Dolutegravir (Tivicay) film-coated tablets 50 mg – patient leaflet, side effects, dosage

1. What Tivicay is and what it is used for

Tivicay contains the active ingredient dolutegravir. Dolutegravir belongs to a group of anti-retroviral medicines called integrase inhibitors (INIs). Tivicay is used to treat HIV (human immunodeficiency virus) infection in adults, adolescents and children of at least 6 years of age or older, and who weigh at least 14 kg. Tivicay does not cure HIV infection; it reduces the amount of virus in your body, and keeps it at a low level. As a result of that, it also increases the CD4 cell count in your blood. CD4 cells are a type of white blood cells that are important in helping your body to fight infection. Not everyone responds to treatment with Tivicay in the same way. Your doctor will monitor the effectiveness of your treatment. Tivicay is always used in combination with other anti-retroviral medicines (combination therapy). To control your HIV infection, and to stop your illness from getting worse, you must keep taking all your medicines, unless your doctor tells you to stop taking any.

2. What you need to know before you take Tivicay

Don’t take Tivicay:

• if you (or your child, if they are the patient) are allergic to dolutegravir or any of the other ingredients of this medicine (listed in section 6).

• if you (or your child) are taking another medicine called fampridine (also known as dalfampridine; used in multiple sclerosis). ➔ If you think any of these apply to you (or

  your child), tell your doctor.

Warnings and precautions

Look out for important symptoms

Some people taking medicines for HIV infection develop other conditions, which can be serious. These include:

• symptoms of infections and inflammation

• joint pain, stiffness and bone problems

  You need to know about important signs and symptoms to look out for while you (or your child, if they are the patient) are taking Tivicay.

  ➔ Read the information in Section 4 of this leaflet.

  Children

  Do not give this medicine to children under 6 years of age, weighing less than 14 kg or with HIV infection that is resistant to other medicines similar to Tivicay. The use of Tivicay film-coated tablets in children under 6 or weighing less than 14 kg has not yet been studied.

  Children must keep planned doctor’s appointments (see ‘Use in children and adolescents’ in Section 3 for more information).

  Other medicines and Tivicay

  Tell your doctor if you (or your child) are taking, have recently taken or are planning to take any other medicines.

  Don’t take Tivicay with the following medicine:

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

Some medicines can affect how Tivicay works, or make it more likely that you will have side effects. Tivicay can also affect how some other medicines work.

Tell your doctor if you (or your child) are taking any of the medicines in the following list:

• metformin, to treat diabetes
• medicines called antacids, to treat indigestion and heartburn. Do not take an antacid during the 6 hours before you take Tivicay, or for at least 2 hours after you take it. (See also Section 3).

• supplements or multivitamins containing calcium, iron or magnesium.

  If you take Tivicay with food, you can take supplements or multivitamins containing calcium, iron or magnesium at the same time as Tivicay. If you do not take Tivicay with food, do not take a supplement or multivitamin containing calcium, iron or magnesium during the 6 hours before you

  take Tivicay, or for at least 2 hours after you take it (see also Section 3).

  • etravirine, efavirenz, fosamprenavir/ritonavir, nevirapine or tipranavir/ritonavir, to treat HIV infection
  • rifampicin, to treat tuberculosis (TB) and other bacterial infections
  • phenytoin and phenobarbital, to treat epilepsy
  • oxcarbazepine and carbamazepine, to treat epilepsy or bipolar disorder

  • St. John’s wort (Hypericum perforatum), a herbal remedy to treat depression ➔ Tell your doctor or pharmacist if you (or

    your child) are taking any of these. Your doctor may decide to adjust your dose or that you need extra check ups.

Pregnancy

If you are pregnant, think you may be pregnant, or if you are planning to have a baby: ➔ Talk to your doctor about the risks and

benefits of taking Tivicay.

Tell your doctor immediately if you become pregnant or are planning to become pregnant. Your doctor will review your treatment. Do not stop taking Tivicay without consulting your doctor, as this may harm you and your unborn child.

Breast-feeding

Breast-feeding is not recommended in women living with HIV because HIV infection can be passed on to the baby in breast milk. A small amount of the ingredient in Tivicay can pass into your breast milk.

If you are breast-feeding, or thinking about breast-feeding, you should discuss it with your doctor as soon as possible.

