ODEFSEY®
INFORMATION FOR PATIENTS
INFORMATION FOR PATIENTS
PREFACE You have been prescribed OdefseyÂŽ to treat HIV-infection. This booklet is designed to support you in using Odefsey and to inform you on how it works. This guide is based on the package leaflet supplied with Odefsey1 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 ODEFSEY
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WHAT IS HIV?
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WHAT IS ODEFSEY?
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BE CAREFUL
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OTHER MEDICINES AND ODEFSEY
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HOW DOES ODEFSEY WORK?
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OPTIMAL USE
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ONE TABLET EVERY DAY
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KEEP TRACK
16
MISSED A DOSE?
18
POSSIBLE SIDE EFFECTS
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PREGNANCY AND BREAST-FEEDING
25
CO-INFECTION
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HEALTHY LIFESTYLE
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SWITCHING FROM ATRIPLA TO ODEFSEY
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SWITCHING FROM EVIPLERA TO ODEFSEY
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SEVEN IMPORTANT TIPS
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FREQUENTLY ASKED QUESTIONS
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05
WHAT IS HIV?
WHAT IS ODEFSEY?
The human immunodeficiency virus (HIV) infects specific
HIV-infection can be treated with Odefsey
cells of the immune system, known as CD4 cells. Prolonged
Odefsey causes the viral load to drop, through the
infection weakens the immune system. The virus continues
inhibition of viral replication. As a result, virus replication
to create multiple copies of itself, causing your CD4 cell
is reduced and many of the remaining virus particles are
count to reduce. As a result, your body is less capable of
eliminated from the body.
fighting infections and illnesses. Odefsey contains a combination of active substances, At the time these infections and illnesses occur, there is
in one tablet. Also, Odefsey can be taken with certain
the risk of Acquired Immune Deficiency Syndrome (AIDS).
medication for other diseases, however not with all
To prevent AIDS, it is important to treat HIV in time with
medications (see page 9: ‘Other medicines and Odefsey’).
the proper treatment.2 This allows the immune system to
This treatment is for use by adults and adolescents aged
continue to do its job. The primary goal of HIV-treatment is
12 years and older, with a body weight of at least 35 kg.
level (undetectable viral load). As a result, the number of
ACTIVE SUBSTANCES IN ODEFSEY:
CD4 cells will remain sufficient, i.e. the immune system is
• emtricitabine
more capable to fight off infections and diseases.
• rilpivirine
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• tenofovir alafenamide HIV can be transmitted from an infected person to an uninfected person through body fluids, such as genital
Emtricitabine, rilpivirine and tenofovir alafenamide are
fluids (semen, pre-seminal fluid, rectal fluids and vaginal
antiretroviral medicines. Each Odefsey tablet contains
fluids) during unprotected sexual contact (vaginal, anal
200 mg emtricitabine, 25 mg rilpivirine and
and oral), donor sperm, donor tissue, blood products,
25 mg tenofovir alafenamide.
INFORMATION FOR PATIENTS
to reduce the amount of viral particles to an undetectable
blood from contaminated needles, or mother to child during pregnancy, childbirth and breast-feeding.2,3
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BE CAREFUL What do you need to know before taking Odefsey? Restrictions apply to all medications, including Odefsey.
OTHER MEDICINES AND ODEFSEY Are you taking any other medicines? Odefsey may interact with other medicines.
DO NOT TAKE ODEFSEY IF: • you are allergic to emtricitabine, rilpivirine, tenofovir
DO NOT TAKE ODEFSEY AND TELL YOUR DOCTOR
alafenamide or any of the other ingredients of
IMMEDIATELY IF YOU ARE TAKING:
this medicine.
• carbamazepine, oxcarbazepine, phenobarbital and phenytoin (used to treat epilepsy and
• you have liver problems or a history of liver disease, including hepatitis; • you are taking any medicines that may cause a
prevent seizures) • rifabutin, rifampicin and rifapentine (used to treat some bacterial infections such as tuberculosis) • omeprazole, dexlansoprazole, lansoprazole,
life-threatening irregular heartbeat
rabeprazole, pantoprazole and esomeprazole (used
(torsades de pointes);
to prevent and treat stomach ulcers, heartburn, acid
• you are lactose intolerant or intolerant to other sugars.
reflux disease) • dexamethasone (a corticosteroid medicine used to treat inflammation and suppress the immune
For additional information, please refer to the package
system) when taken by mouth or injected (except
leaflet. If any of these conditions apply to you, tell your
as a single dose treatment)
doctor, even if he or she has not asked.
