What is efavirenz, emtricitabine, and tenofovir?
Efavirenz, emtricitabine, and tenofovir is an antiviral medication that prevents human
immunodeficiency virus (HIV) from reproducing in your body.
Efavirenz, emtricitabine, and tenofovir treats HIV, which causes acquired immunodeficiency
syndrome (AIDS). Efavirenz, emtricitabine, and tenofovir is not a cure for HIV or AIDS.
Efavirenz, 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 efavirenz, emtricitabine, and tenofovir?
Do not use this medication if you are taking any of the following drugs:
-
cisapride (Propulsid);
-
midazolam (Versed) or triazolam (Halcion);
-
St. John's wort;
-
voriconazole (Vfend);
-
an ergot medicine such as dihydroergotamine (D.H.E. 45,
Migranal), ergonovine (Ergotrate), ergotamine (Ergomar), or methylergonovine (Methergine);
or
-
lamivudine (Combivir, Epivir, Epzicom, or Trizivir); or
-
any other medicines that also contain efavirenz,
emtricitabine, or tenofovir (such as Sustiva, Emtriva, Truvada, or Viread).
If you have certain conditions, you may need a dose adjustment or special
tests to safely use this medication. Before you take efavirenz, emtricitabine, and tenofovir, tell your
doctor if you have:
-
liver or kidney disease;
-
a history of mental illness, use of antipsychotic medication,
or injection drug use;
-
epilepsy or other seizure disorder;
-
osteopenia (low bone mineral density); or
-
hepatitis B or C infection.
FDA pregnancy category D.
Do not use efavirenz,
emtricitabine, and tenofovir if you are pregnant
. It could harm the unborn baby. Tell
your doctor right away if you become pregnant during treatment.
Use two forms of birth control, including an effective barrier form (such as a condom or
diaphragm with spermicide gel or inserts) while taking this medication. Keep using birth control to
prevent pregnancy for at least 12 weeks after you stop taking efavirenz, emtricitabine, and tenofovir. It
may take that long for the medication to completely clear from your body.
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 a pregnancy patient registry when you start using this
medication.
You should not breast-feed while you are using efavirenz, 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
this medication. 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.
How should I take efavirenz, 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. Your doctor may
occasionally change your dose to make sure you get the best results from this medication.
Take this medication on an empty stomach at bedtime.
To be sure this medication is helping your condition, your blood will need to be tested on a
regular basis. Your liver function may also need to be tested. Do not miss any scheduled 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 this medicine at room temperature away from moisture, heat, and direct light. Keep
the medicine in its original bottle with the cap tightly closed.
What happens if I miss a dose of efavirenz, 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 efavirenz, emtricitabine, and tenofovir?
Your pharmacist has information about efavirenz, emtricitabine, and tenofovir written for health professionals that you may read.
What are the possible side effects of efavirenz, 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.
Efavirenz, emtricitabine, and tenofovir 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, stomach pain,
nausea with vomiting, fast or uneven heart rate, dizziness, or feeling very weak or tired.
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);
-
urinating less than usual or not at all;
-
fever, chills, body aches, flu symptoms;
-
unusual thoughts or behavior, severe depression, extreme
fear, thoughts of hurting yourself or others, hallucinations;
-
severe blistering, peeling, and red skin rash; or
-
seizure (convulsions).
Less serious side effects may include:
-
dizziness, drowsiness, anxiety, depressed mood;
-
headache, tired feeling, ringing in your ears, vision
problems;
-
sleep problems (insomnia), confusion, strange dreams,
forgetfulness;
-
mild nausea, vomiting, diarrhea, loss of appetite, upset
stomach;
-
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 efavirenz, emtricitabine, and tenofovir?
Do not use this medication while you are pregnant. It could harm the unborn baby. Use
effective birth control while you are using this medication, and for at least 12 weeks after your treatment
ends. Tell your doctor if you become pregnant during treatment.
Do not take this medication if you are also taking cisapride (Propulsid), midazolam
(Versed), triazolam (Halcion), St. John's wort, voriconazole (Vfend), or an ergot medicine such as
dihydroergotamine (D.H.E. 45, Migranal), ergonovine (Ergotrate), ergotamine (Ergomar), or
methylergonovine (Methergine). Do not take this medication with other medicines that also contain
efavirenz, emtricitabine, tenofovir (Sustiva, Emtriva, Truvada, or Viread), or lamivudine (Combivir,
Epivir, Epzicom, or Trizivir).
There are many other medicines that can cause interactions or serious medical
problems if you take them together with efavirenz, 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.
Some people have developed a life-threatening condition called lactic acidosis while taking
this medication.
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, fast or uneven heart rate, dizziness, or feeling
very weak or tired.
Efavirenz, 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 efavirenz, emtricitabine, and tenofovir?
Avoid drinking alcohol, which can increase some of the side effects of this medication.
This medication can cause side effects that may impair your thinking or reactions. Be
careful if you drive or do anything that requires you to be awake and alert.
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 efavirenz, emtricitabine, and tenofovir?
Before using efavirenz, emtricitabine, and tenofovir, tell your doctor if you regularly use
other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain
medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can
add to sleepiness caused by efavirenz, emtricitabine, and tenofovir.
There are many other medicines that can cause interactions or serious medical
problems if you take them together with efavirenz, emtricitabine, and tenofovir.
Tell
your doctor if you use any of the following:
-
acyclovir (Zovirax), ganciclovir (Cytovene), valacyclovir (Valtrex),
or valganciclovir (Valcyte);
-
sertraline (Zoloft);
-
methadone (Methadose);
-
adefovir (Hepsera) or cidofovir (Vistide);
-
a blood thinner such as warfarin (Coumadin);
-
cholesterol medications such as atorvastatin (Lipitor),
pravastatin (Pravachol), or simvastatin (Zocor);
-
antibiotics such as clarithromycin (Biaxin), itraconazole
(Sporanox), ketoconazole (Nizoral), rifabutin (Mycobutin), rifampin (Rifater, Rifamate);
-
a calcium channel blocker such as amlodipine (Norvasc),
diltiazem (Tiazac, Cartia, Cardizem), felodipine (Plendil), nifedipine (Procardia, Adalat),
verapamil (Calan, Covera, Isoptin, Verelan), and others;
-
seizure medicines such as carbamazepine (Tegretol,
Carbatrol), phenytoin (Dilantin), phenobarbital (Luminal, Solfoton); or
-
certain other HIV medicines such as atazanavir (Reyataz),
didanosine (Videx), indinavir (Crixivan), saquinavir (Invirase), lopinavir/ritonavir (Kaletra),
fosamprenavir (Lexiva), or ritonavir (Norvir).
This list is not complete and there may be other drugs that can interact with
efavirenz, 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. Keep a list with you of all the
medicines you use and show this list to any doctor or other healthcare provider who treats you.
What happens if I have an overdose of efavirenz, emtricitabine, and tenofovir?
