Odefsey 200 mg/25 mg/25 mg film-coated tablets

Patient Information Leaflet

Introduction

Patient Information Leaflet

Odefsey 200mg/25mg/25mg film-coated tablets

emtricitabine/rilpivirine/tenofovir alafenamide

This medicinal product is subject to additional monitoring, which will enable rapid identification of new safety information. You can help by reporting any side effects you may experience. Information on how to report adverse effects is provided at the end of section 4.

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

• Keep this leaflet, as you may need to read 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 adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

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

1. What Odefsey is and what it is used for

Odefsey is an antiviral medicine used to treat infection with the human immunodeficiency virus (HIV). It is a single tablet that contains a combination of three active substances: emtricitabine, rilpivirine, and tenofovir alafenamide. Each of these active substances acts by interfering with an enzyme called "reverse transcriptase," which is essential for HIV-1 virus replication.

Odefsey reduces the amount of HIV in the body. This improves the immune system and reduces the risk of developing illnesses associated with HIV infection.

Odefsey is used in adults and adolescents aged 12 years or older who weigh at least 35 kg.

2. What you need to know before taking Odefsey

Do not take Odefsey:

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

• if you are taking any of the following medicines:

• carbamazepine, oxcarbazepine, phenobarbital, and phenytoin (used to treat epilepsy and prevent seizures)

• rifabutin, rifampicin, and rifapentine (used to treat certain bacterial infections such as tuberculosis)

• omeprazole, dexlansoprazole, lansoprazole, rabeprazole, pantoprazole, and esomeprazole (used to prevent and treat stomach ulcers, heartburn, and acid reflux disease)

• dexamethasone (a corticosteroid used to treat inflammation and suppress the immune system) when taken orally or by injection (except for single-dose treatment)

• products containing St. John’s wort (Hypericum perforatum, a herbal remedy used for depression and anxiety)

? If you are in any of these situations, do not take Odefsey and consult your doctor immediately.

Warnings and precautions

You must remain under medical supervision while taking Odefsey.

While taking this medicine, you may 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 Odefsey, you may still develop infections or other illnesses associated with HIV infection.

Talk to your doctor before starting Odefsey:

• If you have liver problems or a history of liver disease, including hepatitis. Patients with liver disease, including chronic hepatitis B or C, treated with antiretrovirals have a higher risk of serious and potentially life-threatening liver complications. If you have hepatitis B infection, your doctor will carefully consider the best treatment regimen for you.

If you have hepatitis B infection, liver problems may worsen after stopping Odefsey. It is important that you do not stop taking Odefsey without first speaking to your doctor: see section 3, Do not interrupt treatment with Odefsey.

• If you are taking any medicine that may cause an irregular heartbeat (Torsades de Pointes) that could be potentially fatal.

While you are taking Odefsey

Once you start taking Odefsey, be alert for:

• Signs of inflammation or infection
• Joint pain, stiffness, or bone problems

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

Kidney problems may occur in the future if Odefsey is taken for a prolonged period of time.

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 Odefsey has not yet been studied in children aged 11 years or younger or who weigh less than 35 kg.

Other medicines and Odefsey

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. Odefsey can interact with other medicines. As a result, blood levels of Odefsey or other medicines may be affected. 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 that must never be taken with Odefsey:

• carbamazepine, oxcarbazepine, phenobarbital, and phenytoin (used to treat epilepsy and prevent seizures)
• rifabutin, rifampicin, and rifapentine (used to treat certain bacterial infections such as tuberculosis)
• omeprazole, dexlansoprazole, lansoprazole, rabeprazole, pantoprazole, and esomeprazole (used to prevent and treat stomach ulcers, heartburn, and acid reflux disease)
• dexamethasone (a corticosteroid medicine used to treat inflammation and suppress the immune system) when taken orally or by injection (except for single-dose treatment)
• products containing St. John’s wort (Hypericum perforatum, a herbal remedy used for depression and anxiety)

? If you are taking any of these medicines, do not take Odefsey and consult your doctor immediately.

