Dovato is indicated for the treatment of HIV-1 in adults and adolescents above 12 years of age weighing at least 40 kg, with no known or suspected resistance to the integrase inhibitor class, or lamivudine.

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Dovato is a complete treatment regimen that has been prescribed

to you by your doctor because they believe it’s the best treatment for you.

Dovato is taken once a day, with or without food.

Dovato is a treatment for human immunodeficiency

virus (HIV-1, or ‘HIV’) infection.

The most common side effects reported for Dovato are headache, diarrhoea and feeling sick (nausea).

SOME FAST FACTS

This is your Dovato information booklet. This booklet has been designed to help you have the best start on Dovato, and aims to answer any questions you may have about Dovato.

Being actively involved in your care will help you manage your HIV as effectively as possible, so make sure you attend all of your appointments.

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YOUR MEDICINEYour healthcare team have given you this booklet to help explain how Dovato works and how to take it. It also provides other useful information to help you take Dovato correctly.

Dovato comes with its own information leaflet included in the packaging. Make sure you read this carefully as it contains more detailed information.

Dovato is made up of two different medicines, called

dolutegravir and lamivudine, combined in one tablet.

Each Dovato tablet looks like this:

50 mg dolutegravir

+

300 mg lamivudine

Approx 9.5 mm

Approx 18.5 mm

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What’s more, if your viral load decreases to less than 50 copies of HIV per millilitre of blood, this means it has reached an undetectable level.

This is great news, because if your viral load remains at an undetectable level for at least 6 months, you cannot pass HIV on to others.

HOW DOVATO TREATS HIV

CD4 CELL SURFACE

CD4 CELL SURFACE

CD4 cells help your body fight infections and disease. HIV uses CD4 cells to multiply, destroying them in the process.If HIV is left untreated, your CD4 count goes down as the amount of virus in your blood (viral load) goes up. Taking Dovato every day as prescribed aims to strengthen your immune system by decreasing your viral load and allowing your CD4 cell count to recover.

As every person is different, not everyone will respond to Dovato in the same way, so your doctor will carefully monitor how well Dovato is working in your body.

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HOW DOVATO WORKS

Dovato is made up of two different medicines called dolutegravir and lamivudine. Dolutegravir belongs to a group of HIV drugs called integrase inhibitors (INIs). Lamivudine is part of a group called nucleoside reverse transcriptase inhibitors (NRTIs).

As dolutegravir and lamivudine are two different medicines, they work in different ways to stop HIV from multiplying.

HIV

HIV GENETICMATERIAL

L

D

CD4 CELL

CD4 GENETIC MATERIAL

COPYINGSTEP

COMBININGSTEP

CD4 CELL SURFACE

Lamivudine stops HIV from copying its genetic material after it has entered the CD4 cell

Dolutegravir works by stopping the HIV genetic material from combining with that of the CD4 cell

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BEFORE YOU TAKE DOVATO

PREGNANCY• If you are a woman of childbearing

age and are planning to become pregnant you must tell your doctor immediately

• You must use effective contraception whilst taking Dovato

• If you find out that you are pregnant whilst taking Dovato, you should tell your doctor immediately

• You should not stop taking your medicine unless your doctor tells you to

• Do not take Dovato if you are taking a medicine called fampridine (also known as dalfampridine) used in multiple sclerosis.

There are a few things you need to be aware of before you start taking your medicine.

OTHER HEALTH CONDITIONSYou shouldn’t take Dovato if you are allergic to any of the ingredients. For a full list of the ingredients in Dovato, please see the Appendix at the back of this booklet. This information is also provided in the Patient Information Leaflet that you received with your Dovato tablets.

Let your doctor know if you have a liver or kidney problem.

CD4 CELL SURFACE

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Many medicines can be taken alongside Dovato, but some medicines may affect how Dovato works and Dovato can affect how some other medicines work.

Your doctor and pharmacist will check what other medicines you’re taking before they give you Dovato. If you change any of the other medicines you’re taking whilst also taking Dovato, be sure to let them know.

There are some medicines that shouldn’t be taken, or that should be taken in a certain way, whilst you are on Dovato. If you do accidentally take any of these medicines whilst taking Dovato, you may experience some side effects, or it may affect the way Dovato works. You should talk to your doctor, pharmacist or nurse in your clinic for advice on what to do next.

DOVATO AND OTHER MEDICINES

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CD4 CELL SURFACE

Remember to let your doctor know about all other medicines you are taking now, have recently taken or might take in the future.

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DOVATO AND OTHER MEDICINES OR SUPPLEMENTS

Dovato may interact with other medicines, so you must make sure that your doctor and pharmacist know all of the other medicines you are taking.

Dovato is known to interact with sorbitol and similar solutions (may be used as a laxative). Avoid taking these on an ongoing basis with Dovato.