• products that contain St. John’s wort (Hypericum Perforatum, a herbal remedy used for depression and anxiety)
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INFORMATION FOR PATIENTS
BE CAREFUL IF:
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such as: antacids (aluminium/magnesium hydroxide
• any medicines containing: tenofovir alafenamide,
or calcium carbonate), H2-antagonists (famotidine,
tenofovir disoproxil, lamivudine, adefovir dipivoxil. • antibiotics used to treat bacterial infections containing: clarithromycin, erythromycin. • antifungal medicines used to treat fungal infections: ketoconazole, fluconazole, itraconazole, posaconazole, voriconazole. These medicines can increase the amount of rilpivirine and tenofovir alafenamide (components of Odefsey) in your blood. Your doctor will give you a different medicine. • antiviral medicines used to treat hepatitis C containing: boceprevir, telaprevir.
cimetidine, nizatidine or ranitidine). These medicines can decrease the amount of rilpivirine (a component of Odefsey) in your blood. If you are taking one of these medicines your doctor will either give you a different medicine or recommend how and when you take that medicine. • ciclosporin, a medicine used to reduce the strength of the body’s immune system. • methadone, a medicine used to treat opiate addiction, as your doctor may need to change your methadone dose. • dabigatran etexilate, a medicine used to treat heart
These medicines can decrease the amount of tenofovir
conditions, as your doctor may need to monitor the
alafenamide (a component of Odefsey) in your blood.
levels of this medicine in your blood.
Your doctor will give you a different medicine.
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• medicines for stomach ulcers, heartburn or acid reflux
• any medicines used for treating HIV.
INFORMATION FOR PATIENTS
TALK TO YOUR DOCTOR IF YOU ARE TAKING:
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HOW DOES ODEFSEY WORK? • If you take an antacid, take it at least 2 hours before or at least 4 hours after Odefsey. • If you take an H2-antagonist, take it at least
How do you know if your treatment is working well? In order to determine whether Odefsey works for you, blood is taken for examination. Test results can show
12 hours before or at least 4 hours after Odefsey.
whether the amount of virus (viral load) has decreased
H2-antagonists can only be taken once a day if you
and the amount of CD4 cells has increased.
take Odefsey. H2-antagonists should not be taken in a twice a day regimen.
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
Tell your doctor or pharmacist if you are taking, have
to avoid infecting other people.
If you are considering stopping your treatment with
This medicine is not a cure for HIV infection. While
Odefsey, contact your doctor to discuss the
taking Odefsey you may still develop infections or
possibilities. Do not stop your treatment without
other illnesses associated with HIV infection.
contacting your doctor. For full details about using Odefsey please refer to the package leaflet.
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INFORMATION FOR PATIENTS
recently taken or might take any other medicines.
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OPTIMAL USE Intake of Odefsey
ONE TABLET EVERY DAY
When you take Odefsey, the active substances enter your blood stream through the digestive tract. Odefsey then
What to be aware of when taking Odefsey?
disappears from your blood and you need to take another
Once you have started Odefsey, two things are of
dose. The recommended dose is one tablet every day.
importance. First, the level of Odefsey in your body must be maintained. Second, you should immediately talk to
When you miss a dose, less Odefsey is present in your
your doctor if you notice any side effects.
body to inhibit viral replication. This has two serious disadvantages. First, because there is less Odefsey, the virus
The recommended dose is one tablet every day, with food,
is better able to multiply and attack the immune system.
at about the same time. Thereby, the risk of missing a
Second, the virus may change its shape while multiplying,
dose is minimized. However, the absorption of Odefsey is
and the new virus may become resistant.
disrupted if you vomit less than 4 hours after the intake, or if you are suffering from severe diarrhoea. On page 18 ‘Missed a dose?’ you can read what to do in these situations.
