DESCOVY®
INFORMATION FOR PATIENTS
PREFACE You have been prescribed DescovyÂŽ to treat HIVinfection. 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 Descovy1 and should not be used as a replacement. The package leaflet contains the officially approved text. Your doctor, HIV-consulent and pharmacist are the initial contacts for information. If you have any questions after reading this booklet, please remember to contact one of them.
Š Gilead Sciences Netherlands BV This text was composed in 2017 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.
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GETTING STARTED WITH DESCOVY
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WHAT IS HIV?
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WHAT IS DESCOVY?
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BE CAREFUL
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OTHER MEDICINES AND DESCOVY
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HOW DOES DESCOVY WORK?
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OPTIMAL USE
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ONE TABLET EVERY DAY
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KEEP TRACK
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MISSED A DOSE?
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POSSIBLE SIDE EFFECTS
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PREGNANCY AND BREAST-FEEDING
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CO-INFECTION
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HEALTHY LIFESTYLE
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SWITCHING FROM TRUVADA TO DESCOVY
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SIX IMPORTANT TIPS
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FREQUENTLY ASKED QUESTIONS
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WHAT IS HIV?
WHAT IS DESCOVY?
The human immunodeficiency virus (HIV) infects specific
HIV-infection can be treated with Descovy
cells of the immune system, known as CD4 cells. Prolonged
Descovy is an antiretroviral medicine that is to be used in
infection weakens the immune system. The virus continues
combination with other antiretroviral medicines.
to create multiple copies of itself, causing your CD4 cell count to reduce. As a result, your body is less capable of
Descovy in combination with other antiretroviral medicines
fighting infections and illnesses.
is used for the treatment of human immunodeficiency virus 1 (HIV-1) infection in adults and adolescents aged 12
At the time these infections and illnesses occur, there is
years and older, with a body weight of at least 35 kg.
the risk of Acquired Immune Deficiency Syndrome (AIDS).
225 mg
To prevent AIDS, it is important to treat HIV in time with the proper treatment.2 This allows the immune system to
ACTIVE SUBSTANCES IN DESCOVY:
continue to do its job. The primary goal of HIV-treatment is
• emtricitabine
to reduce the amount of viral particles to an undetectable
• tenofovir alafenamide
210 mg
CD4 cells will remain sufficient, i.e. the immune system is
Emtricitabine is an antiretroviral medicine in the class of
more capable to fight off infections and diseases.
medications known as nucleoside reverse transcriptase
2
inhibitors (NRTI). Tenofovir alafenamide is an antiretroviral HIV can be transmitted from an infected person to an
medicine in the class of medications known as nucleotide
uninfected person through body fluids, such as genital
reverse transcriptase inhibitors (NtRTI).
fluids (semen, pre-seminal fluid, rectal fluids and vaginal fluids) during unprotected sexual contact (vaginal, anal and
Each Descovy tablet contains 200 mg emtricitabine and
oral), donor sperm, donor tissue, blood products, blood
10 mg or 25 mg tenofovir alafenamide. The recommended
from contaminated needles, or mother to child during
dose is one tablet every day. Which tablet your doctor
pregnancy, childbirth and breast-feeding.
will prescribe to you, depends on what other medicines
2,3
INFORMATION FOR PATIENTS
level (undetectable viral load). As a result, the number of
you use in combination with Descovy.
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BE CAREFUL What do you need to know before taking Descovy? Restrictions apply to all medications, including Descovy.
OTHER MEDICINES AND DESCOVY Are you taking any other medicines? Descovy may interact with other medicines.
DO NOT TAKE DESCOVY IF: • you are allergic to emtricitabine, tenofovir
DO NOT TAKE DESCOVY AND TELL YOUR DOCTOR
alafenamide or any of the other ingredients
IMMEDIATELY IF YOU ARE TAKING:
of this medicine (see package leafl et for a full list).
• medicines used in treating hepatitis B infection: tenofovir disoproxil fumarate, lamivudine, adefovir
BE CAREFUL IF:
dipivoxil.
• you have liver problems or have suffered liver disease, including hepatitis; • the virus has a K65R mutation.
TALK TO YOUR DOCTOR IF YOU ARE TAKING: • antibiotics, used to treat bacterial infections, including tuberculosis, containing: rifabutin,
leaflet. If any of these conditions apply to you, tell your doctor, even if he or she has not asked.
rifampicin, and rifapentine. • antiviral medicines used to treat hepatitis C: telaprevir and boceprevir. • antiviral medicines used to treat HIV: emtricitabine and tipranavir. • anticonvulsants, used to treat epilepsy, such as: carbamazepine, oxcarbazepine, phenobarbital and phenytoin. • herbal remedies used to treat depression and anxiety
INFORMATION FOR PATIENTS
For additional information, please refer to the package
containing: St. John’s wort (Hypericum perforatum).
