What is emtricitabine and tenofovir?
Emtricitabine and tenofovir are antiviral drugs that work by preventing HIV (human
immunodeficiency virus) cells from multiplying in the body.
The combination of emtricitabine and tenofovir is used to treat HIV, which causes acquired
immunodeficiency syndrome (AIDS). Emtricitabine and tenofovir is not a cure for HIV or AIDS.
Emtricitabine and tenofovir may also be used for other purposes not listed in this medication
guide.
What should I discuss with my healthcare provider before taking emtricitabine and tenofovir?
You should not take this medication if you are allergic to emtricitabine or tenofovir.
Do not take this medication with other medicines that also contain emtricitabine or tenofovir
(Atripla, Emtriva, Viread), or lamivudine (Combivir, Epivir, Epzicom, or Trizivir).
If you have certain conditions, you may need a dose adjustment or special tests to safely use
this medication. Before you take emtricitabine and tenofovir, tell your doctor if you have:
FDA pregnancy category B. Emtricitabine and tenofovir is not expected
to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant
during treatment.
HIV can be passed to the baby if the mother is not properly treated during pregnancy. Tell
your doctor if you are pregnant or plan to become pregnant during treatment. Take all of your HIV
medicines as directed to control your infection while you are pregnant.
Your name may need to be listed on an pregnancy registry if you become pregnant while using
this medication. The purpose of this registry is to track the outcome of the pregnancy and delivery to
evaluate whether emtricitabine and tenofovir had any effect on the baby.
You should not breast-feed while you are using emtricitabine and tenofovir. Women with
HIV or AIDS should not breast-feed at all. Even if your baby is born without HIV, you may still pass
the virus to the baby in your breast milk.
Some people have developed a life-threatening condition called lactic acidosis while taking
emtricitabine and tenofovir. You may be more likely to develop lactic acidosis if you are overweight or
have liver disease, if you are a woman, or if you have taken certain HIV or AIDS medications for a
long time. Talk with your doctor about your individual risk.
Do not give this medicine to anyone under 18 without the advice of a doctor.
How should I take emtricitabine and tenofovir?
Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or
for longer than recommended. Follow the directions on your prescription label.
You may take this medication with or without food.
To be sure this medication is helping your condition and not causing harmful effects, your blood
will need to be tested on a regular basis. Your kidney and liver function or bone density may also need
to be tested.
If you have hepatitis B you may develop liver symptoms after you stop taking emtricitabine and
tenofovir, even months after stopping. Your doctor may want to check your liver function at regular
visits for several months after you stop using the medicine. Do not miss any follow-up visits to your
doctor.
It is important to take this medicine regularly to get the most benefit. Get your prescription
refilled before you run out of medicine completely.
HIV/AIDS is usually treated with a combination of different drugs. To best treat your condition,
use all of your medications as directed by your doctor. Do not change your doses or medication
schedule without advice from your doctor. Every person with HIV or AIDS should remain under the
care of a doctor.
Store emtricitabine and tenofovir at room temperature away from moisture and heat. Keep
the tablets in their original container, along with the packet of moisture-absorbing preservative that
comes with emtricitabine and tenofovir.
What happens if I miss a dose of emtricitabine and tenofovir?
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the
missed dose and take the medicine at the next regularly scheduled time.
Do not
take
extra medicine to make up the missed dose.
Where can I get more information about emtricitabine and tenofovir?
Your pharmacist has information about emtricitabine and tenofovir written for health professionals that you may read.
What are the possible side effects of emtricitabine and tenofovir?
Get emergency medical help if you have any of these
signs of an allergic
reaction:
hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
This medication may cause lactic acidosis (a build-up of lactic acid in the body, which can
be fatal). Lactic acidosis can start slowly and get worse over time.
Get emergency medical
help if you have even mild symptoms of lactic acidosis,
such as:
-
muscle pain or weakness;
-
numb or cold feeling in your arms and legs;
-
trouble breathing;
-
feeling dizzy, light-headed, tired, or very weak;
-
stomach pain, nausea with vomiting; or
-
slow or uneven heart rate.
Call your doctor at once if you have any of these other serious side
effects:
-
signs of liver damage - nausea, stomach pain, low fever, loss of
appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
-
increased thirst and urination, loss of appetite, weakness,
constipation;
-
urinating less than usual or not at all; or
-
signs of infection such as fever, chills, skin lesions, or cough
with yellow or green mucus.
