Important Facts About DOVATO
This is only a brief summary of important information about DOVATO
and does not replace talking to your healthcare provider about your
condition and treatment.
What is the most important information I should know about DOVATO?
If you have both human immunodeficiency virus-1 (HIV-1) infection and
Hepatitis B virus (HBV) infection, DOVATO can cause serious side effects,
including:
�� Resistant HBV. Your healthcare provider will test you for HBV infection before
you start treatment with DOVATO. If you have HIV-1 and hepatitis B, the HBV can
change (mutate) during your treatment with DOVATO and become harder to treat
(resistant). It is not known if DOVATO is safe and effective in people who have
HIV-1 and HBV infection.
�� Worsening of HBV infection. If you have HBV infection and take DOVATO, your
HBV may get worse (flare-up) if you stop taking DOVATO. A “flare-up” is when your
HBV infection suddenly returns in a worse way than before.
° Do not run out of DOVATO. Refill your prescription or talk to your healthcare
provider before your DOVATO is all gone.
° Do not stop DOVATO without first talking to your healthcare
provider.
° If you stop taking DOVATO, your healthcare provider will need to check your
health often and do blood tests regularly for several months to check your liver
function and monitor your HBV infection. It may be necessary to give you a
medicine to treat hepatitis B. Tell your healthcare provider about any new or
unusual symptoms you may have after you stop taking DOVATO.
For more information about side effects, see “What are possible side
effects of DOVATO?”
What is DOVATO?
DOVATO is a prescription medicine that is used without other HIV-1 medicines to treat
human immunodeficiency virus-1 (HIV-1) infection in adults: who have not received
HIV-1 medicines in the past, or to replace their current HIV-1 medicines when their
healthcare provider determines that they meet certain requirements. HIV-1 is the
virus that causes Acquired Immune Deficiency Syndrome (AIDS). It is not known if
DOVATO is safe and effective in children.
Who should not take DOVATO?
Do not take DOVATO if you:
�� have ever had an allergic reaction to a medicine that contains dolutegravir or
lamivudine.
�� take dofetilide. Taking DOVATO and dofetilide can cause side effects that may be
serious or life-threatening.
What should I tell my healthcare provider before using DOVATO?
Tell your healthcare provider about all of your medical conditions,
including if you:
�� have or have had liver problems, including hepatitis B or C infection.
�� have kidney problems.
�� are pregnant or plan to become pregnant. One of the medicines in DOVATO
(dolutegravir) may harm your unborn baby.
° Your healthcare provider may prescribe a different medicine than DOVATO if you
are planning to become pregnant or if pregnancy is confirmed during the first 12
weeks of pregnancy.
° If you can become pregnant, your healthcare provider may perform a pregnancy
test before you start treatment with DOVATO.
° If you can become pregnant, you and your healthcare provider should talk about
the use of effective birth control (contraception) during treatment with DOVATO.
° Tell your healthcare provider right away if you are planning to become pregnant, you
become pregnant, or think you may be pregnant during treatment with DOVATO.
�� are breastfeeding or plan to breastfeed. Do not breastfeed if you take DOVATO.
° You should not breastfeed if you have HIV-1 because of the risk of passing
HIV-1 to your baby.
° One of the medicines in DOVATO (lamivudine) passes into your breastmilk.
° Talk with your healthcare provider about the best way to feed your baby.
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Tell your healthcare provider about all the medicines you take, including
prescription and over-the-counter medicines, vitamins, and herbal supplements.
Some medicines interact with DOVATO. Keep a list of your medicines and show it to
your healthcare provider and pharmacist when you get a new medicine.
�� You can ask your healthcare provider or pharmacist for a list of medicines that
interact with DOVATO.
�� Do not start taking a new medicine without telling your healthcare
provider. Your healthcare provider can tell you if it is safe to take DOVATO with
other medicines.
What are possible side effects of DOVATO?
DOVATO can cause serious side effects, including:
�� See “What is the most important information I should know
about DOVATO?”
�� Allergic reactions. Call your healthcare provider right away if you
develop a rash with DOVATO. Stop taking DOVATO and get medical
help right away if you develop a rash with any of the following signs
or symptoms: fever; generally ill feeling; tiredness; muscle or joint aches;
blisters or sores in mouth; blisters or peeling of the skin; redness or swelling of the
eyes; swelling of the mouth, face, lips, or tongue; problems breathing.
�� Liver problems. People with a history of hepatitis B or C virus may have
an increased risk of developing new or worsening changes in certain
liver tests during treatment with DOVATO. Liver problems, including liver
failure, have also happened in people without a history of liver disease or
other risk factors. Your healthcare provider may do blood tests to check
your liver. Tell your healthcare provider right away if you get any of
the following signs or symptoms of liver problems: your skin or the white
part of your eyes turns yellow (jaundice); dark or “tea-colored” urine; light-colored
stools (bowel movements); nausea or vomiting; loss of appetite; and/or pain,
aching, or tenderness on the right side of your stomach area.
�� Too much lactic acid in your blood (lactic acidosis). Too much lactic
acid is a serious medical emergency that can lead to death. Tell
your healthcare provider right away if you get any of the following
symptoms that could be signs of lactic acidosis: feel very weak or tired;
unusual (not normal) muscle pain; trouble breathing; stomach pain with nausea
and vomiting; feel cold, especially in your arms and legs; feel dizzy or lightheaded;
and/or a fast or irregular heartbeat.
�� Lactic acidosis can also lead to severe liver problems, which can lead to
death. Your liver may become large (hepatomegaly) and you may develop fat in
your liver (steatosis). Tell your healthcare provider right away if you get
any of the signs or symptoms of liver problems which are listed above
under “Liver problems.”
�� You may be more likely to get lactic acidosis or severe liver problems
if you are female or very overweight (obese).
�� Changes in your immune system (Immune Reconstitution Syndrome)
can happen when you start taking HIV-1 medicines. Your immune system may get
stronger and begin to fight infections that have been hidden in your body for a long
time. Tell your healthcare provider right away if you start having new symptoms
after you start taking DOVATO.
�� The most common side effects of DOVATO include: headache; nausea;
diarrhea; trouble sleeping; tiredness; and anxiety.
These are not all the possible side effects of DOVATO. Call your doctor for medical
advice about side effects.
14 November 11, 2021 Schneps Media