Descovy 200 mg/25 mg film-coated tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Descovy 200 mg/25 mg film-coated tablets

emtricitabine/tenofovir alafenamide

This medicinal product is subject to additional monitoring, which will allow for faster detection of new safety information. You can help by reporting any side effects you may experience. Section 4 at the end of this leaflet includes information on how to report side effects.

Read this entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Descovy is and what it is used for
2. What you need to know before taking Descovy
3. How to take Descovy
4. Possible side effects
5. How to store Descovy
6. Contents of the pack and other information

1. What Descovy is and what it is used for

Descovy contains two active substances:

• emtricitabine, an antiretroviral medicine of a type known as nucleoside reverse transcriptase inhibitor (NRTI)
• tenofovir alafenamide, an antiretroviral medicine of a type known as nucleotide reverse transcriptase inhibitor (NtRTI)

Descovy blocks the action of the reverse transcriptase enzyme, which is essential for viral replication. Therefore, Descovy reduces the amount of HIV present in the body.

Descovy, in combination with other medicines, is used for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents 12 years of age and older who weigh at least 35 kg.

2. What you need to know before taking Descovy

Do not take Descovy:

• If you are allergic to emtricitabine, tenofovir alafenamide, or any of the other ingredients of this medicine (listed in section 6 of this leaflet).

Warnings and precautions

You must remain under your doctor's supervision while taking Descovy.

While taking this medicine, you can still transmit HIV to others, even though effective antiretroviral treatment reduces the risk. Consult your doctor about which precautions are necessary to avoid infecting other people. This medicine is not a cure for HIV infection. While you are taking Descovy, you may continue to suffer from infections or other conditions associated with HIV infection.

Talk to your doctor before starting to take Descovy:

• If you have liver problems or have had liver disease, including hepatitis. Patients with liver disease, including chronic hepatitis B or C, who are treated with antiretrovirals, have an increased risk of serious and potentially fatal liver complications. If you have hepatitis B infection, your doctor will carefully consider the best treatment regimen for you.

If you have hepatitis B, liver problems may worsen after stopping Descovy. Do not stop taking Descovy without first talking to your doctor: see section 3, Do not stop treatment with Descovy.

• Your doctor may not prescribe Descovy if the virus has the K65R mutation.

While taking Descovy

Once you start taking Descovy, be alert for:

• Signs of inflammation or infection

• Joint pain, stiffness, or bone problems

• If you notice any of these symptoms, inform your doctor immediately. For more information, see section 4, Possible side effects.

Although kidney problems have not been observed with Descovy, there is a possibility that you may experience kidney problems if you take Descovy for a prolonged period.

Children and adolescents

Do not give this medicine to children aged 11 years or younger or who weigh less than 35 kg.

The use of Descovy has not yet been studied in children aged 11 years or younger.

Other medicines and Descovy

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Descovy can interact with other medicines. As a result, blood levels of Descovy or other medicines may change. This could prevent your medicines from working properly or worsen their possible side effects. In some cases, your doctor may need to adjust your dose or monitor your blood levels.

Medicines used to treat hepatitis B virus infection:

You must not take Descovy with medicines containing:

• tenofovir alafenamide

• tenofovir disoproxil

• lamivudine

• adefovir dipivoxil

• Talk to your doctor if you are taking any of these medicines.

Other types of medicines:

Talk to your doctor if you are taking:

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• antibiotics, used to treat bacterial infections including tuberculosis, containing:

  • rifabutin, rifampicin, and rifapentine

• antiviral medicines used to treat HIV:

• emtricitabine and tipranavir

• antiepileptics, used to treat epilepsy, such as:

  • carbamazepine, oxcarbazepine, phenobarbital, and phenytoin

• herbal medicines used to treat depression and anxiety containing:

  • St. John's wort (Hypericum perforatum)

• Tell your doctor if you are taking these or other medicines. Do not stop your treatment without consulting your doctor.

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

• Use an effective method of contraception while taking Descovy.

Consult your doctor or pharmacist before using any medicine if you are pregnant.

If you have taken Descovy during pregnancy, your doctor may request periodic blood tests and other diagnostic tests to monitor your child's development. In children whose mothers took Descovy during pregnancy, the benefit of protection against HIV outweighed the risk of possible side effects.

Do not breastfeed while taking Descovy. This is because one of the active ingredients in this medicine passes into breast milk. Breastfeeding is not recommended to avoid transmitting the virus to the child through breast milk.

Driving and using machines

Descovy may cause dizziness. If you experience dizziness during treatment with Descovy, do not drive or operate tools or machinery.

3. How to take Descovy

Follow exactly the instructions for taking this medicine as given by your doctor.

If in doubt, consult your doctor or pharmacist again.

The recommended dose is:

Adults: one tablet daily, with or without food

Adolescents aged 12 years or older, weighing at least 35 kg: one tablet daily, with or without food

Do not chew, crush, or split the tablet.

Always take the dose prescribed by your doctor. This is to ensure that your medicine is fully effective and to reduce the risk of developing treatment resistance. Do not change the dose unless your doctor tells you to do so.

If you are on dialysis, take your daily dose of Descovy after dialysis is complete.

If you take more Descovy than you should

If you take more than the recommended dose of Descovy, you may be at increased risk of adverse effects from this medicine (see section 4, Possible side effects).

