GENVOYA®
INFORMATION
FOR PATIENTS
PREFACE
You have been prescribed Genvoya® to treat
HIV infection. This booklet is designed to
support you in using Genvoya and to inform
you how it works.
This guide is based on the patient
information leaflet supplied with Genvoya
and should not be used as a replacement.
The patient information leaflet is the
officially approved text. Your doctor, HIV
consultant and pharmacist are the initial
contacts for information. If you have
any questions after reading this booklet,
please remember to talk to one of them.
© Gilead Sciences Netherlands BV
This text was composed in 2016 with
reference to the official patient information
leaflet. No information contained in
this document should be disclosed to
others without written authorisation of
Gilead Sciences Netherlands BV, Claude
Debussylaan 22, 1082 MD Amsterdam.
02
03
GETTING STARTED
WITH GENVOYA
WHAT IS HIV?
06
WHAT IS GENVOYA
07
HOW DOES GENVOYA WORK?
07
BE CAREFUL
08
OTHER MEDICINES AND GENVOYA
09
OPTIMAL USE
10
EIGHT IMPORTANT TIPS
11
ONE TABLET EVERY DAY
12
KEEP TRACK
13
MISSED DOSE
14
POSSIBLE SIDE EFFECTS
15
PREGNANCY AND BREASTFEEDING
16
CO-INFECTION17
HEALTHY LIFESTYLE
18
FAQ19
04
05
WHAT IS HIV?
WHAT IS GENVOYA?
The human immunodeficiency virus (HIV) attacks cells of the
immune system, known as CD4 cells. These attacks weaken the
immune system. The virus continues to create multiple copies of
itself, causing your CD4 cell count to reduce. As a result, your body
is less capable of fighting infections and illnesses.
HIV-infection can be treated with Genvoya
At the time these infections and illnesses
HIV can be transmitted from an infected
occur, there is the risk of AIDS.
person to an uninfected person through
To prevent AIDS, it is important to treat
body fluids such as genital fluids during
HIV in time with the proper treatment.1
unprotected sexual contact (semen,
Then the immune system can continue
vaginal, anal and oral), blood from
to do its job. The most important goal of
sharing contaminated needles, or
HIV-treatment is to reduce the amount
mother to child during pregnancy,
of virus particles to an undetectable
childbirth or breastfeeding.3,4
level (undetectable viral load). As a
result, the number of CD4 cells will
remain sufficient, i.e. the immune system
is more able to fight off infections and
diseases.2
GENVOYA CONTAINS FOUR COMPONENTS:
Genvoya causes the viral load to
drop, through the inhibition of viral replication. As a result, the increase of virus
particles is reduced and many of the
• elvitegravir
• cobicistat
remaining particles are removed
• emtricitabine
by the body.
• tenofovir alafenamide
5
Genvoya contains a combination of active
substances, wherefore one tablet daily
enhancer) of the effects of elvitegravir,
can treat HIV-infection. Also Genvoya can
without anti-HIV activity, emtricitabine
be taken at the same time with medicati-
and tenofovir alafenamide are antiretro-
on for other diseases, however not all
viral medicines. Each tablet contains 150
medication (see page 9: ‘Genvoya and
mg elvitegravir, 150 mg cobicistat, 200
other medication’). This treatment is for
mg emtricitabine and 10 mg tenofovir
use by adults and adolescents 12 years of
alafenamide.6
age and older, who weigh at least 35 kg.
6
Elvitegravir is an antiretroviral medicine
known as an integrase inhibitor, cobicistat
is a booster (pharmacokinetic
HOW DOES GENVOYA WORK?
How do you know if your treatment
examination. Test results can show
is working well?
whether the amount of virus (viral load)
In order to determine whether Genvoya
is decreased and the amount of CD4
works for you, blood is taken for
cells are increased. Despite effective
antiretroviral therapy, you can still pass
GENVOYA REDUCES
THE AMOUNT OF VIRUS
PARTICLES.
06
on the HIV when taking this medication.
07
BE CAREFUL
OTHER MEDICINES
AND GENVOYA
What do you need to know before taking Genvoya?
Restrictions apply to all medications, including Genvoya.
Are you taking any other medicines?
Genvoya may interact with other medicines.
DO NOT TAKE GENVOYA OR BE
EXTRA CAREFUL IF:
For additional information, please
MEDICINES THAT MUST NEVER
BE TAKEN WITH GENVOYA:
Tell your doctor or pharmacist if you are
refer to the patient information leaflet.
