DUNARID is an antiretroviral medicine. It belongs to a group called protease inhibitors. DUNARID works by reducing the amount of Human Immunodeficiency Virus (HIV) in your body. This will improve your immune system and reduce the risk of developing illnesses linked to HIV infection. DUNARID is used in combination with ritonavir and other antiretroviral medicines to treat adults who are infected by HIV and who have developed resistance to other antiretroviral medicines. Your doctor will discuss with you on which combination of medicines is best for you.
1. What DUNARID is and what it is used for:
2. What you need to know before you use DUNARID:
Do not take DUNARID:
- if you are hypersensitive (allergic) to darunavir or any of the other ingredients of DUNARID (listed in section 6).
- if you have severe liver problems. Ask your doctor if you are unsure about the severity of your liver disease. Some additional tests might be necessary.
Warnings and precautions
Tell your doctor or health care provider before you take DUNARID. Special care should be taken with DUNARID:
- DUNARID must be taken together with ritonavir and food.
- DUNARID is not a cure for HIV infection.
- DUNARID does not reduce the risk of passing HIV to others through sexual contact or blood contaminations. Therefore, you must continue to use appropriate precautions, such as condoms.
- People taking DUNARID may still develop infections or other illnesses associated with HIV infection. You must keep in regular contact with your doctor.
Contact your doctor immediately if the following is experienced:
- severe rash
- sulphonamide (antimicrobial used to treat certain infections) allergy.
Make sure that you check the following points and tell your doctor if any of these apply to you.
3. How to use DUNARID:
Do not share medicines prescribed for you with any other person. Always use DUNARID exactly as your doctor has told you. You must check with your doctor if you are not sure. The usual dose of DUNARID 400 mg is two tablets once daily or PN 800 mg is one tablet once daily. You must take DUNARID every day and always in combination with 100 mg of ritonavir and with food at approximately the same time of day. DUNARID cannot work properly without ritonavir and food. You must eat a meal or snack 30 minutes before you take your DUNARID and ritonavir. The type of food is not important. Swallow the tablet with a drink such as water, milk, or any other nutritional drink. Even if you feel better, do not stop taking DUNARID without talking to your doctor. Make sure that you always have enough DUNARID and ritonavir tablets available so that you don’t run out. For example, in case you cannot return home, need to travel or stay in a hospital.
If you forget to take DUNARID:
If you notice within 12 hours, you must take your tablet immediately. Always take with ritonavir and food. If you notice after 12 hours, then take the next dose as usual. Do not take a double dose to make up for a forgotten dose.
If you stop using DUNARID:
Even when you feel better, do not stop taking DUNARID. Talk to your doctor first.
4. Possible side effects:
DUNARID can have side effects. Not all side effects reported for DUNARID are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking DUNARID, please consult your health care provider for advice. If any of the following happens, stop using DUNARID and tell your doctor immediately or go to the casualty department at your nearest hospital:
- severe rash with blisters
- rash or itching with swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing. These are all very serious side effects. If you have them, you may have had a serious reaction to DUNARID. You may need urgent medical attention or hospitalisation.
Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:
- symptoms of infection or inflammation after the start of treatment (immune reconstitution inflammatory syndrome)
- inflammation of the liver or pancreas (symptoms may include abdominal pain, nausea and vomiting)
- diabetes
These are all serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following:
Frequent side effects:
- headache
- vomiting, nausea
- diarrhoea, stomach pain
- rash
- high cholesterol and other fats in the blood
- high blood sugar
Less frequent side effects:
- changes in body fats (fat redistribution)
- loss of appetite
- abdominal swelling, indigestion, flatulence
- itching
- muscle pain
- loss of strength and energy, tiredness
- increase in pancreatic enzymes
DUNARID may change some values of your blood chemistry. These can be seen in the results of blood tests. Your doctor will explain these to you. In some patients, DUNARID has been reported to cause a severe or life-threatening rash. In patients taking DUNARID and raltegravir, rashes (generally mild or moderate) may occur more frequently than in patients taking either medicine separately. Contact your doctor if you develop a rash. Your doctor will advise you whether your symptoms can be managed on therapy or whether DUNARID should be stopped. DUNARID should not be taken if you suffer from liver problems. Some side effects are typical for anti-HIV medicines in the same family as DUNARID. These include:
- raised blood sugar and worsening of diabetes.
- muscle pain, tenderness or weakness. On rare occasions, these muscle disorders have been serious.
- changes in body shape due to fat redistribution. These may include loss of fat from legs, arms and face, increased fat in the abdomen (belly) and other internal organs, breast enlargement and fatty lumps on the back of the neck (buffalo hump).
- joint aches and pains, joint stiffness or difficulty in movement.
The cause and long-term health effects of these conditions are not known at this time. If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.
Reporting of side effects
If you get side effects, talk to your doctor or, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of DUNARID.
5. How to store DUNARID:
STORE ALL MEDICINES OUT OF REACH OF CHILDREN.
- Store at or below 25°C
- Store in the original package / container
- Keep the container tightly closed
- Do not store in a bathroom
- Do not use after the expiry date stated on the label / carton / bottle
Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).