200 mg / 25 mg / 25 mg film-coated tablets
emtricitabine / rilpivirine / tenofoviralafenamide
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 a combination of three active substances: emtricitabine, rilpivirine, and tenofoviralafenamide. Each of these active substances works by acting on an enzyme called “reverse transcriptase”, which is necessary for the HIV -1 virus to multiply.
Odefsey reduces the amount of HIV in the body. This strengthens the immune system and reduces the risk of developing diseases associated with HIV infection.
Odefsey is used for adults and adolescents 12 years and older who weigh at least 35 kg.
What you need to know before taking Odefsey
Do not take Odefsey
- if you are allergic to emtricitabine, rilpivirine, tenofoviralafenamide 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 (used to treat epilepsy and prevent seizures)
- rifabutin, rifampicin and rifapentin (used to treat certain bacterial infections, eg tuberculosis )
- omeprazole, dexlansoprazole, lansoprazole, rabeprazole, pantoprazole and esomeprazole (used to prevent and treat stomach ulcers , heartburn and acid reflux)
- dexamethasone (a corticosteroid drug used to treat inflammation and suppress the immune system) when taken orally or injected (except as a single dose)
- products containing St. John’s wort ( Hypericum perforatum ) (a traditional herbal medicine used for mild depression and mild anxiety).
→ If this applies to you, do not take Odefsey and inform your doctor immediately.
Warnings and cautions
Your treatment with Odefsey must be constantly monitored by a doctor.
You can still transmit HIV infection when you take this medicine, even though the risk of effective antiviral therapy is reduced. Discuss what measures are needed to avoid infecting other people with your doctor. This medicine does not cure HIV infection. While you are taking Odefsey, you may still develop infections or other illnesses associated with HIV infection.
Talk to your doctor before taking Odefsey:
- if you have liver problems or have had liver disease, including hepatitis . Patients with liver disease, including chronic hepatitis B or C, treated with antiretroviral agents are at increased risk of severe and potentially fatal liver complications. If you have hepatitis B, your doctor will carefully choose the best treatment for you.
If you have hepatitis B infection , your liver problems may worsen after you stop taking Odefsey. It is important that you do not stop taking Odefsey without talking to your doctor. See section 3, Do not stop taking Odefsey .
- if you are taking any medicines that may cause life-threatening irregular heartbeats ( torsades de pointes ) .
- if you have had kidney disease or if tests have shown that you have kidney problems . Your doctor may order blood tests to check how your kidneys are working at the start and during treatment with Odefsey.
When you take Odefsey
Once you start taking Odefsey, you should be observant of:
- Signs of inflammation or infection
- Joint pain, stiffness or problems with the skeleton
→ Contact your doctor immediately if you get any of these symptoms. See section 4, Possible side effects, for more information.
Even if kidney problems have not been observed with Odefsey, there is a risk that you will get kidney problems when you take Odefsey for a long time (see Warnings and Precautions ).
Children and young people
Do not give this medicine to children aged 11 years or younger, or who weigh less than 35 kg. The use of Odefsey in children aged 11 years and younger or weighing less than 35 kg has not 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 affect or be affected by other medicines. This can lead to the amount of Odefsey or other medicines in the blood being affected. The medicines may then not work properly or any side effects may be exacerbated. In some cases, your doctor may need to change the dose or check the amount of medicine in your blood.
Medicines that must never be taken with Odefsey:
- carbamazepine, oxcarbazepine, phenobarbital and phenytoin (used to treat epilepsy and prevent seizures)
- rifabutin, rifampicin and rifapentin (used to treat certain bacterial infections, eg tuberculosis )
- omeprazole, dexlansoprazole, lansoprazole, rabeprazole, pantoprazole and esomeprazole (used to prevent and treat stomach ulcers , heartburn and acid reflux)
- dexamethasone (a corticosteroid drug used to treat inflammation and to suppress the immune system) when taken orally or injected (except as a single dose)
- products containing St. John’s wort (Hypericum perforatum ) (a traditional herbal medicine used for mild depression and mild anxiety).
→ If you are taking any of these medicines, do not take Odefsey and contact your doctor immediately.
Other types of medicines:
Talk to your doctor if you are taking:
- Drugs used to treat HIV
- Any medicine that contains:
- tenofoviralafenamide
- tenofovir disoproxil
- lamivudine
- adefovir dipivoxil
- Antibiotics used to treat bacterial infections that contain:
- clarithromycin
- erythromycinThese medicines may increase the amount of rilpivirine and tenofoviralafenamide (components of Odefsey) in the blood. Your doctor will give you another medicine.
