HIV Treatment with SymtuzaÂŽ
Information for people using Symtuza
Preface Your doctor has prescribed SymtuzaÂŽ (darunavir/cobicistat/emtricitabine/ tenofoviralafenamide)for you. Symtuza is a medicine that is used together with othermedicines to treat HIV. This brochure contains information about Symtuza and about the way it is used. This information does notreplace the Symtuza package leaflet and you should always read the leaflet you find in the box your Symtuza tablets come in. If you have any further questions after reading this brochure and the package leaflet, ask your doctor, HIV counselor or your pharmacist.
This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
Published by: Janssen-Cilag B.V. No part of this publication may be published in any form or by any means, electronically or mechanically, including photo-copying, recording, retrieval system, without written permission from the publisher. This publication was compiled with the utmost care in October 2017. The information is based on the official product information of Symtuza. If you have any suggestions for additions or corrections, please let us know by e-mail via janssen@jacnl.jnj.com
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Contents
What is Symtuza?
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How to take Symtuza
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How to store Symtuza
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The pack
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Pregnancy and breastfeeding
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Who this medicine is suitable for and who should take extra care
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Adherence with therapy
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Tips to improve your adherence with therapy
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Forgotten medication
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Other medicines and Symtuza
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Other interactions
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Side effects
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What your doctor must know
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Long-term use
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Coping with side effects
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Tiredness
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In conclusion
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What is Symtuza? Each tablet Symtuza contains 800 mg darunavir, 150 mg cobicistat, 200 mg emtricitabine and 10 mg tenofoviralafenamide and is an antiretroviral medicine used to treat infection with human immunodeficiency virus 1 (HIV-1). It is used in adults and adolescents aged 12 years and older who weigh at least 40 kg. Symtuza contains 4 active substances:
Darunavir: this medicine belongs to the group of the protease inhibitors. These medicines inhibit enzymes called proteases, which the HIV virus needs to multiply. Cobicistat: this medicine strengthens the activity of other medicines and is also known as a ÍšboosterÍ›. It ensures that the amount of darunavir in your body is high enough to reduce the amount of HIV virus. Cobicistat itself does not have any effect on the HIV virus.
Practical information about Symtuza Symtuza (darunavir/cobicistat/emtricitabine/tenofoviralafenamide) is used to treat HIV and reduces the amount of HIV virus in your body. Choose times that suit you to take your medicines. You need to take Symtuza with some food; the type of food does not matter. It is not possible to cure HIV. Symtuza does not cure HIV either. Your HIV infection may still cause you to get certain conditions. You should therefore be in regular contact with your doctor and take your medicines correctly at all times.
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Emtricitabine: (Also known as FTC): This agent belongs to the group of nucleoside analogue reverse transcriptase inhibitors and works in the same place as tenofoviralafenamide. Tenofoviralafenamide: (Also known as TAF); is an agent which belongs to the group of nucleotide analogue reverse transcriptase inhibitors, and brakes, as well as the above-mentioned emtricitabine, the enzyme reverse transcriptase. Also this enzyme HIV needs to multiply.
Symtuza is a complete therapy against the HIV virus in a single tablet. You can not use Symtuza in combination with another antiviral agent to a reinforcing fabric (booster) contains or with another antiviral agent where reinforcement is needed. The goal of therapy is to reduce the amount of HIV virus in your body. If successful, your immune system recover and you will be less susceptible to infections.
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Objective The objective of the treatment is to reduce the amount of HIV virus in your body. If the amount of virus in your body is no longer detectable, the treatment can be called successful. Your immune system will recover and you will become less susceptible to HIV-related infections.
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How to take Symtuza
How to store Symtuza
If your doctor advises you to take Symtuza, you should:
There are no special storage conditions for Symtuza. Make sure it is kept out of the reach of children and pets. There is a date after EXP on the box and the bottle. This date refers to the last month you This date refers to the last month you can still use the medicine
Take one yellow tablet of Symtuza once daily with something to eat. . with something to eat
Your tablet at the time you choose to take:
(for example, 05/2019 refers to May 2019). Do not use the content after the last day of that month and return the bottle containing any leftover tablets to your pharmacy.
