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) and hepatitis B
virus (HBV) infection, DOVATO can cause serious side effects, including:
• Resistant HBV infection. Your healthcare provider will test you for HBV
infection before you start treatment with DOVATO. If you have HIV-1 and
hepatitis B, the hepatitis B virus 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 HIV-1 and HBV infection, 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. Worsening
liver disease can be serious and may lead to death.
° 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.
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.
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 will perform a
pregnancy test before you start treatment with DOVATO.
° If you can become pregnant, you should consistently use 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:
• Those in the “What is the most important information I should know
about DOVATO?” section.
• 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). Lactic acidosis 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.
18 January 21, 2021 Schneps Media