- Antifungals used to treat fungal infections:
- ketoconazole
- fluconazole
- itraconazole
- posakonazole
- voriconazole
These medicines may increase the amount of rilpivirine and tenofoviralafenamide (components of Odefsey) in the blood. Your doctor will give you another medicine.
- Medicines for stomach ulcers , heartburn or acid reflux, including:
- antacids (aluminum / magnesium hydroxide or calcium carbonate )
- H 2 – antagonist is (famotidine, cimetidine, nizatidine or ranitidine)
These medicines can reduce the amount of rilpivirine (a component of Odefsey) in the blood. If you are taking any of these medicines, your doctor will either give you another medicine or recommend how and when to take this medicine.- If you are taking antacids , take it at least 2 hours before or at least 4 hours after Odefsey.
- If you are taking an H 2 antagonist , take it at least 12 hours before or at least 4 hours after Odefsey. H 2 antagonist can only be taken once daily if you are taking Odefsey. H 2 antagonist should not be taken in a treatment with dose twice daily. Talk to your doctor about an alternative treatment (see How to take Odefsey ).
- Ciclosporin , a medicine used to reduce the strength of the body’s immune system: This medicine may increase the amount of rilpivirine and tenofoviralafenamide (components of Odefsey) in the blood. Your doctor will give you another medicine.
- Methadone , a drug used to treat opiate addiction, as your doctor may need to change your methadone dose.
- Dabigatran etexilate , a medicine used to treat heart problems, as your doctor may need to monitor the levels of this medicine in your blood.
→ Contact your doctor if you are taking any of these medicines. You should not stop treatment without talking to your doctor.
Pregnancy and breastfeeding
- If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine.
- Use effective contraception when taking Odefsey.
If you are pregnant, ask your doctor or pharmacist for advice before taking any medicine.
If you have taken Odefsey during pregnancy, your doctor may ask for regular 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 HIV protection outweighed the risk of side effects.
Do not breast-feed during treatment with Odefsey. The reason is some of the active substances in this drug pass into breast milk. To avoid transmitting HIV to your baby through breast milk, you should not breast-feed your baby.
Driving and using machines
Do not drive or use machines if you feel tired, drowsy or dizzy after taking this medicine.
Odefsey contains lactose and sodium
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, ie essentially ‘sodium-free’.
→ If any of these apply to you, talk to your doctor before taking Odefsey.
How to take Odefsey
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
The recommended dose is:
Adults: one tablet a day with food
Adolescents 12 years and older, weighing at least 35 kg: one tablet a day with food.
It is important to take Odefsey with food to get the right levels of active substance in the body. A nutritional drink alone does not replace a meal.
It is recommended not to chew, crush or split the tablet due to the bitter taste.
If you are taking antacids, e.g. aluminum/magnesium hydroxide or calcium carbonate, you should take it at least 2 hours before or at least 4 hours after Odefsey.
If you are taking an H2 antagonist, e.g. famotidine, cimetidine, nizatidine or ranitidine, you should take it at least 12 hours before or at least 4 hours after Odefsey. H 2 antagonist can only be taken once daily if you are taking Odefsey. H 2 – your antagonist should not be taken twice a day. Talk to your doctor about an alternative treatment.
If you are on dialysis, take your daily dose of Odefsey after completing dialysis.
If you take more Odefsey than you should
If you accidentally take more than the prescribed dose of Odefsey, the risk of side effects with this medicine may increase (see section 4, Possible side effects ).
Contact your doctor or nearest emergency department immediately for advice. Save or take the jar with you so that you can easily describe what you have taken.
If you forget to take Odefsey
You mustn’t miss a dose of Odefsey.
If you miss a dose:
- If you notice it within 12 hours of the time you usually take Odefsey, you must take the tablet as soon as possible. The tablet must always be taken with food. Then take the next dose as usual.
- If you notice it 12 hours or more after the time you usually take Odefsey, do not take the missed dose . Wait and take the next dose of food at the usual time.
If you vomit within less than 4 hours after a dose of Odefsey, take a new tablet of food. If you vomit more than 4 hours after taking Odefsey, you do not need to take a new tablet until the next normally scheduled tablet.
Do not stop taking Odefsey
Do not stop taking Odefsey without talking to your doctor. If you stop taking Odefsey, it could seriously affect the outcome of your future treatment. If for any reason you stop taking Odefsey, talk to your doctor before taking Odefsey tablets again.
When your Odefsey supply starts to run out, get more from your doctor or pharmacist. This is very important because the amount of virus can start to increase even if you only stop taking the medicine for a short time. The disease can then become more difficult to treat.
