Darunavir for HIV

About darunavir

Darunavir is an antiretroviral medicine. It is prescribed for infezione da virus dell'immunodeficienza umana (HIV). It slows the progress of HIV infection, but it is not a cure. HIV destroys cells in the body, called CD4 T cells. These cells are a type of white blood cell and are important because they are involved in protecting your body from infection. If left untreated, the HIV infection weakens your immune system so that your body cannot defend itself against bacteria, viruses and other germs. Darunavir slows down the progress of HIV infection by reducing the amount of virus in your body. It does this by stopping the production of a protein that the virus needs to copy (replicate) itself.

Darunavir will be prescribed for you by a doctor who is a specialist. It belongs to a group of antiretroviral medicines known as protease inhibitors (PIs). It is given alongside a number of other antiretroviral medicines, as part of a combination therapy. Taking three or more antiretroviral medicines at the same time is more effective than taking one alone. Taking a combination of different medicines also reduces the risk that the virus will become resistant to any individual medicine. One brand of darunavir called Rezolsta® also contains a medicine called cobicistat. Cobicistat boosts the effect of darunavir. Not all of the information in this document may apply to the combination brand - please refer to the manufacturer's printed information leaflet from inside the pack.

È fondamentale assumere i farmaci antiretrovirali esattamente come prescritto per mantenere il successo e aiutare a prevenire che il virus diventi resistente ai farmaci. Questi farmaci sono solitamente assunti per tutta la vita.

Some medicines are not suitable for people with certain conditions, and sometimes a medicine can only be used if extra care is taken. For these reasons, before you start taking darunavir it is important that your doctor knows:

• Se sei incinta, stai cercando di avere un bambino o stai allattando.

• Se hai il diabete (diabete mellito).

• Se hai un'infiammazione al fegato (chiamata epatite) o qualsiasi altro problema al fegato.

• Se hai emofilia o porfiria, che sono entrambi rari disturbi ereditari del sangue.

• Se stai assumendo altri medicinali. Questo include qualsiasi medicinale disponibile per l'acquisto senza prescrizione, così come i medicinali a base di erbe e complementari.

• If you have ever had an allergic reaction to a medicine. This is particularly important if you know you are allergic to a medicine known as a sulfonamide.

• Before you start the treatment, read the manufacturer's printed information leaflet from inside the pack. It will give you more information about darunavir, and it will also provide you with a full list of the side-effects which you could experience from taking it.

• Take darunavir exactly as your doctor tells you to. You will be asked to take either one or two doses daily, at the same time as a booster medicine (either ritonavir or cobicistat).

• There are several strengths of darunavir tablets available - your doctor will tell you which is right for you (or your child). It is important that you take darunavir at a mealtime (or within 30 minutes of eating a meal) as this will help your body to absorb the medicine.

• Try to take darunavir at the same time(s) of day each day, as this will help you to remember to take it regularly.

• If you forget to take your dose, take it with something to eat as soon as you remember a meno che:
  

  • You usually take darunavir twice a day and you are more than 6 hours late; in which case do not take the missed dose but do take your next dose when it is due.

  • You usually take darunavir once a day and you are more than 12 hours late; in which case do not take the missed dose but do take your next dose when it is due.

Instructions for using the dosing syringe with Prezista® Oral Suspension

1. Shake the bottle well.

2. Remove the bottle cap.

3. Make sure the plunger of the syringe is pushed in fully, then insert the syringe into the bottle.

4. Gently pull out the plunger of the syringe so that the medicine fills the syringe to the mark which corresponds to your dose.

5. Put the tip of the syringe into your (or your child's) mouth, and gently push the plunger so that the medicine is released.

6. Replace the bottle cap. Wash the syringe with water after each use.

• Keep your regular appointments with your doctor so that your progress can be monitored. You will need to have regular blood tests while you are taking this medicine, to make sure your liver stays healthy.

• It is important that you continue to take darunavir and your other antiretroviral treatment regularly. This will help to prevent the HIV from becoming resistant to the medicines you are taking. Even if you miss only a small number of doses, the virus can become resistant to treatment.

• If you develop any infection soon after you start this treatment, let your doctor know. As a result of taking darunavir, your immune system may start fighting an infection which was present before you started the treatment, but which you may not have been aware of.

• Segui attentamente qualsiasi consiglio che il tuo medico ti dà riguardo ai cambiamenti dello stile di vita per ridurre il rischio di danni al cuore e ai vasi sanguigni. Questi possono includere smettere di fumare, mangiare in modo sano e fare esercizio fisico regolarmente.

• Alcune persone che assumono farmaci antiretrovirali sviluppano cambiamenti nel modo in cui il grasso corporeo è distribuito nel corpo. Questo può comportare cambiamenti nell'immagine corporea. Il tuo medico discuterà con te la possibilità di questo.

• Anche se il trattamento con farmaci antiretrovirali può ridurre il rischio di trasmettere l'HIV ad altri attraverso il contatto sessuale, non lo elimina completamente. È importante che usi i preservativi.

• Being pregnant whilst taking darunavir can lead to lower blood levels of the medicine. This may mean your treatment becomes less effective than it should be. If you are pregnant, or planning to become pregnant, speak with your doctor for advice on alternative treatments.

• It is not uncommon for people with HIV to feel low or even depressed, especially soon after the diagnosis has been made and treatment has been started. If you have any feelings of depression, or any distressing thoughts about harming yourself then you should speak with your doctor immediatamente.

• Alcune persone che hanno assunto farmaci antiretrovirali (soprattutto per un lungo periodo) hanno sviluppato una condizione chiamata osteonecrosi. Questa è una malattia ossea in cui il tessuto osseo muore a causa di una ridotta fornitura di sangue. Porta a dolori articolari e rigidità, e può causare difficoltà nei movimenti. Se noti uno di questi sintomi, parla con il tuo medico.

• If you buy any medicines, check with a pharmacist that they are suitable to take with darunavir and your other medicines. This is because some medicines interfere with darunavir and either stop it from working properly or increase the risk of side-effects. In particular, do not take the herbal remedy St John's wort.

• Se hai il diabete, potresti dover controllare il livello di zucchero (glucosio) nel sangue più frequentemente, poiché questo medicinale può influenzare i livelli di zucchero nel sangue. Il tuo medico ti consiglierà a riguardo.

• Se devi sottoporti a un'operazione o a un trattamento dentistico, informa la persona che esegue il trattamento sui medicinali che stai assumendo.

• Treatment for HIV is usually lifelong. Continue to take darunavir regularly for as long as your doctor tells you to, even if you feel well. This is to keep your immune system healthy.

Along with their useful effects, most medicines can cause unwanted side-effects although not everyone experiences them. The table below contains some of the most common ones associated with darunavir. You will find a full list in the manufacturer's information leaflet supplied with your medicine. The unwanted effects often improve as your body adjusts to the new medicine, but speak with your doctor or pharmacist if any of the following continue or become troublesome.

Importante: although it is common for people taking darunavir to develop a skin rash during the first few weeks of treatment, a severe rash with blisters may be a sign of a more serious allergic-type reaction. Let your doctor know immediatamente if you develop the following:

• Severe blistering rash, high temperature, muscle and joint aches or pains, feeling generally unwell, mouth ulcers, and conjunctivitis.

Se si verificano altri sintomi che ritieni possano essere dovuti al medicinale, parla con il tuo medico o farmacista per ulteriori consigli.

• Tenere tutti i medicinali fuori dalla portata e dalla vista dei bambini.

• Conservare in un luogo fresco e asciutto, lontano da fonti di calore e luce diretta.