Contact your doctor immediately or go to the nearest emergency department. Take the medicine container with you so you can show what you have taken.

If you forget to take Descovy

It is important not to miss a dose of Descovy.

If you miss a dose:

• If you remember within 18 hours of the time you usually take Descovy, take the tablet as soon as possible. Then take the next dose at your usual time.

• If you remember 18 hours or more after the time you usually take Descovy, do not take the missed dose. Wait and take the next dose at your usual time.

If you vomit within 1 hour after taking Descovy, take another tablet.

Do not stop taking Descovy

Do not stop treatment with Descovy without first talking to your doctor. Stopping Descovy may seriously affect the effectiveness of future treatments. If Descovy is stopped for any reason, consult your doctor before restarting Descovy tablets.

When you notice that you are running low on Descovy, contact your doctor or pharmacist to obtain more. This is very important, as the amount of virus may begin to increase if the medicine is stopped, even for a short period of time. This could make the disease more difficult to treat.

If you have both HIV infection and hepatitis B, it is very important not to stop taking Descovy without first speaking to your doctor. You may need to have blood tests for several months after stopping treatment. In some patients with advanced liver disease or cirrhosis, stopping treatment may cause a worsening of hepatitis, a condition that could be potentially fatal.

• Contact your doctor immediately about any new or unusual symptoms after stopping your treatment, particularly symptoms you think may be related to hepatitis B virus infection.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Serious possible side effects: tell a doctor immediately

• Any sign of inflammation or infection. In some patients with advanced HIV infection (AIDS) who have previously suffered from opportunistic infections (infections occurring in people with a weakened immune system), signs and symptoms of inflammation from prior infections may occur shortly after starting antiretroviral treatment. These symptoms are believed to result from an improved immune response, which enables the body to fight infections that may have been present without obvious symptoms.

• Autoimmune disorders (the immune system attacks healthy tissues of the body) may also occur after you start taking medicines for HIV infection. Autoimmune disorders may occur many months after treatment has begun. Watch for any symptoms of infection or other symptoms such as:

• muscle weakness

• weakness starting in the hands and feet and moving toward the trunk

• palpitations, tremor, or hyperactivity

• If you notice any of the side effects described above, tell your doctor immediately.

Very common side effects

(may affect more than 1 in 10 people)

• nausea (feeling sick)

Common side effects

(may affect up to 1 in 10 people)

• abnormal dreams
• headache
• dizziness
• diarrhoea
• vomiting
• stomach pain
• gas (flatulence)
• rash
• tiredness (fatigue)

Uncommon side effects

(may affect up to 1 in 100 people)

• low red blood cell count (anaemia)
• digestive problems causing discomfort after meals (dyspepsia)
• swelling of the face, lips, tongue or throat (angioedema)
• itching (pruritus)
• hives (urticaria)
• joint pain (arthralgia)
• If you consider any of the side effects you experience to be severe, tell your doctor.

Other effects that may occur during HIV treatment

The frequency of the following adverse effects is unknown (cannot be estimated from available data).

• Bone problems. Some patients treated with combined antiretroviral medicines such as Descovy may develop a bone disease called osteonecrosis (death of bone tissue due to loss of blood supply to the bone). Prolonged use of this type of medicine, use of corticosteroids, alcohol consumption, having a very weak immune system, and being overweight may be among the many risk factors for developing this disease. Signs of osteonecrosis are:

• • joint stiffness
  • joint discomfort and pain (especially of the hip, knee, and shoulder)
  • difficulty moving

• If you notice any of these symptoms, tell your doctor.

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During HIV treatment, there may be an increase in weight and in blood glucose and lipid levels. This may be partly related to improved health and lifestyle, and in the case of blood lipids, sometimes to the HIV medicines themselves. Your doctor will monitor these changes.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You may also report them directly through the national reporting system listed in Appendix V.

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

5. Storage of Descovy

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

Do not use this medicine after the expiry date stated on the carton and on the bottle after "EXP". The expiry date refers to the last day of the month indicated.

Store in the original packaging to protect it from moisture. Keep the bottle tightly closed.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Descovy

The active substances are emtricitabine and tenofovir alafenamide. Each Descovy film-coated tablet contains 200 mg of emtricitabine and tenofovir alafenamide fumarate equivalent to 25 mg of tenofovir alafenamide.

The other components are

Tablet core:

Microcrystalline cellulose, sodium croscarmellose, magnesium stearate.

Film coating:

Polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, indigo carmine aluminium lake (E132).

Nature of the product and contents of the container

Descovy film-coated tablets are blue, rectangular tablets, marked on one side with “GSI” and on the other side with the number “225”.

Descovy is available in 30-tablet bottles (with a silica gel desiccant which should be kept in the bottle to help protect the tablets). The silica gel desiccant is contained in a separate sachet or container and must not be swallowed.

This medicine is available in packs containing 1 bottle of 30 film-coated tablets, as well as in packs of 60 (2 bottles of 30) and 90 (3 bottles of 30) film-coated tablets. Only certain pack sizes may be marketed.

Marketing Authorization Holder:

Gilead Sciences Ireland UC
Carrigtohill
County Cork, T45 DP77
Ireland

Manufacturer:

Gilead Sciences Ireland UC
IDA Business & Technology Park
Carrigtohill
County Cork
Ireland

For more information about this medicine, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet: <{MM/YYYY}> <{month YYYY}>.

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.