If you have both HIV infection and hepatitis B, you mustn’t stop taking Odefsey without first talking to your doctor. You may need to submit blood samples for several months after stopping treatment. In some patients with advanced liver disease or cirrhosis, discontinuation of treatment is not recommended, as this may lead to worsening of hepatitis A, which may be life-threatening.
→ Tell your doctor immediately about any new and unexpected symptoms that occur after stopping treatment, especially symptoms that you usually associate with your hepatitis B infection.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Possible side effects: Contact a doctor immediately
- Signs of inflammation or infection . In some patients with advanced HIV infection ( AIDS ) who have previously had opportunistic infections ( infections that occur in people with weakened immune systems), signs and symptoms of inflammation from previous infections may appear shortly after starting HIV treatment. . It is believed that these symptoms are due to the fact that the body’s immune system has been strengthened so that the body can fight infections that may have been present without giving any clear symptoms.
- Autoimmune diseases, when the immune system attacks healthy body tissue, can also occur after you start taking medicines for HIV infection . Autoimmune diseases can occur many months after starting treatment. Be observant of symptoms of infection or other symptoms such as:- muscle weaknessweakness that begins in the hands and feet and moves towards the torsopalpitations, tremors or hyperactivity.
→ If you notice these or other symptoms of inflammation or infection, tell your doctor immediately.
Very common side effects are
(may occur in more than 1 in 10 people)
- insomnia _ _
- headache
- dizziness
- nausea
Tests can 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 are
(can occur in up to 1 in 10 people)
- decreased appetite
- Depression
- abnormal dreams
- sleep disorders
- Depression
- somnolence
- fatigue
- abdominal pain or discomfort
- nausea ( vomiting )
- bloated feeling
- dry mouth
- flatulence _ _
- diarrhea
- rash
Tests can also show:
- low white blood cell count (a decrease in white blood cell count may make you more prone to infection )
- low platelet count (a type of blood cell involved in the coagulation of blood)
- decreased hemoglobin in the blood
- increased fatty acids ( triglycerides ), bilirubin or lipase in the blood
Uncommon side effects are
(can occur in up to 1 in 100 people)
- signs or symptoms of inflammation or infection
- low red blood cell count ( anemia )
- severe skin reactions including rash along with fever, swelling and liver problems
- indigestion which results in discomfort after meals ( dyspepsia )
- swelling of the face, lips, tongue or throat ( angioedema )
- pruritus _ _ _
- hives ( urticaria )
- joint pain ( arthralgia )
→ If any side effects get worse, talk to your doctor.
Other side effects that may occur during HIV treatment
The frequency of the following side effects is not known (frequency can not be calculated from the available data).
- Skeletal problem. Some patients taking combination antiretroviral medicines such as Odefsey may develop a skeletal disease called osteonecrosis (bone tissue dies due to lost blood supply to the skeleton). Some of the many risk factors for developing this disease are long-term use of this type of drug, treatment with corticosteroids , alcohol consumption, a very weak immune system and obesity. Signs of osteonecrosis are:joint stiffness- joint pain and pain (especially in the hips, knees and shoulders)- mobility difficulties
→ Tell your doctor if you notice any of these symptoms.
During HIV treatment, weight gain and increased levels of lipids and glucose in the blood may occur. This is partly related to restored health and lifestyle, but when it comes to blood lipids, there can sometimes be a connection with HIV drugs. Your doctor will perform tests to find such changes.
How to store Odefsey
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and can after {EXP}. The expiration date is the last day of the specified month.
Store in the original package. Moisture sensitive. Close the jar tightly.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
The active substances are emtricitabine, rilpivirine and tenofoviralafenamide. One Odefsey tablet contains 200 mg emtricitabine, rilpivirine hydrochloride equivalent to 25 mg rilpivirine and tenofoviralafenamide fumarate equivalent to 25 mg tenofoviralafenamide.
The other ingredients are
Tablet core:
Croscarmellose sodium, lactose (as monohydrate), magnesium stearate, microcrystalline cellulose, polysorbate 20, povidone.
Film coating:
Macrogol, polyvinyl alcohol, talc, titanium dioxide (E171), black iron oxide (E172).
What the medicine looks like and contents of the pack
Odefsey is a gray, capsule-shaped, film-coated tablet debossed with “GSI” on one side and “255” on the other side. Odefsey is delivered in cans of 30 tablets and packs of 3 cans, each with 30 tablets. Each jar contains a desiccant in the form of silica gel which must be stored in the jar to protect the tablets. The desiccant (silica gel) is in a separate sachet or container and should not be swallowed.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
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