+ The pack You may take the tablet during a meal, but you may also take it with, for example, a biscuit, croissant or some yogurt. Symtuza is absorbed more efficiently in your blood if you eat something when you take the medicine. Once it has been absorbed, it can get to work. Symtuza is not absorbed well without food.
The plastic bottle containing Symtuza has a childproof closure. Open the bottle as follows: press the plastic screw cap down and turn it anticlockwise at the same time. Pull the cap upwards after this.
It is important for you to know how to take your other HIV inhibitors properly.
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Pregnancy and breastfeeding
Who this medicine is suitable for and who should take extra care
If you are planning to have a baby while you are using HIV inhibitors, you should always ask your doctor for advice. If you find out that you are pregnant while you are using Symtuza, you should immediately talk to your doctor. Symtuza may not be taken by pregnant women unless your doctor expressly advises this. Women living with HIV may not breastfeed because this may transfer HIV to the baby via the breast milk.
Symtuza is a medicine suitable for people who have never used HIV inhibitors before and for people who have been treated with other HIV inhibitors before.
You can use Symtuza not simultaneously with drugs for the treatment of a hepatitis B infection. These are medicines containing tenofovir, lamivudine or adefovir dipivoxil.
Patients with allergies Do not use Symuza if you are allergic to darunavir, cobicistat, emtricitabine, tenofoviralafenamide, sulfonamiden or any of the other ingredients of Symtuza
Patients with kidney problems Tell your doctor if you have ever had any kidney problems. Your doctor will make a carefull assessment of wheter he or she will prescribe Symtuza for you.
Patients with liver problems Do not use Symtuza if you have or have ever had serious liver problems. If you have mild to moderate liver problems, your doctor will closely monitor your liver function. If you are being treated for hepatitis B or C, Symtuza may lead to liver problems. Your doctor will weigh up the benefits and risks of being treated with Symtuza at the same time.
Patients with hemophilia Tell your doctor if you have hemophilia (bleeding disorder), because Symtuza may increase the risk of bleeding.
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Elderly patients and children Symtuza been extensively studied in people between 12 and 65 years. It is limited only been studied in people over 65 years. Your doctor will then so be extra vigilant for side effects. Symtuza has not been studied in children younger than 12 years. Patients who also use other medications in addition to Symtuza Certain medicines can not be combined with Symtuza. In the chapter 'Symtuza and other drugs "refer to whatever means it is
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Adherence with therapy It is very important for you to take your HIV inhibitors every day, at the right times and according to the instructions (Symtuza should be taken with food). This is called compliance with therapy. Many people find it easiest to take their medicines at the fixed times they have chosen to take their medicines. That way, they know for sure that they have taken their medicines. HIV inhibitors will work well for long periods of time if you take your tablets properly. Talk to your doctor or HIV counselor if you find it difficult to take your HIV inhibitors at the right times and according to the instructions. It is very important that any problems you experience are solved. If you do not
take your medicines according to the instructions every day, the HIV virus in your body may become resistant to Symtuza and other HIV inhibitors you are using. The medicines will then no longer be effective over time.
You may sometimes need to choose between taking your medicines on time without food and taking your medicines later with food, for example if you are held up in traffic and you have your tablets and water but nothing to eat with you. In that situation, you should preferably take your tablets later with food than take them on time without food. Try to avoid this situation by always having something toeat with you.
Tips to improve your adherence with therapy It is not easy to take prescription medicines according to instructions every day for years on end. There are tips that can help you. Your HIV counselor and your doctor will help and support you with this. Here are a few tips for you. Choose easy times to take your tablets Easy times will fit well into your daily schedule. If you work during the daytime and you do not want to share your HIV status with your colleagues, it may be most practical to take your tablets in the morning before going to work and in the early evening. If you like to sleep in on the weekend, you should choose later times in the morning and evening. The better the times you take your tablets fit into your daily schedule, the easier it will be to keep up the routine of taking them.