Odefsey are no longer able to effectively inhibit the virus. If you consider stopping your treatment with Odefsey, talk
Choose a convenient time of intake
to your doctor or nurse. They can assist you in finding the
For instance, when you take Odefsey in the evening
proper solution.
during dinner, it becomes a habit and the risk of missing a dose is minimized.4
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. If you are considering stopping your treatment with Odefsey, contact
INFORMATION FOR PATIENTS
If the virus develops resistance, the active substances in
your doctor to discuss the possibilities.
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KEEP TRACK Make sure you keep track
Odefsey during your holiday
At times you may not remember if you have taken your
During holidays, daily routines are often broken,
daily dose. If this problem occurs frequently, make sure
especially if you are travelling across time zones.
you set up a monitoring system. For example, use a pill
If you are travelling to a different time zone, please
organiser, labelled with the days of the week, in which
consult your doctor about the best dosing schedule.
you can store your daily dose. There are also daily pill
It is best to maintain the 24 hour interval between doses.
boxes that you attach as a keychain to allow you quick access to spare tablets. Have spare tablets handy Life is full of surprises, and it may happen that you are somewhere else than expected at your scheduled time of intake. Therefore it is important to make sure you
If necessary, set an alarm clock You could set an alarm clock on your mobile phone to remind you to take Odefsey. There are also pill organisers with a built-in alert system.
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INFORMATION FOR PATIENTS
always have some extra tablets with you.
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MISSED A DOSE? Missed a dose?
When your supply of Odefsey starts to run low, go to
It is normal to occasionally forget something. It may
your doctor for a new prescription. This is very important
happen that, despite all good intentions and precautions
because the amount of virus may start to increase if the
you still forget to take your medication. Discuss in
medicine is stopped for even a short time. The disease
advance with your doctor or HIV-consulent what to do
may then become harder to treat. Do not take a double
in this situation.
dose to compensate for the missed tablet.
In general, the following applies:
If you vomit less than 4 hours after taking Odefsey, take another tablet with food. If you are suffering from severe
Did you miss a dose of Odefsey? ... if you notice within 12 hours
... if you notice after 12 hours or more
take the tablet as soon as possible (with food)
skip the missed dose
insufficiently absorbed by the body. Therefore, contact your doctor if you are suffering from severe diarrhoea for
Do not stop taking Odefsey without talking to your doctor. When your supply of Odefsey starts to run low, refill your prescription at your pharmacist.
INFORMATION FOR PATIENTS
more than two days.
WAIT AND TAKE THE NEXT DOSE AT YOUR USUAL TIME (WITH FOOD).
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diarrhoea, there is a risk that Odefsey is not absorbed or
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POSSIBLE SIDE EFFECTS Like all medicines, Odefsey can cause side effects,
Very common side effects
although this differs between individuals. When treating
(may affect more than 1 in 10 people)
HIV infection, it is not always possible to tell whether
• difficulty sleeping (insomnia)
some of the unwanted effects are caused by Odefsey,
• headache
other medicines that you are taking at the same time, or
• dizziness
by the HIV disease itself.
• feeling sick (nausea)
Possible serious side effects
Tests may also show:
• Any signs of inflammation or infection.
• increased levels of cholesterol and/or pancreatic amylase
• Autoimmune disorders. Look out for any symptoms of infection or other symptoms such as muscle weakness,
(a digestive enzyme) in the blood • increased levels of liver enzymes in the blood
up towards the trunk of the body, palpitations, tremor
Common side effects
or hyperactivity.
(may affect up to 1 in 10 people) • decreased appetite
If you notice the side effects described above, tell your
• depression
doctor immediately.
• abnormal dreams • sleep disorders • depressed mood • feeling sleepy (somnolence)
INFORMATION FOR PATIENTS
weakness beginning in the hands and feet and moving
• tiredness
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• stomach pain or discomfort • being sick (vomiting)
• problems with digestion resulting in discomfort after meals
• feeling bloated
• swelling of the face, lips, tongue or throat (angioedema)
• dry mouth
• itching (pruritus)
• wind (flatulence)
• joint pain (arthralgia)
• diarrhoea • rash
If any of the side effects get serious tell your doctor.