Driving and using machines

Tivicay can make you dizzy and have other side effects that make you less alert. ➔ Don’t drive or operate machinery unless

you are sure you’re not affected. Tivicay contains less than 1 mmol sodium (23 mg) per tablet, that is to say is essentially ‘sodium-free.’

3. How to take Tivicay

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

• The usual dose is 50 mg once a day.
• If you are taking certain other medicines, the dose is 50 mg twice a day.
• For HIV that is resistant to other medicines similar to Tivicay, the usual dose is 50 mg, twice a day.

Your doctor will decide on the correct dose of Tivicay for you.

Swallow the tablet(s) with some liquid. Tivicay can be taken with or without food. When Tivicay is taken twice a day, your doctor may advise you to take with food. Tivicay is also available as dispersible tablets. Film-coated tablets and dispersible tablets are not the same, therefore do not switch between film-coated tablets and dispersible tablets without first talking to your doctor.

Use in children and adolescents

• Children’s dose of Tivicay needs to be adjusted as they get older or gain weight. ➔ It is important therefore that children

  keep planned doctor’s appointments.

• Children and adolescents weighing at least 20 kg can take the adult dose of 50 mg, once a day or 25 mg twice daily. Your doctor will decide how Tivicay should be given.
• For children aged between 6 and 12 years your doctor will decide on the correct dose of Tivicay, depending on the weight of your child.
• To reduce the risk of choking, children must not swallow more than one tablet at a time.
• Tivicay should not be used in children and adolescents with HIV infection that is resistant to other medicines similar to Tivicay.

Antacid medicines

Antacids, to treat indigestion and heartburn, can stop Tivicay being absorbed into your body and make it less effective.

Do not take an antacid during the 6 hours before you take Tivicay, or for at least 2 hours after you take it. Other acid-lowering medicines like ranitidine and omeprazole can be taken at the same time as Tivicay. ➔ Talk to your doctor for further advice on

taking acid-lowering medicines with Tivicay.

Supplements or multivitamins containing calcium, iron or magnesium

Supplements or multivitamins containing calcium, iron or magnesium can stop Tivicay being absorbed into your body and make it less effective. If you take Tivicay with food, you can take supplements or multivitamins containing calcium, iron or magnesium at the same time as Tivicay. If you do not take Tivicay with food, do not take a supplement or multivitamin containing calcium, iron or magnesium during the 6 hours before you take Tivicay, or for at least 2 hours after you take it.

➔ Talk to your doctor for further advice on

taking supplements or multivitamins containing calcium, iron, or magnesium with Tivicay.

If you take more Tivicay than you should

If you (or your child) take too many tablets of Tivicay, contact your doctor or pharmacist for advice. If possible, show them the Tivicay pack.

If you forget to take Tivicay

If you (or your child) miss a dose, take it as soon as you remember. But if your next dose is due within 4 hours, skip the dose you missed and take the next one at the usual time. Then continue your treatment as before.

Don’t take a double dose to make up for a missed dose.

Don’t stop taking Tivicay without advice from your doctor

Take Tivicay for as long as your doctor recommends. Don’t stop unless your doctor advises you to.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, but not everybody gets them.

Allergic reactions

These are uncommon in people taking Tivicay. Signs include:

• skin rash
• a high temperature (fever)
• lack of energy (fatigue)
• swelling, sometimes of the face or mouth (angioedema), causing difficulty in breathing
• muscle or joint aches.

➔ See a doctor straight away. Your doctor may decide to carry out tests on your liver, kidneys or blood, and may tell you to stop taking Tivicay.

Very common side effects

These may affect more than 1 in 10 people:

• headache
• diarrhoea
• feeling sick (nausea).

Common side effects

These may affect up to 1 in 10 people:

• rash
• itching (pruritus)
• being sick (vomiting)
• stomach pain (abdominal pain)
• stomach (abdominal) discomfort
• weight gain
• insomnia
• dizziness
• abnormal dreams
• depression (feelings of deep sadness and unworthiness)
• anxiety
• lack of energy (fatigue)
• wind (flatulence)
• increase in the level of liver enzymes

• increase in the level of enzymes produced in the muscles (creatine phosphokinase).

  Uncommon side effects

  These may affect up to 1 in 100 people:

  • inflammation of the liver (hepatitis)
  • suicide attempt*
  • suicidal thoughts*
  • panic attack
  • joint pain
  • muscle pain

* particularly in patients who have had depression or mental health problems before.

