Odefsey

Package leaflet: Information for the user

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

emtricitabine/rilpivirine/tenofovir alafenamide
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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 human immunodeficiency virus (HIV) infection. It is a single tablet containing three active substances: emtricitabine, rilpivirine, and tenofovir alafenamide. Each of these substances inhibits an enzyme called "reverse transcriptase", which is essential for the replication of HIV-1 virus.
Odefsey reduces the amount of HIV in your body. This helps improve your immune system and reduces the risk of developing HIV-related illnesses.
Odefsey is used in adults and adolescents aged 12 years and older, weighing 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 currently taking any of the following medicines:
  • carbamazepine, oxcarbazepine, phenobarbital, and phenytoin (medicines 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)
  • dexamethasone (a corticosteroid used to treat inflammation and suppress the immune system) taken orally or by injection (except for treatment with a single dose)
• products containing St. John’s wort (Hypericum perforatum) (a herbal remedy used for depression and anxiety)

If any of these conditions apply to you, do not take Odefsey and inform your doctor immediately.
Warnings and precautions
While taking Odefsey, you must continue to be monitored by your doctor.
This medicine does not cure HIV infection. While taking Odefsey, you may still develop infections or other illnesses associated with HIV infection.
Talk to your doctor before taking Odefsey:

• If you have or have previously had liver problems, including hepatitis. Patients with liver problems, including chronic hepatitis B or C, treated with antiretrovirals, have a higher risk of serious and potentially fatal liver complications. If you have hepatitis B, your doctor will carefully evaluate the best treatment regimen for you.
• If you have hepatitis B, liver problems may worsen when you stop treatment with Odefsey. Do not stop treatment with Odefsey without first discussing it with your doctor: see section 3, Do not stop treatment with Odefsey.
• If you are taking medicines that may cause potentially life-threatening arrhythmias (torsade de pointes).
• If you have kidney disease or if tests have shown problems with your kidneys. Your doctor may request blood tests to monitor how well your kidneys are functioning, both at the beginning and during treatment with Odefsey.

While taking Odefsey
When you start taking Odefsey, 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.
Kidney problems may occur during long-term use of Odefsey (see Warnings and precautions).
Children and adolescents
Do not give this medicine to children aged 11 years or younger or weighing less than 35 kg. The use of Odefsey in children aged 11 years or younger has not yet been studied.
Other medicines and Odefsey
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Odefsey can interact with other medicines. As a result, the levels of Odefsey or other medicines in your blood may be altered. This may prevent the medicines from working properly or may worsen their side effects. In some cases, your doctor may need to adjust the dose or monitor 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)
• dexamethasone (a corticosteroid used to treat inflammation and suppress the immune system) taken orally or by injection (except for treatment with a single dose)
• 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 inform your doctor immediately.
Other types of medicines:
Talk to your doctor if you are taking:

• Any medicine for the treatment of HIV infection
• Any other medicine containing:
  • tenofovir alafenamide
  • tenofovir disoproxil
  • lamivudine
  • adefovir dipivoxil
• Antibiotics used to treat bacterial infections, containing:
  • clarithromycin
  • erythromycin These medicines can increase the amount of rilpivirine and tenofovir alafenamide (components of Odefsey) in the blood. Your doctor will prescribe a different medicine.
• Antifungals, used to treat fungal infections:
  • ketoconazole
  • fluconazole
  • itraconazole
  • posaconazole
  • voriconazole These medicines can increase the amount of rilpivirine and tenofovir alafenamide (a component of Odefsey) in the blood. Your doctor will prescribe a different medicine.
• Medicines for stomach ulcers, heartburn, and acid reflux, such as:
  • antacids (aluminum/magnesium hydroxide or calcium carbonate)
  • H2-receptor antagonists (famotidine, cimetidine, nizatidine, or ranitidine) These medicines can reduce the amount of rilpivirine (a component of Odefsey) in the blood. If you are taking one of these medicines, your doctor will advise you on how and when to take it, or will prescribe a different 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-receptor antagonist, take it at least 12 hours before or at least 4 hours after Odefsey. H2-receptor antagonists may only be taken once daily while taking Odefsey. H2-receptor antagonists must not be taken twice daily. Consult your doctor regarding an alternative regimen (see How to take Odefsey).
  • Ciclosporin, a medicine used to reduce the activity of the immune system: This medicine can 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 dependence; your doctor may consider adjusting the methadone dose.
  • Dabigatran etexilate, a medicine used to treat heart conditions; your doctor may consider monitoring the medicine levels in the blood.