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Tell your doctor or pharmacist if you are taking, have
HOW DOES DESCOVY WORK?
recently taken or might take any other medicines. If you
How do you know if your treatment is working well?
are considering stopping your treatment with Descovy, contact your doctor to discuss the possibilities. Do not
In order to determine whether Descovy works for you, blood is taken for examination. Test results can show
stop your treatment without contacting your doctor.
whether the amount of virus (viral load) has decreased and the amount of CD4 cells has increased.
For full details about using Descovy please refer to the package leaflet.
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 is not a cure for HIV infection. While illnesses associated with HIV infection.
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INFORMATION FOR PATIENTS
taking Descovy you may still develop infections or other
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OPTIMAL USE Intake of Descovy When you take Descovy, the active substances enter your
If the virus develops resistance, the active substances in
blood stream through the digestive tract. Descovy then
Descovy are no longer able to effectively inhibit the virus.
disappears from your blood and you need to take another
If you consider stopping your treatment with Descovy, talk
dose. The recommended dose is one tablet every day.
to your doctor or nurse. They can assist you in finding the proper solution.
When you miss a dose, less Descovy is present in your body to inhibit viral replication. This has two serious disadvantages.
Tell your doctor or pharmacist if you are taking, have
First, because there is less Descovy, the virus is better able
recently taken or might take any other medicines. If you
to multiply and attack the immune system. Second, the virus
are considering stopping your treatment with Descovy,
may change its shape while multiplying, and the new virus
contact your doctor to discuss the possibilities.
INFORMATION FOR PATIENTS
may become resistant.
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ONE TABLET EVERY DAY
KEEP TRACK
What to be aware of when taking Descovy?
At times you may not remember if you have taken your daily
Once you have started Descovy, two things are of
dose. If this problem occurs frequently, make sure you set
importance. First, the level of Descovy in your body must
up a monitoring system. For example, use a pill organiser,
be maintained. Second, you should immediately talk to
labelled with the days of the week, in which you can store
your doctor if you notice any side effects.
your daily dose. There are also daily pill boxes that you attach
Make sure you keep track
as a keychain to allow you quick access to spare tablets. The recommended dose is one tablet every day, with or without food, at about the same time. Thereby, the risk
Have spare tablets handy
of missing a dose is minimized. However, the absorption
Life is full of surprises, and it may happen that you are
of Descovy is disrupted if you vomit less than 1 hour after
somewhere else than expected at your scheduled time of
the intake, or if you are suffering from severe diarrhoea.
intake. Therefore it is important to make sure you always
On page 16 ‘Missed a dose?’ you can read what to do in
have some extra tablets with you. If necessary, set an alarm clock
Choose a convenient time of intake
You could set an alarm clock on your mobile phone to
For instance, when you take Descovy in the evening
remind you to take Descovy. There are also pill organisers
during dinner, it becomes a habit and the risk of missing a
with a built-in alert system.
dose is minimized.4 Descovy during your holiday During holidays, daily routines are often broken, especially if you are travelling across time zones. If you are travelling
INFORMATION FOR PATIENTS
these situations.
to a different time zone, please consult your doctor about the best dosing schedule. It is best to maintain the 24 hour interval between doses.
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MISSED A DOSE? Missed a dose?
When your supply of Descovy starts to run low, go to your
It is normal to occasionally forget something. It may happen
doctor for a new prescription. This is very important because
that, despite all good intentions and precautions, you still
the amount of virus may start to increase if the medicine is
forget to take your medication. Discuss in advance with your
stopped for even a short time. The disease may then become
doctor or HIV-consulent what to do in this situation.
harder to treat. Do not take a double dose to compensate for the missed tablet.
In general, the following applies: If you vomit less than 1 hour after taking Descovy,
... if you notice within 18 hours
... if you notice after 18 hours or more
take the tablet as soon as possible
skip the missed dose
WAIT AND TAKE THE NEXT DOSE AT YOUR USUAL TIME (WITH OR WITHOUT FOOD).
take another tablet. If you are suffering from severe diarrhoea, there is a risk that Descovy is not absorbed or insufficiently absorbed by the body. Therefore, contact your doctor if you are suffering from severe diarrhoea for more than two days. Do not stop taking Descovy without talking to your doctor. When your supply of Descovy starts to run low, refill your prescription at your pharmacist.
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INFORMATION FOR PATIENTS
Did you miss a dose of Descovy?