Rare side effects

These may affect up to 1 in 1000 people:

• liver failure (signs may include yellowing of the skin and the whites of the eyes or unusually dark urine)
• increase in bilirubin (a test of liver function) in your blood.
• suicide (particularly in patients who have had depression or mental health problems before)

➔ Tell your doctor immediately if you experience any mental health problems (see also other mental health problems above).

Very rare side effects

These may affect up to 1 in 10,000 people:

• a condition where red blood cells do not form properly (sideroblastic anaemia).

Symptoms of infection and inflammation

People with advanced HIV infection (AIDS) have weak immune systems, and are more likely to develop serious infections (opportunistic infections). Such infections may have been “silent” and not detected by the weak immune system before treatment was started. After starting treatment, the immune system becomes stronger, and may attack the infections, which can cause symptoms of infection or inflammation. Symptoms usually include fever, plus some of the following:

• headache
• stomach ache
• difficulty breathing

In rare cases, as the immune system becomes stronger, it can also attack healthy body

tissue (autoimmune disorders). The symptoms of autoimmune disorders may develop many months after you start taking medicine to treat your HIV infection. Symptoms may include:

• palpitations (rapid or irregular heartbeat) or tremor
• hyperactivity (excessive restlessness and movement)
• weakness beginning in the hands and feet and moving up towards the trunk of the body.

If you (or your child) get any symptoms of infection and inflammation or if you notice any of the symptoms above:

➔ Tell your doctor immediately. Don’t take other medicines for the infection without your doctor’s advice.

Joint pain, stiffness and bone problems

Some people taking combination therapy for HIV develop a condition called osteonecrosis. With this condition, parts of the bone tissue die because of reduced blood supply to the bone. People may be more likely to get this condition:

• if they have been taking combination therapy for a long time
• if they are also taking anti-inflammatory medicines called corticosteroids
• if they drink alcohol
• if their immune systems are very weak
• if they are overweight.

Signs of osteonecrosis include:

• stiffness in the joints

• aches and pains in the joints

  (especially in the hip, knee or shoulder)

• difficulty moving.

If you notice any of these symptoms: ➔ Tell your doctor.

Weight, blood lipid and blood glucose effects

During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose. This is partly linked to restored health and lifestyle, and sometimes to the HIV medicines themselves. Your doctor will test for these changes.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Tivicay

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated after EXP on the carton and bottle.

Tivicay 10 mg film-coated tablets

Store in the original package in order to protect from moisture. Keep the bottle tightly closed. Do not remove the desiccant. Do not swallow the desiccant. This medicine does not require any special temperature storage conditions.

Tivicay 25 mg and 50 mg film-coated tablets This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Tivicay contains

• The active substance is dolutegravir. Each tablet contains dolutegravir sodium equivalent to 10 mg, 25 mg or 50 mg dolutegravir.

  • The other ingredients are mannitol (E421), microcrystalline cellulose, povidone, sodium starch glycolate, sodium stearyl fumarate, poly(vinyl alcohol) partially hydrolyzed, titanium dioxide (E171), macrogol, talc and for 25 mg and 50 mg tablets, iron oxide yellow (E172).

What Tivicay looks like and contents of the pack

Tivicay 10 mg film-coated tablets are white, round, biconvex tablets marked with the code ‘SV 572’ on one side and ‘10’ on the other side. The bottle contains a desiccant to reduce moisture. Once the bottle has been opened keep the desiccant in the bottle, do not remove it.

Tivicay 25 mg film-coated tablets are pale yellow, round, biconvex tablets marked with the code ‘SV 572’ on one side and ‘25’ on the other side.

Tivicay 50 mg film-coated tablets are yellow, round, biconvex tablets marked with the code ‘SV 572’ on one side and ‘50’ on the other side.

The film-coated tablets are provided in bottles containing 30 or 90 tablets. Not all pack sizes may be available in your country.

Marketing Authorisation Holder

ViiV Healthcare UK Limited

79 New Oxford Street

London

WC1A 1DG

United Kingdom

Manufacturer

Delpharm Poznań Spółka Akcyjna, ul. Grunwaldzka 189,

60-322 Poznan,

Poland.

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This leaflet was last revised in May 2025

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