Prezista
(Darunavir Ethanolate)

What Prezista is and what it is used for

What is PREZISTA? PREZISTA contains the active substance darunavir. PREZISTA is an antiretroviral medicine used in the treatment of Human Immunodeficiency Virus (HIV) infection. It belongs to a group of medicines called protease inhibitors. PREZISTA works by reducing the amount of HIV in your body. This will improve your immune system and reduces the risk of developing illnesses linked to HIV infection. What it is used for? PREZISTA is used to treat HIV infected adults as well as HIV infected children of 3 years of age and above, and at least 15 kilogram body weight (see How to take PREZISTA). PREZISTA must be taken in combination with a low dose of cobicistat or ritonavir and other anti-HIV medicines. Your doctor will discuss with you which combination of medicines is best for you.

How to take Prezista

Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has told you. Check with your doctor, pharmacist or nurse if you are not sure. Even if you feel better, do not stop taking PREZISTA and cobicistat or ritonavir without talking to your doctor. After therapy has been initiated, the dose or dosage form must not be changed or therapy must not be stopped without instruction of the doctor. Dose for children of 3 years of age and above, weighing at least 15 kilograms who have not taken antiretroviral medicines before (your child’s doctor will determine this) The doctor will work out the right once daily dose based on the weight of the child (see table below). This dose must not exceed the recommended adult dose, which is 800 milligram PREZISTA together with 100 milligram ritonavir once a day. The doctor will inform you on how much PREZISTA oral suspension and how much ritonavir (capsules, tablets or solution) the child must take. Weight One PREZISTA dose is One ritonavira dose is between 15 and 30 kilograms 600 milligram (6 milliliter) 100 milligram (1.2 milliliter) between 30 and 40 kilograms 675 milligram (6.8 milliliter) 100 milligram (1.2 milliliter) more than 40 kilograms 800 milligram (8 milliliter) 100 milligram (1.2 milliliter) a ritonavir oral solution: 80 milligram per milliliter The child must take PREZISTA every day and always in combination with 100 milligram of ritonavir and with food. PREZISTA cannot work properly without ritonavir and food. The child must eat a meal or a snack within 30 minutes prior to taking PREZISTA and ritonavir. The type of food is not important. Dose for children of 3 years of age and above, weighing at least 15 kilograms who have taken antiretroviral medicines before (your child’s doctor will determine this) The doctor will work out the right dose based on the weight of the child (see table below). The doctor will determine if once daily dosing or twice daily dosing is appropriate for the child. This dose must not exceed the recommended adult dose, which is 600 milligram PREZISTA together with 100 milligram ritonavir two times per day or 800 milligram PREZISTA together with 100 milligram ritonavir once a day. The doctor will inform you on how much PREZISTA oral suspension and how much ritonavir (capsules, tablets or solution) the child must take. Twice daily dosing Weight One PREZISTA dose is One ritonavira dose is between 15 and 30 kilograms 380 milligram (3.8 milliliter) 50 milligram (0.6 milliliter) between 30 and 40 kilograms 460 milligram (4.6 milliliter) 60 milligram (0.8 milliliter) more than 40 kilograms 600 milligram (6 milliliter) 100 milligram (1.2 milliliter) a ritonavir oral solution: 80 milligram per milliliter Once daily dosing Weight One PREZISTA dose is One ritonavira dose is between 15 and 30 kilograms 600 milligram (6 milliliter) 100 milligram (1.2 milliliter) between 30 and 40 kilograms 675 milligram (6.8 milliliter) 100 milligram (1.2 milliliter) more than 40 kilograms 800 milligram (8 milliliter) 100 milligram (1.2 milliliter) a ritonavir oral solution: 80 milligram per milliliter 6 Instructions for children
•The child must take PREZISTA always together with ritonavir. PREZISTA cannot work properly without ritonavir.
•The child must take the appropriate doses of PREZISTA and ritonavir two times per day or once a day. If prescribed PREZISTA twice daily the child must take one dose in the morning, and one dose in the evening. Your child’s doctor will determine the appropriate dosing regimen for your child.
•The child must take PREZISTA with food. PREZISTA cannot work properly without food. The type of food is not important. Dose for adults who have not taken antiretroviral medicines before (your doctor will determine this) The usual dose of PREZISTA is 800 milligram once daily. You must take PREZISTA every day and always in combination with 150 milligram of cobicistat or 100 milligram of ritonavir and with food. PREZISTA cannot work properly without cobicistat or ritonavir and food. You must eat a meal or a snack within 30 minutes prior to taking your PREZISTA and cobicistat or ritonavir. The type of food is not important. Even if you feel better, do not stop taking PREZISTA and cobicistat or ritonavir without talking to your doctor. Dose for adults who have taken antiretroviral medicines before (your doctor will determine this) The dose is either:
•600 milligram PREZISTA together with 100 milligram ritonavir twice daily. OR
•800 milligram PREZISTA together with 150 milligram cobicistat or100 milligram ritonavir once daily. Please discuss with your doctor which dose is right for you. Instructions for adults
•Take PREZISTA always together with cobicistat or ritonavir. PREZISTA cannot work properly without cobicistat or ritonavir.
•Take PREZISTA with food. PREZISTA cannot work properly without food. The type of food is not important. Instructions for use Use the dosing pipette supplied with the pack to measure your dose accurately: 1. Shake the bottle well before each use. 2. Open the bottle of PREZISTA oral suspension by pushing downward on the cap and twisting it counter-clockwise. 3. Insert the supplied oral dosing pipette all the way into the bottle. 4. Pull the plunger until the top of the barrel meets the line that matches the dose prescribed by your health care provider. 5. Take the dose of PREZISTA. Place the tip of the oral dosing pipette in the mouth. Press on the plunger of the pipette towards the mouth, then swallow. 6. Close the bottle with the cap after use, and store PREZISTA oral suspension as directed in section 5 below. 7. Remove the plunger from the barrel of the pipette, rinse both with water and allow to air dry after each use. 7 8. Put the oral dosing pipette back together after air drying and store with the PREZISTA bottle. Do not use the dosing pipette for any other medicines. If you take more PREZISTA than you should Contact your doctor, pharmacist or nurse immediately. If you forget to take PREZISTA If you take PREZISTA two times a day and if you notice within 6 hours, you must take the oral suspension immediately. Always take with ritonavir and food. If you notice after 6 hours, then skip the intake and take the next doses as usual. Do not take a double dose to make up for a forgotten dose. If you take PREZISTA once a day and if you notice within 12 hours, you must take the oral suspension immediately. Always take with cobicistat or ritonavir and food. If you notice after 12 hours, then skip the intake and take the next doses as usual. Do not take a double dose to make up for a forgotten dose. Do not stop taking PREZISTA without talking to your doctor first Anti-HIV medicines may make you feel better. Even when you feel better, do not stop taking PREZISTA. Talk to your doctor first. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