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POSSIBLE SIDE EFFECTS Like all medicines, Descovy can cause side effects,
Common side effects
although this differs between individuals. When treating
(may affect up to 1 in 10 people)
HIV infection, it is not always possible to tell whether
• abnormal dreams
some of the unwanted effects are caused by Descovy,
• headache
other medicines that you are taking at the same time,
• dizziness
or by the HIV disease itself.
• diarrhoea • vomiting
Possible serious side effects
• stomach pain
• Any signs of inflammation or infection.
• wind (flatulence)
• Autoimmune disorders. Look out for any symptoms of
• rash
infection or other symptoms such as: muscle weakness,
• tiredness (fatigue)
up towards the trunk of the body. palpitations, tremor
Uncommon side effects
or hyperactivity.
(may affect up to 1 in 100 people) • low red blood cell count (anaemia)
If you notice the side effects described above, tell your doctor immediately.
• problems with digestion resulting in discomfort after meals (dyspepsia) • swelling of the face, lips, tongue or throat (angioedema)
Very common side effects
• itching (pruritus)
(may affect more than 1 in 10 people)
• joint pain (arthralgia)
• feeling sick (nausea)
INFORMATION FOR PATIENTS
weakness beginning in the hands and feet and moving
If any of the side effects get serious tell your doctor.
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Other effects that may be seen during HIV treatment
PREGNANCY AND BREAST-FEEDING
During HIV therapy there may be an increase in weight
You cannot use Descovy during pregnancy, unless this is
and in levels of blood lipids and glucose. This is partly
specifically discussed with your doctor.
linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves.
Contraception
Your doctor will test for these changes.
Women are advised to use effective contraception while taking Descovy to avoid pregnancy.
Some patients may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of
Pregnancy
blood supply to the bone). Signs of osteonecrosis are:
If you are pregnant, think you may be pregnant or are
• joint stiffness;
planning to have a baby, ask your doctor for advice
• joint aches and pains (especially of the hip, knee,
before you start taking this medicine.
and shoulder); Breast-feeding Do not breast-feed during treatment with Descovy. Reporting of side effects
Active substances in this medicines are excreted in
If you get any side effects, talk to your doctor or
breast milk.
pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects
It is also recommended that you do not breast-feed to
directly via the national reporting system:
avoid passing the virus to the baby through breast milk.
Nederlandse Bijwerkingen Centrum Lareb
Website: www.lareb.nl
INFORMATIE VOOR PATIËNTEN
• difficulty with movement.
By reporting side effects you can help provide more information on the safety of this medicine.
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CO-INFECTION
HEALTHY LIFESTYLE
Hepatitis
Tips for a healthy lifestyle
Patients with liver disease, including chronic hepatitis B or
The HIV-virus suppresses your immune system. Although
C, who are treated with antiretrovirals, have a higher risk
Descovy reduces this suppression, it is still important to
of severe and potentially fatal liver complications. If you
not impose an extra burden on your immune system, and
are infected with the hepatitis B-virus, your doctor should
adopt a healthy lifestyle. Live healthy, eat healthy, sleep well.
carefully consider the best treatment regimen for you. HEALTHY LIFESTYLE If you are infected with the hepatitis B-virus and stop taking Descovy, you may put yourself at risk of severe
• perform physical activity (e.g. walking, playing sports, cycling) on regular basis
acute liver complications. It is therefore important to not
• do relaxation exercises (e.g. yoga)
stop taking Descovy without talking to your doctor.
• eat fruits and vegetables • quit smoking
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)
INFORMATION FOR PATIENTS
• limit or avoid the use of alcohol and recreational drugs
• do not oversleep
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THE INFORMATION PROVIDED ON THESE PAGES IS INTENDED FOR PEOPLE WHO SWITCH FROM TRUVADA TO DESCOVY.
SWITCHING FROM TRUVADA TO DESCOVY What is the difference between Truvada and Descovy?
Active substances
Truvada contains two active substances, emtricitabine
Emtricitabine is an antiretroviral medicine, known as
and tenofovir disoproxil (as fumarate, TDF). In addition to
nucleoside reverse transcriptase inhibitor (NRTI).
Truvada, you have been prescribed a third antiretroviral medication, sometimes in combination with a booster.