Your doctor may need to adjust your Dovato dose if you take any of these:

• Metformin (an oral medication often used for type 2 diabetes)

• Rifamipicin (an antibiotic, also called rifampin)

• Carbamazepine (used for epilepsy or nerve pain)

• Oxcarbazepine (used for epilepsy or bipolar disorder)

• Phenytoin (used for epilepsy)• Phenobarbital (used for epilepsy)• St John’s wort (an over the counter

supplement used for mild and moderate depression, seasonal affective disorder [SAD], mild anxiety and sleep problems)

CD4 CELL SURFACE

The time you take your Dovato may need to change if you are taking antacids or supplements - please speak to your pharmacist if you are taking any of these medicines.

Do not take Dovato on an empty stomach with:

• Antacids containing aluminium, calcium, iron, magnesium, or zinc (polyvalent cations)

• Supplements or multivitamins containing calcium, iron, or magnesium

Take them either 2 hours after or 6 hours before Dovato

If you’re taking your Dovato with food, you can take supplements or multivitamins containing calcium, iron, or magnesium at the same time.

If you drink alcohol or use recreational drugs, even if just occasionally, be sure to let your healthcare team know, because interactions between your medicine and recreational drugs may increase the risk of side effects.

Don’t take Dovato with the following medicine:

• fampridine (also known as dalfampridine), used in multiple sclerosis.

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HOW TO TAKE DOVATO

Dovato should be taken once daily, ideally at the same time of day each day.

Swallow your tablet together with some water or juice. Dovato can be taken with or without food.

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REMEMBERING TO TAKE DOVATOTaking Dovato every day as prescribed can help you achieve and maintain an undetectable viral load. If your viral load becomes undetectable and stays at this level for at least 6 months, you cannot pass HIV on to others. This is known as:

It is important that you try to take Dovato at about the same time of day, every day, for it to work properly. However, this can sometimes be challenging with the ups and downs of daily life. To help make things easier, there are a number of ways you can remind yourself to stay on top of your treatment.

UNDETECTABLE = UNTRANSMITTABLE

(U=U)OR

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Create a reminder: this could be an alarm, an app or a calendar alert on your phone.

Plan ahead: keep extra medicine with you at all times, in case you forget to take your dose, or in case of travel or a change in your routine.

Keep a diary: record when you have taken your medicine. You could also put a tick in a calendar.

Try keeping your medicine in a memorable, but safe, spot: for example, on your bedside table.

Make it routine: taking Dovato as part of your morning or bedtime routine can help you get into the habit of taking your medicine at the same time every day.

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If your sleep, work, or school schedule, or your responsibilities at home, interfere with taking your medicine on time, discuss this with your healthcare team.

REMEMBERING TO TAKE DOVATO

Male, age 23, living with HIV for 23 years

I WEAVE MY TREATMENT IN ALONGSIDE MY DAILY HYGIENE ROUTINE, E.G. BEFORE SHOWERING, TEETH BRUSHING, NIGHT-TIME FACE MASK.

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If you do accidentally miss one dose of Dovato there is no need to panic.

If you are not due another dose in the next 4 hours, just take your tablet as soon as you remember. Speak to your pharmacist if you are unsure.

If you are due another dose of Dovato in the next 4 hours, simply skip the missed dose and take your next dose at the regular time.

If you continue to miss doses and are not sure what to do, speak to your doctor.

Dovato does not require any special storage conditions, but as with all medicines, you should keep Dovato away from children and pets.

Make sure you don’t take your Dovato after the expiry date shown on the packaging. The expiry date refers to the last day of the month. For example, an expiry date of March 2019 would mean that your tablets expire on 31st March 2019.

WHAT TO DO IF YOU MISS A DOSE

HOW TO STORE DOVATO

Do not take two doses at the same time to make up for a missed dose.

Female, age 50, living with HIV for 11 years

AS HUMAN BEINGS WE DO SOMETIMES FORGET THINGS... IF YOU DO FORGET A TABLET THE SIMPLE THING IS JUST DON’T PANIC, AND ALSO REMEMBER YOU DON’T NEED TO STRUGGLE, YOU DON’T NEED TO DO IT ALONE, YOU CAN TALK TO SOMEBODY ELSE WHEN YOU ARE STRUGGLING.

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THE POSSIBLE SIDE EFFECTS OF DOVATO

Like all medicines, Dovato may cause side effects. It’s hard to know if you will have side effects or how long they will last if you do—it’s different for everybody.

If you do experience side effects or symptoms, even those not listed in the Patient Information Leaflet, be sure to let your healthcare team know so they can help you to manage them.

The complete list of possible side effects is included in the Patient Information Leaflet that came with your medicine, but the most common ones (affecting more than 1 in 10 people) reported for Dovato are:

• diarrhoea• feeling sick (nausea)• headache.

If you experience signs of an allergic reaction, such as swelling of the face and mouth causing breathing difficulties, a skin rash or a high temperature, see a doctor straight away.

If you experience signs of an infection, such as a fever, headache, stomach ache or difficulty breathing, see a doctor straight away.

Other common side effects (affecting up to 1 in 10 people) reported for Dovato are:

• abnormal dreams• anxiety• being sick (vomiting)• depression• difficulty sleeping• dizziness• feeling sleepy• hair loss• itching• joint pain• lack of energy• muscle pain• rash• stomach pains• wind.

