Name: Rezolsta

About darunavir

Type of medicineA protease inhibitor (PI) antiretroviral medicine
Used forHuman immunodeficiency virus (HIV) infection in adults and in children over 3 years of age
Also calledPrezista®
There is also a combination tablet available called Rezolsta® (darunavir with cobicistat)
Available asTablets and oral liquid medicine

Darunavir is an antiretroviral medicine. It is prescribed for human immunodeficiency virus (HIV) infection. 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.

It is vital to take your antiretroviral medicines exactly as prescribed to maintain success and to help to prevent the virus from becoming resistant to the medicines. These medicines are usually taken for life.

Before taking darunavir

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:

  • If you are pregnant, trying for a baby or breast-feeding.
  • If you have sugar diabetes.
  • If you have liver inflammation (called hepatitis), or any other liver problem.
  • If you have either haemophilia or porphyria, which are both rare inherited blood disorders.
  • If you are taking any other medicines. This includes any medicines which are available to buy without a prescription, as well as herbal and complementary medicines.
  • 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.

How to take darunavir

  • 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 unless:
    • 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.

Can darunavir cause problems?

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.

Very common darunavir side-effects (these affect more than 1 in 10 people)
What can I do if I experience this?
DiarrhoeaDrink plenty of water to replace lost fluids
Common darunavir side-effects (these affect less than 1 in 10 people)What can I do if I experience this?
RashSpeak with your doctor about this (see below)
Feeling or being sick, tummy (abdominal) pain, feeling bloated, wind, indigestionStick to simple meals - avoid fatty or spicy food
HeadacheAsk your doctor to recommend a suitable painkiller
Feeling tired, sleepy or dizzyDo not drive and do not use tools or machines while affected
Body fat changes, difficulty sleeping, tiredness, tingling or numb feelings in your hands or feetDiscuss these with your doctor if troublesome
Changes to the results of some blood testsYour doctor will check for this

Important: 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 straightaway if you develop the following:

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

If you experience any other symptoms which you think may be due to the medicine, speak with your doctor or pharmacist for further advice.

How to store darunavir

  • Keep all medicines out of the reach and sight of children.
  • Store in a cool, dry place, away from direct heat and light.