ATRIPLA® (efavirenz/emtricitabine/tenofovir disoproxil fumarate)
ATRIPLA® (efavirenz/emtricitabine/tenofovir disoproxii fumarate)
What should I tell my healthcare provider before taking ATRIPLA?
Tell your healthcare provider if you;
■ Are pregnant or planning to become pregnant (see “What should I avoid while taking
ATRIPLA?").
■ Are breastfeeding (see “What should I avoid while taking ATRIPLA?”).
■ Have kidney problems or are undergoing kidney dialysis treatment.
■ Have bone problems.
■ Have liver problems, including hepatitis B virus infection. Your healthcare provider
may want to do tests to check your liver while you take ATRIPLA or may switch you to
another medicine.
■ Have ever had mental illness or are using drugs or alcohol.
■ Have ever had seizures or are taking medicine for seizures.
What important information should I know about taking other medicines
with ATRIPLA?
ATRIPLA may change the effect of other medicines, including the ones for HIV-1,
and may cause serious side effects. Your healthcare provider may change your other
medicines or change their doses. Other medicines, including herbal products, may affect
ATRIPLA. For this reason, it is very important to let all your healthcare providers and
pharmacists know what medications, herbal supplements, or vitamins you are taking.
MEDICINES YOU SHOULD NOT TAKE WITH ATRIPLA
■ ATRIPLA also should not be used with Combivir (lamivudine/zidovudine), COMPLERA®,
EMTRIVA, Epivir, Epivir-HBV (lamivudine), Epzicom (abacavir sulfate/lamivudine),
STRIBILD®, Trizivir (abacavir sulfate/lamivudine/zidovudine), TRUVADA, or VIREAD.
ATRIPLA also should not be used with SUSTIVA unless recommended by your
healthcare provider.
■ Vfend (voriconazole) should not be taken with ATRIPLA since it may lose its effect or may
increase the chance of having side effects from ATRIPLA.
■ ATRIPLA should not be used with HEPSERA® (adefovirdipivoxil).
It is also important to tell your healthcare provider if you are taking any of the following:
■ Fortovase, Invirase (saquinavir), Biaxin (clarithromycin), Noxafil (posaconazole),
Sporanox (itraconazole), Victrelis (boceprevir), or Olysio (simeprevir); these medicines
may need to be replaced with another medicine when taken with ATRIPLA.
■ Calcium channel blockers such as Cardizem or Tiazac (diltiazem), Covera HS
or Isoptin (verapamil) and others; Crixivan (indinavir), Seizentry (maraviroc);
the immunosuppressant medicines cyclosporine (Gengraf, Neoral, Sandimmune, and
others), Prograf (tacrolimus), or Rapamune (sirolimus); Methadone; Mycobutin (rifabutin);
Rifampin; cholesterol-lowering medicines such as Lipitor (atorvastatin), Pravachol
(pravastatin sodium), and Zocor (simvastatin); or the anti-depressant medications
bupropion (Wellbutrin, Wellbutrin SR, Wellbutrin XL, and Zyban) or Zoloft (sertraline);
dose changes may be needed when these drugs are taken with ATRIPLA.
■ Videx, Videx EC (didanosine); tenofovir DF (a component of ATRIPLA) may increase
the amount of didanosine in your blood, which could result in more side effects. You
may need to be monitored more carefully if you are taking ATRIPLA and didanosine
together. Also, the dose of didanosine may need to be changed.
■ Reyataz (atazanavir sulfate), Prezista (darunavir) with Norvir (ritonavir), or Kaletra
(lopinavir/ritonavir); these medicines may increase the amount of tenofovir DF (a
component of ATRIPLA) in your blood, which could result in more side effects. Reyataz
is not recommended with ATRIPLA. You may need to be monitored more carefully if
you are taking ATRIPLA, Prezista, and Norvir together, or if you are taking ATRIPLA and
Kaletra together. The dose of Kaletra should be increased when taken with efavirenz.
■ Medicine for seizures [for example, Dilantin (phenytoin), Tegretol (carbamazepine), or
phenobarbital]; your healthcare provider may want to switch you to another medicine or
check drug levels in your blood from time to time.
These are not all the medicines that may cause problems if you take ATRIPLA.
Be sure to tell your healthcare provider about ail medicines that you take.
Keep a complete list of all the prescription and nonprescription medicines as well as any
herbal remedies that you are taking, how much you take, and how often you take them.
Make a new list when medicines or herbal remedies are added or stopped, or if the dose
changes. Give copies of this list to all of your healthcare providers and pharmacists every
time you visit your healthcare provider or fill a prescription. This will give your healthcare
provider a complete picture of the medicines you use. Then he or she can decide the best
approach for your situation.
How should I take ATRIPLA?
■ Take the exact amount of ATRIPLA your healthcare provider prescribes.
Never change the dose on your own. Do not stop this medicine unless your healthcare
provider tells you to stop.
■ You should take ATRIPLA on an empty stomach.
■ Swallow ATRIPLA with water.
