If you take TRUVADA to reduce the risk of getting HIV through sex (pre-exposure prophylaxis or PrEP), the most important information you should know is that you:
- Are
completely sure you do not have HIV. Tell your healthcare provider if you
have symptoms like fever, feeling tired, sweating a lot (especially at
night), rash, vomiting, diarrhea, joint or muscle aches, headache, sore throat,
and/or enlarged lymph nodes in your neck or groin, as these may be signs
of HIV infection. You must not take TRUVADA for PrEP if you have HIV or do
not know your status.
- TRUVADA
by itself is not a complete treatment for HIV infection. If you have HIV or get HIV
while taking TRUVADA, you may develop resistance which makes your
infection harder to treat.
- Just
taking TRUVADA may not keep you from getting HIV. TRUVADA does not always
prevent HIV infection.
- You must
practice safer sex at all times and do not have any kind of sex without
protection.
- Safer sex practices include consistent use of
condoms, knowing your HIV status and the HIV status of your partner(s),
getting tested for other sexually transmitted infections (like syphilis),
and taking action to limit contact with other body fluids are needed to
help you limit exposure to the HIV virus.
- You must get tested regularly (at least every 3
months) or as recommended by your healthcare provider. Ask your partners
to also get tested. You also should get tested for other sexually
transmitted infections like syphilis and gonorrhea.
- If you
are already taking TRUVADA to prevent HIV-1 infection, and think you were
exposed to the virus and have symptoms of HIV infection, your doctor may
tell you to stop taking TRUVADA until an HIV test confirms that you do not
have HIV-1 infection.
- Take your
dose of TRUVADA every day, as prescribed by your doctor, and see your
healthcare provider regularly.
YOU SHOULD NOT
TAKE TRUVADA to prevent HIV infection if you are HIV positive or if your HIV
status is not known.
The most
serious possible side effects of TRUVADA when taken for PrEP or for treating
HIV infection are:
·
A buildup of acid in the blood (lactic acidosis), which is a serious
medical emergency may occur. Symptoms of lactic acidosis include weakness,
unusual muscle pain, trouble breathing, nausea, vomiting, a fast or irregular
heartbeat, and/or feeling cold, dizzy, or lightheaded.
·
Serious liver problems (hepatotoxicity), with liver enlargement
(hepatomegaly), and fat in the liver (steatosis). Symptoms of liver problems
include your skin or the whites of your eyes turning yellow (jaundice), dark
colored urine, light colored stools, lack of appetite, nausea, and/or pain in
your lower stomach area.
o
You may be more likely to get lactic acidosis or serious liver problems if
you are female, very overweight (obese), or have been taking TRUVADA or similar
medicines for a long time. In some cases, these serious conditions have lead to
death. Call your healthcare provider right away if you have any symptoms of
these conditions.
·
If you have hepatitis B virus (HBV) and stop taking TRUVADA, your
hepatitis may suddenly get worse. Your healthcare provider will monitor your
condition for several months.
Do not take
TRUVADA if you also take: Products containing emtricitabine or tenofovir disoproxil fumarate
(a/k/a/ tenofovir DF) like ATRIPLA(efavirenz/emtricitabine/tenofovir DF),
COMPLERA (emtricitabine/rilpivirine/tenofovir DF), VIREAD (tenofovir DF),
EMTRIVA (emtricitabine), Combivir (lamivudine/zidovudine), Epivir or Epivir-HBV
(lamivudine), Epzicom (abacavir sulfate/lamivudine), or Trizivir (abacavir
sulfate/lamivudine/zidovudine) because these medicines contain the same or
similar active ingredients. TRUVADA should also not be used with HEPSERA
(adefovir dipivoxil).
Other serious
side effects include:
·
New or worsening kidney problems: If you have had kidney problems or take other
medicines that can cause kidney problems, your healthcare provider should do
regular blood tests to check your kidneys.
·
Bone problems: Lab
tests show changes in the bones of patients treated with VIREAD (tenofovir DF),
a medicine in TRUVADA. Some patients have developed thinning of the bones
(osteopenia), which could lead to fractures.
·
Changes in body fat: Changes in the distribution of body fat have been seen in some
people taking TRUVADA. The long term health effect of this is not known.
·
Symptoms of inflammation: In some patients with advanced HIV-1 infection
symptoms of inflammation from previous infections may occur soon after TRUVADA
is started. If you notice any symptoms of infection, tell your healthcare
provider right away.
Common side
effects include:
·
The most
common side effects of TRUVADA when taken with other anti-HIV-1 medicines to
treat HIV infection are diarrhea, dizziness, nausea, headache, fatigue,
abnormal dreams, sleeping problems, rash, and depression. In clinical trials of
TRUVADA taken alone for pre-exposure prophylaxis, the most common side effects
reported were stomach area (abdomen) pain, headache, and decreased weight.
Tell your
healthcare provider if you:
·
Are pregnant or plan to become pregnant: It is not known if TRUVADA can harm your unborn
baby, so speak to your doctor about the risk of using TRUVADA while pregnant.
·
Are breastfeeding: Women with HIV should not breastfeed, because HIV can be passed
through breast milk to the baby. Also, the components of TRUVADA can pass
through breast milk, and it is not known if this will harm your baby. Talk to
your healthcare provider about the best way to feed your baby.
·
Have or had liver, kidney, or bone problems, including hepatitis virus infection
or if you have ever been on dialysis.
Tell your
healthcare provider about all the medicines you take, including prescription and
non-prescription medicines, vitamins, and herbal supplements. Your healthcare
provider may need to follow you more closely or adjust your therapy if you take
Videx EC (didanosine), Reyataz (atazanavir sulfate), or Kaletra
(lopinavir/ritonavir) with TRUVADA.
