DESCOVY®
EMTRICITABINE 200 MG/
TENOFOVIR ALAFENAMIDE 10/25 MG (FUMARATE)
INFORMATION
FOR PATIENTS
PREFACE
You have been prescribed Descovy® to treat
HIV-infection. This booklet is designed to
support you in using Descovy and to inform
you on how it works.
This guide is based on the package leaflet
supplied with Descovy and should not be
used as a replacement.
The package leaflet contains 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 contact
one of them.
© Gilead Sciences Netherlands BV
This text was composed in 2016 with
reference to the official package 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 DESCOVY
04
WHAT IS HIV?
06
WHAT IS DESCOVY?
07
HOW DOES DESCOVY WORK?
07
BE CAREFUL
08
OTHER MEDICINES AND DESCOVY
09
OPTIMAL USE
10
SIX IMPORTANT TIPS 11
ONE TABLET EVERY DAY
12
KEEP TRACK
13
MISSED DOSE 14
POSSIBLE SIDE EFFECTS
15
PREGNANCY AND BREAST-FEEDING
16
CO-INFECTION
17
HEALTHY LIFESTYLE
18
FAQ 19
05
WHAT IS HIV?
WHAT IS DESCOVY?
The human immunodeficiency virus (HIV) infects specific cells of
the immune system, known as CD4 cells. Prolonged infection
weakens 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 Descovy.
At the time these infections and illnesses
HIV can be transmitted from an infected
occur, there is the risk of Acquired
person to an uninfected person through
immune deficiency syndrome (AIDS).
body fluids, such as genital fluids
To prevent AIDS, it is important to treat
(semen, pre-seminal fluid, rectal fluids,
HIV in time with the proper treatment.1
and vaginal fluids) during unprotected
This allows the immune system to
sexual contact (vaginal, anal and oral),
continue to do its job. The primary goal
blood from contaminated needles, or
of HIV-treatment is to reduce the
mother to child during pregnancy,
amount of viral particles to an undetec-
childbirth and breast-feeding.3,4
table level (undetectable viral load). As
Descovy is an antiretroviral medicine that
Emtricitabine is an antiretroviral medicine
is to be used in combination with other
in the class of medications known
antiretroviral medicines.5
as nucleoside reverse transcriptase
inhibitors (NRTI). Tenofovir alafenamide
Descovy in combination with other
is an antiretroviral medicine in the class
antiretroviral medicines is used for the
of medications known as nucleotide
treatment of human immunodeficiency
reverse transcriptase inhibitors (NtRTI).
virus 1 (HIV-1) infection in adults and
adolescents aged 12 years and older, with
Each Descovy tablet contains
a body weight of at least 35 kg
200 mg emtricitabine and 10 mg or
5
25 mg tenofovir alafenamide.
ACTIVE SUBSTANCES IN DESCOVY:
The recommended dose is one tablet
every day. Which tablet your doctor will
• emtricitabine
prescribe to you, depends on what other
• tenofovir alafenamide
medicines you use in combination with
Descovy.5
a result, the number of CD4 cells will
remain sufficient, i.e. the immune system
is more capable to fight off infections
and diseases.2
HOW DOES DESCOVY
WORK?
How do you know if your treatment is
tion. Test results can show whether the
working well?
amount of virus (viral load) has de-
In order to determine whether Descovy
creased and the amount of CD4 cells has
works for you, blood is taken for examina-
increased. Despite effective antiretroviral
therapy with Descovy, you can still
DESCOVY REDUCES THE
AMOUNT OF VIRAL
PARTICLES.
06
transmit HIV to other persons.
07
BE CAREFUL
OTHER MEDICINES
AND DESCOVY
What do you need to know before taking Descovy?
Restrictions apply to all medications, including Descovy
Are you taking any other medicines?
Descovy may interact with other medicines.
DO NOT TAKE DESCOVY OR BE
EXTRA CAUTIOUS IF:
For additional information, please refer
to the package leaflet.