• You are allergic to any of the
If any of these conditions apply to you,
• Alfuzosin
take any other medicines. If you consider
ingredients (see package leaflet
tell your doctor. Even if your doctor
• Amiodarone, quinidine (used to
stop taking Genvoya, contact to your
for a full list)
did not ask for it.
• You have liver problems, or a history
or have high cholesterol
• You are intolerant to lactose or
other sugars
doctor about the possibilities.
• Carbamazepine, phenobarbital,
of liver disease, including hepatitis
• You have diabetes, are overweight
correct irregular heartbeat)
taking, have recently taken or might have
phenytoin (used to prevent seizures)
TALK TO YOUR DOCTOR
BEFORE TAKING GENVOYA.
• Rifampicin (used to prevent and
treat tuberculosis and other
For full details about using
Genvoya please refer to the
patient information leaflet.
infections)
• Dihydroergotamine, ergomemtrine,
ergotamine
• Cisapride (used to relieve certain
stomach problems)
• St. John’s wort (Hypericum
perforatum)
• Lovastatin, simvastatin (used
to lower blood cholesterol)
• Pimozide (used to treat abnormal
thoughts or feelings)
• Sildenafil (when used to treat
pulmonary arterial hypertension)
• Orally administered midazolam,
triazolam
• tenofovir disoproxil fumarate
• Lamivudine
• Adefovir dipivoxil
08
09
OPTIMAL USE
EIGHT IMPORTANT TIPS
Intake of Genvoya
When you take Genvoya, the active substances enter your blood
through the intestines. During a considerable time, sufficient amount
of medicine is active to inhibit the virus. Genvoya slowly disappears
from your body and you need to take another dose.
1.Take one tablet about the same time every day. This makes
it easier to remember to take your tablet every day.
For example, take Genvoya every day with a particular meal.
One tablet should be taken every day.
substances in Genvoya are no longer able
When you miss a dose, less Genvoya is
to effectively inhibit the virus. If you are
3.Do not chew, crush or split the tablet into pieces.
present in your body to inhibit the virus.
considering stopping your treatment with
As a result, Genvoya is less effective.
Genvoya, talk to your doctor or nurse.
This has two serious disadvantages.
They can assist you in finding the proper
First, the effect of Genvoya weakens
solution.7
and the virus is able to make copies of
itself again, that will attack the immune
system. Second, the virus may change its
shape tiny bits while multiplying. The new
virus may become resistant. The active
2.Take one tablet each day with some food (breakfast, lunch,
dinner or snack).
4.If you vomit less than 1 hour after taking your medicine,
take another tablet with food.
5.It is important to not miss a dose of this treatment.
When you miss a dose, take the tablet as soon as you
remember. If you noticed that you missed a dose more than
18 hours after the time you should have taken it, skip that
dose and simply resume the usual dosing schedule. Unless
indicated otherwise by your doctor.
6.If you take antacids or multivitamins, take it at least 4 hours
before or at least 4 hours after Genvoya.
7.If you are suffering from severe diarrhoea for more than two
days, please contact your doctor or nurse.
8.Make sure you always have a supply of Genvoya at home.
Remember to request for a repeat prescription in time. If you
leave home or if you go traveling, always take Genvoya with you.
10
11
ONE TABLET EVERY DAY
KEEP TRACK
What to be aware of when taking Genvoya?
Once you have started Genvoya, two things are of interest. First,
the level of Genvoya in your body must be maintained. Second, you
should immediately talk to your doctor if you experience any serious
side effects.
Make sure you keep track
At times, you may not remember if you have taken your daily dose.
If this occurs more often, make sure you set up a monitoring system.
For example, there are pill organisers labelled with the days of the
week in which you can keep your daily dose. Also, there are daily pill
boxes that you can take as a keychain. Then you can have quick
access to spare tablets.
The recommended daily intake is one
Choose a convenient time of intake
tablet every day, with food, at about the
When, for instance, you take Genvoya
same time. Thereby, the risk of missing
in the evening during dinner, it becomes
one dose is as small as possible. However,
a habit and the risk of missing a dose
the uptake of the medication is disrupted
is smaller.6
if you vomit less than 1 hour after the
intake, or if you are suffering from severe
diarrhoea. On page 11, in the ‘Eight
Important Tips’ you can read what to
IF YOU GET ANY SIDE
do in these situations.
EFFECTS, TALK TO YOUR
DOCTOR OR PHARMACIST.