Set an alarm Many people benefit from being reminded about taking their tablets by setting an alarm. You can set your alarm to go off at specific times on your mobile phone and on some watches. There are also special tablet boxes that come with an alarm. Every option has its own advantages and disadvantages. You should check that you can indeed program the alarm to go off automatically at the same time every day. Tablet box If you use a weekly tablet box, you do not need to take any bottles or strips with you each time. The box also allows you to check whether or not you have taken your tablets. There are daily tablet boxes that come as a key ring, which allows you to have a spare set of tablets on you at all time.
If compliance with therapy is difficult for you If you find it difficult to take your tablets at the right times, talk to your doctor or HIV counselor about what you might be able to do about this. If you regularly forget to take your tablets or take them too late, or do not follow the advice to take Symtuza with food, the HIV virus may become resistant, which will prevent the medicine from working properly.
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Forgotten medication
Spare tablets It is a good idea to keep some spare tablets in your bag or coat pocket and in place you visit often, for example your family, your work and so on. Spare food You should keep a supply of food in places where you come often. You shoulf, for example, keep a prepackaged biscuit or candy bar in your car, desk drawer or sprt bag. Pillcoach There are several apps available for mobile phones that can remind you to take your medicine. Let us inform you that therapietrouw- app suits you, or ask your HIV consultant.
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Forgotten medication It may happen that you do once forget your medication. The instruction was what to do when you forgot? ' may be different for the different HIV inhibitors. It may therefore be useful in advance to discuss with your doctor or HIV consultant what you do best if you find you have forgotten your medication.
doctor, nurse or HIV pharmacist. Try to avoid this situation by using a pillbox or medicatierol, or by scoring each intake.
Advice missed dose Symtuza If you forget a dose of Symtuza within 12 hours after the normal time of intake, the advice is to take as soon as possible with food dose Symtuza. If a missed dose later than 12 hours it is observed following the normal time of ingestion, do not occupy more of the missed dose but continue to follow the normal dosing schedule. It may also happen that you really do not know whether you have taken or not your Symtuza. If in such a situation, your
Ask your doctor or HIV consultant in advance what to do if you forgot your medication again. You need no longer to find out if it happens again.
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Other medicines and Symtuza
Other interactions
Symtuza combination therapy A combination therapy is an HIV-treatment in which a combination of different anti-HIV drugs, usually from different classes, at the same time will be taken. Symtuza is a combination therapy in a single tablet that is typically prescribed as complete HIV-therapy. If your doctor next Symtuza also advise other HIV drugs, it requires additional control. Symtuza can not be combined with any anti-retroviral drugs.
Always discuss with your doctor and your pharmacist what medications you are taking besides Symtuza (which includes non-prescription medicines - so without a prescription - and also for alternative medicines and "recreational drugs"). Medicines can influence each other strongly, making them less likely to work or giving you, sometimes extremely serious, side effects can experience. This is known as interaction or interaction. Sometimes this can be solved by side to keep extra eye, sometimes by changing the dosage and sometimes by choosing a different means.
Report what you use Always discuss with your doctor or pharmacist which medicines you are taking. This is also true for non-prescription drugs, for alternative medicines, and also for recreational drugs.
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Here is a brief list of the main interactions with Symtuza. The fabric names of drugs are always on the packaging. The names may vary. In the leaflet of Symtuza you will find the complete list of interactions.
This means you may only use a customized dosage with Symtuza:
Medicines for erectile dysfunction:: Symtuza increases the amount of these substances in the blood significantly, which may have serious side effects. Your doctor will therefore sildenafil, vardenafil or tadalafil prescription at greatly reduced doses and a longer time between intake moments.
Digoxine (for arrhythmias): Symtuza may increase the amount of this substance in the blood, which may have serious side effects. It is recommended to start with the lowest possible dose of digoxin, when combined with Symtuza.
Metformin (for diabetes): Symtuza may increase the amount of this substance in the blood, which may have serious side effects.
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A doctor should keep an eye on this and adapt the metformin dose is recommended in patients taking Symtuza.