Test may also show:
Other effects that may be seen during HIV treatment
• low white blood cell count (a reduced white blood cell
During HIV therapy there may be an increase in weight
• low platelet count (a type of blood cell involved in clotting blood) • decrease in haemoglobin in your blood
and in levels of blood lipids and glucose. This is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves. Your doctor will test for these changes.
• increased fatty acids (triglycerides), bilirubin or lipase in the blood
Some patients may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of
Uncommon side effects
blood supply to the bone). Signs of osteonecrosis are:
(may affect up to 1 in 100 people)
• joint stiffness;
• signs or symptoms of inflammation or infection
• joint aches and pains (especially of the hip, knee,
• low red blood cell count (anaemia) • severe skin reactions including rash accompanied
and shoulder); • difficulty with movement.
INFORMATION FOR PATIENTS
count can make you more prone to infection)
with fever, swelling and liver problems
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Reporting of side effects
PREGNANCY AND BREAST-FEEDING
If you get any side effects, talk to your doctor or
You cannot use Odefsey during pregnancy, unless this
pharmacist. This includes any possible side effects not
is specifically discussed with your doctor.
listed in this leaflet. You can also report side effects directly via the national reporting system:
Contraception
Nederlandse Bijwerkingen Centrum Lareb
Women are advised to use effective contraception while
Website: www.lareb.nl
taking Odefsey to avoid pregnancy.
By reporting side effects you can help provide more information on the safety of this medicine.
Pregnancy If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you start taking this medicine.
Do not breast-feed during treatment with Odefsey. Active substances in this medicines are excreted in breast milk. It is also recommended that you do not breast-feed to avoid passing the virus to the baby through breast milk.
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INFORMATION FOR PATIENTS
Breast-feeding
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CO-INFECTION
HEALTHY LIFESTYLE
Hepatitis
Tips for a healthy lifestyle
Patients with liver disease, inclusing chronic hepatitis B or
The HIV-virus suppresses your immune system. Although
C, who are treated with antiretrovirals have a higher risk
Odefsey reduces this suppression, it is still important to not
of severe and potentially fatal liver complications. If you
impose an extra burden on your immune system, and adopt
are infected with the hepatitis B-virus, your doctor should
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
• perform physical activity (e.g. walking, playing
Odefsey, you may put yourself at risk of severe acute liver
sports, cycling) on regular basis
complications. It is therefore important to not stop taking
• do relaxation exercises (e.g. yoga)
Odefsey 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 ATRIPLA TO ODEFSEY.
Active substances
SWITCHING FROM ATRIPLA TO ODEFSEY
Efarvirenz is an antiretroviral medicine known as non-nucleoside reverse transcriptase inhibitor (NNRTI). Rilpivirine is an antiretroviral medicine known as non-
What is the difference between Atripla and Odefsey?
nucleoside reverse transcriptase inhibitor (NNRTI).
Atripla contains three active substances, efavirenz, emtricitabine and tenofovir disoproxil (as fumarate).
Emtricitabine is an antiretroviral medicine, known as nucleoside reverse transcriptase inhibitor (NRTI).
Odefsey also contains three substances, emtricitabine, rilpivirine and tenofovir alafenamide (as fumarate).
Tenofovir disoproxil (as fumarate, TDF) is an antiretroviral
In the following chart you will find an overview.
medicine known as a nucleotide reverse transcriptase
ATRIPLA®
ODEFSEY®
• Efavirenz 600 mg
• Rilpivirine (as
• Emtricitabine 200 mg
• Emtricitabine 200 mg
antiretroviral medicine known as a nucleotide reverse
• Tenofovir disoproxil
• Tenofovir alafenamide
transcriptase inhibitor (NtRTI). It is converted to tenofovir
hydrochloride) 25 mg
(as fumarate) 245 mg
(as fumarate) 25 mg
Tenofovir is the active substance. Tenofovir alafenamide (as fumarate, TAF) is an
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. This means that you can use a lower dose of TAF and get the same effect on the virus.
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SWITCHING FROM ATRIPLA TO ODEFSEY
inhibitor (NtRTI). It is converted to tenofovir in the body.
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THE INFORMATION PROVIDED ON THESE PAGES IS INTENDED FOR PEOPLE WHO SWITCH FROM ATRIPLA TO ODEFSEY.