In exceptional cases, the ingredients of
Genvoya not only attack the hiv virus, but
also affect other parts of your body.8
Have spare tablets handy
Genvoya during the holiday
Life is full of surprises. It might happen
During the holiday, daily routines are
that you are somewhere else at the
often broken, especially if you are
scheduled time of intake than you had
traveling across time zones. If you are
planned. Make sure you always have
travelling to a different time zone you can
some extra tablets with you.
keep your holiday intake time the same as
your usual time of intake at home. When
If necessary, set an alarm clock
there are, because of time differences,
You can set an alarm clock on your mobile
more or less hours in between the intake,
phone to remind you to take Genvoya.
you do not have to take this into account.
There are also pill organisers with a
That is one of the advantages of Genvoya.
built-in alert system.
12
13
MISSED DOSE
POSSIBLE
SIDE EFFECTS
Missed a dose?
It is normal to occasionally forget something. It may happen that,
despite all good intentions and precautions, you still forget to take
your medication. Therefore, discuss with your doctor or HIV
consultant in advance what to do in that case. They are up to date
with the latest insights, and these sometimes differ from general
guidelines.
Like all medicines, this medicine can cause side effects, although not
everybody gets them. When treating HIV infection, it is not always
possible to tell whether some of the unwanted effects are caused by
Genvoya or by other medicines that you are taking at the same time,
or by the HIV disease itself.
Possible serious side effects
Uncommon side effects
In general, the following applies: when
Do not stop taking Genvoya without first
• Any signs of inflammation or infection
(may affect up to 1 in 100 people)
you miss a dose, take the tablet as soon
talking to your doctor. Make sure your
• Autoimmune disorders, look out for any
• low red blood cell count (anaemia)
as you remember and resume the
supply of Genvoya is not running low,
symptoms such as muscle weakness,
• depression
normal dosing schedule. Unless
get more from your pharmacist in time.
weakness beginning in the hands and feet
• problems with digestion resulting in
indicated otherwise by your doctor. If
you miss a dose of Genvoya by more
than 18 hours, you should not take the
DID YOU MISS A DOSE OF GENVOYA?
missed dose and simply resume the
• If you notice within 18 hours
and moving up towards the trunk of the
discomfort after meals (dyspepsia)
body, palpitations and tremor of hyper-
• swelling of the face, lips, tongue or
activity
usual dosing schedule. Do not take a
you must take the tablet as soon as
If you experience any of these symptoms,
double dose to compensate for the
possible. Then take the next dose as usual.
please tell your doctor immediately.
missed tablet.
If you vomit just after taking Genvoya,
you should take another tablet with a
throat (angioedema)
• itching (pruritus)
• If you notice 18 hours or more
Bone problems
Some patients may develop a bone
do not take the missed dose. Wait and take
Very common side effects
disease called osteonecrosis (death
the next dose, with food, at your usual time.
(which may affect more than 1 in 10 people)
of bone tissue caused by loss of
• feeling sick (nausea)
blood supply to the bone). Signs of
meal. If you are suffering from severe
osteonecrosis are:
diarrhoea, there is a risk that Genvoya is
Common side effects
• joint stiffness
not absorbed or insufficiently absorbed
(may affect up to 1 in 10 people)
• joint aches and pains (especially of
into the body. Therefore, contact your
• abnormal dreams
doctor if you are suffering from severe
• headache
diarrhoea for more than two days.
• dizziness
the hip, knee and shoulder)
• difficulty with movement
• diarrhoea
If you notice any of these symptoms
• vomiting
tell your doctor.
• stomach pain
• wind (flatulence)
• rash
• tiredness (fatigue)
14
15
PREGNANCY AND
BREASTFEEDING
CO-INFECTION
You cannot use Genvoya during pregnancy, unless this
is specifically discussed with your doctor. There are
no clinical data available on the use of Genvoya in
pregnant women.
Hepatitis
Patients with liver disease, including chronic hepatitis B or C,
who are treated with antiretrovirals, have a higher risk of severe
and potentially fatal liver complications.9 If you have hepatitis B
infection, your doctor will carefully consider the best treatment
regimen for you.
Women are advised to use effective
If you are a woman with HIV, it is
If you have hepatitis B infection, liver
contraception during their treatment of
recommended that you do not
problems may become worse after you
Genvoya to avoid becoming pregnant.
breastfeed to avoid passing the
stop taking Genvoya. It is important to
virus to the baby in breast milk.
not stop taking Genvoya without talking
However if you are pregnant, think you
to your doctor.