Other types of medicines:

Talk to your doctor if you are taking:

• Any medicine used to treat HIV

• Any medicine that contains:

• tenofovir alafenamide

• tenofovir disoproxil

• lamivudine

• adefovir dipivoxil

• Antibiotics used to treat bacterial infections containing:

• clarithromycin

• erythromycin

These medicines may increase the amount of rilpivirine and tenofovir alafenamide (components of Odefsey) in the blood. Your doctor will prescribe a different medicine.

• Antifungal medicines used to treat fungal infections:

• ketoconazole

• fluconazole

• itraconazole

• posaconazole

• voriconazole

These medicines may increase the amount of rilpivirine and tenofovir alafenamide (components of Odefsey) in the blood. Your doctor will prescribe a different medicine.

• Medicines for stomach ulcers, heartburn, or acid reflux such as:

• antacids (aluminium/magnesium hydroxide or calcium carbonate)

• H2 antagonists (famotidine, cimetidine, nizatidine, or ranitidine)

These medicines may reduce the levels of rilpivirine (a component of Odefsey) in the blood. If you are taking one of these medicines, your doctor will either prescribe a different medicine or advise you on how and when to take this medicine:

• If you are taking an antacid, take it at least 2 hours before or at least 4 hours after Odefsey.

• If you are taking an H2 antagonist, 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 are taking Odefsey. H2 antagonists should not be taken twice daily. Talk to your doctor for an alternative regimen (see How to take Odefsey).

• Cyclosporine, a medicine used to reduce the activity of the body’s immune system:

This medicine may increase the amount of rilpivirine and tenofovir alafenamide (components of Odefsey) in the blood. Your doctor will prescribe a different medicine.

• Methadone, a medicine used to treat opioid addiction, as your doctor may need to adjust your methadone dose.

• Dabigatran etexilate, a medicine used to treat heart conditions, as your doctor may need to monitor blood levels of this medicine.

? Talk to your doctor if you are taking any of these 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 Odefsey.

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

If you have taken Odefsey during pregnancy, your doctor may request periodic blood tests and other diagnostic tests to monitor your baby’s development. In children whose mothers took nucleoside reverse transcriptase inhibitors (NRTIs) during pregnancy, the benefit of protection against HIV was greater than the risk of adverse effects occurring.

Do not breastfeed while taking Odefsey. This is because some of the active substances in this medicine pass into breast milk. You are advised not to breastfeed to avoid transmitting the virus to the child through breast milk.

Driving and using machines

Do not drive or operate machinery if you feel tired, drowsy, or dizzy after taking your medicine.

Odefsey contains lactose

If your doctor has informed you of an intolerance to certain sugars, consult with him before taking this medicine.

? If you are in any of these situations, consult your doctor before starting to take Odefsey.

3. How to take Odefsey

Follow exactly the instructions for using 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 food

Adolescents aged 12 years or older weighing at least 35 kg: one tablet daily with food

Do not chew, crush, or split the tablet.

If you are taking an antacid, such as aluminium/magnesium hydroxide or calcium carbonate, take it at least 2 hours before or at least 4 hours after Odefsey.

If you are taking an H2 antagonist, such as famotidine, cimetidine, nizatidine, or ranitidine, take it at least 12 hours before or at least 4 hours after Odefsey. H2 antagonists may only be taken once daily if you are taking Odefsey. H2 antagonists should not be taken twice daily. Speak with your doctor to determine an alternative regimen.

If you are on dialysis, take your daily dose of Odefsey after dialysis is completed.

If you take more Odefsey than you should

If you accidentally take more than the recommended dose of Odefsey, you may be at increased risk of experiencing possible adverse effects with this medicine (see section 4, Possible adverse effects).

Contact your doctor immediately or go to the nearest emergency department. Keep or bring the bottle of tablets with you so you can easily describe what you have taken.

If you forget to take Odefsey

It is important not to miss a dose of Odefsey.

If you miss a dose:

• If you remember within 12 hours of the time you usually take Odefsey, take the tablet as soon as possible. Always take the tablet with food. Then take your next dose at the usual time.
• If you remember 12 hours or more after the time you usually take Odefsey, do not take the missed dose. Wait and take your next dose at the usual time, with food.

If you vomit within 4 hours after taking Odefsey, take another tablet with food. If you vomit more than 4 hours after taking Odefsey, you do not need to take another tablet until your next scheduled dose.