WHAT REMAINS THE SAME WHEN YOU SWITCH FROM ATRIPLA TO ODEFSEY
WHAT CAN CHANGE WHEN YOU SWITCH TO FROM ATRIPLA TO ODEFSEY
One tablet a day
Long-term effects
You take one tablet each day.
As you can see on page 28, Odefsey contains other active substances than Atripla. These active substances may have
Pharmacy
different long-term effects. Your doctor or HIV-consulent
Your medicines will be supplied by your regular pharmacy.
can tell you more about the long-term effects of Odefsey.
Your pharmacy will be able to supply medication for at Side effects All medicines can cause side effects, and switching to A fixed time of intake
a new HIV-treatment may also cause new side effects.
You have to take your HIV-medication at a fixed time of
The possible side effects of Odefsey are described in
the day.
this brochure. Discuss with your doctor or HIV-consulent what differences you can expect between your current
Missed a dose? If you do miss a dose and notice within 12 hours of the time you usually take Odefsey, you should take the tablet as soon as possible. Always take the tablet with food. However, if you notice 12 hours or more after the time you usually take Odefsey, then do not take the missed dose.
treatment and Odefsey.
SWITCHING FROM ATRIPLA TO ODEFSEY
least three months.
Wait and take the next dose, with food, at your usual time.
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THE INFORMATION PROVIDED ON THESE PAGES IS INTENDED FOR PEOPLE WHO SWITCH FROM ATRIPLA TO ODEFSEY.
THE INFORMATION PROVIDED ON THESE PAGES IS INTENDED FOR PEOPLE WHO SWITCH FROM EVIPLERA TO ODEFSEY.
Kidney monitoring
SWITCHING FROM EVIPLERA TO ODEFSEY
Before your treatment with Atripla started, your blood was tested to assess kidney function. Your doctor possibly ordered blood tests during treatment to monitor your
What is the difference between Eviplera and Odefsey?
kidneys. If you switch from Atripla to Odefsey, it is not
Eviplera contains three active substances, emtricitabine,
necessary to assess your kidneys on a regular basis.
rilpivirine and tenofovir disoproxil (as fumarate).
It is up to your doctor, whether he continues these blood tests.
Odefsey also contains three substances, emtricitabine, rilpvirine and tenofovir alafenamide (as fumarate). In the
Intake with food
following chart you will find an overview.
to take the tablet with a meal.
EVIPLERA®
ODEFSEY®
• Rilpivirine 25 mg
• Rilpivirine 25 mg
• Emtricitabine 200 mg
• Emtricitabine 200 mg
• Tenofovir disoproxil
• Tenofovir alafenamide
(as fumarate) 245 mg
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(as fumarate) 25 mg
SWITCHING FROM EVIPLERA TO ODEFSEY
You have to take Odefsey with food. It is not necessary
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THE INFORMATION PROVIDED ON THESE PAGES IS INTENDED FOR PEOPLE WHO SWITCH FROM EVIPLERA TO ODEFSEY.
Active substances
WHAT REMAINS THE SAME WHEN YOU SWITCH FROM EVIPLERA TO ODEFSEY
Rilpivirine is an antiretroviral medicine, known as nonnucleoside reverse transcriptase inhibitor (NNRTI).
The number of tablets you take each day You take one tablet each day.
Emtricitabine is an antiretroviral medicine, known as nucleoside reverse transcriptase inhibitor (NRTI).
Pharmacy Your medicines will be supplied by your
Tenofovir disoproxil (as fumarate, TDF) is an antiretroviral
regular pharmacy. Your pharmacy will be able to supply
medicine known as a nucleotide reverse transcriptase
medication for at least three months.
inhibitor (NtRTI). It is converted to tenofovir in the body. A fixed time of intake You have to take your HIV-medication at a fixed time Tenofovir alafenamide (as fumarate, TAF) is an
of the day.
antiretroviral medicine known as a nucleotide reverse transcriptase inhibitor (NtRTI). It is converted to tenofovir
Intake with food
in the body. Tenofovir is the active substance. TAF is
You should take Odefsey with food.
converted to tenofovir in a different way compared to TDF, leading to a higher level of tenofovir in the cells.
Missed a dose?