NEVER STOP TAKING
GENVOYA WITHOUT TALKING
TO YOUR DOCTOR.
may be pregnant or are planning to have
a baby, ask your doctor for advice
before taking this medicine. Do not
breastfeed during treatment with this
medicine. This is because some of the
active substances in this medicine pass
into human breast milk.
16
17
HEALTHY LIFESTYLE
Tips for a healthy lifestyle
The HIV virus suppresses your immune system. Although Genvoya
reduces this suppression, it is rational to not impose an extra burden
on your immune system. Therefore, it is wise to follow the healthiest
possible lifestyle. Live healthy, eat healthy, sleep well.
HEALTHY LIFESTYLE
• Perform physical activity (sport, walking, cycling) on regular basis
• Do relaxation exercises (for example: yoga)
• Eat fruit and vegetables
• Quit smoking
• Use little or no alcohol or party drugs
SLEEP WELL
• Ensure a regular sleep-/wake pattern
• Relax before going to bed (reading, a hot bath)
• Do not work out before going to bed
• Do not take coffee or chocolate in the evening.
• Do not eat a large meal before going to bed
• Ensure a dark, quiet bedroom (use earplugs if necessary)
• Do not sleep too long
FREQUENTLY ASKED
QUESTIONS
Why have I been prescribed
this medicine?
Genvoya is an anti-human immunodeficiency virus (HIV) medicine. This means
that it is a medicine used for treatment of
HIV infection. It helps keep the HIV from
making copies of itself and slows down
the progress of the disease.
What does my medicine look like?
Genvoya are green, capsule-shaped,
film-coated tablets, with “GSI” on one
side of the tablet and “510” on the other
side. Genvoya comes in a bottle containing 30 tablets, and a silica gel desiccant
(that must be kept in the bottle to protect
your tablets). The silica gel desiccant is
contained in a separate sachet or canister
and should not be swallowed.
How does this medicine work?
HIV attacks specific cells of the immune
system. Therefore, it weakens the immune
system. The HIV-virus creates multiple
copies of itself that continue to attack the
immune system. As a result, your body is
less capable of fighting infections and
illnesses.11 Genvoya reduces the amount of
virus particles as the multiplication of the
virus is inhibited. The increase in virus
particles is reduced and many of the
remaining particles are removed by the
body. The treatment works if the amount
of virus particles (viral load) in your blood
is reduced to an undetectable level. Then,
the number of CD4 cells will increase, i.e.
18
the immune system is more powerful than
the virus attacks.
What are the ingredients of Genvoya?
Each tablet contains four different
medicines in one pill: elvitegravir,
cobicistat, emtricitabine, tenofovir
alafenamide. Elvitegravir is an integrase
inhibitor, cobicistat is a booster without
anti-HIV activity and emtricitabine and
tenofovir alafenamide are antiretroviral
medicines. Each tablet contains 150 mg
elvitegravir, 150 mg cobicistat, 200 mg
emtricitabine and 10 mg tenofovir
alafenamide.
Does this medicine cure HIV?
No. This medicine cannot cure HIV.
To control your HIV-infection and
decrease illnesses caused by HIV
infection, you should take your medication as prescribed by your doctor.
You can still pass on HIV when taking
this medicine. Discuss with your doctor
the precautions needed to avoid infecting
other people.
Who can take this medicine?
Genvoya is a prescription medicine that
can only be prescribed by a healthcare
professional. You should only take this
medication if it has been prescribed by
your doctor.
19
FREQUENTLY ASKED
QUESTIONS
When should I not take this medication?
If you are allergic to any of the ingredients. You can find all ingredients in the
patient information leaflet. Or you use
any of the other medicines mentioned on
page 9 ‘Other medicines and Genvoya’.
Does my medicine reduce the risk of me
passing on HIV to other people?
You can still pass on HIV when taking this
medicine, although the risk is lowered by
effective antiretroviral therapy. Discuss
with your doctor the precautions needed
to avoid infecting other people. This
medicine cannot cure an HIV infection.
It is still possible that infections or other
HIV related illnesses occur while taking
Genvoya.
How do I take my medicine?
Always take your medicine exactly as
your doctor has prescribed. Check with
your doctor or pharmacist if you are not
sure. One tablet of your medication
should be taken each day with food.
Do not chew, crush or split the tablet.