Possible side effects

During HIV therapy there may be an increase in weight and in levels of blood lipids and glucose. This is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves. Your doctor will test for these changes. Like all medicines, this medicine can cause side effects, although not everybody gets them. Tell your doctor if you develop any of the following side effects. Liver problems that may occasionally be severe have been reported. Your doctor should do blood tests before you start PREZISTA. If you have chronic hepatitis B or C infection, your doctor should check your blood tests more often because you have an increased chance of developing liver problems. Talk to your doctor about the signs and symptoms of liver problems. These may include yellowing of your skin or whites of your eyes, dark (tea coloured) urine, pale coloured stools (bowel movements), nausea, vomiting, loss of appetite, or pain, aching, or pain and discomfort on your right side below your ribs. Skin rash (more often when used in combination with raltegravir), itching. The rash is usually mild to moderate. A skin rash might also be a symptom of a rare severe situation. It is important to talk to your doctor if you develop a rash. Your doctor will advise you how to deal with your symptoms or whether PREZISTA must be stopped. Other severe side effects were diabetes (common) and inflammation of the pancreas (uncommon).

Very common side effects (may affect more than 1 in 10 people)
•diarrhoea.

Common side effects (may affect up to 1 in 10 people)
•vomiting, nausea, abdominal pain or distension, dyspepsia, flatulence
•headache, tiredness, dizziness, drowsiness, numbness, tingling or pain in hands or feet, loss of strength, difficulty falling asleep. 8

Uncommon side effects (may affect up to 1 in 100 people)
•chest pain, changes in electrocardiogram, rapid heart beating
•decreased or abnormal skin sensibility, pins and needles, attention disturbance, loss of memory, problems with your balance
•difficulty breathing, cough, nosebleed, throat irritation
•inflammation of the stomach or mouth, heartburn, retching, dry mouth, discomfort of the abdomen, constipation, belching
•kidney failure, kidney stones, difficult discharge of urine, frequent or excessive passage of urine, sometimes at night
•urticaria, severe swelling of the skin and other tissues (most often the lips or the eyes), eczema, excessive sweating, night sweats, hair loss, acne, scaly skin, colouration of nails
•muscle pain, muscle cramps or weakness, pain in extremity, osteoporosis
•slowing down of the thyroid gland function. This can be seen in a blood test.
•high blood pressure, flushing
•red or dry eyes
•fever, swelling of lower limbs due to fluids, malaise, irritability, pain
•symptoms of infection, herpes simplex
•erectile dysfunction, enlargement of breasts
•sleeping problems, sleepiness, depression, anxiety, abnormal dreams, decrease in sexual drive

Rare side effects (may affect up to 1 in 1,000 people)
•a reaction called DRESS [severe rash, which may be accompanied by fever, fatigue, swelling of the face or lymph glands, increase of eosinophils (type of white blood cells), effects on liver, kidney or lung]
•heart attack, slow heart beating, palpitations
•visual disturbance
•chills, feeling abnormal
•a feeling of confusion or disorientation, altered mood, restlessness
•fainting, epileptic fits, changes or loss of taste
•mouth sores, vomiting blood, inflamation of the lips, dry lips, coated tongue
•running nose
•skin lesions, dry skin
•stiffness of muscles or joints, joint pain with or without inflammation
•changes in some values of your blood cells or chemistry. These can be seen in the results of blood and/or urine tests. Your doctor will explain these to you. Examples are: increase in some white blood cells. Some side effects are typical for anti-HIV medicines in the same family as PREZISTA. These are:
•muscle pain, tenderness or weakness. On rare occasions, these muscle disorders have been serious.

Reporting of side effects If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

How to Store Prezista

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 on the bottle after EXP. The expiry date refers to the last day of that month. 9 Do not store above 30°C. Do not refrigerate or freeze. Avoid exposure to excessive heat. Store in the original container. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away any medicines you no longer use. These measures will help protect the environment.