If you experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the patient information leaflet. You can also report side effects directly via HPRA Pharmacovigilance, Earlsfort Terrace, IRL-Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; email: medsafety@hpra.ie. By reporting side effects you can help provide more information on the safety of this medicine.

Female, age 50, living with HIV for 11 years

IF YOU THINK THAT YOU ARE EXPERIENCING SIDE EFFECTS, KEEP A WRITTEN DIARY OF WHAT IS HAPPENING… HAVING SIDE EFFECTS WRITTEN DOWN IS FAR BETTER THAN TRYING TO RECALL THEM, AND YOU ARE MORE LIKELY TO REMEMBER WITH A VISIBLE REMINDER.

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HEALTHCARE APPOINTMENTS

It is important that you talk openly to and work together with your healthcare team because:

• this will help you better understand HIV and your treatment

• this will help your healthcare team build a treatment plan suited to your personal needs.

MAKING THE MOST OF YOUR

CD4 CELL SURFACE

Did you know… that people living with HIV who talk about their concerns with their healthcare team feel significantly more empowered about their treatment than those who don’t?

Guitart J, et al. 22nd International AIDS Conference 2018. Poster TUPED4325.

Male, age 23, living with HIV for 23 years

TALK TO YOUR HEALTHCARE TEAM AND AIR OUT ANY CONCERNS… THEY’LL BE ABLE TO COMMUNICATE THE DO’S, THE DON’T’S AND, MAINLY, THE WHY’S. UNDERSTANDING WHY I’M TAKING MY TREATMENT AND HAVING ALL MY SEEMINGLY SILLY QUESTIONS ANSWERED HELPED ME TO MAKE ADHERENCE A TOP PRIORITY.

Being actively involved in your care can go a long way, so:

Be prepared: take some time to think about your health before each appointment. Write down any questions or concerns you may have so you don’t forget to talk about them with your doctor (you can use the Appointment Tracker section in the back of this booklet for this).

Ask! Speak up if you don’t understand something your doctor tells you. You may want to bring a partner, family member or friend with you to appointments—they can help you ask questions and/or remember useful information.

Stay informed: your healthcare team is a great source of information, but it helps to do your own research too. The more you know about HIV and your treatment, the more motivated you will be to stay healthy.

You can make your own short guide that can offer support during health appointments at: https://livlife.com/en-ie/unity-tool/

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HELPFUL INFORMATIONMy clinic is:

My clinic’s contact number is:

My doctor’s name is:

My emergency contact is:

My next appointments are:

Date Time With

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APPOINTMENT TRACKERMy medicines: My viral load and CD4 count tracker:

Date Viral load (copies/mL) CD4 count (cells/mm3)

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APPOINTMENT TRACKERKey topics to discuss:

If you have experienced any side effects or symptoms, make a note of them here:

Don’t forget to tell your doctor about any side effects or symptoms next time you see them.

Date Side effect or symptom

How bad (1-10, mild-severe)

How long (start time, and has it stopped?)

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TRAVEL CHECKLIST

• Talk to your healthcare team about your plans

• If you require vaccinations, get these at least 8 weeks before you travel

• Check the time zone difference and set your alarms or reminders accordingly

• Pack medicines that will help you manage potential side effects

• Make sure you have appropriate travel insurance

• Count out doses, packing extra in case of delays or changes to your plans

• Pack your medicine in your carry-on bag in case your checked-in luggage is lost

• Customs Officials require all prescription medicines (not just HIV ones) to be accompanied by a letter from your doctor. Make sure to ask for this when discussing your travel plans

CD4 CELL SURFACE

Taking some time to plan how you will store and take your medicine away from home can make your trip go a lot more smoothly. The list below contains some useful tips to consider before you travel.

If you run out of tablets whilst you’re away, contact your clinic as soon as possible as they may be able to help arrange extra supplies, even if you’re abroad (however, this is not guaranteed).

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RESOURCES

Always remember that you don’t need to go through this on your own. There are many people and organisations that can help you, including HIV support organisations and your healthcare team.

Local resources

Ask your doctor if there are any local resources that they would recommend and make a note of them here:

Name of resource Contact information

NOTES

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NOTES

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APPENDIX

Dovato ingredients list

Dovato contains the following ingredients:

• 50 mg dolutegravir• 300 mg lamivudine• Hypromellose (E464)• Macrogol• Magnesium stearate• Mannitol (E421)• Microcrystalline cellulose• Povidone (K29/32)• Sodium starch glycolate• Sodium stearyl fumarate• Titanium dioxide (E171).

This information is also provided in the Patient Information Leaflet that you received with your Dovato tablets.

DOVATO is owned by or licensed to the ViiV Healthcare group of companies. ©2020 ViiV Healthcare group of companies or its licensor.

NP-IE-DLL-PINF-200001 Date of Preparation May 2020.

Male, age 28, living with HIV for 8 years

SO... THERE’S A LOT GOING ON FOR YOU RIGHT NOW. IT’S NORMAL TO BE SCARED OR WORRIED BUT TAKE A BREATH AND SLOW DOWN YOU ARE GOING TO BE OKAY...