This means that you can use a lower dose of TAF and get
If you do miss a dose and notice within 12 hours of the
the same effect on the virus.
time you usually take Odefsey, you should take the tablet as soon as possible. Always take the tablet with food. However, if you notice 12 hours or more after the time
SWITCHING FROM EVIPLERA TO ODEFSEY
Tenofovir is the active substance.
you usually take Odefsey, then do not take the missed dose. Wait and take the next dose, with food, at your usual time.
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THE INFORMATION PROVIDED ON THESE PAGES IS INTENDED FOR PEOPLE WHO SWITCH FROM EVIPLERA TO ODEFSEY.
WHAT CAN CHANGE WHEN YOU SWITCH FROM EVIPLERA TO ODEFSEY
Kidney monitoring tests When you were taking Eviplera, your doctor possibly ordered blood tests during treatment to monitor your kidneys. When you take Odefsey it is not necessary to
Long-term effects
assess your kidneys on a regular basis. It is up to your
As you can see on page 33, Odefsey contains other active
doctor, whether he continues these blood tests.
substances than Atripla. These active substances may have different long-term effects. Your doctor or HIV-consultant can tell you more about the long-term effects of Odefsey.
All medicines can cause side effects, and switching to a new HIV-treatment may also cause new side effects. Some of the possible side effects of Odefsey are described in this booklet. Discuss with your doctor or HIV-consulent what differences you can expect between your current treatment and Odefsey.
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SWITCHING FROM EVIPLERA TO ODEFSEY
Possible side effects
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SEVEN IMPORTANT TIPS 1. Take one tablet at about the same time every day. This makes it easier to remember your daily intake of
6. If you are taking an antacid (aluminium/magnesium
Odefsey. For example, take Odefsey every day with a
hydroxide or calcium carbonate), take it at least 2
particular meal.
hours before, or at least 4 hours after Odefsey. If you are taking an H2-antagonist (famotidine, cimetidine,
2. Take one tablet every day with food (breakfast, lunch, dinner or snack).
nizatidine or ranitidine), take it at least 12 hours before or at least 4 hours after Odefsey. H2-antagonists can only be taken once a day if you take Odefsey.
3. Do not chew, crush or split the tablet. 7. Make sure you always have a supply of Odefsey at 4. If you vomit less than 4 hours after taking Odefsey,
home. Remember to request for a prescription refill in
take another tablet. When in doubt, always contact
time. If you leave home or are travelling, always take
your doctor or HIV-consulent.
Odefsey with you.
5. It is important not to miss a dose of Odefsey. If you do miss a dose: • If you notice within 12 hours of the time you usually take Odefsey, you must take the tablet with food as soon as possible. Then take the next dose as usual.
• If you notice 12 hours or more after the time you usually take Odefsey, then do not take the missed dose. Wait and take the next dose, with food, at
IMPORTANT TIPS
your usual time.
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Why have I been prescribed this medicine?
amount of viral particles by inhibiting the replication of
Odefsey is an anti-human immunodeficiency virus (HIV)
the virus. The treatment is successful if the amount of
medicine. This means that this medicine contributes to
viral particles (viral load) in your blood is reduced to
the treatment of HIV-infection. It helps prevent the HIV
an undetectable level. Then, the number of CD4 cells
from replicating and creating copies of itself, and slows
will increase, i.e. the immune system recovers from its
down the progression of the disease.
weakened state.
What does my medicine look like?
What are the ingredients of Odefsey?
Odefsey tablets are grey capsuleshaped tablets,
Odefsey contains three active substances: emtricitabine,
debossed on one side with “GSI” and the number “255”
rilpivirine and tenofovir alafenamide. These are
inscribed on the other side of the tablet. Odefsey comes
antiretroviral medicines. Each tablet contains 200 mg
in bottles of 30 tablets, and a silica gel desiccant (that
emtricitabine, 25 mg rilpivirine and 25 mg tenofovir
must be kept in the bottle to help protect your tablets).
alafenamide.
The silica gel desiccant is packaged in a separate sachet or canister and should not be swallowed.
Does this medicine cure HIV? No, this medicine is not a cure for HIV-infection.
How does this medicine work?