Do not stop treatment with Odefsey

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

When you are running low on Odefsey, see your doctor or pharmacist to get more. This is very important, as the amount of virus may start to increase if the medicine is interrupted, 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 especially important not to stop your treatment with Odefsey without first talking to your doctor. You may need blood tests for several months after stopping treatment. In some patients with advanced liver disease or cirrhosis, stopping treatment is not recommended, as this may lead to worsening of hepatitis, a condition that could be potentially life-threatening.

? Contact your doctor immediately about any new or unusual symptoms after stopping your treatment, particularly symptoms you associate with hepatitis B virus infection.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Possible adverse effects: inform a doctor immediately

• Any sign of inflammation or infection. In some patients with advanced HIV infection (AIDS) and a history of opportunistic infections (infections that occur in people with a weakened immune system), signs and symptoms of inflammation from previous infections may occur shortly after starting HIV treatment. These symptoms are believed to result from an improvement in the body's immune response, enabling it to fight infections that may have been present without obvious symptoms.

• Autoimmune disorders may also occur, in which the immune system attacks the body's healthy tissues, after starting medications for HIV infection. Autoimmune disorders can occur many months after treatment initiation. Be alert for any symptoms of infection or other symptoms such as:

• muscle weakness

• weakness beginning in the hands and feet and spreading toward the trunk

• palpitations, tremor, or hyperactivity

? If you notice any of these symptoms or any signs of inflammation or infection, inform your doctor immediately.

Very common adverse effects

(may affect more than 1 in 10 people)

• difficulty sleeping (insomnia)
• headache
• dizziness
• feeling sick (nausea)

Blood tests may also show:

• increased levels of cholesterol and/or pancreatic amylase (a digestive enzyme) in the blood
• increased levels of liver enzymes in the blood

Common adverse effects

(may affect up to 1 in 10 people)

• decreased appetite
• depression
• abnormal dreams
• sleep disorders
• depressed mood
• drowsiness (somnolence)
• fatigue
• stomach pain or discomfort
• vomiting (vomiting)
• bloating
• dry mouth
• gas (flatulence)
• diarrhoea
• rash

Blood tests may also show:

• low white blood cell count (a reduced number of white blood cells may make you more prone to infection)
• low platelet count (a type of blood cell involved in blood clotting)
• decreased haemoglobin in the blood
• increased levels of fatty acids (triglycerides), bilirubin, or lipase in the blood

Uncommon adverse effects

(may affect up to 1 in 100 people)

• signs or symptoms of inflammation or infection
• low red blood cell count (anaemia)
• severe skin reactions including rash accompanied by fever, swelling, and liver problems
• digestive problems causing discomfort after meals
• swelling of the face, lips, tongue, or throat (angioedema)
• itching (pruritus)
• hives (urticaria)
• joint pain (arthralgia)

? If you consider any of the adverse effects you experience to be severe, inform your doctor.

Other effects that may occur during HIV treatment

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

• Bone problems. Some patients treated with combination antiretroviral medicines such as Odefsey may develop a bone disease called osteonecrosis (death of bone tissue due to loss of blood supply to the bone). Prolonged use of these types of medicines, corticosteroid use, alcohol consumption, having a severely weakened immune system, and being overweight may be some of the many risk factors for developing this condition. Signs of osteonecrosis include:

• joint stiffness

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

• difficulty moving

? If you notice any of these symptoms, inform your doctor.

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 adverse effects

If you experience any adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Odefsey

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 from moisture. Keep the bottle tightly closed.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Odefsey

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

The other components are

Tablet core:

Sodium croscarmellose, lactose (as monohydrate), magnesium stearate, microcrystalline cellulose, polysorbate 20, povidone.

Film coating:

Macrogol, polyvinyl alcohol, talc, titanium dioxide (E171), iron oxide black (E172).

Nature of the product and contents of the pack

Odefsey is a grey, capsule-shaped, film-coated tablet, marked on one side with “GSI” and “255” on the other side. Odefsey is available in bottles of 30 tablets and in packs of 3 bottles, each containing 30 tablets. Each bottle contains 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.

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 and Technology Park

Carrigtohill

County Cork

Ireland

Further information on this medicinal product is available by contacting 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 medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.