Inform your doctor if you are taking any of these medicines. Do not stop treatment without contacting your doctor.
Pregnancy and breastfeeding

• If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, ask your doctor for advice before taking this medicine.
• Use an effective method of contraception during treatment with Odefsey.

Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant.
If you have taken Odefsey during pregnancy, your doctor may require periodic blood tests and other diagnostic examinations to monitor the baby’s development. In babies whose mothers have taken nucleoside reverse transcriptase inhibitors (NRTIs) during pregnancy, the benefit of protection against HIV infection outweighs the risk of side effects.
Do not breastfeed during treatment with Odefsey. The reason is that some active substances of this medicine are excreted in human breast milk.
Breastfeeding is not recommended for HIV-positive women, as HIV infection can be transmitted to the baby through breast milk.
If you are breastfeeding or considering breastfeeding, you must discuss this with your doctor as soon as possible.
Driving and using machines
Do not drive and do not use machines if you feel tired, sleepy, or dizzy after taking this medicine.
Odefsey contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol of sodium (23 mg) per tablet, i.e., it is essentially “sodium-free”.
If any of these conditions apply to you, talk to your doctor before taking Odefsey.

3. How to take Odefsey

Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is:
Adults: One tablet daily, taken with food.
Adolescents aged 12 years and older, with a body weight of at least 35 kg: One tablet daily, taken with food.

It is important to take Odefsey with food to ensure an adequate amount of the active substance enters the body. A nutritional drink alone does not replace food.

Due to its bitter taste, it is recommended not to chew, split, or crush 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 taking Odefsey.

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

If you are undergoing dialysis, take your daily dose of Odefsey after completion of dialysis.

If you take more Odefsey than you should
If you accidentally take more Odefsey than recommended, you may have an increased risk of experiencing possible side effects of this medicine (see section 4, Possible side effects).
Contact your doctor or the nearest emergency department immediately. Bring the bottle of tablets with you so you can clearly describe what you have taken.

If you forget to take Odefsey
It is important not to miss any dose of Odefsey.
If you miss a dose:

• If you remember within 12 hours of your usual time of taking 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 after 12 hours (or more) from your usual time of taking Odefsey, do not take the missed dose. Wait and take your next dose with food at the usual time.

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

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

When your supply of Odefsey tablets is running low, get a new supply from your doctor or pharmacist. This is very important because the amount of virus may start to increase if the medicine is stopped, even for a short time. The disease may become more difficult to treat.

If you have both HIV infection and hepatitis B, it is especially important not to stop treatment with Odefsey without first contacting your doctor. You may need to have blood tests repeated for several months after stopping treatment. In some patients with advanced liver disease or cirrhosis, stopping treatment is not recommended, as it may lead to worsening of hepatitis, which can be potentially fatal.

Contact your doctor immediately if you notice any new or unusual symptoms after stopping treatment, particularly symptoms normally associated with hepatitis B infection.

If you have any questions about how to use 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.

Possible side effects: tell your doctor immediately

• Signs of inflammation or infection. In some patients with advanced HIV infection (AIDS) and a history of prior opportunistic infections (infections that occur in people with weakened immune systems), signs and symptoms of inflammation from previous infections may occur shortly after starting anti-HIV treatment. These symptoms are believed to be due to an improved immune response, which enables the body to fight infections that may have been present without obvious symptoms.
• Autoimmune disorders may also occur, in which the immune system attacks healthy body tissue, when you start taking medicines for HIV infection. Autoimmune disorders may occur many months after starting treatment. Be alert for any infection symptoms or other symptoms such as:
  • muscle weakness
  • weakness starting in the hands and feet and progressing towards the trunk
  • palpitations, tremor, or hyperactivity

If you notice any of these, or any other symptoms of inflammation or infection, tell your doctor immediately.

Very common side effects
(may occur in more than 1 in 10 people)

• difficulty sleeping (insomnia)
• headache
• dizziness
• feeling unwell (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 side effects
(may occur in more than 1 in 10 people)

• reduced appetite
• depression
• abnormal dreams
• sleep disorders
• depression and depressed mood
• drowsiness
• fatigue
• stomach discomfort and pain
• nausea (vomiting)
• abdominal bloating
• dry mouth
• intestinal gas (flatulence)
• diarrhoea
• rash

Blood tests may also show:

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

Uncommon side 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)
• sensation of itching (pruritus)
• hives
• joint pain (arthralgia)

If any of these side effects worsen, tell your doctor.