Do not take antacids or multivitamins at
the same time as Genvoya. Take it at least
4 hours before or at least 4 hours after
Genvoya.
after its expiry date. For details on how to
dispose of medicines you no longer use,
ask your pharmacist.
What do I need to tell my doctor before
I start taking this medicine?
Tell your doctor or pharmacist if you are
taking, have recently taken or are taking
any other medicines. Tell your doctor if
you are allergic to any of the ingredients
(see package leaflet for a full list). If you
are pregnant or likely to become pregnant or you are breastfeeding. Also tell
your doctor if you have liver problems,
or a history of liver disease, including
hepatitis. Moreover, consult your doctor
if you have diabetes, are overweight or
have high cholesterol and/or if you are
intolerant to lactose or other sugars.
Can this medicine cause side effects?
As with all medicines, you may
experience some side effects. For a full
list of side effects, please refer to the
patient information leaflet that is supplied
with your medication. If you experience
any side effects, talk to your doctor or
pharmacist. This includes any possible
side effects not listed in the patient
information leaflet.
Are more serious side effects possible
with this medicine?
Yes. You should look out for signs of
inflammation, infection or autoimmune
disorders, such as muscle weakness
beginning in the hands and feet and
moving up toward the trunk of the body,
palpitations and tremor. If you experience
one of these symptoms or hyperactivity,
please tell your doctor immediately.
For more information, please refer to
the package leaflet.
What do I do if I miss a dose
of my medicine?
It is important to not miss a dose of
your medicine. If you notice within 18
hours of the time you usually take your
medication, you must take the tablet as
soon as possible. Always take the tablet
with food. Then take your next dose as
usual. If you notice 18 hours or more
after the time you usually take your
medication, do not take the missed dose.
Wait and take the next dose with food,
at your usual time. If you vomit less than
1 hour after taking your medication you
should take another tablet with a meal.
Do not stop taking Genvoya without first
talking to your doctor.
Should I take this medicine if I am
pregnant or if I am breastfeeding?
If you are pregnant or breastfeeding,
think you may be pregnant or are
planning on having a baby, ask your
doctor for advice before taking this
medicine. Use effective contraception
while taking this medicine to avoid
getting pregnant. Do not breastfeed
during treatment with this medicine.
This is because some of the active
substances in this medicine pass into
human breast milk. It is recommended
that you do not breastfeed to avoid
passing the virus to the baby in
breast milk.
How should I store this medicine?
Store Genvoya in its original packaging
to protect the tablets from moisture.
Keep the tablets out of sight and reach
of children. Do not use this medication
20
21
NOTES
22
NOTES
23
TAF/NL/16-01/NPM/1035a Date of preparation: May 2016
REFERENCES
1. NHS Choices. HIV and AIDS – Treatment. Accessed June 2015. Available at:
http://www.nhs.uk/Conditions/HIV/Pages/Treatmentpg.aspx.
2.DHHS guidelines April 2015. Guidelines for the use of antiretroviral agents in HIV-1-Infected adults and
adolescents. Accessed November 2015. Available at: https://aidsinfo.nih.gov/contentfiles/lvguidelines/
AdultandAdolescentGL.pdf.
3.AIDS.gov. Pregnancy & childbirth – can I transmit HIV to my baby? Accessed June 2015. Available at:
https://www.aids.gov/hiv-aids-basics/prevention/reduce-your-risk/pregnancy-and-childbirth/.7.
Patient Information Leaflet Genvoya®. Available at: http://www.ema.europa.eu.
4.NHS Choices. Living with HIV and AIDS. Accessed June 2015. Available at: http://www.nhs.uk/
Conditions/HIV/Pages/living-with.aspx.
5.AIDS.gov. Treatment adherence. Accessed June 2015. Available at: https://www.aids.gov/
hiv-aids-basics/staying-healthy-with-hiv-aids/taking-care-of-yourself/treatment-adherence/.
6. Patient Information Leaflet Genvoya® Available at: http://www.ema.europa.eu.
7.AIDS.gov. Drug resistance. Accessed June 2015. Available at: https://www.aids.gov/hivaids-basics/
just-diagnosed-with-hiv-aids/treatment-options/drug-resistance/.
8.AIDSmap. Side effects. Accessed June 2015. Available at: http://www.aidsmap.com/resources/
living-with-hiv/Side-effects/page/1254858/.
9.NHS Choices. HIV and AIDS. Accessed June 2015. Available at:
http://www.nhs.uk/Conditions/HIV/Pages/Introduction.aspx.