Odefsey (Emtricitabine/Rilpivirine/Tenofovir Alafenamide)

During treatment with Odefsey it is necessary to be monitored by a doctor.

Odefsey should not be used to treat other diseases, nor in other people.

To keep your HIV infection under control and prevent your disease from getting worse, you should follow your doctor’s recommendations regarding the duration of treatment with Odefsey. Your doctor will periodically monitor the effectiveness (including viral load) of your treatment and will discuss with you the risk of HIV transmission.

This medicine does not cure HIV infection. While taking Odefsey you may still develop infections or other diseases associated with HIV infection. Your doctor will monitor you in this regard.

  . Do not take Odefsey

• if you are allergic (hypersensitive) to emtricitabine, rilpivirine, tenofovir alafenamide or any of the auxiliary substances of this medicine.
• if you currently take any of these medicines:
  • carbamazepine, oxcarbazepine, phenobarbital and phenytoin (medicines to treat epilepsy and prevent seizures)
  • Rifabutin, Rifampicin and Rifapentine (medicines to treat some bacterial infections such as tuberculosis)
  • omeprazole, dexlansoprazole, lansoprazole, rabeprazole, pantoprazole and esomeprazole (medicines for the prevention and treatment of gastric ulcers, heartburn and reflux disease)
  • dexamethasone (a corticosteroid medicine used to treat inflammation and suppress the immune system) if swallowed or injected (except for a single dose)
  • products containing St. John’s wort ( Hypericum perforatum) (a herbal remedy for depression and anxiety)

• When is caution required when administering Odefsey?

  Tell your doctor:

  • if you have or have had in the past liver problems, including hepatitis (inflammation of the liver). Patients with liver disease such as chronic hepatitis B or C who are treated with antiretroviral medications are at increased risk of serious and potentially fatal liver complications. If you have hepatitis B, your doctor will consider the best treatment for you.

  If you have hepatitis B, your liver problems may get worse when you stop taking Odefsey. It is important that you do not stop taking Odefsey without talking to your doctor (see “How to use Odefsey?”).

  • if you suffer or have suffered from serious kidney disease or if blood or urine tests have shown abnormal results indicating kidney problems. There is a possibility that if you take Odefsey for a long time you may develop kidney problems. Before starting treatment and during treatment with Odefsey your doctor may prescribe blood tests to monitor the function of your kidneys.
  • if you are taking medicines that can cause a life-threatening irregular heartbeat ( torsades de pointes ).

  Taking Odefsey with other medicines

  Odefsey may interact with other medicines. As a result, the quantities of Odefsey or other medicines in the blood may be altered. This may prevent the medicines from working properly or may make side effects worse. In some cases, your doctor will then need to change the dose or check your blood levels.

  For this reason, tell your doctor if you take any of the following medicines:

  • medicines for the treatment of HIV
  • medicinal products containing one of the following active ingredients:
    • tenofovir alafenamide
    • tenofovir disoproxil
    • lamivudine
    • adefovir dipivoxil
    • didanosina
  • antibiotics for the treatment of bacterial infections containing any of the following active substances:
    • clarithromycin
    • erythromycin
  • antifungals to treat fungal infections:
    • ketoconazole
    • fluconazole
    • itraconazole
    • posaconazole
    • voriconazolo
  • medicines to treat stomach ulcers, heartburn or reflux disease, such as:
    • antacids (aluminium/magnesium hydroxide or calcium carbonate)
    • receptor antagonists _{H 2} (famotidine, cimetidine, nizatidine or ranitidine)
  • ciclosporin, a medicine to reduce the action of the body’s immune system
  • methadone, a medicine to treat opioid addiction, as your doctor will probably need to change the dosage of methadone
  • dabigatran etexilate, a medicine to treat heart disease, as your doctor will probably need to check the levels of this medicine in your blood

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

  The use and safety of Odefsey in children and adolescents under 18 years of age have not been investigated so far.

  Lactose

  Odefsey contains 190 mg of lactose monohydrate. If your doctor has diagnosed an intolerance to some sugars, contact him before taking this medicine.

  Sodium

  Odefsey contains less than 1 mmol sodium (23 mg) per tablet, i.e. Odefsey is essentially ‘sodium-free’.

  Driving vehicles and using machines

  This medicine may reduce your ability to react, your ability to drive a vehicle and your ability to use tools or machines! Odefsey may cause fatigue, dizziness and drowsiness. If you experience dizziness while taking Odefsey, do not drive or use tools or machines.

  How to use Odefsey?

  Always take this medicine exactly as prescribed by your doctor to ensure that Odefsey is fully effective and to reduce the risk of developing drug resistance to treatment.

  The recommended dose is:

  Adults: 1 film-coated tablet once daily to be taken with food.

  Due to the bitter taste, it is recommended not to chew, break or crush the tablet.

  Children and adolescents

  The use and safety of Odefsey in children and adolescents under 18 years of age have not been investigated so far. Odefsey should not be used in these patients.

  Do not change the prescribed dosage on your own initiative. If you think that the action of the medicine is too weak or too strong, talk to your doctor or pharmacist.

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

  receptor antagonists _{If you take H 2} such as famotidine, cimetidine, nizatidine or ranitidine, you should take them at least 12 hours before or at least 4 hours after taking Odefsey. receptor antagonist _{If you are taking Odefsey, you may take an H 2} only once a day. receptor antagonists _{H 2} cannot be taken twice a day. Discuss other treatment options with your doctor.

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