What is TIVICAY?
TIVICAY(dolutegravir) is a prescription HIV-1 medicine that is
used with other antiretroviral medicines to treat
Human Immunodeficiency Virus-1 (HIV-1) infection. HIV-1 is the
virus that causes Acquired Immune Deficiency
Syndrome (AIDS). It is not known if TIVICAY is
safe and effective in children younger than 12
years or who weigh less than 88 pounds.
TIVICAY does not cure HIV-1 infection or AIDS.
You must stay on continuous HIV-1therapy to
control the HIV-1 infection and decrease HIV-related
IMPORTANT SAFETY INFORMATION
Who should not take TIVICAY?
Do not take TIVICAY if you:
- have ever had an allergic reaction to a
medicine that contains dolutegravir (TIVICAY, TRIUMEQ®).
- take dofetilide (Tikosyn®) because of a life-threatening interaction.
What are the most serious side effects of
Allergic reactions. Stop taking TIVICAY and
get medical help right away ifyou have:
- A rash with any of these symptoms:
fever; general ill feeling; extreme
tiredness; muscle or joint aches; blisters
or sores in mouth; blisters or
peeling of the skin; redness or swelling
in the eyes; swelling of the
face, lips or tongue; problems breathing.
- Any of the following signs or
symptoms of liver problems: yellowing
of the skin or whites of the eyes; dark
or tea-colored urine; pale-colored
(bowel movements); nausea or vomiting;
loss of appetite; pain,aching, or
tenderness on the right side below the
- Changes in liver tests. People with a history
of hepatitis B or C virus may havean increased
risk of developing new or worsening changes
in certain liver tests
during treatment with
TIVICAY. Your healthcare provider may do
tests to check
your liver function before and during treatment with TIVICAY.
- Changes in body fat can happen in people
who take HIV-1 medicines, including
amount of fat in the upper back and neck
(“buffalo hump”), breast, and
around the middle
of your body. Loss of fat from the legs, arms,
and face mayalso happen. The exact cause
and long-term health effects of these problems
- Changes in your immune system can
happen when you start taking HIV-1
Your immune system may get stronger and
begin to fight infectionsthat have been hidden
in your body for a long time. Tell your
healthcare providerright away if you start
having new symptoms after starting your HIV-1
What are the other possible side effects of
- See “Allergic reactions.” The most common side effects of TIVICAY include trouble sleeping, tiredness, and headache.
Tell your healthcare provider about any side effect
that bothers you or that does not goaway.
These are not all the possible side effects of
What should I tell my healthcare provider before I
Before you take TIVICAY, tell your healthcare
provider if you:
- have ever had an allergic reaction to TIVICAY
- have or had liver problems, including hepatitis
B or C
- have any other medical condition
- are pregnant or plan to become pregnant. It is
not known if TIVICAY will harmyour unborn
- are breastfeeding or plan to breastfeed. Do not
breastfeed if you take TIVICAY.
You should not
breastfeed if you have HIV-1 because of the
risk of passing HIV-1
to your baby. It is not
known if TIVICAY passes into your breast milk.
Talk to your
healthcare provider about the best
way to feed your baby.
Tell your healthcare provider about all
prescription and over-the-counter medicines,
vitamins, and herbal supplements you take.
TIVICAY and other medicines may affect each other
causing side effects. TIVICAY may affect the way
other medicines work, and other medicines may
affect how TIVICAY works.
Especially tell your healthcare provider if you take:
- other HIV-1 medicines including: efavirenz
(Sustiva®), etravirine (Intelence®),
fosamprenavir (LEXIVA®)/ritonavir (Norvir®),
nevirapine (Viramune®),or tipranavir
- another medicine that contains dolutegravir (TRIUMEQ)
- antacids, laxatives, or other medicines that contain aluminum, magnesium, sucralfate (Carafate®), or buffered medicines. TIVICAY should be taken at least 2 hours before or 6 hours after you take these medicines.
- iron or calcium supplements. Supplements
including multivitamins containing calcium or
iron may be taken at the same time with
TIVICAY if taken with food. Otherwise,
TIVICAY should be taken at least 2 hours
before or 6 hours after you take these
- anti-seizure medicines: oxcarbazepine
(Trileptal®), phenytoin (Dilantin®,
Dilantin®-125, Phenytek®), phenobarbital
(Luminal®), carbamazepine (Carbatrol®,
Equetro®, Tegretol®, Tegretol®-XR,
- St. John’s wort (Hypericum perforatum)
- a medicine that contains metformin
- rifampin (Rifater®, Rifamate®,
You are encouraged to report negative side
effects of prescription drugs to the FDA.Visit
www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please read the
and discuss it with your healthcareprovider.
TIVICAY, TRIUMEQ, and LEXIVA are registered trademarks of ViiV Healthcare.
Other brands listed are trademarks of their respective
owners and are not trademarks of ViiVHealthcare.
The makers of these brands are not affiliated with
and do not endorse ViiVHealthcare or its products.
To learn about another prescription product for HIV-1, CLICK HERE.