• sleeping problems or anxiety), • lurasidon, pimozide, quetiapine, sertindoel (for mental disorder),
• medicines containing ergot or rye, such as Beta blockers (for high blood pressure and other conditions): carvedilol, metoprolol, timolol: Symtuza may increase the amount of these substances in the blood, leading to side effects may occur. A doctor can keep an eye on this and consider a lower dose of the beta blocker when these agents are combined. Do not use these medicines with Symtuza: Do not use Symtuza with any of the following medicines. If you use any of these medicines, ask your doctor to switch you to another medicine. • triazolam, midazolam (for
• • • • • • • •
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ergotamine (for migraines/headaches), amiodarone, bepridil, dronedarone, quinidine, ranolazine, systemic lidocaine (for certain heart disorder), lovastatin and simvastatin (cholesterol lowering medicines), rifampicin (treatment for infections, e.g. tuberculosis), alfuzosin (for enlarged prostate), sildenafil (if prescribed for high blood pressure in de lungs), carbamazepine, fenobarbital, fenytoïne (medicines against epilepsy), St John͛s wort (Hypericum perforatum) (a herbal remedy) colchicine (a medicine against gout)if used in patients with kidney or liver failure,
• ticagrelor (antiplatelet medicines), • the co-formulation lopinavir/ ritonavir (for the treatment of HIV),
• avanafil (for the treatment of erectile dysfunction) Medicines against high cholesterol levels: simvastatin and lovastatin may not be combined with Symtuza. Pravastatin and atorvastatin may be combined, but at a lower initial dosage. You should not use any medicines containing St John͛s wort (most of these are intended to treat depression). Please note: this medicine is sometimes an ingredient in herbal remedies bought from a health food store or drug store. Tell your doctor if you are using any medicines to control hepatitis B or C. Symtuzamay be combined with medicines against heartburn. There are also medicines that may interact with Symtuza. The effect of Symtuza
may then be reduced, or the dosage of the other medicines may need to be adjusted. This includes certain medicines against epilepsy, inflammation/infection (also fungal infections), heart disorders, blood clotting, asthma, depression/anxiety, nerve pain, high blood pressure in the lungs, medicines to control symptoms of the menopause, malaria, hormon birth control and gout. A full list of these medicines can be found in the ͚Other medicines and Symtuza section of the package leaflet. Read this section carefully before using Symtuza.
Please note: If you buy any medicines, e.g. medicines against erectile dysfunction, outside your pharmacy, you will not know exactly what they contain. The interactions these medicines may cause present a risk and it is not known how big this risk is.
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Side effects
Interactions between Symtuza and recreational drugs Symtuza significantly slows down the breakdown process of certain substances in your blood. This means that the levels of these substances may increase dramatically. This may also apply to recreational drugs. If you use recreational drugs, you should discuss this openly with your doctor or pharmacist. This may not be easy, but it may prevent serious problems later on.
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You should realize that you can never be entirely certain what your recreational drugs contain. This is why you will never be entirely certain how big the risk of taking them truly is.
Like all medicines, Symtuza may cause side effects. Whether or not you will get them and how long they will last for cannot be predicted. This is different for everyone. Studies among Symtuza users have identified the following side effects:
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headache Vomiting, diarrhea, nausea fatique huiduitslag allergic reactions such as nettle rash (utricaria), itching, severe swelling of the skin and other tissues (most often the lips or the eyes)
• decreased appetite (anorexia) • abnormal dreams • vomiting, pain or swelling of the belly, indigestion, flatulence (wind)
• abnormal blood test results such as some • • • •
tests for your pancreas or kidney. Your doctor will explain these to you. dizziness joint pain muscle pain, muscle cramps or weakness weakness
Details of other side effects which occur less frequently when using Symtuza are given in the package leaflet.
