HIV-1 if you do not take it exactly as

  • prescribed. Be sure to stick to the TRUVADA daily dosing schedule

    • TRUVADA by itself is not a complete treatment for HIV-1. If you

  • already have HIV-1 or get HIV-1 and take TRUVADA by itself without

  • other anti–HIV-1 medicines, you may develop resistance to TRUVADA

    • TRUVADA needs to be in your blood to work. You may have to take

  • TRUVADA for a few days before there is enough in your blood for it

  • to help decrease your chance of getting HIV-1. Even after it is in your

  • blood, it is still very important to practice safer sex

  • TRUVADA for a PrEP indication was tested in adults who were at high

  • risk for getting infected with HIV-1 through sex.

  • When you should not take

  • TRUVADA for a PrEP indication

  • Do not take TRUVADA to help prevent HIV-1 infection...

    • If you have been tested for HIV-1 and have found out you are infected

    • If you are already taking ATRIPLA® (efavirenz/emtricitabine/tenofovir

  • disoproxil fumarate), COMPLERA® (emtricitabine/rilpivirine/tenofovir

  • disoproxil fumarate), Combivir® (lamivudine/zidovudine), EMTRIVA®

  • (emtricitabine), Epivir® or Epivir-HBV® (lamivudine), Epzicom® (abacavir

  • sulfate/lamivudine), Trizivir® (abacavir sulfate/lamivudine/zidovudine),

  • or VIREAD® (tenofovir disoproxil fumarate). These medicines have the

  • same or similar active ingredients as TRUVADA

    • Do not take TRUVADA with HEPSERA® for hepatitis B virus (HBV)

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  • Things to tell your healthcare

  • provider

  • Tell your healthcare provider if you...

    • Are pregnant or plan to become pregnant. There is an increased

  • risk of HIV-1 infection during pregnancy. It is not known if TRUVADA

  • can harm your unborn child. You and your healthcare provider will need

  • to decide if TRUVADA is right for you. If you use TRUVADA while you are

  • pregnant, talk to your healthcare provider about joining the TRUVADA

  • Antiviral Pregnancy Registry

    • Are breast-feeding. You should not breast-feed if you have HIV-1

  • because you may pass HIV-1 to your baby. Also, the components of

  • TRUVADA (emtricitabine/tenofovir disoproxil fumarate) can pass into

  • your breast milk, and it is not known if this will harm your baby. If you

  • are a woman who has or will have a baby, talk with your healthcare

  • provider about the best way to feed your baby

    • Have kidney problems or get kidney dialysis treatment

    • Have bone problems

    • Have liver problems, including hepatitis B virus infection

  • Your healthcare provider needs to know what other

  • medicines you take

    • Make sure you tell your doctor if you take didanosine (VIDEX EC),

  • atazanavir (REYATAZ), or lopinavir with ritonavir (KALETRA) because the

  • doses of these medications may need to change

  • Tell your healthcare provider about all of the medicines you take. That

  • means prescription and non-prescription medicines, vitamins, and herbal

  • supplements. TRUVADA may affect the way other medicines work, and

  • other medicines may affect how TRUVADA works.

  • Show a list of all your medicines to your healthcare provider or

  • pharmacist when you get a new medicine.

  • Possible side effects of

  • TRUVADA

  • TRUVADA may cause these serious side effects:

    • New or worse kidney problems, including kidney failure. If you have

  • had kidney problems in the past or need to take another medicine that

  • can cause kidney problems, your healthcare provider may need to do

  • blood tests to check your kidneys while you are taking TRUVADA

    • Bone problems. Bone problems, like bone pain, softening, or thinning

  • (which may lead to fractures), can occur. Your healthcare provider may

  • need to do tests to check your bones

    • Changes in body fat. These changes may include increased amount

  • of fat in the upper back and neck (“buffalo hump”), breast, and around

  • the main part of your body (trunk). Loss of fat from the legs, arms, and

  • face may also happen. The cause and long-term health effects of these

  • conditions are not known

    • Changes in your immune system (immune reconstitution

  • syndrome). This can occur if you have active HIV-1 infection and take

  • TRUVADA

  • Complete management to lower the risk of acquiring HIV-1

  • Use TRUVADA for a PrEP indication only as part of a complete prevention

  • strategy that includes other prevention measures, such as safer sex

  • practices, because TRUVADA is not always effective in preventing the

  • acquisition of HIV-1.

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  • Common side effects of TRUVADA

  • No new side effects emerged in the iPrEx and Partners PrEP clinical

  • trials. The most common reported with the use of TRUVADA alone in

  • these clinical trials include abdominal pain, headache, and decreased

  • weight.

  • The most common side effects of EMTRIVA or VIREAD, the medicines in

  • TRUVADA, when used with other anti–HIV-1 medicines are:

    • Diarrhea • Abnormal dreams

    • Dizziness • Problems sleeping

    • Nausea • Rash

    • Headache • Depression

    • Fatigue • Vomiting

  • These are not all of the possible side effects of TRUVADA. For more

  • information, ask your healthcare provider or pharmacist.

  • Talk with your healthcare provider

  • Tell your healthcare provider if you have any side effect that bothers you

  • or does not go away.

  • Call your doctor for medical advice about side effects. You may also

  • report side effects to FDA at 1-800-FDA-1088.

  • Please see the Full Prescribing Information with Medication Guide,

  • including “What is the most important information I should know

  • about TRUVADA?” that goes with this brochure.

  • Make sure you understand the risks and benefits of taking TRUVADA for

  • a PrEP indication as outlined in the TRUVADA Medication Guide and in

  • the Agreement Form, and you have spoken with your healthcare provider

  • about questions and concerns.

  •  

 

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