■ Taking ATRIPLA at bedtime may make some side effects less bothersome.
a Do not miss a dose of ATRIPLA. If you forget to take ATRIPLA, take the missed dose right
away, unless it is almost time for your next dose. Do not double the next dose. Carry on
with your regular dosing schedule. If you need help in planning the best times to take your
medicine, ask your healthcare provider or pharmacist. ^
■ If you believe you took more than the prescribed amount of ATRIPLA, contact your local
poison control center or emergency room right away.
■ Tell your healthcare provider if you start any new medicine or change how you take old
ones. Your doses may need adjustment.
■ When your ATRIPLA supply starts to run low, get more from your healthcare
provider or pharmacy. This is very important because the amount of virus
in your blood rnay increase if the medicine is stopped for even a short time.
The virus may develop resistance to ATRIPLA and become harder to treat.
■ Your healthcare provider may want to do blood tests to check for certain side effects while
you take ATRIPLA.
What should I avoid while taking ATRIPLA?
■ Women should not become pregnant while taking ATRIPLA and for 12 weeks after
stopping it. Serious birth defects have been seen in the babies of animals and women
treated with efavirenz (a component of ATRIPLA) during pregnancy. It is not known
whether efavirenz caused these defects. Tell your healthcare provider right away if
you are pregnant. Also talk with your healthcare provider if you want to become pregnant.
■ Women should not rely only on hormone-based birth control, such as pills, injections, or
implants, because ATRIPLA may make these contraceptives ineffective. Women must
use a reliable form of barrier contraception, such as a condom or diaphragm, even if they
also use other methods of birth control. Efavirenz, a component of ATRIPLA, may remain
in your blood for a time after therapy is stopped. Therefore, you should continue to use
contraceptive measures for 12 weeks after you stop taking ATRIPLA.
« Do not breastfeed if you are taking ATRIPLA. Some of the medicines in ATRIPLA can
be passed to your baby in your breast milk. We do not know whether it could harm your
baby. Also, mothers with HIV-1 should not breastfeed because HIV-1 can be passed to the
baby in the breast milk. Talk with your healthcare provider if you are breastfeeding. You
should stop breastfeeding or may need to use a different medicine.
■ Taking ATRIPLA with alcohol or other medicines causing similar side effects as ATRIPLA,
such as drowsiness, may increase those side effects.
■ Do not take any other medicines, including prescription and nonprescription medicines
and herbal products, without checking with your healthcare provider.
■ Avoid doing things that can spread HIV-1 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 and razor blades.
■ Do not have any kind of sex without protection. Always practice safe sex by using
a latex or polyurethane condom to lower the chance, of sexual contact with semen,
vaginal secretions, or blood.
What are the possible side effects of ATRIPLA?
ATRIPLA may cause the following serious side effects:
■ Lactic acidosis (buildup of an acid in the blood). Lactic acidosis can be a medical
emergency and may need to be treated in the hospital. Call your healthcare provider
right away if you get signs of lactic acidosis. (See “What is the most important
information I should know about ATRIPLA?")
■ Serious liver problems (hepatotoxicity), with liver enlargement (hepatomegaly) and fat
in the liver (steatosis). Call your healthcare provider right away if you get any signs of liver
problems. (See “What is the most important information I should know about ATRIPLA?”)
■ “Flare-ups” of hepatitis B virus (HBV) infection, in which the disease suddenly returns
in a worse way than before, can occur if you have HBV and you stop taking ATRIPLA.
Your healthcare provider will monitor your condition for several months after stopping
ATRIPLA if you have both HlV-1 and HBV infection and may recommend treatment for
your HBV. ATRIPLA is not approved for the treatment of hepatitis B virus infection. If you
have advanced liver disease and stop treatment with ATRIPLA, the “flare-up” of hepatitis B
may cause your liver function to decline.
■ Serious psychiatric problems. A small number of patients may experience severe
depression, strange thoughts, or angry behavior while taking ATRIPLA. Some patients
have thoughts of suicide and a few have actually committed suicide. These problems
may occur more often in patients who have had mental illness. Contact your healthcare
provider right away if you think you are having these psychiatric symptoms, so your
healthcare provider can decide if you should continue to take ATRIPLA.
■ Kidney problems (including decline or failure of kidney function). If you have had kidney
problems in the past or take other medicines that can cause kidney problems, your
healthcare provider should do regular blood tests to check your kidneys. Symptoms that
may be related to kidney problems include a high volume of urine, thirst, muscle pain, and
muscle weakness.
■ Other serious liver problems. Some patients have experienced serious liver problems
including liver failure resulting in transplantation or death. Most of these serious side
effects occurred in patients with a chronic liver disease such as hepatitis infection, but
there have also been a few reports in patients without any existing liver disease.
■ Changes in bone mineral density (thinning bones). Laboratory tests show changes
in the bones of patients treated with tenofovir DF, a component of ATRIPLA. Some HIV
patients treated with tenofovir DF developed thinning of the bones (osteopenia) which
could lead to fractures. If you have had bone problems in the past, your healthcare provider
may need to do tests to check your bone mineral density or may prescribe medicines to
help your bone mineral density. Additionally, bone pain and softening of the bone (which
may contribute to fractures) may occur as a consequence of kidney problems.
April 8-21.2016 qnotes 7