YOU SHOULD NOT TAKE DESCOVY
WITH MEDICINES CONTAINING:
• herbal remedies used to treat
• you are allergic to emtricitabine,
If any of these conditions apply to you,
• tenofovir disoproxil fumarate
St. John’s wort
tenofovir alafenamide or any of the
tell your doctor, even if he or she has
• lamivudine
(Hypericum perforatum)
other ingredients of this medicine
not asked.
• adefovir dipivoxil
depression and anxiety containing
(see package leaflet for a full list)
• you have liver problems or have
suffered liver disease, including
hepatitis
• the virus has a K65R mutation
TALK TO YOUR DOCTOR
BEFORE TAKING DESCOVY.
TELL YOUR DOCTOR IF YOU ARE
TAKING ANY OF THE FOLLOWING
MEDICINES:
Tell your doctor or pharmacist if you
• antibiotics containing rifabutin,
take any other medicines. If you are
are taking, have recently taken or might
rifampicin or rifapentine (commonly
considering stopping your treatment with
used to treat bacterial infections
Descovy, contact your doctor to discuss
such as tuberculosis)
the possibilities.
• antiviral medicines used to treat
hepatitis C; telaprevir and boceprevir
• antiviral medicines used to treat HIV;
For full details about using Descovy
please refer to the package leaflet.
emtricitabine and tipranavir
• anticonvulsants used to treat
epilepsy, such as; carbamazepine,
oxcarbazepine, phenobarbital and
phenytoin
08
09
OPTIMAL USE
SIX IMPORTANT TIPS
Intake of Descovy
When you take Descovy, the active substances enter your blood
stream through the digestive tract. After a considerable amount
of time sufficient amount of medicine is active to inhibit the virus.
Descovy slowly disappears from your body and you need to take
another dose.
1. Take
one tablet at about the same time every day. This makes it
easier to remember your daily intake of Descovy.
The recommended dose is one tablet
If the virus develops resistance, the active
every day. When you miss a dose, less
substances in Descovy are no longer able
Descovy is present in your body to inhibit
to effectively inhibit the virus. If you
the virus and Descovy is therefore less
consider stopping your treatment with
4. If you vomit less than 1 hour after taking your medicine or if
you are suffering from severe diarrhoea, take another tablet.
If you are in doubt, always contact your hiv-consultant.
effective. This has two serious
Descovy, talk to your doctor or nurse.
disadvantages. First, the effect of
They can assist you in finding the
Descovy weakens and the virus is able to
proper solution.5
make copies of itself again, that will
weaken the immune system. Second, the
virus may change its shape tiny bits while
multiplying, and the new virus may
2. Take one tablet each day with or without food
3. Do not chew, crush or split the tablet into pieces.
5. It is important to not miss a dose of Descovy. When you miss a
dose, take the tablet as soon as you remember. If you notice 18
hours or more after the time you usually take Descovy, then do
not take the missed dose. Wait and take the next dose at your
usual time, unless indicated otherwise by your doctor.
become resistant.
6. M
ake sure you always have a supply of Descovy at home.
Remember to request for a prescription refill in time. If you
leave home or are traveling, always take Descovy with you.
10
11
ONE TABLET EVERY DAY
KEEP TRACK
What to be aware of when taking Descovy?
Once you have started Descovy, two things are of importance.
First, the level of Descovy in your body must be maintained.
Second, you should immediately talk to your doctor if you notice
any side effects.
Make sure you keep track
At times you may not remember if you have taken your daily dose.
If this problem occurs frequently, make sure you set up a monitoring
system. For example, use a pill organiser, labelled with the days of the
week, in which you can store your daily dose. There are also daily pill
boxes that you attach as a keychain to allow you quick access to
spare tablets.
The recommended dose is one tablet
Choose a convenient time of intake
each day, with or without food, at about
For instance, when you take Descovy in
the same time. Thereby, the risk of missing
the evening during dinner, it becomes
a dose is minimized. However, the uptake
habitual and the risk of missing a dose is
of Descovy is disrupted if you vomit less
minimized.7
than 1 hour after the intake, or if you are
suffering from severe diarrhoea. On page
11 (Six Important Tips) you can read what
to do in these situations.
IF YOU NOTICE ANY SIDE
In exceptional cases, the ingredients of
EFFECTS, TALK TO YOUR
DOCTOR OR PHARMACIST.
Descovy not only inhibit the virus, but also
affect other parts of your body.6
Have spare tablets handy
Descovy during the holiday
Life is full of surprises, and it may happen
During the holiday, daily routines are
that you are somewhere else than
often broken, especially if you are
expected at your scheduled time of
traveling across time zones. If you are
intake. Therefore it is important to make
travelling to a different time zone, you
sure you always have some extra tablets
can keep your holiday intake time the
with you.
same as your usual time of intake at
home. When there are, because of
If necessary, set an alarm clock
time differences, more or less hours in
You could set an alarm clock on your
between the intake, you do not have to
mobile phone to remind you to take
take this into account.
Descovy. There are also pill organisers
with a 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. Discuss in advance with your doctor or
HIV-consultant what to do in this situation.
Like all medicines, Descovy can cause side effects, although this differs
between individuals. When treating HIV infection, it is not always
possible to tell whether some of the unwanted effects are caused by
Descovy, other medicines that you are taking at the same time, or by
the HIV disease itself.
In general, the following applies; if you do
Possible serious side effects
Uncommon side effects
miss a dose, take the tablet as soon as
Do not stop taking Descovy without
• any signs of inflammation or infection
(may affect up to 1 in 100 people)
possible. Then take the next dose as
talking to your doctor. When your supply
• autoimmune disorders, look out for any
• low red blood cell count (anaemia)
usual, unless indicated otherwise by your
of Descovy starts to run low, refill your
symptoms of infection or other symptoms
doctor. If you miss a dose of Descovy by
prescription at your pharmacist.
such as muscle weakness, weakness
discomfort after meals (dyspepsia)
beginning in the hands and feet and
• swelling of the face, lips, tongue or
more than 18 hours, you should not take
the missed dose. Wait and take the next
DID YOU MISS A DOSE OF DESCOVY?
moving up towards the trunk of the body,
dose at your usual time. Do not take a
• If you notice within 18 hours
palpitations, tremor or hyperactivity
double dose to compensate for the
you must take the tablet as soon as
missed tablet.
possible. Then take the next dose as usual.
• If you notice 18 hours or more
If you vomit less than 1 hour taking
do not take the missed dose. Wait and take
Descovy, take another tablet. If you are
the next dose at your usual time.
• problems with digestion resulting in
throat (angioedema)
• itching (pruritus)
• joint pain (arthralgia)
If you notice the side effects described
above, tell your doctor immediately.
Other effects that may be seen during
HIV treatment.
Very common side effects
• Bone problems: Some patients may
suffering from severe diarrhoea, there is
(may affect more than 1 in 10 people)
develop a bone disease called osteone-
a risk that Descovy is not absorbed or
• feeling sick (nausea)
crosis (death of bone tissue caused by
insufficiently absorbed by the body.
loss of blood supply to the bone).
Therefore, contact your doctor if you are
Common side effects
Signs of osteonecrosis are:
suffering from severe diarrhoea for more
(may affect up to 1 in 10 people)
• joint stiffness
than two days.
• abnormal dreams
• joint aches and pains (especially of
• headache
• dizziness
the hip, knee, and shoulder)
• difficulty with movement
• diarrhoea
• vomiting
If you notice any of these symptoms,
• stomach pain
tell your doctor.
• wind (flatulence)
• rash
• tiredness (fatigue)
14
15
PREGNANCY
AND BREAST-FEEDING
CO-INFECTION
You cannot use Descovy during pregnancy, unless this
is specifically discussed with your doctor. There are no
clinical data available on the use of Descovy 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.8 If you are infected with the
hepatitis B virus, your doctor should carefully consider the best
treatment regimen for you.
Women are advised to use effective
If you are a woman with HIV, it is
contraception while taking Descovy to
recommended that you do not
avoid pregnancy.
breast-feed to avoid passing the virus
If you are infected with the hepatitis
to the baby through breast milk.
B virus and stop taking Descovy, you
If you are pregnant, think you may be
may put yourself at risk of severe acute
pregnant or are planning to have a baby,
liver complications. It is therefore
ask your doctor for advice before you
important to not stop taking Descovy
start taking this medicine. Do not
without talking to your doctor.
NEVER STOP TAKING
DESCOVY WITHOUT TALKING
TO YOUR DOCTOR.
breast-feed during treatment with
Descovy. One of the active substances in
this medicine is excreted in breast milk.
16
17
HEALTHY LIFESTYLE
Tips for a healthy lifestyle
The HIV-virus suppresses your immune system. Although Descovy
reduces this suppression, it is still important to not impose an extra
burden on your immune system, and adopt a healthy lifestyle. Live
healthy, eat healthy, sleep well.
HEALTHY LIFESTYLE
• Perform physical activity (e.g. walking, playing sports, cycling) on regular basis
• Do relaxation exercises (e.g. yoga)
• Eat fruits and vegetables
• Quit smoking
• Limit or avoid the use of alcohol and recreational drugs
SLEEP WELL
• Maintain a regular sleep pattern
• Relax before going to bed (e.g. reading, a hot bath)
• Do not work out before going to bed
• Do not drink coffee or eat 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 oversleep
FREQUENTLY ASKED
QUESTIONS
Why have I been prescribed this
medicine?
Descovy is an anti-human immunodeficiency virus (HIV) medicine. This means
that this medicine contributes to the
treatment of HIV-infection. It helps
prevent the HIV from replicating and
creating copies of itself, and slows down
the progression of the disease.
What does my medicine look like?
Descovy 10 mg tablets are grey,
rectangular-shaped tablets, debossed on
one side with “GSI” and the number “210”
inscribed on the other side of the tablet.
Descovy 25 mg tablet are blue,
rectangular-shaped tablets, debossed on
one side with “GSI” and the number “225”
on the other side of the tablet. Descovy
comes in bottles of 30 tablets, and a silica
gel desiccant (that must be kept in the
bottle to help protect your tablets).
The silica gel desiccant is packaged in a
separate sachet or canister and should
not be swallowed.
How does this medicine work?
HIV infects specific cells of the immune
system and therefore weakens the
immune system. The HIV-virus creates
multiple copies of itself that continue to
weaken the immune system. As a result,
your body is less capable of fighting
infections and illnesses.8 Descovy reduces
the amount of viral particles by inhibiting
the replication of the virus.
18
The treatment is successful if the amount
of viral particles (viral load) in your blood
is reduced to an undetectable level. Then,
the number of CD4 cells will increase, i.e.
the immune system recovers from its
weakened state.
What are the ingredients of Descovy?
Descovy contains two active substances:
emtricitabine and tenofovir alafenamide.
These are antiretroviral medicines. Each
tablet contains 200 mg emtricitabine and
25 mg tenofovir alafenamide or 200 mg
emtricitabine and 10 mg tenofovir
alafenamide.
Does this medicine cure HIV?
No, this medicine is not a cure for
HIV-infection. To control your
HIV-infection and infections or other
illnesses associated with HIV-infection,
you should always take this medication
exactly as your doctor has prescribed it.
You can still transmit HIV when taking this
medicine. Discuss with your doctor the
precautions needed to be taken to avoid
infecting other people.
Who can prescribe Descovy?
Descovy 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 emtricitabine,
tenofovir alafenamide or any of the other
ingredients in this medicine (you can find
all ingredients in the package leaflet) or if
you use any of the other medicines
mentioned on page 9 in the section
“Other medicines and Descovy”.