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What your doctor must know
There is a chance that the restoration of your body͛s defenses will be associated with unpleasant manifestations: due to this restoration your body is suddenly able to respond actively to infections that were previously present without symptoms; you notice this, for example, in symptoms such as fever, chills, severe headache, breathlessness or exhaustion. If that does happen, then it is usually in the first weeks or months of treatment. Advise your doctor or HIV consultant immediatelyif you have these sorts of symptoms. In addition to these infections, autoimmune diseases (a disorder which occurs when the immune system attacks healthy body tissue) may develop. Autoimmune diseases may occur many months after the start of treatment. If you notice symptoms such as muscle weakness,
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weakness, beginning in the hands and feet and moving up towards the trunk of the body, palpitations, tremor or hyperactivity, please inform your doctor or HIV-consultant immediately. Treatment of HIV infection can increase the risk of developing osteonecrosis (a bone disease in which bone tissue is lost). Tell your doctor if your joints are stiff or painful and you have difficulties moving. Tell your doctor if you notice changes in body shape or fat distribution, because a gain, loss or redistribution of body fat may occur. As a general rule, if you are suffering significantly from a side effect, or if you notice a side effect which is not in the package leaflet, contact your doctor or HIV consultant.
Long-term use
Long-term users of HIV inhibitors may eventually experience symptoms where it is not entirely clear which medicines caused them. This is due to the fact that everyone takes several HIV inhibitors at the same time. In some such patients, the following problems arise: Metabolism: sugar levels in the blood can increase and existing diabetes can become worse. Certain blood fat levels can increase (triglycerides or cholesterol). Your doctor will monitor these values regularly.
Contact your doctor immediately if you develop a skin rash, or a swollen face or breathlessness. If you cannot reach either your doctor or your HIV consultant, ask for another doctor and explain the situation (in hospital a duty doctor is always available for emergencies). Contact your doctor also if you develop signs of infection after starting Symtuza, such as fever, chills, severe headache, breathlessness or exhaustion.
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Coping with side effects
If you suffer side effects from taking Symtuza, these will often decrease or disappear altogether after the first six to eight weeks. What if that does not happen? Treatment Sometimes your doctor can do something about your side effects. For example, he can treat diarrhea with diarrhea inhibitors and raised cholesterol levels with cholesterollowering agents. Learning to live with it Sometimes the side effects you experience cannot be treated and it may not be possible to switch to other HIV inhibitors.
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In that situation not much can be done and you need to learn to live with the side effects. You can talk to your HIV consultant about this. He or she may possibly be able to help you to reduce your symptoms somewhat. A few general tips are given below. Diarrhea Remember to take sufficient fluid, salt and sugar. Try to adapt your diet; some people experience an improvement by avoiding, coffee, spices, alcohol or cheese, for example. Continue to eat enough fiber because it binds the feces (whole grain bread, vegetables and hard fruit such as
apples). You can also consult a dietician. As a precaution, keep a spare set of clothing at places where you spend a lot of time: at work, at your partner͛s, in the car.
Do not dry yourself after bathing but lie on a towel to dry off. Use a fatty cream, a menthol cream or menthol powder on sites that itch. If your itching is severe, talk to your doctor or HIV consultant.
Itching It is not easy to cope with severe itching. What can you do about it? Do not scratch the itchy site, but pat it gently with the flat of your hand. Have a warm shower, not a hot one, and shower less often than you usually do. It can also help to take a bath rather than stand under a jet of water. Use little or no soap.
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Tiredness
In conclusion
Chronic tiredness can be very disabling. General tips about tiredness are: continue to exercise regularly (walking, cycling), maintain a regular dayand-night rhythm and set priorities in your (daily) life. If you can no longer do everything, make sure that you do the things that you think are really important.
We hope that this information has been useful for you. If you still have questions after reading this brochure, contact your doctor, HIV consultant or pharmacist.
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You can also contact Janssen, the manufacturer of Symtuza, by e-mailing to janssen@jacnl.jnj.com
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Notes
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Notes
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More information? Janssen Customer Service Center Tel: 0800 - 242 42 42 janssen@jacnl.jnj.com www.janssennederland.nl
Janssen-Cilag B.V.
ŠJanssen-Cilag B.V. - PHNL/SYM/1017/0008
This information is meant to inform patients with HIV about treatment with Symtuza. You will recieve this information through your physician, hiv-consultant or pharmacist.