Tenofovir disoproxil (as fumarate, TDF) is an antiretroviral medicine known as a nucleotide reverse
Descovy also contains two substances, emtricitabine and
transcriptase inhibitor (NtRTI). It is converted to tenofovir
tenofovir alafenamide (as fumarate, TAF). In addition to
in the body. Tenofovir is the active substance.
medication, sometimes in combination with a booster. In
Tenofovir alafenamide (as fumarate, TAF) is an
the following chart you will find an overview.
antiretroviral medicine known as a nucleotide reverse transcriptase inhibitor (NtRTI). It is converted to tenofovir
TRUVADA®
DESCOVY®
• Emtricitabine 200 mg
• Emtricitabine 200 mg
• Tenofovir disoproxil (as fumarate) 245 mg
• Tenofovir alafenamide (as fumarate) 25 mg or • Tenofovir alafenamide (as fumarate) 10 mg
This means that you can use a lower dose of TAF and get
• + 3rd medication*
a booster.
• + 3rd medication*
in the body. Tenofovir is the active substance. TAF is converted to tenofovir in a different way compared to TDF, leading to a higher level of tenofovir in the cells. the same effect on the virus. 3rd medication. In addition to Descovy you are taking a third antiretroviral, sometimes in combination with
SWITCHING FROM TRUVADA TO DESCOVY
Descovy you have been prescribed a third antiretroviral
* In addition to a third medication, sometimes a so-called booster is also prescribed. This booster can be a component of the third medication or prescribed as a separate tablet.
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THE INFORMATION PROVIDED ON THESE PAGES IS INTENDED FOR PEOPLE WHO SWITCH FROM TRUVADA TO DESCOVY.
WHAT REMAINS THE SAME WHEN YOU SWITCH FROM TRUVADA TO DESCOVY
WHAT CAN CHANGE WHEN YOU SWITCH FROM TRUVADA TO DESCOVY
The number of tablets you take each day
Intake with or without food
In addition to Descovy you will take a third medication,
You can take Descovy with or without food. It is not
sometimes in combination with a booster.
necessary to take the tablet with a meal. However, it may be possible that your third medication needs to be taken
A fixed time of intake
with food. If necessary, consult your HIV-consulent.
You take your HIV-medication at a fixed time of the day. Possible side effects All medicines can cause side effects, and switching to Pharmacy
a new HIV-treatment may also cause new side effects.
Your medicines will be supplied by your regular
The possible side effects of Descovy are described in
pharmacy. Your pharmacy will be able to supply
this booklet. Discuss with your doctor or HIV-consulent
medication for at least three months.
what differences you can expect between your current treatment and Descovy. Kidney monitoring tests When you were taking Truvada, your doctor possibly ordered blood tests during treatment to monitor your kidneys. When you take Descovy it is not necessary to
SWITCHING FROM TRUVADA TO DESCOVY
With Descovy this will remain the same.
assess your kidneys on a regular basis. Your doctor will decide whether or not to continue kidney monitoring.
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SIX IMPORTANT TIPS 1. Take one tablet at about the same time every day. This
6. Make sure you always have a supply of Descovy at home.
makes it easier to remember your daily intake of Descovy.
Remember to request for a prescription refill in time. If you leave home or are travelling, always take
2. Take one tablet every day with or without food.
Descovy with you.
3. Do not chew, crush or split the tablet. 4. If you vomit less than 1 hour after taking Descovy, take another tablet. When in doubt, always contact your doctor or HIV-consulent. 5. It is important not to miss a dose of Descovy. If you do miss a dose: • If you notice within 18 hours of the time you usually take
Descovy, you must take the tablet as soon as possible. Then take the next dose as usual.
• If you notice 18 hours or more after the time you usually take Descovy, then do not take the missed
IMPORTANT TIPS
dose. Wait and take the next dose at your usual time.
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FREQUENTLY ASKED QUESTIONS Why have I been prescribed this medicine?
How does this medicine work?
Descovy is an anti-human immunodeficiency virus (HIV)
HIV infects specific cells of the immune system and
medicine. This means that this medicine contributes to
therefore weakens the immune system. The HIV-virus
the treatment of HIV-infection. It helps prevent the HIV
creates multiple copies of itself that continue to weaken
from replicating and creating copies of itself, and slows
the immune system. As a result, your body is less capable
down the progression of the disease.
of fighting infections and illnesses.1 Descovy reduces the the virus. The treatment is successful if the amount of
Descovy 10 mg film-coated tablets are grey, rectangular-
viral particles (viral load) in your blood is reduced to
shaped tablets, debossed on one side with “GSI” and the
an undetectable level. Then, the number of CD4 cells
number “210” on the other side of the tablet. Descovy
will increase, i.e. the immune system recovers from its
25 mg film-coated tablets are blue, rectangular-shaped
weakened state.
tablets, debossed on one side with “GSI” and the number “225” on the other side of the tablet. Descovy comes in
What are the ingredients of Descovy?
bottles of 30 tablets, and a silica gel desiccant (that must
Descovy contains two active substances: emtricitabine
be kept in the bottle to help protect your tablets). The
and tenofovir alafenamide. These are antiretroviral
silica gel desiccant is packaged in a separate sachet or
medicines. Each tablet contains 200 mg emtricitabine
canister and should not be swallowed.
and 10 mg or 25 mg tenofovir alafenamide.