Other effects that may occur during HIV treatment

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

• Bone problems. Some patients taking combination antiretroviral medicines such as Odefsey may develop a bone disease called osteonecrosis (death of bone tissue due to reduced blood supply to the bone). Taking this type of medicine for a prolonged period, use of corticosteroids, alcohol consumption, having a weakened immune system, and being overweight may be some of the many risk factors for developing this condition. Signs of osteonecrosis include:
  • joint stiffness
  • aching and joint pain (especially in the hips, knees, and shoulders)
  • difficulty moving

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

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

Reporting of side effects

If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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. How to store 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 bottle after {Exp.}. The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from moisture. Keep the bottle tightly closed.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Odefsey contains
The active substances are emtricitabine, rilpivirine, and tenofovir alafenamide. Each Odefsey 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 (monohydrate), magnesium stearate, microcrystalline cellulose, polysorbate 20, povidone.
Film coating:
Macrogol, polyvinyl alcohol, talc, titanium dioxide (E171), iron oxide black (E172).

Description of the appearance of Odefsey and pack contents
Odefsey film-coated tablets are grey, capsule-shaped, engraved with “GSI” on one side and the number “255” on the other. Odefsey is supplied in bottles of 30 tablets and in packs of 3 bottles, each containing 30 tablets. Each bottle contains a silica desiccant packet or canister, which should remain in the bottle to protect the tablets. The desiccant is contained in a separate sachet or canister and must not be swallowed.
Not all pack sizes may be marketed.

Marketing Authorisation 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
Gilead Sciences Belgium SRL-BV
Tél/Tel: +32 (0) 24 01 35 50

България
Gilead Sciences Ireland UC
Тел.: +353 (0) 1 686 1888

Česká republika
Gilead Sciences s.r.o.
Tel: +420 910 871 986

Danmark
Gilead Sciences Sweden AB
Tlf: +46 (0) 8 5057 1849

Deutschland
Gilead Sciences GmbH
Tel: +49 (0) 89 899890-0

Eesti
Gilead Sciences Ireland UC
Tel: +353 (0) 1 686 1888

Ελλάδα
Gilead Sciences Ελλάς Μ.ΕΠΕ.
Τηλ: +30 210 8930 100

España
Gilead Sciences, S.L.
Tel: +34 91 378 98 30

France
Gilead Sciences
Tél: +33 (0) 1 46 09 41 00

Hrvatska
Gilead Sciences Ireland UC
Tel: +353 (0) 1 686 1888

Ireland
Gilead Sciences Ltd.
Tel: +353 (0) 214 825 999

Ísland
Gilead Sciences Sweden AB
Sími: +46 (0) 8 5057 1849

Italia
Gilead Sciences S.r.l.
Tel.: +39 02 439201

Κύπρος
Gilead Sciences Ελλάς Μ.ΕΠΕ.
Τηλ: +30 210 8930 100

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Gilead Sciences Ireland UC
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Gilead Sciences Belgium SRL-BV
Tél/Tel: +32 (0) 24 01 35 50

Magyarország
Gilead Sciences Ireland UC
Tel.: +353 (0) 1 686 1888

Malta
Gilead Sciences Ireland UC
Tel: +353 (0) 1 686 1888

Nederland
Gilead Sciences Netherlands B.V.
Tel: +31 (0) 20 718 36 98

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Gilead Sciences GesmbH
Tel: +43 1 260 830

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Tel.: +48 22 262 8702

Portugal
Gilead Sciences, Lda.
Tel: +351 21 7928790

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Gilead Sciences (GSR) S.R.L.
Tel: +40 31 631 18 00

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Gilead Sciences Ireland UC
Tel: +353 (0) 1 686 1888

Slovenská republika
Gilead Sciences Slovakia s.r.o.
Tel: +421 232 121 210

Suomi/Finland
Gilead Sciences Sweden AB
Puh/Tel: +46 (0) 8 5057 1849

Sverige
Gilead Sciences Sweden AB
Tel: +46 (0) 8 5057 1849

United Kingdom (Northern Ireland)
Gilead Sciences Ireland UC
Tel: +44 (0) 8000 113 700

More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu