ATRIPLA® (efavirenz/emtricitabine/tenofovir disoproxil fumarate)
Common side effects:
Patients may have dizziness, headache, trouble sleeping, drowsiness, trouble
concentrating, and/or unusual dreams during treatment with ATRIPLA. These side effects
may be reduced if you take ATRIPLA at bedtime on an empty stomach. They also tend to
go away after you have taken the medicine for a few weeks. If you have these common
side effects, such as dizziness, it does not mean that you will also have serious psychiatric
problems, such as severe depression, strange thoughts, or angry behavior.. Tell your
healthcare provider right away if any of these side effects continue or if they bother you. It is
possible that these symptoms may be more severe if ATRIPLA is used with alcohol or mood
altering (street) drugs.
If you are dizzy, have trouble concentrating, or are drowsy, avoid activities that may be
dangerous, such as driving or operating machinery.
Rash may be common. Rashes usually go away without any change in treatment. In a
small number of patients, rash may be serious. If you develop a rash, call your healthcare
provider right away. Rash may be a serious problem in some children. Tell your child’s
healthcare provider right away if you notice rash or any other side effects while your child is
taking ATRIPLA.
Other common side effects include tiredness, upset stomach, vomiting, gas, and diarrhea.
Other possible side effects with ATRIPLA:
■ Changes in body fat. Changes in body fat develop in some patients taking anti
HIV-1 medicine. These changes may include an increased amount of fat in the
upper back and neck (“buffalo hump”), in the breasts, and around the trunk.
Loss of fat from the legs, arms, and face may also happen. The cause and long-term
health effects of these fat changes are not known.
■ Skin discoloration (small spots or freckles) may also happen with ATRIPLA.
■ In some patients with advanced HIV infection (AIDS), signs and symptoms of inflamrnation
from previous infections may occur soon after anti-HIV treatment is started. It is believed
that these symptoms are due to an improvement in the body’s immune response, enabling
the body to fight infections that may have been present with no obvious symptoms. If you
notice any symptoms of infection, please inform your doctor immediately.
■ Additional side effects are inflammation of the pancreas, allergic reaction (including
swelling of the face, lips, tongue, or throat), shortness of breath, pain, stomach pain,
weakness and indigestion.
Tell your healthcare provider or pharmacist if you notice any side effects while
taking ATRIPLA.
Contact your healthcare provider before stopping ATRIPLA because of side effects or for
any other reason.
This is not a complete list of side effects possible with ATRIPLA. Ask your healthcare
provider or pharmacist for a more complete list of side effects of ATRIPLA and all the
medicines you will take.
How do I store ATRIPLA?
■ Keep ATRIPLA and all other medicines out of reach of children.
■ Store ATRIPLA at room temperature 77°F (25°C).
■ Keep ATRIPLA in its original container and keep the container tightly closed.
■ Do not keep medicine that is out of date or that you no longer need. If you throw any
medicines away make sure that children will not find them.
General information about ATRIPLA:
Medicines are sometimes prescribed for conditions that are not mentioned in patient
information leaflets. Do not use ATRIPLA for a condition for which it was not prescribed. Do
not give ATRIPLA to other people, even if they have the same symptoms you have. It may
harm them.
This leaflet summarizes the most important information about ATRIPLA. If you would like
more information, talk with your healthcare provider. You can ask your healthcare provider
or pharmacist for information about ATRIPLA that is written for health professionals.
Do not use ATRIPLA if the seal over bottle opening is broken or missing.
What are the ingredients of ATRIPLA?
Active Ingredients: efavirenz, emtricitabine, and tenofovir disoproxil fumarate
Inactive Ingredients: croscarmellose sodium, hydroxypropyl cellulose, microcrystalline
cellulose, magnesium stearate, sodium lauryl sulfate. The film coating contains black iron
oxide, polyethylene glycol, polyvinyl alcohol, red iron oxide, talc, and titanium dioxide.
Revised: November 2015
ATRIPLA is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC. COMPLERA,
EMTRIVA, HEPSERA, STRIBILD, TRUVADA, and VIREAD are trademarks of Gilead
Sciences, Inc., or its related companies. SUSTIVA is a trademark of Bristol-Myers Squibb
Pharma Company. Reyataz and Videx are trademarks of Bristol-Myers Squibb Company.
Pravachol is a trademark of ER Squibb & Sons, LLC. Other brands listed are the trademarks
of their respective owners.
21-937-GS-015
ATRC0130
8 qnotes
697US1503729-34-01
Bristol-Myers Squibb GILEAD ^
April 8-21.2016