Less serious side effects may include:
-
dizziness, anxiety, depressed mood;
-
headache, tired feeling;
-
sleep problems (insomnia), strange dreams;
-
mild nausea, vomiting, diarrhea, upset stomach;
-
mild itching or skin rash;
-
darkened skin on the palms of your hands or the soles of
your feet;
-
joint pain, back pain;
-
numbness or tingly feeling;
-
runny or stuffy nose, cough; or
-
changes in the shape or location of body fat (especially in
your arms, legs, face, neck, breasts, and waist).
This is not a complete list of side effects and others may occur. Call your
doctor for medical advice about side effects. You may report side effects to FDA at
1-800-FDA-1088.
What is the most important information I should know about emtricitabine and tenofovir?
You should not take this medication if you are allergic to emtricitabine (Emtriva) or
tenofovir (Viread).
Do not take this medication with other medicines that also contain emtricitabine or tenofovir
(Atripla, Emtriva, Viread), or lamivudine (Combivir, Epivir, Epzicom, or Trizivir).
Some people have developed a life-threatening condition called lactic acidosis while taking
emtricitabine and tenofovir. Early signs of lactic acidosis generally get worse over time and this
condition can be fatal.
Get emergency medical help if you have even mild symptoms of
lactic acidosis, such as:
muscle pain or weakness, numb or cold feeling in your arms and
legs, trouble breathing, stomach pain, nausea with vomiting, slow or uneven heart rate, dizziness, or
feeling very weak or tired.
Emtricitabine and tenofovir can cause severe or fatal liver problems. Call your doctor at
once if you have symptoms such as nausea, stomach pain, low fever, loss of appetite, dark urine,
clay-colored stools, or jaundice (yellowing of the skin or eyes).
What should I avoid while taking emtricitabine and tenofovir?
Avoid having unprotected sex or sharing needles, razors, or toothbrushes. Taking this
medication will not prevent you from passing HIV to other people. Talk with your doctor about safe
methods of preventing HIV transmission during sex. Sharing drug or medicine needles is never safe,
even for a healthy person.
What other drugs will affect emtricitabine and tenofovir?
This medication can be harmful to the kidneys, and this effect is increased when emtricitabine
and tenofovir is used together with other medicines that can harm the kidneys. Before taking this
medication, tell your doctor if you have recently used:
-
lithium (Lithobid);
-
methotrexate (Rheumatrex, Trexall);
-
pain or arthritis medicines such as aspirin (Anacin,
Excedrin), acetaminophen (Tylenol), diclofenac (Cataflam, Voltaren), etodolac (Lodine),
ibuprofen (Advil, Motrin), indomethacin (Indocin), naproxen (Aleve, Naprosyn), and others;
-
medicines used to prevent organ transplant rejection, such
as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune) or tacrolimus (Prograf);
-
IV antibiotics such as amphotericin B (Fungizone,
AmBisome, Amphotec, Abelcet), amikacin (Amikin), bacitracin (Baci-IM), capreomycin
(Capastat), gentamicin (Garamycin), kanamycin (Kantrex), streptomycin, or vancomycin
(Vancocin, Vancoled);
-
antiviral medicines such as adefovir (Hepsera), cidofovir
(Vistide), or foscarnet (Foscavir); or
-
cancer medicine such as aldesleukin (Proleukin),
carmustine (BiCNU, Gliadel), cisplatin (Platinol), ifosfamide (Ifex), oxaliplatin (Eloxatin),
plicamycin (Mithracin), streptozocin (Zanosar), or tretinoin (Vesanoid).
You may need dose adjustments or special tests when taking any of these
medications together with emtricitabine and tenofovir.
Other medications that can affect emtricitabine and tenofovir include:
-
the herpes medications acyclovir (Zovirax) or valacyclovir
(Valtrex);
-
medications to treat cytomegalovirus (CMV) such as
cidofovir (Vistide), ganciclovir (Cytovene) or valganciclovir (Valcyte); or
-
certain other HIV medicines such as atazanavir (Reyataz),
didanosine (Videx), indinavir (Crixivan), saquinavir (Invirase), lopinavir/ritonavir (Kaletra), or
ritonavir (Norvir).
This list is not complete and there may be other drugs that can interact with
emtricitabine and tenofovir. Tell your doctor about all the prescription and over-the-counter
medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other
doctors. Do not start using a new medication without telling your doctor.
What happens if I have an overdose of emtricitabine and tenofovir?