Does my medicine reduce the risk of me
transmitting HIV to other people?
You can still transmit 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 is not a cure for HIV-infection.
While taking Descovy you may still
develop infections or other illnesses
associated with HIV-infection.
How do I take my medicine?
Always take this medicine exactly as your
doctor has prescribed it. Check with your
doctor or pharmacist if you are not sure.
The recommended daily intake is one
tablet every day with or without food.
Do not chew, crush or split the tablet.
How should I store this medicine?
Store Descovy in its original packaging to
protect from moisture. Keep the tablets
out of sight and reach of children and
keep the bottle tightly closed. Do not use
this medication after the expiry date. Ask
your pharmacist how to throw away
medicines you no longer use.
20
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 going
to take any other medicines. Tell your
doctor if you are allergic to any of the
ingredients (see package leaflet for a full
list) or if you are pregnant, are likely to
become pregnant or if you are breastfeeding. Also tell your doctor if you have
liver problems, or a history of liver
disease, including hepatitis.
Can this medicine cause side effects?
As with all medicines, you may get side
effects. For a full list of side effects,
please refer to the package leaflet that is
supplied with your medication. If you
notice any side effects, talk to your
doctor or pharmacist. This includes any
possible side effects not listed in the
package leaflet.
Is it possible to experience serious side
effects while taking Descovy?
Yes. You should look out for symptoms of
inflammation, infection or autoimmune
disorders, such as muscle weakness,
palpitations, tremors or hyperactivity. If
you notice one of these symptoms,
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 not to miss a dose of
Descovy. If you notice within 18 hours of
the time you usually take your medication,
take the tablet as soon as you remember.
Take the tablet with or without food and
then take the next dose at the usual time.
If you notice 18 hours or more after the
time you usually take Descovy, then do
not take the missed dose. Wait and take
the next dose at your usual time. If you
vomit less than 1 hour after taking your
medication, take another tablet. Do not
stop taking Descovy without first talking
to your doctor.
Should I take this medicine if I am
pregnant or if I am breast-feeding?
If you are pregnant, think you may be
pregnant or are planning to have a baby,
ask your doctor for advice before taking
this medicine. Use effective contraception
while taking Descovy to avoid getting
pregnant. Do not breast-feed during
treatment with this medicine. This is
because some one of the active substances in this medicine is excreted in
breast milk. It is also recommended that
you do not breast-feed to avoid transmitting the virus to the baby through
breast milk.
21
NOTES
22
NOTES
23
TAF/NL/16-04/NPM/1085a Date of preparation: October 2016
REFERENCES
1. Treatment. Accessed February 2016, http://www.rivm.nl/Documenten_en_publicaties/
Professioneel_Praktisch/Richtlijnen/Infectieziekten/LCI_richtlijnen/LCI_richtlijn_Hivinfectie
2. HIV diagnostic http://www.rivm.nl/Documenten_en_publicaties/Professioneel_Praktisch/Richtlijnen/
Infectieziekten/LCI_richtlijnen/LCI_richtlijn_Hivinfectie
3.Transmit HIV to baby. http://www.rivm.nl/Documenten_en_publicaties/Professioneel_
Praktisch/Richtlijnen/Infectieziekten/LCI_richtlijnen/LCI_richtlijn_Hivinfectie
4. Living with HIV and aids. www.nhs.uk/Conditions/HIV/Pages/living-with.aspx.
5.Package leaflet Descovy®. Available at http://www.ema-europa.eu/
6.http://www.aidsmap.com/resources/living-with-hiv/Side-effects/page/1254858/
7.Compliance. http://www.rivm.nl/Documenten_en_publicaties/Professioneel_Praktisch/Stappenplannen/
Infectieziekten/VSI/VSI_Hiv
8.HIV and aids introduction. http://www.rivm.nl/Documenten_en_publicaties/Professioneel_Praktisch/
Richtlijnen/Infectieziekten/LCI_richtlijnen/LCI_richtlijn_Hivinfectie