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FREQUENTLY ASKED QUESTIONS
amount of viral particles by inhibiting the replication of What does my medicine look like?
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Does this medicine cure HIV?
Does my medicine reduce the risk of me transmitting
No, this medicine is not a cure for HIV-infection. To
HIV to other people?
control your HIV-infection and infections or other illnesses
You can still transmit HIV when taking this medicine,
associated with HIV-infection, you should always take this
although the risk is lowered by effective antiretroviral
medication exactly as your doctor has prescribed it.
therapy. Discuss with your doctor the precautions needed to avoid infecting other people. This medicine is not a
Who can prescribe Descovy?
cure for HIV-infection. While taking Descovy you may
Descovy is a prescription medicine that can only be
still develop infections or other illnesses associated with
prescribed by a healthcare professional. You should only
HIV-infection.
take this medication if it has been prescribed by your doctor. When should I not take this medication?
Always take this medication exactly as your doctor has
If you are allergic to emtricitabine, tenofovir alafenamide
prescribed it. Check with your doctor or pharmacist if you
or any of the other ingredients of this medicine (you can
are not sure. The recommended daily intake is one tablet
find all ingredients in the package leaflet) or if you use
every day with or without food. Do not chew, crush or
any of the other medicines mentioned on page 9 in the
split the tablet.
section “Other medicines and Descovy�.
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FREQUENTLY ASKED QUESTIONS
How do I take my medicine?
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How should I store this medicine?
Is it possible to experience serious side effects while
Store Descovy in its original packaging to protect from
taking Descovy?
moisture. Keep the bottle tightly closed. Keep the
Yes. You should look out for symptoms of inflammation,
tablets out of sight and reach of children. Do not use this
infection or autoimmune disorders, such as muscle
medication after the expiry date. Ask your pharmacist
weakness, palpitations, tremors or hyperactivity.
how to throw away medicines you no longer use.
If you notice one of these symptoms, please tell your doctor immediately. For more information, please refer
What do I need to tell my doctor before I start taking
to the package leaflet.
Tell your doctor or pharmacist if you are taking, have
What do I do if I miss a dose of my medicine?
recently taken or are going to take any other medicines.
It is important to not miss a dose of Descovy. If you
Tell your doctor if you are allergic to any of the
notice within 18 hours of the time you usually take your
ingredients (see package leaflet for a full list) or if you
medication, take the tablet as soon as you remember.
are pregnant, are likely to become pregnant or if you
Take the tablet and then take the next dose at the usual
are breastfeeding. Also tell your doctor if you have liver
time. If you notice 18 hours or more after the time you
problems, or a history of liver disease, including hepatitis.
usually take Descovy, then do not take the missed dose. Wait and take the next dose at your usual time. If you
Can this medicine cause side effects?
vomit less than 1 hour after taking your medication, take
As with all medicines, you may get side effects. On page 18
another tablet. Do not stop taking Descovy without first
you will find possible side effects. For a full list of side
talking to your doctor.
effects, please refer to the package leaflet that is supplied with your medication. If you notice any side effects, talk
FREQUENTLY ASKED QUESTIONS
this medicine?
to your doctor or pharmacist. This includes any possible side effects not listed in the package leaflet.
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NOTES 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 of the active substances in this medicine are excreted in breast milk. It is also recommended that you do not breast-feed to avoid transmitting the virus to the baby through
NOTES
breast milk.
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NOTES
NOTES
NOTES
FTAF/NL/16-04/NPM/1085a(1) Date of preparation: November 2017
REFERENCES 1. Package leaflet Descovy, www.geneesmiddeleninformatiebank.nl/ 2. Rijksinstituut voor Volksgezondheid en Milieu. Ministerie van Volksgezondheid, Welzijn en Sport. LCI guideline HIV infection. Verkregen op 11 februari 2016, van https://lci.rivm.nl/richtlijnen/hivinfectie 3. Living with HIV and AIDS, www.nhs.uk/Conditions/HIV/Pages/living-with.aspx. 4. Compliance, www.rivm.nl/Documenten_en_publicaties/Professioneel_Praktisch/ Stappenplannen/Infectieziekten/VSI/VSI_Hiv