To control your HIVinfection and infections or other
HIV infects specific cells of the immune system and
illnesses associated with HIV-infection, you should
therefore weakens the immune system. The HIV-virus
always take this medication exactly as your doctor has
creates multiple copies of itself that continue to weaken
prescribed it.
the immune system. As a result, your body is less capable
FREQUENTLY ASKED QUESTIONS
FREQUENTLY ASKED QUESTIONS
of fighting infections and illnesses.2 Odefsey reduces the
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Who can prescribe Odefsey?
How do I take my medicine?
Odefsey is a prescription medicine that can only be
Always take this medication exactly as your doctor has
prescribed by a healthcare professional. You should
prescribed it. Check with your doctor or pharmacist if you
only take this medication if it has been prescribed by
are not sure. The recommended daily intake is one tablet
your doctor.
every day with food. Do not chew, crush or split the tablet. If you take an antacid, take it at least 2 hours before or at
When should I not take this medication?
least 4 hours after Odefsey. If you take an H2-antagonist,
If you are allergic to emtricitabine, rilpivirine, tenofovir
take it at least 12 hours before or at least 4 hours after
alafenamide or any of the other ingredients in this
Odefsey. H2-antagonists can only be taken once a day if
medicine (you can find all ingredients in the package
you take Odefsey. H2-antagonists should not be taken in
leaflet) or if you use any of the other medicines
a twice a day regimen.
mentioned on page 9 in the section “Other medicines How should I store this medicine? Store Odefsey in its original packaging to protect from Does my medicine reduce the risk of me transmitting
moisture. Keep the bottle tightly closed. Keep the
HIV to other people?
tablets out of sight and reach of children. Do not use this
You can still transmit HIV when taking this medicines,
medication after the expiry date. Ask your pharmacist how
although the risk is lowered by effective antiretroviral
to throw away medicines you no longer use.
therapy. Discuss with your doctor the precautions needed to avoid infecting other people. This medicine is not a cure for HIV-infection. While taking Odefsey you may still develop infections or other illnesses associated
FREQUENTLY ASKED QUESTIONS
and Odefsey�.
with HIV-infection.
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43
What do I need to tell my doctor before I start taking
If you notice one of these symptoms, please tell your
this medicine?
doctor immediately. For more information, please refer
Tell your doctor or pharmacist if you are taking, have
to the package leaflet.
recently taken or are going to take any other medicines. Tell your doctor if you are allergic to any of the
What do I do if I miss a dose of my medicine?
ingredients (see package leaflet for a full list)
It is important to not miss a dose of Odefsey. If you
or if you are pregnant, are likely to become pregnant
notice within 12 hours of the time you usually take your
or if you are breastfeeding. Also tell your doctor if
medication, take the tablet as soon as you remember.
you have liver problems, or a history of liver disease,
Take the tablet with food and then take the next dose
including hepatitis.
at the usual time. If you notice 12 hours or more after
Can this medicine cause side effects?
missed dose. Wait and take the next dose at your usual
As with all medicines, you may get side effects. On page
time. If you vomit less than 4 hours after taking your
20 you will find possible side effects. For a full list of side
medication, take another tablet. Do not stop taking
effects, please refer to the package leaflet that is supplied
Odefsey without first talking to your doctor.
with your medication. If you notice any side effects, talk to your doctor or pharmacist. This includes any possible side
Should I take this medicine if I am pregnant or if I am
effects not listed in the package leaflet.
breast-feeding? If you are pregnant, think you may be pregnant or are
Is it possible to experience serious side effects while
planning to have a baby, ask your doctor for advice
taking Odefsey?
before taking this medicine. Use effective contraception
Yes. You should look out for symptoms of inflammation,
while taking Odefsey to avoid getting pregnant.
FREQUENTLY ASKED QUESTIONS
the time you usually take Odefsey, then do not take the
infection or autoimmune disorders, such as muscle weakness, palpitations, tremors or hyperactivity.
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45
NOTES 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.
ODE/NL/16-09/NPM/1094(1) Date of preparation: November 2017
REFERENCES 1. Package leaflet Odefsey. http://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, http://www.rivm.nl/Documenten_en_publicaties/Professioneel_ Praktisch/Stappenplannen/Infectieziekten/VSI/VSI_Hiv